pharmaceutics exam 3 Flashcards

Question

Ex: 1 Oral Rehydration Solutions what can lead to dehydration and/or death what can rapid fluid loss lead to depeltion of what ions results from this as well what kind of solutions are effective for this problem

Answer 1

Bodily fluid loss (such as with diarrhea) can lead to dehydration and/ or death. 5 million children < 4 years old die from diarrhea annually worldwide. The rapid fluid loss can lead to loose, watery stools and dehydration. Depletion of sodium, potassium, and bicarbonate ions results as well. Oral rehydration solutions are effective with volume depletion of 5 to10% of body weight.

Answer 2

Preparation of the bowel for colonoscopy Clear liquid diet for 24-48 hrs prior to procedure Oral laxative (i.e., magnesium citrate or bisacodyl) night before; cleansing enema 2 to 4 hours prior. Poor compliance can be a problem, but often not. Hospital stays are sometimes recommended to monitor the period prior to procedure Alternative to this procedure: PEG-3350-Electrolyte Solution Oral administration of balanced solution of electrolytes with polyethylene-glycol.

Answer 3

Adult dose: 4 L of solution before GI procedure. Patient should rapidly consume 240 mL of solution every 10 minutes until all is consumed. First bowel movement will occur within 1 hr. Different regimens 3 hrs drinking, 1 hr waiting to complete waste removal Ideally, NO food intake 3 to 4 hrs prior to procedure Definitely, NO food intake 2 hrs prior to procedure. Product is to be stored in refrigerator after reconstitution Formulation: PEG-3350 236.00g Sodium sulfate 22.74g Sodium bicarbonate 6.74g Sodium chloride 5.86g Potassium chloride 2.97g

Answer 4

Official Solution: Sodium citrate 100 mg/mL Citric acid 67 mg /mL Dose 10 to 30 mL, up to 4 times daily Useful for patients requiring alkaline urine For example, uric acid with urinary tract Or, gout therapy- to reduce crystallization of urates

Answer 5

Alcohol content - very little if any Standard components - purified water - sucrose - flavoring agents - coloring agents - therapeutic agents Purpose of dosage form - pleasant tasting vehicle for extemporaneous preparations - added to the standard formula for medicated syrups - To be added to the preparation of standard formula for medicated syrups (syrups containing medicinal agents). - Medicated syrups are commercially prepared from individual components (i.e., purified water, sucrose, flavoring agents, coloring agents, therapeutic agents, etc…).

Answer 6

Alcohol content - 10-12% Standard components - alcohol and water, additives: glycerin, propylene glycol, colorants, flavorants Purpose of dosage form - Nonmedicated elixirs used as vehicles - Medicated elixirs used to exert drug effect orally used

Answer 7

Alcohol content - very little if any Standard components - can have antibiotics and antihistamines Purpose of dosage form - Often administered intranasally to relieve nasal congestion and inflammation applied in the nose to relieve nasal congestion - apply drugs systemically and quickly - one-way pump sprays prevent the drawback of particles in the bottle, nothing can go inside the product to contaminate it - One-way pump sprays, developed to deliver drugs to the nose. Used for prescription and non-prescription medications. - dosage form for the nasopharyngeal tract or to the skin

Answer 8

Alcohol content - 15% - 80% Standard components - vegetable materials - alcohol and water Purpose of dosage form - - to dissolve inorganic compounds due to high amount of alcohol

Answer 9

simple syrup is another name - made of purified water and sucrose, medicate syrup add on flavoring agents, coloring agents, therapeutic agent - preservatives are used to prevent microbial growth and to ensure their stability during their period of use and storage.

Answer 10

Alcoholic or hydroalcoholic solution; high [ ] of plant extract - high alcohol helps to dissolve inorganic compounds and help preserve

Answer 11

- for eye drops have to be sterile - some have preservatives and some do not - buffer

Answer 12

To achieve greater comfort to the eye (because if too acidic, would be irritating for people that cannot produce tears) To render the formulation more stable To enhance aqueous solubility To enhance the drug’s bioavailability To maximize preservative efficacy

Answer 13

Increasing the viscosity of the solution will improve the duration that the eye is exposed to the drug, compared to when a less viscous substance is employed. - more viscous stays on the eye longer

Answer 14

want eye drop content to stay on eye as much as possible, so make eye drops more viscous because we want it to stay on the eye - Tears can neutralize any excess hydrogen and hydroxyl ions introduced with the medicated solution. So the eye drop cannot be acidic. - Tears can prevent any discomfort associated with use of medicines; most agents are weakly acidic (and have a weak buffering capacity). So patient is not able to prevent discomfort because they do not have tears and so eye drop cannot be overstimulating or acidic because they cannot prevent discomfort

Answer 15

“Concentrated aqueous preparations of sugar (or a sugar substitute) with or without a flavoring agent and medicinal substances” Non-medicated (flavored vehicles) Intended Purpose: Pleasant-tasting vehicles to be added to extemporaneously compounded preparations To be added to the preparation of standard formula for medicated syrups (syrups containing medicinal agents). Medicated syrups are commercially prepared from individual components (i.e., purified water, sucrose (the active substance in syrup), flavoring agents, coloring agents, therapeutic agents etc…). can have medicated and non-medicated

Answer 16

Syrups contain very little (if any) alcohol so preferred by parents over other alternatives for their kids If the drug is stable in solution it can be added to flavored syrup. ---Be mindful of unfavorable drug interactions ---what versatile drug substance The syrup medium may be basic, acidic, or neutral, and should be selected with knowledge of drug stability in each. So can use syrup for any drug The most frequently used medications in syrup form are, Antitussive agents and Antihistamines

Answer 17

Opioid Analgesic, Demerol® Hydrochloride Syrup Active agent: Meperidine HCL, Concentration of active agent, 50 mg/5ml For the treatment or relief of moderate to severe pain Antihistamine, CHLOR-TRIMETON SYRUP OTC Active agent: Chlorpheniramine maleate, Concentration of active agent, 2 mg/5ml For the prevention, treatment of allergic reactions Antiviral, NORVIR® (ritonavir) Active agent: Ritonavir Concentration of active agent, 80 mg/ml For the treatment of HIV Antidepressant, Celexa (Forest) Active agent: Citalopram hydrobromide Concentration of active agent, 10 mg/5ml For the treatment of depression (alternative to antipsycotic agents) soothing, yummy taste, very stable over long period of time

Answer 18

Most syrups contain: - Purified water - Sugar (usually sucrose)- typically 60 to 80% ----Sorbitol, glycerin, and propylene glycol are all alternatives - Antimicrobial preservative? - Flavorants? - Colorants? - Not uncommon to find the following in commercially prepared syrups, -----Solubilizing agents, thickeners, stabilizers add the low amount of sugar, will not be as thick compared to the high amount of sugar simple syrup: 85 grams of sucrose to 100 mL of water, so much sucrose that it is a self-preservative do I need antimicrobial preservatives or flavorants, depends on the amount of sucrose For diabetic patients: - replace sucrose with methyl cellulose to get the same viscosity but is tasteless then add artificial sweetener, this is equivalent to 60 to 80% sucrose

Answer 19

One of 4 methods are generally employed, 1. Solution of ingredients with aid of heat 2. Solution of ingredients with agitation (no heat) 3. Addition of sucrose to a prepared medicated (or to a flavored) liquid 1, 2 & 3 are preferred 4. Percolation of either the source of the medicating substance or the sucrose. Ex. Ipecac syrup

Answer 20

“Clear, sweetened hydroalcoholic (has water and alcohol) solutions intended for oral use, and are usually flavored to enhance their palatability.” --Nonmedicated elixirs used as vehicles --Medicated elixirs used to exert drug effect Are easier to manufacture compared to syrups Are not as sweet or viscous (thick) as syrups. Contain less sugar, and so are less able to mask the unpleasant tastes of medicinal agents Are capable of solubilizing both water-soluble and alcohol-soluble, components in solution. use drug that is water soluble and low aqueous solubility-- uh okay

Answer 21

Amount of alcohol required to prepare an elixir will depend on water solubility of the medicinal agent The addition of several different drug agents will require specific blending of alcohol and water to achieve the desired solution. Glycerin, propylene glycol, colorants and flavorants are all commonly used additives Artificial sweeteners (i.e., saccharin) are used as substitutes to prepare elixirs containing a high alcohol content. This is because sucrose is only partially soluble in alcohol and requires a lot more to achieve the same effect. Elixirs containing high amounts of alcohol (10% – 12%) are “self-preserving” (not requiring the addition of antimicrobial agents). Due to high oil and alcohol content, elixirs should be stored in tight, light-resistant containers and protected from excessive heat --*USP monographs provide standards for preparing Elixirs, but NOT formulas. The individual manufacturer can decide on the formula* if not stored correctly, like leaving the cap loose, then the alcohol can evaporate

Answer 22

The agitation of components in solution (~ simple solution) and/ or admixture of two or more liquid ingredients Alcohol-soluble drugs are dissolved in alcohol, and then Water-soluble drugs are dissolved in purified water The water drug solution is added to the alcohol solution (not the other way around). Why? ---When added In this order the highest alcohol content is maintained Once the two mixtures have been mixed the desired solvent is added until the desired volume is achieved. --Cloudy final mixture often results from the separation of flavorant oils in the reduced alcoholic solution. If this occurs, the mixture sits (typically for a couple of hours) for the globules to coalesce. The formation of large globules makes for easier removal by filtration.

Answer 23

Talc is a frequently used filter which can absorb the excess amount of oils from the solution. Presence of glycerin, syrup, sorbitol and propylene glycol in elixirs can assist with dissolution of the solute, and enhance stability. The downside is the additionally added components will slow down rate of filtration due to the increased viscosity resulting from the addition of the 4 different components.

Answer 24

Alcoholic or hydroalcoholic solution preparations prepared from vegetable materials or chemical substances” ---Vary in terms of method of preparation, strength of active ingredient, alcoholic content, and intended use in pharmacy Alcohol content: ranges from 15% to 80% - The alcohol content protects against microbial growth and keeps alcohol-soluble agents in the solution Due to high alcohol content, tinctures must be kept away from heat and tightly stopped. Not preferred by physicians (or by parents of children) for the same reason. Many of the components are light-sensitive so should be stored in light-resistant containers (protected from light). So usually in dark bottles Examples, Opium Tincture, USP highest alcohol content. compared to syrups (0%) and elixirs (10-12%) sometimes has dye used for disinfection

Answer 25

*Vanilla, cut into small pieces 100g *Purified Water 200mL *Alcohol 207mL *Sucrose, in coarse granules 200g *Diluted Alcohol, a sufficient quantity to make 1000mL procedure: Add Purified Water to the comminuted Vanilla in a suitable covered container, and macerate for 12 hours, preferably in a warm place. Add Alcohol to the mixture, mix, and macerate for about 3 days. Transfer the mixture to a percolator containing Sucrose, and drain. Pack the drug firmly, and percolate slowly, using Diluted Alcohol as the menstruum.

Answer 26

Iodine Tincture, USP A tincture of iodine can be used to disinfect the area around an epidural catheter. Marks the area really well Usually, between 2 and 7% Iodine is used 47% alcohol! from tutor: iodine is an inorganic molecule adding it to a tincture will help it to dissolve because tinctures have a lot of alcohol

Answer 27

“Aqueous or oleaginous solutions (no alcohol, similar to syrups in regards to alcohol content) in the form of coarse droplets or as finely divided solids to be applied topically, most usually to the nasopharyngeal tract or to the skin.” Often administered intranasally to relieve nasal congestion and inflammation Often contain antibiotics, antihistamines Can administer drugs systemically and quickly ---For example, Insulin, glucagon One-way pump sprays were developed to deliver drugs to the nose. Used for prescription and non-prescription medications. Why one-way pump sprays are important?- Prevents drawback contamination of nasal fluids into the bottle after administration such as viral particles with the common cold. Medications for external use to read: FOR EXTERNAL USE ONLY and keep out of reach of children *make sure to put on* be careful in lab do not put a label on top of a label

Answer 28

B Cetyl esters wax stiffening agent!

Answer 29

D All of the above topical application for B: in the video: use an ointment slab in oleaginous, there is no water

Answer 30

B Propylene glycol *CORRECT- GREAT JOB MICHELLE* it is the only one here that is viscous can be glycerol but it is sweet and do not want for diabetic patients viscosity thickness etc

Answer 31

Note: If a drug has bioavailability Issues, or if patient has had success with a particular product in the past, product should not be changed without an understanding of behavior of the new product on graph looks like solutions works a little better

Answer 32

Liniments are nonaqueous solutions that can be alcoholic, oleaginous solutions, or emulsions, intended to be rubbed on skin. there are two types: - oleaginous with alcohol - emulsions 1) Alcoholic-based liniments ---Counter irritant or if penetrating action is needed 2) Oleaginous liniments - When massage desired; less irritating to the skin compared to alcoholic liniments - The solvent may be almond oil, peanut oil, sesame oil cottonseed oil, or some volatile substance (i.e., wintergreen) or a combination of oil & volatile substance 3) Emulsion liniments Emulsions are prepared first, and added to desired solvent Linaments that are emulsions or contain insoluble matter must bear suitable labels such as - SHAKE WELL (to distribute disperse phase) Linaments should bear a label indicating - for EXTERNAL USE ONLY

Answer 33

Powders are used to prepare solutions for vaginal douche, i.e., for irrigation cleansing of the vagina. Powders can be prepared and packaged in bulk or as unit packages ---Bulk powders are used by the teaspoonful or tablespoonful to prepare solution A measured amount of powder is added to warm water, stirred, and dissolved The purpose is for their hygienic effects.

Answer 34

These solutions possess additional features making them better suited for ophthalmic, nasal, or otic use. Based on Chapt. 13 (Solutions) and 14 (Suspension) lectures. The specific sites of application are, *Ophthalmic Drugs* Nasal Preparations Otic Preparations

Answer 35

The normal volume of tear fluid in the cul-de-sac of the human eye is *~7 to 8 μl*. When an eye does not blink, it accommodates a maximum of 30 μl of fluid. When blinking it can retain ~10 μl. Whether externally added or naturally produced, excessive liquids rapidly drain from the eye. Can only have so much there, issue: hard to deliver a good amount of drug to the eye A single drop of an ophthalmic solution or suspension measures about 50 μl, so the majority of it gets drained. The optimal volume to add is 5 to 10 μl. ---Unfortunately, the average dropper delivers ~25 to 50 μl/ drop, and other microliter dosing droppers do not exist cannot be too small otherwise will poke eye

Answer 36

The retention time of ophthalmic solution on the eye surface is short. The amount of ophthalmic solution absorbed is thus a small fraction of the dose administered. For example, - When pilocarpine ophthalmic solution is flushed from the eye within 1 to 2 minutes, the amount absorbed is <1%. Due to the small fraction of absorbed drugs, repeated administration of solutions is required to achieve the maximum benefit of the therapy. Increasing the viscosity of the solution will improve the duration that the eye is exposed to the drug, compared to when a less viscous substance is employed. because methyl cellulose is tasteless and can be used in opth. solutions too

Answer 37

lacrimal gland lacrimal sac To minimize systemic absorption of active agents apply pressure to the lacrimal sac for 3 to 5 minutes following administration. A recommendation to pharmacists: May be useful to inform patients using eye drops

Answer 38

1) Anesthetics 2) Antibiotic and Antimicrobial agents 3) Antifungal agents 4) Anti-inflammatory agents 5) Antiviral agents 6) Astringents 7) Beta-adrenergic blocking agents 8) Miotics and other glaucoma agents 9) Mydriatics 10) Protectants and artificial tears 11) Vasoconstrictors

Answer 39

Ophthalmic preparations must be sterilized Sterilization by bacterial filtration or by autoclave has been used. The benefit of filtration is the removal of all particulate matter (microbial, dust, fibers) from preparation. If antimicrobial preservatives are to be added, formulation stability, chemical and physical compatibility with other formulation components, and effectiveness must be determined. --This is generally done at the preformulation stage If antimicrobial preservatives are not added they are generally packaged in single-use containers.

Answer 40

Benzalkonium chloride, 0.004% to 0.01% Benzethonium chloride, 0.01% Chlorobutanol, 0.5%* Phenylmercuric acetate, 0.004% Phenyl mercuric nitrite, 0.004% Thimerosal, 0.005% to 0.01% There are limitations to their use, For example, It is not possible to autoclave chlorobutanol* due to instability when exposed to even moderate heat because the heat decomposes it to HCL

Answer 41

Physical changes that result when adding solute to solvent ( the properties will always change when solute is added to solvent) - The properties depend on how many solute particles are present, and the solvent amount - The properties do not depend on the type of solute, but rather the solvent type employed increase solute: more and more changes

Answer 42

Vapor pressure lowering Boiling point elevation to a certain point Freezing point depression, usually much greater Osmotic pressure

Answer 43

“Water flows through the semipermeable membrane to dilute the alcohol solution until the force of gravity pulling down on the column of this solution balances the osmotic pressure, pushing the water through the membrane. “

Answer 44

Osmosis: The movement of water across a selectively permeable membrane from an area of high water potential (low solute concentration) to an area of low water potential (high solute concentration). Osmotic pressure: the minimal pressure applied by a solution to prevent the inward flow of water across a semi-permeable membrane. ---The concentration of a solution with respect to osmotic pressure is concerned with the # of particles of solute in a solution. If the solute is not an electrolyte, the concentration of the solution depends on the number of particles. - For electrolytes, such as sodium chloride, the number of particles and degree of ionization are both critical. - Highly ionized substances contribute a greater number of particles to the solution, compared to the same amount of poorly ionized particles- if more ionized then there will be higher pressure So What?? The greater the number of ionized particles the greater the pressure

Answer 45

Body Fluids (blood and tears) have an osmotic pressure corresponding to that of 0.9% solution of sodium chloride. --Therefore, the solution is ‘isosmotic’ (or having an osmotic pressure equal to physiologic fluids). Solutions with lower osmotic pressure than body fluids (or 0.9% sodium chloride) are called hypotonic solutions. so less than 0.9% --Hypotonic solutions may cause hemolysis of red cells Solutions with higher osmotic pressure than body fluids are hypertonic. --Hypertonic solution added to the body can draw water from cells toward the site of topical application, causing blood cells to shrink (crenate- crenation). Isotonicity limits of an ophthalmic solution (in terms of sodium chloride) may range from 0.6% to 2.0%, that is without causing any discomfort.

Answer 46

To achieve greater comfort to the eye To render the formulation more stable To enhance aqueous solubility To enhance the drug’s bioavailability To maximize preservative efficacy do not want too acidic

Answer 47

pH of normal tears is 7.4. Tears have a buffering capacity. Tears can neutralize any excess hydrogen and hydroxyl ions introduced with the medicated solution. Tears can prevent any discomfort associated with the use of medicines; most agents are weakly acidic (and have a weak buffering capacity). When a drug is very acidic (i.e., pilocarpine hydrochloride, epinephrine bitartrate) it can overwhelm the natural buffering capacity of tears.

Answer 48

Viscosity: The force required to move one plane surface past another when the space between the surfaces is a liquid. -- Viscosity of water is given as 1 centipoise (1.0087cP). A liquid material that is 10 times as viscous as water (at the same temperature) has a viscosity of 10 cP. -- The optimal range for ophthalmic use is between 15 to 25 cP. Viscosity generally decreases with increasing temperature, so important to note temperature.

Answer 49

Methylcellulose is added to increase viscosity during the preparation of ophthalmic solutions. --Hydroxypropyl methylcellulose and polyvinyl alcohol are often used as thickeners in ophthalmic solutions as well. Why is increasing viscosity important? - This helps to retain the drug in contact with the tissues to enhance therapeutic effectiveness. - enhance duration of drug exposure

Answer 50

Most are packaged in small plastic containers with a fixed built-in dropper. Ophthalmic solutions are commonly packaged in containers holding 2, 2.5,5,10, 15, and 30 mL of product. Patients should protect ophthalmic solutions or suspensions from external contamination. ---Avoid the tip of the dropper from touching eyes or eyelids Ophthalmic solutions used as eyewashes are packaged with eye cup, it must be washed and dried before use, and following each use.

Answer 51

To minimize systemic absorption of active agents as opposed to oral system which uses the systemic system to treat the illness - so parenteral will cause more localized absorption A finished product must be - Sterile, - Non-pyrogenic* - Free from insoluble materials Pyrogens: “fever-producing organic substances from microbial contamination”

Answer 52

The syringe is used to administer sterile preparations via intravenous push or infusion systems Positive Flow hood

Answer 53

Intravenous injection (I.V.) of drugs had its scientific origin in 1656 of Sir Christopher Wren who was an amateur scientist. Injected wine, opium and other substances into dog veins and studied their effects Drugs were administered to humans in 1662 but for some time were not used due to the occurrence of thrombosis and embolism in treated patients

Answer 54

Thrombus (blood clot) embolus (traveling blood clot) thrombus and embolus formation may be induced by intravenous administration. These clots can lodge in a blood vessel and obstruct flow, and this happens when the needle comes in direct contact with the vessel wall The Hypodermic needle was later introduced for injection of sodium chloride and glucose

Answer 55

Should be sterile, pyrogen-free preparations Used when rapid drug action is desired & when drug is ineffective by other routes Used when patients are uncooperative or unconscious and when patients cannot tolerate medicine

Answer 56

Advantage: - Rapid action due to direct injection into the blood Disadvantage: - Once a dose has been administered it cannot be retrieved

Answer 57

superficial veins can be used for venipuncture basilic and cephalic veins on the back of the hand and dorsal forearm are best for peripheral veins for IV therapy Aseptic precautions must be taken at all times to avoid the risk of infection Small and large volumes of drug solutions may be administered intravenously. - 23 gauge size (for bolus injections) - 18 gauge size (for continuous IV infusions) 1000 ml containers of solutions for IV infusion used frequently Flow rates: 42-150 mL/hour and lower flow rates are used to maintain open infusion lines.

Answer 58

cephalic vein (on hand) median cubital vein (on arm)

Answer 59

Provides drug effects that are less rapid than intravenously administered substances, but generally longer lasting. Drugs in solution are more likely to be absorbed than those in suspension. Drugs in aqueous preparations are more rapidly absorbed than drugs in oleaginous preparations. The physical type of preparation employed is based mainly on drug properties and therapeutic goals

Answer 60

The point of injection should enter deep into the skeletal muscles, and must NOT come in contact with major nerves and blood vessels Injuries are usually related to point of injection and where medication is deposited (i.e., paralysis resulting from neural damage, scarring, abscess cysts) In adults, the upper outer quadrant of the gluteus maximus is used for injection purposes In children, the gluteus maximus is composed primarily of fat (NOT muscle). So……there is a chance of hitting the sciatic nerve, especially if the child is not cooperating. In these cases an injection of drug in the deltoid would be a suitable alternative

Answer 61

The dose administered is limited 5 ml is the maximum administered normally to the gluteus 2 ml is the maximum administered to the deltoid Injections are 2 to 3 inches deep and a 20 to 22 guage needle is utilized.

Answer 62

This route may be suitable for small amounts of medication Injections are to the… - Loose interstitial tissue areas of the outer surface of the upper arm - Anterior surface of the thigh - The lower portion of the abdomen - Site of injection rotates when the drug is administered daily as with daily insulin injections

Answer 63

The skin should be thoroughly cleansed The maximum volume injected comfortably is approximately 1.3 ml and slightly above. 2 ml is enough to cause painful pressure Syringes with up to 3 ml capacities [24 to 26] gauges are used for this purpose Insulin is administered using 25 to 30 gauge needles Upon insertion of the needle if blood appears in the syringe a new site should be selected Make NOTE: Irritating drugs and thick suspensions may be painful and so are not considered suitable for SC injections

Answer 64

Substances are injected into the corium (dermis). This is the more vascular layer of the skin located just beneath the epidermis Substances include diagnostics agents and for purposes of immunization The usual site for intradermal injection is the anterior surface of the forearm The injection is made when the bevel just disappears into the corium Needle size: 23 to 26 gauge The volume injected: approximately 0.1 ml is the limit Vaccines can be administered via the intradermal route, i.e. injection in the dermis,

Answer 65

Water for injection, USP Sterile water for injection, USP Bacteriostatic water for injection, USP Ringer’s injection, USP

Answer 66

USP designation small volume injection applies to an injection packaged in containers labeled as containing 100 ml or less liquid. --Premixed IV delivery systems are available for product administration ---Ex. of solutions, Digoxin (cardiotoxin) given IM or IV with carefully monitored dosage- “ready-to-use systems” Advantages: Require very little manipulation to make patient-specific pH can range between 4 to 10 Disadvantages: No flexibility in changing the volume or concentration Thawing of the frozen drug product High-energy microwave --- water bath---- room temperature

Answer 67

USP designation for large volume parenteral applies to a single dose injection intended for IV use and packaged in containers labeled as containing more than 100 ml of liquid Ex. Of solutions are, Ringer’s injection, USP Lactated Ringers injection, USP Sodium chloride injection, USP These are generally used for IV infusion to replenish body fluids or electrolytes or nutrition, and 100 ml to 1L is typically used. Be aware of different issues with compatibilities. --During compounding procedures --During multiple infusions

Answer 68

Injection For Injection Injectable emulsion Injectable suspension For injectable suspension

Answer 69

Most frequently used solvent in the large scale manufacturer of injections Water used for injection is usually purified by distillation or reverse osmosis, and should be used within 24 hrs after collection Not required to be sterile (free from all live bacteria and microorganisms) Must be pyrogen-free (whatever organisms are present should not result in an infection or fever) at time of use. Once product is prepared is must be sterilized. Water should be collected in sterile and pyrogen-free containers, and the containers are usually glass or glass lined

Answer 70

Water that is sterilized and packaged in single-dose containers of not more than 1-liter size. Must be pyrogen-free and may not contain antimicrobial agents or any other added substances Water is intended to be used as a solvent, vehicle or diluent for already sterilized and packaged injectable medications One-liter bottles cannot be administered intravenously because they lack tonicity. These are used to reconstitute antibiotics. -----Suitable injection: water is added directly to the medicinal substance such as with dry powders or granular substances ********************************************************************* Tonicity: For our purposes, it is the osmotic pressure or tension of a solution, usually relative to that of blood

Answer 71

Sterile water for injection containing one or more suitable antimicrobial agents Packaged in pre-filled syringes or in vials containing not more than 30 ml of water Label must state proportion of antimicrobial agent to water used to prepare vial In theory, the presence of bacteriostatic agent should allow for multiple-dose vials (use a single vial for multiple purposes) ----Inadvertent contamination of vial during use should not be a problem (in theory).

Answer 72

Gives the flexibility of multiple-dose vials because of presence of antimicrobial agents The presence of antimicrobial agents in this water limits use of these vials to parenterals that are administered in small volumes only. ----Packaged in prefilled syringes or vials containing ≤30 ml of the water Large injected volumes of antimicrobial agents are toxic. For this reason, if volumes more than 5 ml of solvent is required, sterile water for injection is preferred over bacteriostatic water You should also think about the compatibility issues regarding the interaction(s) of bacteriostatic agents and the medicinal drug substance

Answer 73

Demands that labels must state the following, “Not for use in newborns” - Due to problems resulting from benzyl alcohol - which caused gasping syndrome which resulted in death :(. - This caused problems to the liver when administered in mg/kg quantities; the limited detoxification capacity of liver in newborn infants was not sufficient to avoid toxicity - The solution was/has not been reported to have such effects in older infants, children or in adults.

Answer 74

Benzyl alcohol poisoning (“gasping syndrome”) One study reported that 10 premature infants developed this clinical syndrome characterized by multi-organ failure and eventually death Typical clinical course: Metabolic acidosis (decrease pH and bicarbonate conc. of body fluids), respiratory distress requiring mechanical ventilation, CNS dysfunction, apnea, seizure, coma and …… cardiovascular collapse and death. In 1980 FDA said , stop the use of fluids preserved with benzyl alcohol for use in neonates for any purpose.

Answer 75

A sterile solution of sodium chloride, potassium chloride and calcium chloride in water for injection. Ratios are consistent with physiological fluids. Used as a vehicle for other drugs, alone, as an electrolyte replenisher and plasma volume expander. Lactate Ringer’s Injection, USP: ----Different quantities of the same salts used for Ringer’s injection + sodium lactate (used as an electrolyte replenisher and/or systemic alkalizer).

Answer 76

Aqueous vehicles are preferred for injection nonaqueous vehicle is perferred for poor drug solubility in water (or drug is susceptible to hydrolysis) Like water, must not exert pharmacological activity nor adversely affect activity of drug substance. What are some examples, Vegetable oil, glycerin, polyethylene glycols etc…….

Answer 77

No single solvent is free from all limitations Disadvantages and advantages should be noted to match the appropriate drug with the most appropriate non-aqueous solutions Fluidity of vegetable oil: Proportion of vegetable oil, degree of unsaturated fatty acids to saturated variety Oleaginous injections are administered intramuscularly, and must not be administered intravenously as the oil globules will occlude the pulmonary microcirculation

Answer 78

Steam Dry Heat Filtration Others include sterilization by gas and ionizing radiation

Answer 79

This sterilization method uses steam under pressure. Temperature is responsible for sterilization and not the pressure. The pressure is only responsible for increasing the temperature 10 lbs of pressure (115.5 ˚ C)-30 minutes 15 lbs of pressure (121.5 ˚C)-20 minutes 20 lbs of pressure (126.5 ˚C)-15 minutes Most autoclaves operate at: 121 ˚C May be used to sterilize bulk solutions, glassware, surgical dressings and instruments. Not useful for oils, fats and oleaginous preparations

Answer 80

Sterilization by this method is carried out in ovens Higher temperatures and longer sterilization times - 150 to 170 ˚C and not for less than 2 hrs. Ovens are heated by gas or electricity Used for sterilizing glassware, surgical instruments, oils, glycerin, mineral oil and heat-stable powders; for steam sterilization, cannot use oils, oleaginous or fats I would rather use the autoclave which is usually used for 15 lbs items at 121* C for 20 minutes! which is much better than 2 hours for dry heat!

Answer 81

This method involves the removal of all bacteria and spores with use of a 0.22 µm filter Millipore Filter: plastic membrane with millions of uniform pores made of cellulosic esters Advantage of filter units: Speed in filtration, relatively inexpensive and complete removal of living and dead microorganisms Disadvantage of filter units: Proper inspection of filter unit is necessary to avoid using systems that are ruptured or faulty in some other way. Systems can be flawed during assembly

Answer 82

This happens when drugs adsorb to inner lining of intravenous containers and tubing sets Ex: [Diazapam, Insulin, Nitroglycerin, Warfarin sodium] Ex: Nitroglycerin loss as much as 40 - 80% of dose to PVC Pharmacists must prevent this from occurring How? Administer infusions through short lengths of small-diameter tubing made of inert plastic ---for Nitroglycerin: use non-PVC tubing results in <5% loss PVC = Polyvinyl chloride

Answer 83

factors that effect it: - Concentration of insulin - Contact time of insulin with glass & tubing - Flow rate of infusion - Charged protein interactions Up to 80% loss of dose, usually between 20-30% Percent loss is inversely proportional to concentration and takes between 30-60 minutes It is recommended that patient be monitored due to unpredictable nature of clinical situation

Answer 84

Training and quality assurance programs needed Minimize unnecessary exposure with these steps Use laminar flow hoods or bacteriologic glove boxes for preparing reconstitution of cytotoxic drugs Wear mask during preparation Use special waste containers Periodic monitoring of personnel who handle cytotoxic drugs Informing personnel handling cytotoxic drugs of risk to health Specialized labeling of containers to ensure proper handling and disposal of cytotoxic drug agent

Answer 85

Instruct patient on proper storage and use of parenterals Explain proper method of maintaining a sterile administration site, and proper handling of any equipment. 3) Explain importance of expiration date and beyond-use date of the dispensed parenteral product 4) Discuss correct disposal of parenteral preparations, needles, syringes, tubing etc… 5) Explain importance of keeping the medication and supplies such as needles/syringes out of the reach of children

Answer 86

lungs heart tissues some go to the gut then to liver some go back to the heart directly from tissues the flow that went to the liver meets up with the flow that went directly to the heart liver cells have and what the function of each - Kupffer cell - liver macrophages, remove foreign debris - sinusoid - space between epithelial cells - hepatocytes - liver cell - basement membrane - membrane below - fenestrations - pores - tight junctions - junctions between cells - lumen - space within

Answer 87

I II - A1 - A2 - B1 - B2 (I think) III

Answer 88

Defined as: – Any substance produced by a living source. – Biologics include antibiotics, hormones, vitamins, etc... Also known as immunobiology * Code of Federal Regulations defines Biologics as: “any virus, therapeutic serum, toxin, antitoxic, or analogous product employed for the prevention, treatment, or cure of disease in humans.” - kill living system and weaken them so they will not cause harm Not administered IV sterility is still important

Answer 89

During the 1950s, # of polioviruses ~20,000 cases – Inactivated Polio vaccine- introduced in 1955 – Oral Poliovirus (OPV)- introduced in the 1960s By the 1960s the # of polioviruses was ~3,000. By 1979 the # of polio cases was ~10 in the U.S. German measles (an acute viral disease) ~58,000 cases – Rubella vaccine- introduced in 1969 By 1992 the # of infected individuals dropped to less than 500 per year biologics can address a clinical unmet need

Answer 90

Species Immunity – Some diseases naturally occur in humans, some in animals * Racial Immunity – Human races differ in general susceptibility to common infections -- not the same as environmental immunity which means a pop. recent to a place may be more susceptible to diseases * Individual Immunity – Differences in capacity to resist familiar diseases (i.e., common cold, skin disorders) - factors: smoker, alcohol, food, exercise --these can play a role - person to person

Answer 91

Active immunity- body builds up its own defense against the antigen * Passive immunity- introduction of antibodies produced in another individual (human or animal) into the host, who was not involved in the antibody production * During this event T-lymphocytes augment the activity of B lymphocytes primarily involved in humoral immunity and antibody production, which helps individuals to resist infections the next time they are exposed.

Answer 92

* B cell activation

Answer 93

All biologics must meet standards as set by Center for Biologics Evaluation and Research of the FDA. * Tests must be performed to establish product, – Potency – General safety – Sterility – Purity – Water (residual moisture) – Pyrogens – Identity – Constituent materials - important: potency and general safety if contaminated: see color change, and bubbling but they take time to show themselves so we use BSC. Maintain stability and safety level

Answer 94

Packaging and labeling requirements are similar to all other injectables * Other packaging requirements include, – Title or proper name (name under which the product is licensed under Public Health Service Act) – Name, address, license number of manufacturer – Lot number and expiration date – Recommended individual dose for multiple-dose containers – Preservative type and amount – Amount of product in the container – Recommended storage conditions – Statement that freezing is to be avoided (if necessary) And, anything else the FDA believes to be important to ensure the safe and effective use of the product. sometimes no preservatives

Answer 95

Majority of biologics are stored in refrigerator (2°C to 8°C) – Generally no freezing of biologics which protects * The active biologic material * Expansion of aqueous material (because When water freezes, it expands and takes up more space) could result in expansion of glass and breakage and loss of product Expiration dates are usually one year following the date of manufacture * Exception: Some COVID-19 vaccines require freezing, exp. dates are also less than one year. See supplemental COVID-19 manufacturing details for this lecture

Answer 96

Biologics are sensitive to extreme temperatures – Heating or freezing can decrease potency and effectiveness Real Potential Dangers: – Patient gets little or no intended benefit. - The patient does not build up immunity and is now exposed Pharmacists should maintain the “cold chain” – If you receive it from the manufacturer cold, keep it cold: - Refrigerators should not be overstocked with products; cool air must have room to circulate - A separate refrigerator for biologics is advisable, this will cut down on the number of times the refrigerator is opened and closed

Answer 97

The door should not be opened frequently, no more than 4 times per day * Doors should be closed as quickly as possible after securing the product * Pharmacists should not use the inside of the door to store biologics, this contributes to temperature variations – Inside of the door can be used to store diluents or bottles of water for better insulation * Vaccines should be stored in top or bottom shelves of the refrigerator due to temperature variations. Not floor * Coolant packs should be kept in freezer and ready for use in shipping. They are handy to have if there are interruptions in freezing. National Immunization Program recommends twice daily temperature monitoring and recording – Logs of these temperature should be kept for 3 years

Answer 98

Pharmacists should educate and train every person who will handle biologics in good storage and handling procedures Always store bottles containing the same vaccine material together. This will reduce chances of selecting the wrong product. – “Look-alike packaging and sound-alike names can confuse even most conscientious practitioner” * Center for Disease control issues on line publication describing storage and handling requirements for vaccines

Answer 99

types: Bacterial Vaccines * Viral Vaccines * Cancer Vaccines purpose: - A vaccine tricks the body into thinking an infection has occurred. - A vaccinated person’s immune system attacks the harmless injected vaccine and then prepares for invasions against the same microbe the vaccine contained needs time for production to occur

Answer 100

“A suspension (if not can lose potency) of attenuated (living) or inactivated (killed) microorganisms or fractions administered to induce immunity and prevent disease” * Organism is grown in broth medium (amino acids, glucose etc) * Temperature, pH and Oxygen tension-sensitive * Chemically defined ingredients used to prepare broth medium * Following bacteria growth the culture is processed in 2 steps: inactivated and live attenuated Inactivated Vaccines: – Produced by exposure to phenol or formaldehyde. For e.g., heat + phenol employed for typhoid fever vaccine. – Next, organisms are separated from the medium through centrifugation (get rid of formaldehyde and phenol) and suspended (in sterile water or 0.9% sodium chloride) for injection. – If further purification is required dialysis and special centrifugation methods can be used.

Answer 101

Live attenuated vaccine: Produced by genetic alteration of pathogenic organisms – Several base pairs of DNA are deleted (or altered). – Organism is now incapable of reverting to pathogenic form * Other methods to create vaccines do exist Regardless of the method the vaccine may be expressed as – Total # of organisms, – Total protective units per milliliter or dose, or – Micrograms of immunogen in each milliliter, or in each dose of vaccine.

Answer 102

Viruses grow differently from bacteria and thus require different media * What growth conditions have been used for viral propagation? – Embryonic egg, – Cell cultures of chick embryo, – Monkey cell culture, – Skin of living calves and – Intact mice * Separation of the virus from the host cell is required * Purification step required to reduce the incidence of hypersensitivity reactions to media or host cells * The final viral product may contain a single or multiple immunogen(s) to elicit immunity against the disease

Answer 103

The vaccine may remain as the entire virion or split into a subvirion vaccine: The influenza virus vaccine is a subvirion vaccine and since 1977 it is prepared yearly using three different strains – 1) HINI (Influenza A) – 2) H3N2 (Influenza A) – 3) Influenza B * Vaccination with all three (trivalent influenza) is the standard practice. – This provides partial protection against related strains, reducing risk of influenza-related complications & deaths – Communities can have an outbreak of more than one strain of influenza

Answer 104

The WHO recommends the following for the Northern Hemisphere's quadrivalent (four-strain) vaccines: * For H1N1, an A/Michigan/45/2015-like virus * For H3N2, an A/Singapore/INFIMH/2016-like virus *For B Victoria, a B/Colorado/06/2017-like virus B Yamagata, a B/Phuket/3073/2013 - * For trivalent (three-strain) vaccine formulations, the group recommended including the Victoria lineage influenza B vaccine strain

Answer 105

The goal is to increase the recognition of cancer cells by the immune system An additional treatment modality How do they work? – Immune cells recognize foreign antigens on the tumor cells, and receive co-stimulatory signals as foreign to the body. Otherwise, tumor cells go undetected and proliferate. The cancer vaccine increases - antigen awareness of your immune cells, or increase co-stimulatory signals that induce an immune response - so they increase the recognition that your immune system has for tumor cells; makes immune system recognize tumor cells more Immune cells having natural antitumor activity are - T cells - Lymphokine-activated killer cells - Natural killer cells. Cancer vaccines stimulate these immune cells. * Tumor-killing cells recognize tumor-associated antigens (TAA) on tumor cell surface. Tumor Vaccines: Autologous, Allogeneic, Gene Therapy

Answer 106

Autologous –vs- Allogeneic * autologous vaccines * Derived from a tumor removed from a patient – Biopsy, Surgery * Cells are killed or attenuated and reinjected into the patient - has tumor antigen (TAA) * Disadvantage: – Cost – No antigenic expression - so do not have immune system address tumor - patient-specific and the TAA will be raised against that tumor from that patient allogenic vaccines * Derived from cell lines that express tumor-specific or shared TAAs. * To induce immune response- a fragment, or whole (attenuated) cell so admin. IM route is injected into the patient. * Benefit is wider population of patients

Answer 107

Traditional vaccines constituted by inactivated whole cells can cause unwanted side effects * Use of selected antigens demonstrates fewer side effects * Over-the-counter analgesic agents are often used to control, – Itching, pain, and tenderness around the injection site (in connection with SubQ, IM, ID administration – Analgesics are used only if they agree with the patient’s health status and other drug therapy NO IV!

Answer 108

Hypersensitivity-anaphylaxis is a major concern – Bronchospasm – Respiratory distress – Laryngeal edema – Circulatory collapse – Death 1 in every 600,000 to 6.4 million doses of vaccine distributed Because hypersensitivity reactions are so rare it’s not clear whether patients are allergic to proteins that make up the active antigenic portion of the vaccine, or the excipients (i.e., neomycin, gelatin, aluminum gels).

Answer 109

Thimerosal: A preservative used in many vaccines; vaccine perservative Since 1930s, Thimerosol (49.6 w/v%) has been used in multidose vials What went wrong and why? * In children, metabolism of Thimerosol produced methyl mercury and ethyl mercury resulting in neurotoxicity * 1999, American Academy of Pediatrics (AAP) Committee on Environmental Health encouraged pharmaceutical industry and government agencies to reduce child exposure to mercury. * Since 2001, very little (98% less) if any Thimerosol is used. * Structure * Issued guidelines for women of childbearing age to amounts of mercury that could be toxic

Answer 110

passive: injected Human Immune Sera and Globulins (Homologous Sera) * Antibodies derived from human blood. * Produced as a result of having disease, or immunized against it with a specific biologic product * Source is from pooled plasma of adults * Must be free of hepatitis B antigen and antibodies to HIV Animal Immune Sera (Heterologous Sera) * Prepared by immunization of horses against specific immunogen (e.g., toxin, venom). * After several injections over weeks/months horse is bled. Contamination must be avoided, and plasma harvested * Precautions must be taken to ensure safety of patients sensitive to horse protein

Answer 111

More than 95% of U.S. Citizens are immune to VZV. * The varicella virus vaccine for adults is intended to cover those who have not had chickenpox, or those without a reliable clinical history of varicella infection * Those receiving the vaccine may transmit the vaccine virus to close contacts – Recipients should avoid close contact with high-risk individuals (Such as pregnant women, newborns, and immunocompromised individuals) * Avoid vaccination during pregnancy – Women contemplating pregnancy should be counseled to avoid pregnancy within 4 weeks of vaccination * Varicella vaccination is contraindicated for use in patients with immunocompromising conditions – (For i.e., HIV infections with CD4+ T lymphocyte count of 200 cells/μl)

Answer 112

Botulinum Toxin Type A – Available as a powder for injection; reconstituted with sterile 0.9% sterile saline – Must be used within 4 hrs following reconstitution – Should be clear, colorless and free from particulate matter – Unopened vials can store in refrigerator for up to 24 months. Botulinum Toxin Type A (i.e, Botox) – Used to decrease severity of pain associated with abnormal head position and neck pain associated cervical dystonia (CD). - this toxin is botox Botulinum Toxin Type A (i.e, Botox cosmetic) – Used for temporary improvement in the appearance of moderate to severe facial frown lines in adult patients ≤65 year of age. – 21 guage needle to draw up 0.5 to 2.5 ml of saline containing reconstituted material. - this toxin is botox cosmetic do not shake up and down oooh...BOtulinum TOXin = BOTOX

Answer 113

How can pharmacists protect the public? Pharmacists can encourage, – Formulary management – Participate on infection committees, policy and procedure development – Participation in administrative programs – Patient history and screening – Counseling and documentation – Public administration and advocacy All may not be possible but do what you can

Answer 114

a solvent USP Composition 94.9% to 96.9% ethanol internal/external - can be for external or internal primary purpose - primary solvent for organic compounds - used for drugs not soluble in water (for its miscibility in water) - help dissolve organic compounds to be mixed in water

Answer 115

solvent NF composition - 50% alcohol - 50% purified water internal/external - can be for external or internal primary purpose - useful hydroalcoholic solvent - help to dissolve organic compounds

Answer 116

USP comp. 70% ethyl alcohol by volume 30% water, stabilizers, perfume oils, color additives, denaturants intern/external external (educated guess, discourage oral by adding sucrose octa-acetate) disinfectant (educated guess)

Answer 117

USP comp/ glycerin Internal but can be for external too - preservative -stabilizer

Answer 118

USP ~70% isopropyl alcohol the remaining amount is water, stabilizers, perfumes internal/external externally but 91% can be internal purpose - To prepare diabetic needles and syringes for hypodermic injections of insulin, a commercially available ~91% isopropyl rubbing alcohol is used also. - as *rubefacient and soothing rub vehicle for topical purposes.

Answer 119

USP comp: propylene glycol internal or external purpose: - Used as a solvent for flavors, extracts, drugs, and food antioxidants as well as a heat transfer medium - Can substitute for glycerin in pharmaceutical formulations

Answer 120

USP pure water Internal or external Used in the preparation of aqueous dosage forms (except for IV administered drug substances)

Answer 121

- personnel & environmental protection - uses uncirculated inward air flow away from operator

Answer 122

- for personnel, product & environmental protection - open front, inward air flow for personnel protection - hepa flow downward air into work area for product protection -hepa filter exhaust air for environmental protection

Answer 123

minimum in flow velocity of 75 ft per minute through work area access opening - no suitable for work with volatile toxic chemicals and volatile radionuclides

Answer 124

-- minimum in flow velocity of 100 ft per minute through work area access opening - used for work with minute quantities of volatile toxic chemicals and tracer amounts of radionuclides required as an adjunct to microbio. studies

Answer 125

- minimum in flow velocity of 100 ft per minute through work area access opening - work with for work treated with volatile toxic volatile toxic chemicals and tracer amounts of radionuclides required as an adjunct to microbio. studies

Answer 126

-- minimum in flow velocity of 100 ft per minute through work area access opening - for work treated with minute quantities of volatile toxic volatile toxic chemicals and tracer amounts of radionuclides required as an adjunct to microbio. studies if work is done in the direct exhaustive portion of the cabinet or if chemicals and radionuclides will not interfere with the work when recirculated in down flow air

Answer 127

It uses a totally inclosed ventilated cabinet with gas tight construction - operations in the cabinet are conducted through attached rubber gloves

Answer 128

biosimilar is a biological product that is approved based on demonstrating that is it highly similar to the FDA-approved biological product, with no clinically meaningful differences in terms of safety and effectiveness from the original biological product less expensive facilitates access state-by-state regulations biosimilar is not the same as biologics not identical but are similar

Answer 129

B cells come from bone marrow there are 3 types B cells but there are 10 billion different combinations goes through: - replication - differentiation - and turns to either memory cells or effector cells one of the 10,000 will find the antigen and be a good fit for it and sends a signal that it is the one that fits best and then: goes through: - replication - differentiation - and turns to either memory cells or effector cells memory cells: next time you have the infection it will recognize effector cells are made 2000 per second increase size of antigen and so macrophase can engulf them 1- foriegn antigen 2- B cell 3- replaicaion 6-

Answer 130

E Memory cells key: *second time*

Answer 131

do - place vaccine in breathable plastic - spearate adult and child vaccines; group vaccines by age group - spearate the VFC (vax for children) vaccine supply from privately purchase vaccine - keep baskets 2-3 inches from walls and other baskets - keep vaccines in their original boxes until you are ready to use them - store only vaccine and other med invaccne storage do not - store on the floor

Answer 132

Pfizer Vaccine Moderna Vaccine Janssen COVID-19 Vaccine:

Answer 133

mRNA lipids ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl) bis(2-hexyldecanoate) 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide for mRNA stablity 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol) potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate - stable sucrose for cryo protection and because it is frozen very concerned with stability acetic acid, maintain stability

Answer 134

sucrose not need because not frozen Recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2- hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.

Answer 135

mRNA lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG] cholesterol 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose.

Answer 136

no eggs not latex no preservatives nothing in here that is a problem and is very safe, safer than all vaccines that we have known

Answer 137

(1) Pfizer must be maintained at -70 degrees Celsius. (2) Moderna can be shipped at -20 degrees Celsius, and can be comfortably stored in refrigerator units for up to 30 days after that. (3) Jansen Covid-19 vaccine. Store unpunctured multi-dose vials of Janssen COVID-19 Vaccine between 2°C to 8°C. Protect from light. Do not store frozen. Vaccine is initially stored frozen by manufacturer, then shipped at 2°C to 8°C. If vaccine is still frozen upon receipt, thaw at 2°C to 8°C. Do not re-freeze once thawed.

Answer 138

weights (lbs), temps + time - 10, 115.5*C , 30 min - 15, 121.5 *C, 20 min - 20, 126.5*C, 15 min

Answer 139

- cephalic vein on hand - median cubital vein on arm 23 guage size (for bolus injections) 18 guage size (for continuous IV infusions) - 100% bioavailability of med. - rapid action due to direct injection into blood

Answer 140

- adults: gluteus maximus - child: deltoid in arm - 5mL for gluteus - 3mL for deltoid - injections are 2 - 3 inches - 20-22 gauge needle is used - less rapid but long lasting

Answer 141

- upper arm - thigh - abdomen - 1.3mL (not more the 2mL) - 3mL syringe - 24 - 26 gauge needle - 25 - 30 gauge for insulin for drugs administered daily like insulin

Answer 142

- anterior surface of forearm 23 - 26 gauge needle 0.1mL volume immunizations

Answer 143

Optimization of duration of action of the drug - increase viscosity; for ophthalmic - importance for contact time - absorb to the site and keep on-site; develop delivery system with high affinity for site for drug to stay there - have more time of absorption Decreasing dosing frequency Controlling the site of release Maintaining constant drug levels on exam: think of why you want to use it

Answer 144

Degradable bonds- bond that degrades in response to physio. system. Under pH 7.4, the complex stays in tact but at pH 6 (tumor of pH) then bond breaks and allows release of drug substance. Can get rapid or controlled release Implantable drugs - put drug in body and surgically close - with timelike 3 months, the system will continously release the durg in resposne to either pH, osmotic pressure, time-release capsule - after time, drug is released - long polymers or shorter chains will impact the time in which is releases - short chain: release faster What are some potential problems associated with polymer use? High molecular weight - Slow permeability - Delay excretion Unfavorable Immunologic or toxic reactions Expense associated with preparation

Answer 145

Why have long-acting parenteral systems? - To extend rates of drug action following injection of the final product - conjugate polymer to drug and administer it to patient: will extend circulation half-life, % of blood will go up In what ways is this accomplished? - Slowly dissolving chemical complexes of drug entity - Slow erosion of drugs encapsulated in microspheres - Mechanically controlled-rate drug infusion pumps

Answer 146

For spinal cord stimulation (SCS) (Implantable system Interferes with pain signaling to the brain gets interrupted - implant pulse generator by surgical op. - signal pulses are released - interfere with the pain signals to the brain - last resort for pain (have even tried morphine) - for chronic pain - 50-75% of the pain pop. say they feel better - no drugs released For SCS therapy (External system) Patient can expect 50—75% pain relief

Answer 147

- Can administer small doses over an extended period - Weighs ~6 ounces Drug can be injected into device from outside of the body - Requires smaller doses than with pills or IV - Patients report fewer side effects and better pain relief - Offers greater flexibility with matching dose with patient needs - localized, more effective and little side effects - no electrical signals - implant a pump with a catheter and release small doses over time to area with pain - not like a pill, very effective - patients have tried other things

Answer 148

- Sterile off-white to pale yellow wafer approximately 1.45 cm in diameter and 1 mm thick. - The wafers contain 192.3 mg of a biodegradable polyanhydride copolymer and 7.7 mg of carmustine. - Designed to deliver carmustine directly into the surgical cavity created when a brain tumor is resected (cut out) - Within 3 weeks more than 70% of the copolymer degrades not the drug. The polymer relases the drug in a controlled way over 3 weeks. Take away copolymer, just have carmustine - release quickly/immediate release - if drug released right away, it is a issue because the residual cells have a doubling time and want drug to be there for doubling time, only works if cell is dividing. In G0 cell is resting and not dividing and spared the effects of the therapeutic drug. So any residual cells will be eradicating - targets DNA replication in dividing cells - brain tumor removed first - this implant is for residual cancer cells that could still be dividing

Answer 149

Overall patient survival: - Median survival was 13.5 months with 20% survival at 2 years for Grade IV gliomas (more severe), and … - 57 months with 66% survival at 2 years for Grade III gliomas - higher success rate for patients with less severe disease more survived when condition was less severe than if condition was severe. Grade III survived more than Grade IV

Answer 150

- Wafers designed as a single-dose treatment box as opposed to what... - Each box contains 8 individually pouched wafers, all 8 is a single dose. Just 6 if you need 6 - Each wafer is double-pouched in foil, Inner pouch is sterile WHY make sure to stay sterile inside - Must be stored at or below -20ºC, -20 is always

Answer 151

“Small clusters of molecules in which the nonpolar hydrocarbon groups are in the center, and the hydrophilic polar groups are on the outside.” - not implantable, using detergents and lipids and polymers

Answer 152

- Detergents at low concentration in aqueous solution form a monolayer at the air-liquid interface. - no longer a monomer - At higher concentrations, detergent monomers aggregate into structures called micelles inside is sheilded in water chemotherapy will be lipophilic feature is a sphere can make using skin

Answer 153

- Spontaneously forming microparticulates used to deliver drugs, genes, proteins etc.. to target cells - one of the very first drug delivery systems - many other drug deliveries are modeled after this system Liposomes are composed of small vesicles of a bilayer of phospholipids encapsulating an aqueous space Both aqueous and bilayer compartments are capable of incorporating drug substances

Answer 154

- Liposomes mimic the structure of biological membranes so biocompatiable - In aqueous solutions lipids form organized structures by hydrophobic and hydrophilic interactions - in membrane there is protein, lipids

Answer 155

Myristoyl 14:0 (no kink) Palmityol 16:0 (2 more carbons than myristoyl) Stearyl 18:0 (2 more carbons than Palmityol) Oleoyl 18:1 (one double bond) polar head group - phosphate, glycerol backbone hydrophobic tails - satrurated (straight) and unsaturated fatty acid (kink) double bonds affect melting temp. - has two phases of equal amounts, - 50% gel phase - 50% lipocrystaline phase want more drug into bilayer portion of liposome, put into the. things that look like fingers lol DPPC on right - larger so use to incorporate more drugs DMPC on left

Answer 156

1) Adds firmness and integrity and stability - retain drugs in the liposome better 2) Helps separate the phospholipids- - orients into the bilayer - if too high or too low then unfavorable Orients similar to Sucrose sucrose is a cryoprotetcant in vaccines - sucrose also prevents mobility of chains by also going in between - if you are freezing the vaccine then you do not want them moving around - helps to protect - not in Janssen because you do not freeze that one

Answer 157

The phospholipids used to make liposomes are amphipathic, possessing both a hydrophilic (or polar) and a hydrophobic (non-polar) tail. The tail is composed of fatty-acids containing generally 10 to 24 carbon atoms and a polar end that can interact with the aqueous environment

Answer 158

Chain 14:0 (Myristoyl) 20 °C [saturated] 16:0. (Palmitoyl) 41 °C [saturated] 18:0 (Stearyl) 55 °C [saturated] 18:1 (Oleoyl) -20*C [unsaturated] one double bond, then temp. goes to negative -20*C with DOPC, there is still 50% gel and 50% lipocyrstalline phase ex: 14:0, 14 is # of carbons, 0 is the # of double bonds Phospholipid head groups: PC, PG, PE, PS etc….

Answer 159

goal: To reduce toxic side effects of agents in sensitive organs such as heart and kidneys, and to target diseased tissues. Potent medicinal substances are usually the most toxic and so there is an urgent need for effective drug delivery systems. Less than 5% of the injected drug accumulates at the target site, the remaining drug interacts with healthy host tissues.

Answer 160

they are pretty much the same thing except the liposome has a hollow pore that be used to put in drugs like Doxirubicin liposome has an aqeuous internal compartment micelle is closed Liposomes are composed of a lipid bilayer separating an aqueous internal compartment from the bulk aqueous phase. Micelles are closed lipid monolayers with a fatty acid core and polar surface, or polar core with fatty acids on the surface (inverted micelle).

Answer 161

lipoceutical - better penetration - permeation is greater with liposomal encapsulation - eliminates irritation and optimizes dosage - greater concentration and residue time in the epidermis and dermis for prolonged release - protects encapsulated material from metobolic degradation - reduces systemic absorption conventional vehicle with free active - less permeation - has higher systemic adsorptio

Answer 162

Parenterally topically inhalation methods orally or possibly by other routes. Intravenously (chemotherapy) Aerosol particles Cream

Answer 163

- In general, a required amount of lipid is dissolved in chloroform [selection of lipid type is important]. Remove chloroform - Solvent is removed usually with a rotary evaporator to form a thin film on the wall of a flask [selection of buffer is important] - Film is then hydrated with a buffer of choice. The temperature of the buffer to be added to the lipid film is usually above the melting temperature of the dominant phospholipid used to prepare film. - Vortex and heat and repeat sequence until lipid film has completely dissolved in the aqueous solution. - Control liposome size using mini-extruder [their size is important]

Answer 164

blood vessels in tumor become more permeable the particle extravasate (flow out from the vessel that naturally contains it into the surrounding area - so leaves?) and move from intracellular to extracellulae space heat - make blood vessles more permeable

Answer 165

Wide range of vascular pore sizes - gap junctions are much wider in tumors - tumor are quite permeable Heterogeneous blood supply - blood supply in tumor is irregular some might be flowing, some flowing and some not Irregular blood flow velocities (same as heterogenous) - hard to depend upon Elevated interstitial pressures - inside of tumor - high pressure inside due to cells dividing inside Long interstitial transport distances - once drug in the tumor, takes a long time to get access to all of the cancer cells -- a problem elevated or high collagen content - lots of collagen - helps to impede the delivery and transport of drug once they get into the tumor - blood vessles extravascate

Answer 166

liposomal therapeutics

Answer 167

Conventional Liposome - bilayer - aqueous core Stealth Liposome - longer circulating in tumor due to PEG on surface - Doxorubicin inside - PEG absorbs water and protects contents of drug on the inside. Proteins do not come into contact with proteins in the blood and some into contact with PEG and circulate longer and will not be eliminated - drug encounter blood, and the absorption allows for premature release - stay in system for 3 days carmustine - want drug to be present during doubling time doxil - shows on NAPLEX - PEG - cholesterol

Answer 168

PEG on the outside protecting liposome bilayer doxorubicinn in the core (is this part of the long-acting release therapeutic like Gliadel wafer?)

Answer 169

Lipid composition Liposomal size Membrane fluidity - cholesterol - degree of saturation - have to do with tails; kink Surface charge - head group Steric stabilization (or stealth liposome technology) - PEG - liver, and spleen cannot eliminate it

Answer 170

Formulations incorporating doxorubicin have been developed to decrease the incidence of severe toxicity seen with the conventional formulation of doxorubicin, while taking advantage of the unique delivery properties of liposomes and the cytotoxic effects of doxorubicin. Approved for treatment of Aids-related Kaposi Sarcoma, Ovarian cancer and many other Solid tumor varieties

Answer 171

Amphotericin B is an antifungal antibiotic. Because of the many well-known side effects and certain dose-limiting toxicities associated with conventional amphotericin B, lipid-based formulations were developed to increase the tolerability (e.g., decrease nephrotoxicity) of the drug without compromising its antifungal effects. Ambisome powder for injection

Answer 172

B - phospholipid hydrocarbon chain length (so more space to input drug because more carbons)

Answer 173

need time for healthy tissue to repair but also tumor is also repairing we want more target and selective delivery that only selects for the tumor and not the health cells how close are we to getting a magic bullet

pharmaceutics exam 3 Flashcards

(197 cards)