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z F1: Pharmaceutics > Exam 1 Lecture > Flashcards

Exam 1 Lecture Flashcards

1
Q

Drug discovery lead identification and target identification

A

Lead Identification: Natural products, synthesis, rational drug design, focus mainly on molecule

Target Identification: genomics proteomics, metabolomics, looks at the target

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2
Q

Bioprospecting

A

Exploitation of biodiversity for the purpose of pharm development

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3
Q

Combinatorial Chemistry

A

large numbers of compounds generated quickly (AxBxC)

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4
Q

What is Pharmacogenomics

A

Study of different genes that determine drug behavior
Genes show small variation in nucleotides (SNPs)
SNPs used to predict drug response in people

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5
Q

Pharmacogenetics clinical use currently

A

Address severe cutaneous adverse reactions
Human Leukocyte Antigen
Cystic Fibrosis

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6
Q

Drug substances are generally administered to the patient as a formulation/ dosage form/ pharm product in combination with one or more __________________

A

non-medicinal agents

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7
Q

Non-medicinal agents may be used for various reasons so the drug is administered how

A

safe, efficacious, and appealing manner

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8
Q

A dosage form is defined as the ________ manifestation that contains the active or inactive ingredients that deliver a ____ of the drug

A

physical, dose

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9
Q

What are some key characteristics of the dosage form

A

state of matter (solid, liquid, gas)
delivery method (injection, transdermal, etc)
release characteristic (SR, CR)
administration site or route (SQ, intraarticular)

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10
Q

What is the need for dosage forms

A

Protect drug substance from degradation from O2/humitity
Protect drug substance from deleterious effects of gastric juices
Conceal offensive taste
Provide liquid preparations of substanced that are insoluable or unstable

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11
Q

What are excipients

A

Non-medicinal agents used in drugs
They should be compatible with drug substances

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12
Q

Requirements for excipients

A

-Must be nontoxic
-Must be commercially available
-Cost must be low
-Can not contraindicated by themselves or because of a component
-Physiologically inert
-Physically and chemically stable
-Free of microbiologic “load”
-No deleterious effect

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13
Q

What are solid dosage forms

A

Oral route of drug
Low error margin
More chemically and physically stable
Longer expiration states

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14
Q

What are some types of solid dosage forms

A

Powders
gelatin capsules
tablets
gummies

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15
Q

What are liquid dosage forms

A

oral use of liquid dosage forms who cant swallow
faster onset action than solid dosage

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16
Q

What are some types of liquid dosage forms

A

solutions
syrups
elixirs
tinctures
suspensions
emulsions

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17
Q

What are semi-solid dosage forms

A

Ointments, pastes, creams, gels
Medicated or non-medicated
Used for topical local effects
Some used for systemic effects (absorbed through skin)

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18
Q

Pharmaceutical inserts

A

-Medicated solid dosage forms for rectum, vagina, urethra
-Melt or soften at body temperature
-Disintegrate in body fluids

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19
Q

Sterile dosage forms

A

-Free of viable microorganisms
-Parenteral, ophthalmic, irrigating preparations are most common
-must be free from microbial contamination and toxic components because they travel throughout the body

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20
Q

Modified-release dosage forms

A

-Delay or extend release of drug
-Enteric coated tablets or capsules that pass through stomach unaltered & release medicine in intestine
-Release in a controlled manner, predetermined tate, duration, location

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21
Q

What are powders

A

-single solid or mixture of solids in a finely divided state
-one or more drugs that can be used or mixed
-external use by dusting onto the skn, bandages, clothing
-internal use applied to mucous membranes, air steams to nose or lungs

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22
Q

Efflorescent powders
Hygroscopic powders
Deliquescent powders

A

Efflorescent powders: drugs containing water that are released when powders are manipulated or stored under low RH
Hygroscopic powders: solid drugs or chemicals that absorb moisture from air
Deliquescent powders: subset of hygroscopic powers

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23
Q

Uses of powders

A

Topical bulk powders (50-150 mcg)
Bulk powder for internal use
Powders and granules for capsules and tablets
Aerosol powders (1-5 mcm)

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24
Q

Physico-chemical properties of powders

A

-Atoms or ions on surface of solid particle exposed to different kinds of forces
-Gives rise to surface free energy which plays a role in interaction between particles

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25
What factors affect the flow properties of powders
Powers are hydrogenous entity which include solids, liquids, or gases
26
Presence or absence of ____________ moisture at the sollid-air interface affects interparticle interactions
absorbed
27
Mechanical Interlocking
particles of a certain shape can mechanically interlock and resist flow
28
How do you measure the flow of powders
The angle of repose -Its the max angle possible between the surface of a pile of powder and horizontal plane
29
Eutectic Mixtures
Mixture of two or more substances that become sticky, pasty, or may liquefy when mixed together at room temp -Concentration dependent -Have to be completely miscible
30
The increase of eutectic mixture dissolution rate is achieved by a combination of what effects
Reduction of particle size unachievable with other methods of particle size reduction Increased wettability Reduced aggregation and agglomeration
31
What does d50 sieve opening mean
It is the size at which 50% of powder will pass through the sieve
32
What factors does surface area influence
Dissolution rate Suspendability Uniform distribution Penetrability Level of grittiness
33
Microscopy
Sample sized through the use of calibrated grid background
34
Sedimentation rate
settling velocity of particles measured through a liquid medium using gravity or centrifuge
35
What are the steps in compounding powders
Particle size reduction Sieving Mixing Packaging
36
What are the particle size reduction techniques used in compounding
Trituration (mortar and pestle) Pulverization by intervention (recrystallization) Levigation (mortar and pestle with some liquid)
37
What is geometric dilution and spatulation
geometric dilution: blending two or more powder ingredients of in equal quantities until final volume achieved spatulation: mixing powders on an ointment slab using a spatula
38
Cambia brand name
diclofenac potassium
39
Psyllium brand name and active ingredient
metamucil, psyllium husk
40
Methylcellulose brand name and active ingredient
citrucel, citric acid
41
Polyethylene Glycol 3350 brand name and active ingredient
Miralax, PEG 3350
42
Nystatin topical powder brand name and active ingredient
Nystop, nystatin
43
Secnidazole brand name and active ingredient
solosec, secnidazole antibacterial
44
Fosfomycin brand name and active ingredient
monurol, fosfomycin tromethamine
45
Nitroglycerin sublingual powder brand name and active ingredient
GoNitro, sublingual powder
46
What are capsules made out of
Gelatin, starch, or plant (cellulose)
47
What are some advantages of capsules
-Better bioavailability than tablets -Ideally suited for clinical trails and used in prelim drug studies
48
What are hard gelatin capsules made out of
cattle bones, cattle hides, pork skin
49
What are additional additives in hard gelatin capsule shells
Dyes opacifiers plasticizers preservatives
50
How does humidity effect gelatin
Moisture gets absorbed and capsules distort/stick together In dryness capsules become brittle and breal
51
How is gelatin created
By hydrolytic extraction of treated animal collagen -have a body and cap and interlock
52
What are important considerations for hard gel capsule manufacturing
Viscosity Mold pin dimensions Drying time Moisture content
53
What are the excipients used in hard gel capsules
Diluent/Filler Disintegrates Lubricant/Glidant
54
Capsules are filled with powders of various densities therefore need to calibrate with specific powder. What are the calibration steps
Only bodies are filled Pack body Weight capsules and determine average capacity use capacity to calculate amount of diluent needed to fill
55
Capsule manufacturing steps
Rectification: capsule orientation Separation of caps from body Dosing of fill material Replacement of caps and ejection of filled capsules
56
Capsules quality control test steps
Description, identification, strength, impurities Weight variation test (need 30 units) Dissolution testing Content Uniformity Test Loss on drying Water determination Disintegration testing
57
What are the plasticizers used in gelatin
Glycerol, sorbitol, water the amount of plasticizer determine the hardness of the shell
58
What kind of drugs are these Trimterene Ramipril Diltiazem Disopyramide Dabigatran
Hard gelatin capsules
59
What kind of drugs are these Aspiring Doxycycline Emtricitabine Typhoid live vaccine Carbidopa Methylphenidate
Hard gelatin capsules
60
What kind of drugs are these icosapent ethyl dronabinol benzonatate
Soft gel
61
What is U.S. pharmacopeia
set up standards for medicines, pharm ingredients, and excipients
62
Activities of pharmacopeia include
quality standards of article performance verification tests
63
What is USP 797, USP 797, USP 800
USP 797: non-sterile compounding USP 797: sterile compounding USP 800: handling hazardous drugs
64
What is simple compounding
USP monograph or peer-reviewed journal article reconstituting or manipulating commercial products
65
What is moderate compounding
stability data unavailable requires speical calculations or procedures
66
What is complex compounding
requires special training enviornment, facilities, equipment, and procedures
67
What is the beyond use date for non-preserved aqueous, preserved aqueous, non-aquesous oral liquids, and other non-aqueous forms
non-preserved aqueous: 14 days (aw>0.6) preserved aqueous: 35 days (aw>0.6) non-aquesous oral liquids: 90 days (aw<0.6) other non-aqueous forms: 180 days (aw<0.6)
68
What is the difference between master formulation record and compounding record
master formulation record: what you should do (reference) compounding record: what you did (use the reference)
69
What is selection, handling, and storage compounding components
selection: use best judgement handling: use before expiration date storage: store as directed
70
Immedite release tablets contain what three things
wet granulation double compaction direct compression
71
What are buccal tablets
absorbed directly through oral mucosa
72
What are effervescent tablets
produce bubbles when placed in water (mix of acids)
73
What are the two modified-release tablets
delayed-release extended-release
74
Advantages and disadvantages of tablets
advantages: lowest cost production, greatest dose precision and least variable, best combine properties disadvantages: amorphous drugs resist compression and form poor compacts
75
challenges during preparation if tablets
need to use more binder and increase compression pressure
76
Difference between lubricants and glidants
lubricants: reduces friction glidants: reduce resistance to flow
77
Direct compression
blending the API with excipients compressing finished tablets
78
Wet granulation
moisten powder by adding aqueous or hydro-alcoholic agent, then passed through meshes
79
Fluidized bed granulation
powder mix is suspended in air in a fluidized bed granulator
80
Capping and lamination
capping: partial or complete separation of the top or bottom crowns of a tablet from main body lamination: separation of tablet into two or more layers
81
Tablet picking and sticking
picking: material from tablet removed by punch sticking: material removed from adhesion to die wall
82
Mottling
unequal distribution of color on a tablet due to dye migration
83
What is this process apart of: description, identify, assay, impurities, weight variation, loss on drying, water determination, residual solvents, disintegration, tablet friability, breaking force, uniformity test, dissolution test
quality control of tablets
84
Importance of tablet coating
control release of drug from tablet protect drug from gastric environment of stomach
85
Film-coated tablets
thin layer of polymer better mechanical strength, good protection designed to rupture or expose core at desired pH
86
Enteric coated tablets
pass unchanged through stomach to intestines resistance to acid disintegration in higher pH environment
87
What are warfin, oxycodone hydrochloride, abuse deterrent formulation, doxycycline, isosorbide mononitrate, methylphenidate, OROS, ondansetron ODT
Tablet and ODT examples
88
What are ODTs
intended to disintegrate rapidly w/in mouth fast
89
Advantages of ODT
increase bioavailability rapid onset aciton
90
What is the difference between excipients used in ODT and tablets
ODTs have super disintegrants
91
Melt granulation
mix of active agent and water-soluable carrier
92
Effervescent granules
contains medicinal agent in a dry mixture usually composed of acid release CO2
93
Three methods of effervescent granules
wet method hot melt extrusion technique dry method
94
Solution
contains one or more dissolved chemical substances in a suitable solvent or mixture of mutually miscible solvents
95
Spirits and Tinctures
Spirits: alcohol vehicles containing volatile substances Tinctures: alcohol vehicles containing chemical derived from plants and minerals
96
Elixirs Syrups
Elixirs: sweetened hydroalcoholic vehicle containing pharmacological active ingredients Syrups: sweetened, non alcoholic vehicle containing pharmacological active ingredients
97
Disadvantages of solutions
drugs less stable in solution vs solid product difficult to transport require proper measurement
98
Ideal solution
forces that hold the solute molecules together, solvent molecules together, solvent and solute molecules
99
Non-ideal or real solutions
solutions in which the solute-solute, solvent-solvent, solute-solent interactions are not equal
100
The process of dissolution involves
-breaking IMF in solute -separation of molecules of solvent to provide a hole in solvent for the solute molecule -interaction between solvent and solute molecules or ions
101
Solubility issues with most pharmaceuticals
solubility in water depends on presence of polar groups increase in molecular weight decrease water solubility
102
Factors affecting solubility
Particle size pH Temperature
103
Sterile water for inhalation
same as sterile water for injection pyrogen free no parenteral use
104
Sterile water for irrigation
same as sterile water for injection unique packaging requirements
105
Bacteriostatic water for injection
made from sterile water for injection contains one or more antimicrobial agents pyrogen free not for neonates
106
Alcohol solvent
95% v/v issue = pharmacological effects
107
Ways to enhance dissolution
increase surface area, reduce particle size add ingredient to vehicle stir vehicle while adding solute
108
Solubility enhancing technique has to be adopted to improve ____________
bioavailability
109
Cosolvents
-aux solvent employed to improve solubility of dug substances -enhance physical and chemical stability of prep -increase solubility hydrophobic molecules by reducing constant solvent
110
Under no circumstances are ____________ and __________ permitted in any pharmaceutical preparation
methyl alcohol and ethylene glycol
111
Surfactants
when placed in water it forms micelles micellar solubilization
112
Complex agents
complexation relies on weak forces between drug and complex agent
113
Sprays and liniments
sprays: aq or oleaginous solutions in coarse droplets or finely divided solids applied topically to skin or naso tract liniments: alcoholic or oleaginous solutions or emulsions of medication intended for external use
114
What are disperse systems
pharmaceutical preparations comprised of a dispersed phase and dispersion medium
115
What are suspensions
a biphasic preparation consisting of solid particles dispersed throughout a liquid phase
116
What is a main reason for preparing suspensions
control duration or on set action
117
What is sedimentation
smaller particles move slower density of particles is greater than vehicle
118
What are the two electric properties of suspensions
selective adsorption of a particular ion species ionization due to surface groups
119
Stern layer + diffuse layer =
electric layer
119
Effective charge of particle is known as what
zeta potential
120
When attractive force exceed repulsion forces and particles come together what do they form
floccules
121
How does flocculation affect stability of suspension
-enhance stability by decreasing sedimentation rate -high or low charge leading to irreversible sedimentation of particles (caking)
122
What is rheology
study of flow of fluids and deformation of solids
123
Non-newtonian fluids
substances that fail to follow newtons equation of flow
124
Plastic fluids
does not flow until yield point from stress is reached ex: flocculated suspensions (more flocculation = higher yield value)
125
Pseudoplastic fluids
Linear polymers in solution viscosity of substance decreases with increasing rate of shear
126
Dilatant fluids
certain suspensions with a high percentage of dispersed solids increase volume when sheared
127
What factors affect rheologic properties and viscosity measurement of disperse systems like suspensions
Temperature Shear rate/Shear stress Composition and excipients
128
How to prepare a suspension
reduce particle size blend powder adding wetting agent add liquid ingredients transfer suspension into appropriate size conical use vehicle to rinse material from mortar
129
What are these examples of: Fluticasone Propionate Inhalation Aerosol Insulin NPH Medroxyprogesterone acetate Amoxicillin/Clavulanate Cefixinme Exenatide ER Aripiprazole ER
suspensions

z F1: Pharmaceutics (10 decks)

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