1
Q
definition of ointments
A
USP: semisolid preparations intended for external application to the skin or mucous membranes
–loosely to include: pastes, creams, gels, plasters, poultices (all semisold topicals)
UNG (latin): fatty substance
2
Q
Specific definition of ointments
A
- an unofficial specific classification for oleaginous topicals (petrolatum, lanolin or other semisolid oil/grease based preps)
- insoluble in water, not water washable, emollient, occlusive & greasy
3
Q
Levigation - when is it used?
A
- powders must be insoluble in UNG base
- to make smooth
- particle size reduction
- minimal amount of base
4
Q
what is incorporation?
A
-the processes of combining semi-solid masses
5
Q
when do you use geometric?
A
-used with “geometric incorporation”
6
Q
What are levigating agents?
A
- often not specified by the prescriber
- SA, not necessary to call physician, use professional judgement
- optional (when not specified)
- always used in a MINIMAL amount!
7
Q
When are levigating agents used?
A
- used to facilitate wetting of powders & incorporation efficiency
- powders must be insoluble with the agent
- ideally a low molecular weight version of the base itself or a low viscosity agent compatible with the base
- EXs: mineral oil (use with petrolatum), glycerin (use with PEG) & low molecular weight PEG (use with PEG)
8
Q
what are solubilization agents?
A
- should be compatible with the UNG base itself or a suitable adjunct absorption base
- used to facilitate compounding efficiency
- powder must be soluble with the agent
9
Q
Scenario: a solid, oil-soluble drug to be incorporated with petrolatum
A
1) dissolve the drug in a minimal amount of mineral oil (on the ointment slab)
2) incorporate (geometrically if needed) oil solution with the petrolatum
10
Q
Scenario: a solid, water-soluble drug is to be incorporated with petrolatum
A
1) dissolve the drug in a minimal amount of distilled H2O (usually on the ointment slab)
2) incorporate the solution in a minimal amount of an appropriate absorption base
3) incorporate the above with the petrolatum
11
Q
Scenario: a solid, powder substance is to be incorporated in an ointment base in which it it NOT soluble
A
1) levigate the powder in a minimal amount of the base (or levigating agent)
2) incorporate the remaining ointment base with the product
12
Q
Definition of creams
A
- USP: creams are semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base
- separate USP classification reserved for water-removable/soluble ointments
- usually not termed an ointment
13
Q
Definition of gels
A
USP: gels are semisolid systems consisting of either suspensions made up of small inorganic particles or large organic molecules interpenetrated by a liquid
–> a specific type of ointment
14
Q
Definition of pastes
A
USP: pastes are semisolid dosage forms that contain one or more drug substances intended for topical application
-generally high viscosity: stiff, protective property, generally an ointment with >20% w/w powder = paste
15
Q
How are ointments generally used?
A
- application to the skin/mucous membranes
- external use only –> exceptions = gels! (mylanta gelcaps, metrogel)
16
Q
Topical ointments
A
- applied to the tissues in which the element actually exists
ex) hydrocortisone to a rash
17
Q
Transdermal ointments
A
-site of application may be the same but the intent is for the active ingredient to become systemically distributed through absorption into the blood
18
Q
Ointment uses: emollient*
A
- a substance that has the ability to help promote the moisturization of tissues that it comes into contact with
- ->*an ointment product may or may not exhibit these properties
19
Q
is an ointment protective?*
A
yes! depending on the viscosity & stiffness of the individual base, one may be more protective than the other
20
Q
Is an ointment a medication vehicle?*
A
usually yes, but maybe not –> can have active ingredient or are sometimes just used for their protective or emollient properties alone
21
Q
Use of ointment as a term *(both general & specific)
A
- general: ointment = semi-solid
* specific: ointment = oleaginous/hydrocarbon base class
22
Q
what is the ideal ointment?
A
- spreads easily, compatible with tissues (non-irritating, hypoallergenic, non-abrasive, isotonic)
- smooth & pliable, softens or melts at body temp, easily removed, ready release of medication & doesnt stain skin or clothing
23
Q
what stability characteristics do we wants in an ointment?
A
physical, chemical, microbiologic
24
Q
What are some ointment bases? (5)
A
1) hydrocarbon/oleaginous
2) anhydrous absorption
3) water in oil emulsion (topical)
4) oil in water emulsion (oral)
5) water soluble
25
anhydrous
-contains no water
26
absorbs water
-able to form an emulsion upon the addition of energy
27
emollient
does it have the ability to promote moisturization of the tissues that is comes into contact with
28
occlusive
-does it have the ability to shut off the free exchange of gases between the inside & the outside of the skin
29
*Hydrocarbon/oleaginous bases (only listing the YES* properties)
- emollient
- occlusive
- greasy
- anhydrous (does not contain water in their pure form)
*EAT OLD GREASY ASS*
30
*Anhydrous Absorption Bases (only listing YES* properties)
- anhydrous
- absorbs water
- emollient
- occlusive
- greasy
EAT OUT ADAMS GREASY ASS
31
*water-in-oil emulsion absorption bases (only listing YES* properties)
- absorbs water (somewhat--> since they are already an emulsion, they have some ability to contain water)
- emollient
- occlusive
- greasy
ADAM EATS OLD GREASY
32
*oil-in-water emulsion, water-removable bases (only listing YES* properties)
- water washable
- absorbs water (somewhat)
*WET ASS*
33
*water soluble bases (only listing YES* properties)
- water soluble
- water washable
- anhydrous ****(does NOT contain water in their pure form but in the manufacturing process, there are some trace amounts of water that are simply there b/c of limitations )
- absorbs water (somewhat)
*WET WASH ADAMS ASS*
34
Hydrocarbon/oleaginous bases (detailed info)
-useful when high % of powder (that is insoluble) is to be incorporated into base (10-25% w/w)
Source: petroleum, animal fats/oils, vegetable oils
-wont dry out
35
Skin Physiology
- pliability of skin is due to moisture content, not oil content
- skin is moisturized from the inside out
- occlusive barrier at skin surface minimizes moisture loss due to evaporation
- washing removed the occlusive barrier
- repeated washing will result in dry skin
- > 20 mins of water immersion = needed to moisturize skin from the outside in
36
Petrolatum (white or yellow details) H/O bases
- purified mixture of semi-solid hydrocarbons obtained from petroleum
- high viscosity due to high molecular weight only
- will not become rancid (self preserving)
37
Animal fats/oils (details) H/O base
- lard, suet not commonly used today
- lanolin derivatives (lanolin oil, hydrogenated lanolin)
- may become rancid
38
Vegetable oils (details) H/O base
- useful as an additive to lower melting point & to soften a product
- may be hydrogenated to promote solidification at room temp (crisco- viscosity partially due to H bonds)
- may become rancid
39
What is the definition of parenteral?
adj: administered by any way other than through the mouth: applied, for ex, to the introduction of drugs or other agents into the body by injection
para enteron: beside from the intestine
parenteral products must be sterile!!
40
Definition of aseptic technique
-the ability of personnel to manipulate sterile preparations, sterile packaging components, & sterile administration devices in a way that excludes the introduction of viable microorganisms
41
Intravenous injections
* peripheral: injection to the arm or leg
| * central: use of a central venous catheter)
42
Intra-arterial (IA)
- uncommon for the administration of medication --> to the high pressure side of the circulatory system
- testing (1st pass kinetics, arterial pressure)
43
Intramuscular (IM)
-injection to within muscle tissues
44
Intrathecal (IT)
-injection to the meninges of the spinal cord
45
Epidural
-injection to the tissues surrounding the spinal cord, not the spinal cord itself
46
intradermal (ID)
injection *within* the skin
47
Subcutaneous (Sc, SQ)
injection *beneath* the skin
48
Definition of Sterility
* freedom from all living organisms, an absolute term & no such thing as almost sterile*
- all parenteral & ophthalmic dosage forms must be sterile!
49
Health status in terms of sterility
-sterile prep personnel should be free from infectious diseases
--> if you have a "cold" and are coughing and/or sneezing stay out of the sterile prep room!
(chills, fever)
50
Personal Prep for sterile room
- cover both head and facial hair
- remove cosmetics likely to flake
- remove finger and wrist jewelry
51
Hand-washing rules
- scrub hands & arms to elbows
- plain soap and water not enough for high risk situations (alcohol, chlorhexidine gluconate, iodophors, hexachliphene, parachlorometaxylenol & triclosan)
- use 3-5ml for 30 secs
- wash hands even if gloves are to be worn (leakage rate can be more than 50%) also wash hands after gloves removed
52
Gloves
- selection based on type of compounding, material durability, reliability, comfort & protection from bacteria or hazardous drug penetration
- for IV room- use SURGICAL gloves
- change ~1 hour
53
Glove composition**
- latex
- vinyl
- synthetic
54
Gowns
- should be made of a low-particulate material that protects against bacterial passage and drug permeability
- Tyvek: standard for non-permeable garments
55
other coverings (shoes & masks)
- shoe covers & sticky mats (change frequently)
- masks: don just prior to working in hood, change each time leaving compounding area, surgical masks offer no protection against inhaling of powdered or aerosolized hazardous drugs
56
*LAFS* horizontal flow hood
- filtered air is directed toward the pharmacist/tech from a plenum (and HEPA filter) located at the back of the hood
- most common for general purpose parenteral
57
*BSC* Vertical flow hood
- filtered air is directed downward from a plenum (and HEPA filter) located at the top of the hood
- used for chemo therapy
- provides more protection for the pharmacist/tech than does the horizontal hood
58
Laminar Air Flow
- HEPA Filter removes 99.97% of all particles 0.3 microns or larger
- operate for at least 15 min prior to use --> most institutions require 30 mins
59
What is the greatest disadvantage of a laminar air flow vibe?
*a false sense of security*
60
ISO classifications of particulate matter in room air
(0.5 um and >) theres a whole chart but basically the smaller the number- the higher the air quality
61
What are pyrogens?
- metabolic products of living organisms, or the dead microorganisms themselves
- chemically: lipopolysassharides, soluble in water but insoluble in organic solvents
- aseptic technique (ideally) prevents the introduction of pyrogens to parenteral products
62
pharmacologic effects of pyrogens
- vary with the microbial source of the pyrogen & pt receiving the injection
- in man, pyrogenic reaction is fever & chills
- following injection, latent period 45-90 mins, then rapid rise in body temp, chills, headache & malaise
- anaphylaxis
63
Sources of pyrogens
- water used as the solvent
- containers used in preparation, packaging, storage or administration
- chemicals used in the preparation of the solution
64
Elimination of pyrogens
-dry heat: for metal and glass containers
-chemically: for solutions (disadvantage: can destroy drugs)
-synthetic filter media: 0.22 micron filter
Best approach: *prevent them from occurring*
65
unnecessary factors for when preparing sterile products
talking, laughing, chewing gum, eat/drink
66
CSP risk levels
-assigned according to relative possibility that a compounded sterile product might become contaminated
67
*LAFS
laminar airflow system
68
*BSC
biologic safety cabinet
69
*RABS (CAI & CACI)*
-restricted access barrier system
CAI: compounding aseptic isolator
CACI: compounding aseptic containment isolator
70
```
*give an example of each ointment base:
1- H/O
2- anhydrous
3- water in oil emulsion
4-oil in water emulsion
5- water soluble
```
```
1- petrolatum
2- aquaphor
3- eucerin
4- hydrocphilic ointment
5- polyethylene glycol
```
71
**Anhydrous absorption bases
- can absorb up to twice their weight in water *1:1 allowance*
- will not dissolve in water
- forms a W/O emulsion when incorporated with an aqueous substance *not emulsions by themselves*
- useful for incorporation of aqueous liquids and/or water soluble drugs to the emulsions internal phase
72
**anhydrous absorption base (round 2)
-absorption base means absorptive of water- *absorption bases will absorb oil based substances as well*
-basic properties very similar to those of oleaginous
bases
Origin: petroleum, animal
73
Hydrophilic Petrolatum
- hydrophilic due to cholesterol and stearyl alcohol content
- also contains White Wax
74
Lanolin USP (anhydrous)
- less than 0.35% H2O
| - allergens: thumbs down from many dermatologists
75
Modified lanolin USP
reduced alcohol and detergent content
76
Other petrolatum variations
aquaphor, aquabase & polysorb
77
Water-in-oil emulsion absorption bases
- contains water
- already an emulsion
- will absorb aqueous substances on a limited scale
- often used for emollient properties alone, but still suitable for incorporation of drug
78
examples of water-in-oil emulsion absorption bases
- hydrous lanolin (25-30% H2O)
- cold cream
- rose water ointment
- eucerin
- hydrocream
79
Oil-in-water emulsion water-removable bases
- generally less viscous than other bases
- often termed "cream"
- since water is the external phase: *water washable (advantage), but dries out easily (disadvantage/advantage), vanishing cream*
80
examples of oil-in-water emulsion water-removable bases
- hydrophilic ointment (35-37% H2O, will absorb water, but semi-solid viscosity is eventually lost-lotion)
- vanishing cream
- dermabase
- unibase
81
Water soluble bases
(ex- PEG)
- wide range of viscosity due to wide range of molecular weight
- polar nature leads to instability & compatibility issues with some drugs
- irritating to mucous membranes
- does not contain oil
- does not contain water
82
Clean rooms: an environment where contamination is limited/controlled:
*particles, organisms & pyrogens*
83
Clean rooms: environmental control:
*temperature, humidity & relative barometric pressure*
84
Clean room design (list all the things in there and they supplies they are made from)
- layout: equipment & traffic flow
- walls: epoxy coated
- flooring: seamless, vinyl
- ceiling system: gasketed, t-grid
- filtreation/Air flow: HEPA, positive pressure
- lighting: sealed, gasketed
- easy clean surfaces
85
Clean room classifications: class 100,000
- particle count not to exceed a total of 100,000 particles per cubic foot of a size 0.5 micron and larger
- and/or 700 particles per cubic foot of a size 5 microns and larger
86
Clean room classifications: class 100
- particle count not to exceed a total of 100 particles per cubic foot of a size 0.5 micron and larger
- and/or 0.7 particles per cubic foot of a size 5 micron and larger
87
end product testing: product observation
- container leaks & integrity
- particulates in solution
- solution color, volume and odor
88
end product testing: retrospective check:
- calculations
- ingredients
- quantities
- containers
89
end product testing: analytical testing
- evaluates the contents of prepared sterile products
| - weight verification (specific gravity), refractometry verification, spectrometry, pH testing, microbial testing
90
Process Validation
- systematically demonstrates that a process will reproducibly meet its claim
- involves manipulation of microbial growth media according to the aseptic process being validated
- should schedule process under worst conditions
91
How to validate aseptic processes
- a growth medium: is introduced with a sample of the process being evaluated (product/process sample)
- the medium will support organisms introduced to the process by the operator
- the sample must be a product of the same aseptic process being validated
* should be conducted: at random intervals & without the operator's knowledge*
92
more stability: *3 things in green*
- the extent to which a Rx preparation remains within specified limits in terms of: *chemical composition, physical composition & microbiologic activity/contamination*
- at the time of use a medication must be: *at the stated potency & safe for administration to the pt*
93
Product stability:
*is subject to specific storage conditions & is the primary basis for an expiration date/time*
94
Lyophilzation
- drugs in solution tend to be less stable than those in dry or suspended form
- a process of *rapid freezing & drying under high vacuum (sublimation), the product is a dry powder*
95
Sterilization
- 0.22 micron filter
| - autoclave
96
antioxidants
- metasulfite & sulfite ions
| - sodium salts, potassium salts (metabisulfite, bisulfite & sulfite)
97
Inert and semi-inert gasses
*nitrogen, carbon dioxide & helium*
98
Particulate matter
-may be present in parenteral products: undesirable, unintentional, potentially harmful to the pt, mobile, undissolved substances
99
Sources of particulate matter
- IV solution and/or additives: manufacturing process
- packaging components: paper, cardboard
- IV tubing/sets and administration devices
- preparation processes: laminar flow hood, patient bedside
100
IV fluid incompatibility*
* occurs when a drug is combined with an IV fluid or another drug, to produce by physiochemical means, a product unsuitable for administration to the patient *
ex: phenytoin in D5W (a physical & chemical incompatibility)
101
Therapeutic classification of incompatibilities
-2 or more drugs administered concurrently, result in undesirable antagonistic or synergistic pharmacologic action - drug/drug interaction
102
Physical classification of incompatibilities
the combination of ONE or more drugs in solution resulting in compositional change & appearance (change in color, formation of turbidity, precipitation & evolution of a gas)
103
Chemical classification of incompatibilites
-degradation of drug substances as a result of being in solution & as a result of being in contact with other drugs
104
The greatest single factor causing incompatibility between IV fluids and their contents:
*variations in pH, solubility & stability*
105
minimizing incompatibilities
- use freshly prepared solutions whenever possible
- encourage use of as few additions as possible
- study to demonstrate proficiency in IV therapy
- educate MDs/Rns
- be skillfull with reference materials (Trissel's, Clinical Pharmacology)
106
Parenteral administration advantages
- fast
- some drugs not effective orally
- uncomplicated admin. where the pt is: uncooperative, nauseous, unconscious *NPO*
- patient compliance: gives MD control of drug, pt must return for therapy, cant trust some pts to take medications
- correction of fluid/electrolyte imbalance
- TPN administration: when pt is NPO
107
Parenteral administration disadvantages
- special training required (special procedure, aseptic)
- invasive
- pain
- difficult to reverse
- more expensive
- incompatibilities
108
IV compatibility *idk other green things to know*
* -in general, use smallest possible bag
- refrigerate vs room temp
- light sensitivity
- pay attention to manufacture's codes when provided*
109
sterility & integrity requirements for sterile IV admixtures
*freedom from living organisms, freedom from dead organisms & pyrogens*
110
H2O insoluble
*dead organisms, parts of dead organisms & metabolic products of organisms*
111
H2O soluble
*lipopolysaccharides, metabolic products of organisms*
112
hypotonic
< 277 mM
113
isotonic
~277 mM
114
hypertonic
> 277 mM
115
where does the central route access?
- major veins
- access to the venous system close to the heart
- *superior vena cava, inferior vena cava & subclavian vein (PICC line)*
116
indications for peripheral admin.
- administration of drugs
- administration of fluids (maintain hydration & volume)
- surgery (anesthesia, drugs)
- transfusion
- to maintain or correct electrolyte imbalance
- administration of nutritional solutions
117
advantages of peripheral admin (with respect to central**
- veins are relatively easy to access
- drugs, solutions and blood can be administered quickly
- administration is easy to see and monitor
118
Disadvantages of peripheral admin (with respect to central) **
- short term access
- immobilization of the limb
- less forgiving of tonicity extremes
119
indications for central admin
- large volume fluids
- hypo/hypertonic fluids
- pH imbalanced fluids
120
**advantages of central admin (compared to peripheral)
1-rapid infusion of large volumes
2-a means of measuring CVP (*central venous pressure)
3-eliminates repeat peripheral venipuncture (decreased vein irritation & vein damage)
4-decrease patient discomfort
121
**disadvantages of central admin. (with respect to peripheral)
risk of complications: pneumothorax, sepsis, thrombosis/embolism, organ perforation
- decreased in patient mobility
- surgical implant
122
intra-aeticular
*injection to the joints
123
intra-synovial
*injection to the joint fluid areas
124
intraventicular
*injection to the ventricles of the brain
125
intra-cardiac
*injection to the heart (epi)
126
Potential complications of IV therapy
- bad news: most medical & pharmacologic interventions present some risk to patient
- parenteral therapies are more likely to have serious complications
- good news: most complications can be prevented or minimized
- precautions
127
phlebitis
- inflammation of the veins
- can be induced by insertion of VADs *vascular access device*
- characterized by tenderness, redness, puffiness, hardness & increased temp
- at tip of VAD & in the direction of blood flow
128
extravasation
- undesirable
- liquids are infused into peripheral space surrounding vein
- misplaced VAD
129
infiltration
- undesirable
| - extravasation fluids are absorbed by surrounding tissues
130
Extravasation/Infiltration (general signs and symptoms)
-at the IV site: pain, discomfort, burning, feeling of tightness, decreased temp, cant back flow blood, decreased flow rate
131
Extravasation/Infiltration (drug specific signs & symptoms)
- tonicity & pH extremes (hypo/hypertonic solutions)--> v irritating
- tissue necrosis: chemo, dopamine, epinephrine
132
infection
local: contaminated IV site and/or tissues near VAD, sterile and non-sterile necrosis & sepsis (tissue destruction)
Systemic: fever, chills, malaise & septicemia
133
Air Embolism
- an object blocking a blood vessel- blood clot, fat, amniotic fluid, air, other objects --> MI
- > 5ml of air- right ventricle of the heart, cavitation & fatal
134
Air embolism (signs and symptoms)
-respiratory distress, weak pulse, increased CVP, decreased BP & unconsciousness
135
Allergic reactions
-histamine release: itching, tearing, runny nose, coughing, wheezing, anaphylaxis
136
Why the suppository?
1) an alternative administration route for: NPO pts, unconscious pts & infants
2) non invasive: alternative to IV
137
Why not the suppository?
1) PO vs PR: dignity, comfort, convenience
| 2) privacy: cant be administered in public
138
Suppositories
- solid, unit dose, dosage forms intended for administration of medicine via the rectum, vagina, or urethra
- melt or dissolve in the body cavity
- indicated for administering drugs to infants/small children, severely debilitated patients
139
Local suppositories
-hemorrhoids, itching, infections
140
systemic suppositories
-analgesics, anti-nausea, anti-histamine
141
suppository uses
- recal: adult ~2grams (d= 13-7mm, L= 23-35mm) children 1 gram, more pencil shaped
- vaginal-pessaries
- uretheral- bougies
- nasal
- aural (ear canal)
142
therapeutic uses for suppositories
rectal: local effect, laxation effect, systemic effect
vaginal: fertility
urethral
143
ideal base for suppositories
-stable, non-irritating, bland, chemically & physiologically inert, compatible with a variety of drugs, melt or dissolve in rectal fluids, solid below 98.6, liquid above 98.6F, not bind or interfere with release of drug substances
144
Cocoa butter (suppository base)
- Theobroma oil
- does not become rancid, may leak from body orifice since it is immiscible with body fluids
- softens at 30C, melts at 34C
- no longer the base of choice
145
Fattibase
-preblended suppository base, similar to cocoa butter, no special conditions, good mold release characteristics
146
PEG
- water soluble
| * base of choice when none is specified
147
Glycerin
- water soluble
| - glycerin, gelatin, sodium stearate, water
148
Fusion
- when the drug/base compound is a suspension: levigation/geometric combination may be necessary
- constant stirring during pour is necessary
- pour at relatively cool temps (high viscosity & longer setting time)
149
Mold lubrication
- lubrication/release agent should not be miscible with the base
* *green soup for cocoa butter & fattibase*
* *mineral oil for PEG and glycerin*
- apply with cotton tip applicator
150
Compounding considerations for suppositories
- use of water should be avoided!
- accelerate oxidation of fats, increase the degradation of drugs, support bacterial/fungal growth, dissolved drugs may crystallize as water evaporates, viscosity & bitterness.
151
example of drug drug incompatibilities
**PEG & aspirin, benzocaine*
152
```
Rate of drug release:
1-cocoa butter
2-fattibase
3-glycerinated gelatin
4-polyethylene glycol
```
```
**
1- 3-7 min
2- 3-7 min
3- 30-40mins
4- 30-50mins
```
153
```
match the drugs with their drug absorption
1-oil soluble
2-water soluble
3-oil soluble
4-water soluble
```
```
**1-slow
2-rapid
3-moderate
4-moderate
*oily bases will melt, water soluble bases will dissolve*
```
154
Calibration value
- the average mass of one pure base suppository cast in the mold
* mold specific, base specific & not drug specific*
155
Density factor
- the ratio of a unit mass of drug powder to the amount of suppository base displaced by the powder
* *not mold specific, is base specific & is drug specific*
Compound My Ass ( P2 Fall)
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