Spring Exam 1 Flashcards
definition of ointments
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
Specific definition of ointments
- 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
Levigation - when is it used?
- powders must be insoluble in UNG base
- to make smooth
- particle size reduction
- minimal amount of base
what is incorporation?
-the processes of combining semi-solid masses
when do you use geometric?
-used with “geometric incorporation”
What are levigating agents?
- 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!
When are levigating agents used?
- 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)
what are solubilization agents?
- 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
Scenario: a solid, oil-soluble drug to be incorporated with petrolatum
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
Scenario: a solid, water-soluble drug is to be incorporated with petrolatum
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
Scenario: a solid, powder substance is to be incorporated in an ointment base in which it it NOT soluble
1) levigate the powder in a minimal amount of the base (or levigating agent)
2) incorporate the remaining ointment base with the product
Definition of creams
- 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
Definition of gels
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
Definition of pastes
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
How are ointments generally used?
- application to the skin/mucous membranes
- external use only –> exceptions = gels! (mylanta gelcaps, metrogel)
Topical ointments
- applied to the tissues in which the element actually exists
ex) hydrocortisone to a rash
Transdermal ointments
-site of application may be the same but the intent is for the active ingredient to become systemically distributed through absorption into the blood
Ointment uses: emollient*
- 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
is an ointment protective?*
yes! depending on the viscosity & stiffness of the individual base, one may be more protective than the other
Is an ointment a medication vehicle?*
usually yes, but maybe not –> can have active ingredient or are sometimes just used for their protective or emollient properties alone
Use of ointment as a term *(both general & specific)
- general: ointment = semi-solid
* specific: ointment = oleaginous/hydrocarbon base class
what is the ideal ointment?
- 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
what stability characteristics do we wants in an ointment?
physical, chemical, microbiologic
What are some ointment bases? (5)
1) hydrocarbon/oleaginous
2) anhydrous absorption
3) water in oil emulsion (topical)
4) oil in water emulsion (oral)
5) water soluble
anhydrous
-contains no water
absorbs water
-able to form an emulsion upon the addition of energy
emollient
does it have the ability to promote moisturization of the tissues that is comes into contact with
occlusive
-does it have the ability to shut off the free exchange of gases between the inside & the outside of the skin
Hydrocarbon/oleaginous bases (only listing the YES properties)
- emollient
- occlusive
- greasy
- anhydrous (does not contain water in their pure form)
EAT OLD GREASY ASS
Anhydrous Absorption Bases (only listing YES properties)
- anhydrous
- absorbs water
- emollient
- occlusive
- greasy
EAT OUT ADAMS GREASY ASS
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
oil-in-water emulsion, water-removable bases (only listing YES properties)
- water washable
- absorbs water (somewhat)
WET ASS
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
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
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
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)
Animal fats/oils (details) H/O base
- lard, suet not commonly used today
- lanolin derivatives (lanolin oil, hydrogenated lanolin)
- may become rancid
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
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!!
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
Intravenous injections
- peripheral: injection to the arm or leg
* central: use of a central venous catheter)
Intra-arterial (IA)
- uncommon for the administration of medication –> to the high pressure side of the circulatory system
- testing (1st pass kinetics, arterial pressure)
Intramuscular (IM)
-injection to within muscle tissues
Intrathecal (IT)
-injection to the meninges of the spinal cord
Epidural
-injection to the tissues surrounding the spinal cord, not the spinal cord itself
intradermal (ID)
injection within the skin
Subcutaneous (Sc, SQ)
injection beneath the skin
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!
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)
Personal Prep for sterile room
- cover both head and facial hair
- remove cosmetics likely to flake
- remove finger and wrist jewelry
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
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
Glove composition**
- latex
- vinyl
- synthetic
Gowns
- should be made of a low-particulate material that protects against bacterial passage and drug permeability
- Tyvek: standard for non-permeable garments
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
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
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
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
What is the greatest disadvantage of a laminar air flow vibe?
a false sense of security
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
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
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