Midterms Flashcards
They serve as carriers for drugs that are topically delivered by way of the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue, urethral membrane, and external ear lining
SEMI-SOLID DOSAGE FORMS
advantageous in terms of its easy application, rapid
formulation, and ability to topically deliver a wide variety of drug molecules
SEMI-SOLID DOSAGE FORMS
usually are intended for localized drug delivery
SEMI-SOLID DOSAGE FORMS
PHYSICAL PROPERTIES OF SEMI-SOLID DOSAGE FORMS
▪ Smooth texture ▪ Elegant in appearance ▪ Non dehydrating ▪ Non gritty ▪ Non greasy and non-staining ▪ Non hygroscopic
PHYSIOLOGICAL PROPERTIES OF SEMI-SOLID DOSAGE FORMS
▪ Non irritating
▪ Do not alter membrane / skin functioning
▪ Miscible with skin secretion
▪ Have low sensitization index
APPLICATION PROPERTIES
▪ Easily applicable with efficient drug release.
▪ High aqueous wash ability
homogenous, translucent, viscous, semi solid preparation intended for external application to skin or mucous membranes
Ointments
Ointments also called
(Unguents)
should be of such composition that they soften but not
necessarily melt when applied to the body
Ointments
GENERAL USES OF OINTMENTS
- Acts as protective or protectant - serve as physical barrier to environment
- Acts as emollient - softens skin and makes it pliable
- Carrier of medicament – vehicle
TYPES OF OINTMENTS
Medicated
non-medicated
FACTORS OF SELECTING OINTMENT BASES Characteristics
- Physicochemical properties of the medicaments
- Patient’s conditions
- Intended site of application
- Characteristics of the various vehicles available
are water-free, and aqueous preparations may only be incorporated into them in small amounts and then with difficulty
HYDROCARBON BASES
HYDROCARBON BASES uses
- used mainly for their emollient effect and not intended for penetration into the skin.
- They are difficult to wash off.
- They do not “dry out” or change noticeably upon aging
Characteristics of HYDROCARBON BASES
a) Retained on the skin for prolong period of time
b) Do not permit the escape of moisture to the skin to the atmosphere
c) Difficult to wash as such they act as occlusive dressing
d) They do not change noticeably upon aging
e) Insoluble in water
f) Not water-washable
g) Anhydrous
h) Will not absorb water
i) Emollient
j) Occlusive
k) Greasy
l) Nonirritating
m) Inexpensive, non-reactive
Sources Of Hydrocarbon Bases
Vegetable Oil
Animal Fat
HC
Liquid hydrocarbon
mineral oil
Animal Fat
Oleic oil
HC from
Petrolatum
3 Forms of HC
Liquid hydrocarbon
Semi-solid HC petrolatum
Solid HC
Semi-solid HC petrolatum
Vaseline
Solid HC
Paraffin
Examples Of Hydrocarbon Bases
- Petrolatum, NF
- White Petrolatum, USP
- Yellow Ointment
- White Ointment, USP
- Mineral Oil, USP
- Paraffin, NF
- Olive Oil, USP
mixture of semisolid HC obtained from petroleum
Petrolatum, NF
Properties of Petrolatum, NF
An unctuous mass, color yellowish to light amber
Petrolatum, NF melts between
380C -600C
Petrolatum, NF synonyms
Yellow petrolatum, Petroleum jelly
Commercial product of Petrolatum, NF
Vaseline
is petrolatum that has been decolorized
White Petrolatum, USP
White Petrolatum, USP uses
diaper rash, dry skin
White Petrolatum, USP synonym
White Petroleum Jelly
White Petrolatum, USP commercial
White Vaseline
Yellow Ointment contains
Each 100 g contains 5 g yellow wax and 95 g of
petroleum
purified wax obtained from honeycomb of the bee (Apis mellifera)
Yellow wax
Yellow Ointment synonyms
Simple Ointment
White Ointment, USP contains
100 g contains 5% of white wax (bleached purified beeswax) and 95% white petrolatum
is a mixture of liquid HC obtained from petroleum
Mineral Oil, USP
Mineral Oil, USP is useful in
levigating of substances insoluble in it in the
preparation of ointment base
Mineral Oil, USP
Salicylic acid, Zinc oxide
Mineral Oil, USP synonyms
Liquid Petrolatum
a purified mixture of solid HC obtained from petroleum
Paraffin, NF
Characteristics of Paraffin, NF
colorless or white, more or less translucent mass that may be used to harden or stiffen oleaginous semisolid ointment bases
from crushed olives- also called ___________
Olive Oil, USP - sweet oil
Those that permit the incorporation of
aqueous solutions resulting in the formation of water-in-oil emulsion.
Anhydrous absorption bases
Anhydrous absorption bases characteristics
a) Insoluble in water
b) Not water washable
c) Anhydrous
d) Can absorb water
e) Emollient
f) Occlusive
g) Greasy
Greasy examples
Hydrophilic Petrolatum and Anhydrous Lanolin
Those that are already water-in-oil emulsion that permits the incorporation of small additional quantities of aqueous solution
Emulsion Base
Emulsion Base characteristics
a) Insoluble in water
b) Not water washable
c) Contains water (limited)
d) Emollient
e) Occlusive
f) Greasy
Are oil-in-water emulsion that are capable of being washed from skin or clothing with water
water removable base
water removable base frequently referred to as
“water washable” ointment base
By this method, all or some of the components of an ointment are combined by melting together and cooled with constant stirring until congeal.
Fusion method
In fusion method added last when temperature is low enough not to cause decomposition
heat labile substances and volatile constituents
Semisolid pharmaceuticals frequently either in
jars or in tubes
The jars may be made
glass, uncolored, colored green, amber or blue or
opaque and porcelain white
The tubes are made of tin or plastic. These are called
“collapsible tube”
TESTS REQUIREMENTS FOR OINTMENTS
Microbial Content
Minimum Fill Test
Packaging, Storage, and Labeling
Additional Standards
Microbial Content
▪ Meet acceptable standard for microbial
▪ Must contain antimicrobial preservatives
Microbial Content: Preservatives
methylparaben, propyl paraben, phenols, benzoic acid,
sorbic, quaternary ammonium salts
example of Microbial Content
Betamethasone Valerate Ointment
Betamethasone Valerate Ointment – must be absence of
Staphylococcus aureus and Pseudomonas aeruginosa
net weight and volume
Minimum Fill Test
Packaging, Storage, and Labeling
▪ metal, plastic tubes, jar
▪ Well close containers, light sensitive, light resistant
▪ Labeling- type of base used (water soluble or insoluble)
Additional Standards
▪ Examine the viscosity
▪ Vitro drug release to ensure within lot and lot-to-lot uniformity
A semisolid dosage form containing one or more drug substances dissolved or dispersed in either a water-in-oil emulsion or an oil-in-water or in another
type of water-washable base.
creams
These are viscous semisolid emulsions which are meant for external use
creams
Cream is divided in to two types namely as
1) Aqueous creams
2) Oily creams
the emulsions are o/w type & it is relatively non
greasy
Aqueous creams
The emulsifying waxes are (examples)
anionic, cationic & non –ionic
used as emulsifying agent in creams
polysorbate, triethanolamine soap
In case of oily creams w/o type & it is relatively
greasy
emulsifying agent in oily creams
wool fat, wool alcohols, beeswax & calcium soap
The cream should be store in
collapsible tube & supplied in well closed
container to prevent evaporation & contamination.
are semi-solid systems consisting of dispersions of small or large molecules in an aqueous liquid vehicle rendered jellylike by the addition of a gelling agent.
gels
gels are sometimes called
“Jellies”