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Ointments, creams and gels. Phardose

Ointments, creams and gels. Phardose

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Published by Kim Manlangit

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Published by: Kim Manlangit on Aug 16, 2010
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1
 Name:Pharmaceutical DosageChapter 10: Ointments, Creams, and GelsOintments, Creams, and Gels
y
 
S
emisolid dosage forms for topical application
y
 
A
 pplied to the: skin, surface of the eye, nasally, vaginallyor rectally
y
 
U
sed for therapeutic effects of the agents they contain(emollients, protective barriers, and vehicles)Topical Dermatological Products
y
 
Drugs delivered into the skin for treatment of dermaldisorder 
y
 
F
or local effects
y
 
S
kin as the target organTransdermal Products
y
 
Drugs delivered through the skin (percutaneousabsorption) to the general circulation
y
 
F
or systemic effects
y
 
S
kin not the target organOintments
y
 
S
emisolid preparations for external application to theskin or mucous membranesTypes of Ointments
y
 
M
edicated
 
F
or treatments of cutaneous (skin disease)
 
F
or both local and systemic effects
 
S
ystemic drug absorption considered sincedrugs:
 
E
nter the fetal blood supply
 
B
reast milk can be transferred to thefetus or nursing mother 
 
E
xamples:
S
ulfur Ointment, Zinc OxideOintment and Compound Resorcinol
y
 
 Non-medicated
 
Referred to as ³ointment bases´
 
U
se as for their physical effects: protectant,emollient or lubricating effect or use asvehicles in medicated ointments
 
E
xample: White OintmentOintment
B
ases
y
 
U
sed for medicated ointments:
 
Physical effects
 
V
ehicles
y
 
F
our general groups:
 
Oleaginous bases
 
A
 bsorption bases
 
Water-removable bases
 
Water-soluble basesOleaginous or Hydrocarbon
B
ases
y
 
U
ses: emollient effect
 
E
ffective as occlusive dressing
y
 
Remain on the skin for long periods without drying out
y
 
I
mmiscibility with water (difficult to wash off)
y
 
Characteristics
 
Retained on the skin for prolong period of time
 
Do not permit the escape of moisture of theskin to the atmosphere
 
Difficult to wash: act as occlusive dressing
 
They do not change noticeably upon aging
y
 
L
evigating agent: liquid petrolatum when powderedsubstance is incorporated into HC bases
 
Petrolatum,
US
P (yellow petrolatum and petroleum jelly)
 
Purified mixture of semisolid HCsobtained from petroleum
 
Product:
V
aseline (Chesebrough-Ponds)
 
White Petrolatum,
US
P (white petrolatum jelly)
 
Wholly or nearly decolorized purified mixture of semisolid HCsfrom petrolatum
 
U
ses: diaper rash, dry skin
 
Commercial product: White
V
aseline(Chesebrough-Ponds)
 
Y
ellow Ointment,
US
P (simple ointment)
 
Purified wax obtained from thehoneycomb of the bee
A
 pis mellifera
 
Has slightly greater viscosity than plain petrolatum
 
White Ointment
 
Consists of white wax and white petrolatum
A
 bsorption
B
ases
y
 
2
types those that:
 
Permit the incorporation of aqueous solutionsresulting in the formation of water in oilemulsions
 
E
xamples: hydrophilic petrolatum and anhydrouslanolin
 
Water in oil emulsions that permit theincorporation of additional quantities of aqueous solutions
 
E
xamples: lanolin (as emollient)and cold cream
y
 
Characteristics
 
 Not easily removed from the skin with water washing
 
M
ay possess some power of penetration intothe deepest layers of the skin
 
Therefore are used for ³endodermic´ ointment
y
 
U
ses
 
A
s emollient but do not provide the degree of occlusion
 
I
ncorporates aqueous solutions into oleaginous basesTypes of 
A
 bsorption
B
ases
y
 
Hydrophilic petrolatum
 
Composed of stearyl alcohol, white wax,cholesterol, and white petrolatum
 
Characteristics: ability to absorb water with theformation of water in oil emulsion
 
Commercial product: aquaphor (variation of hydrophillic petrolatum)
y
 
A
nhydrous lanolin,
US
P
 
M
ay contain no more than 0.
25%
water 
 
Characteristics:
 
I
nsoluble in water but mixeswithout separation with abouttwo times its weight in water 
 
2
 
o
 
incorporation of water results inthe formation of a water in oilemulsion
 
S
ynonym: refined wool fat
y
 
L
anolin,
US
P
 
Obtained from wool of sheep (Ovis aries)
 
Purified wax-like substance: cleaned,deodorized, and decolorized
 
Processed to reduce contents of free lanolinalcohols, any detergent and pesticide residues
 
Characteristics:
o
 
Water in oil emulsion thatcontains between
25%
to 30
%
 water 
o
 
A
dditional water may beincorporated by mixing
 
S
ynonym: hydrous wool fat
y
 
Cold cream,
US
P
 
S
emisolid white water in oil emulsion preparedwith cetyl esters wax, white wax, mineral oil,sodium borate, and purified water 
 
U
ses: emollient and base
 
E
xamples:
E
ucerin cream: a water in oilemulsion of petrolatum, mineral oil, mineralwax, wool wax, alcohol and bronopolWater-Removable
B
ases (Water Washable
B
ases)
y
 
Oil in water emulsion resembling creams
y
 
A
queous external phase
y
 
E
asily washed from skin
y
 
Can absorb serous discharges
y
 
Characteristics:
 
Resemble creams in their appearance
 
M
ay be diluted with water or with aqueoussolution
 
Can absorb serous discharges
 
Certain medicinal agents may be better absorbedin the skinTypes of Water-Removable
B
ases (Water Washable
B
ases)
y
 
Hydrophilic ointment
 
S
odium lauryl sulfate (emulsifying agent)
 
S
tearyl alcohol and white petrolatum (oleaginous phase of the emulsion)
 
M
ethylparaben and propylparaben (antimicrobial preservatives)
 
USE
: employed as water removable vehicle for medicinal substancesWater-
S
oluble
B
ases
y
 
Do not contain oleaginous components
y
 
Water washable, referred to as greaseless
y
 
S
often greatly with water, large amount of aqueoussolutions not effectively incorporated
y
 
U
sed for incorporation of solid substances
y
 
Polyethylene Glycol Ointment
 
Polymer of ethylene oxide and water 
 
Combining P
E
G 33
5
0 (solid) with P
E
G 400(liquid), results in a very pliable semisolidointment
S
election of the
A
 ppropriate
B
ase
y
 
S
election for use in the formulation of an ointment dependson a number of factors:
 
Desired released rate of the drug substance fromthe ointment base
 
Desirability of topical or percutaneous drugabsorption
 
Desirability of occlusion of moisture from theskin
 
S
tability of the drug in the ointment base
 
E
ffect if any of the drug on the consistency or other features of the ointment base
 
Desire for a base that is easily removed bywashing off water 
 
Characteristic of the surface to which it is applied
 
S
elected: base that provides the best combinationof the most desired attributesPreparation of Ointments:
y
 
I
ncorporation
y
 
F
usion
I
ncorporation
y
 
Components mixed until a uniform preparation isattained
y
 
On a small scale (extemporaneous compounding):components mixed using a mortar and pestle or spatulato rub the ingredients together on an ointment slab
y
 
 Non-absorbent parchment paper used to cover theworking surface
I
ncorporation of 
S
olid
y
 
The particle size of a powder or crystalline material isreduced before incorporation into the ointment base for the final product not to be gritty
y
 
Done by levigating (mineral oil) or mixing the solidmaterial in a vehicle in which it is insoluble to make asmooth dispersion
I
ncorporation of 
L
iquids
y
 
S
mall amounts of an aqueous solution may beincorporated into an oleaginous ointment
y
 
B
ases, even if hydrophilic have limits to retain liquids, beyond: become too soft and semiliquid
y
 
A
lcohol solution (small volume) may be added easily tooleaginous vehicle or emulsion bases
y
 
L
arge scale: roller mills force coarsely formed ointmentsthrough stainless steel rollers to produce ointments thatare uniform in composition and smooth in texture
y
 
S
mall ointment mills: used also in product developmentlaboratories and in small batch manufactureOintment Roller 
M
ill
y
 
S
uitable for grinding ointment, paste, paints, printer¶sink, etc. in the pharmaceutical plastic industry
y
 
The machine is conducted on a closed sheet iron base,with in-built foot mounting, for floor positioning
F
usion
M
ethod
y
 
A
ll or some of the components of an ointment arecombined by being meted together and cooled withconstant stirring until congealed
y
 
The heat labile substances and volatile constituents areadded last when temperature is low enough not to causedecomposition
y
 
Carried out:
 
S
mall scale: porcelain dish or glass beaker 
 
L
arge scale: large steam-jacketed kettle
y
 
Prepared by fusion:
 
M
edicated ointments and ointment bases (with beeswax, paraffin, stearyl alcohol, and highmolecular weight P
E
G)
 
Preparation of ointments with an emulsion base: manufacturing involves melting andemulsification
 
3
 
S
tainless
S
teel Tank 
y
 
Creams and ointments in batch sizes up to 1
5
00 kilos aremanufactured in stainless steel tanks.Compendial Requirements (
US
P Tests) for Ointments
y
 
M
icrobial content
 
Topical applications are not required to be sterile(except ophthalmic preparations)
 
S
trict adherence to environment control andapplication of good manufacturing practices: tominimize the microorganisms in unstrerilized pharmaceutical products
 
A
ntimicrobial preservatives in topical preparations:methylparaben, propylparaben, phenols, benzoicacid, sorbic acid amd quarternary ammonium salts
 
M
ust meet the requirements of the test for absenceof 
S
tap.
A
ureus and Pseudomonas aeruginosa
 
F
or rectal, urethral, vaginal use: tested for yeast andmolds
y
 
M
inimum fill
 
Determination of the net weight or volume of thecontents of containers: to ensure proper contentscompared with labeled amount
y
 
Packaging, storage and labeling
 
Packaging:
 
Ointments and other semisolid preparation:large-mouth ointment jars, metal or plastictubes
 
L
ight-sensitive preparations: opaque of light-resistant containers
 
S
torage
 
Well-closed containers to productcontamination
 
L
abeling (
US
P):
 
I
nclude the type of base used
A
dditional
S
tandards
y
 
US
P requires manufacturer: examine semisolid preparation for viscosity and for in vitro drug releaseCreams
y
 
S
emisolid preparations containing one or more medicinalagents dissolved
y
 
Dispersed either in W/O emulsion or O/W emulsion or inanother type of water-washable base
 
V
anishing cream: O/W emulsions containing large percentages of water and stearic acid or other oleaginous components
 
Primary application:
 
Topical skin products used rectally andvaginally
 
E
asier to spread and remove, preferred thanointments
E
xamples of Ointments and Creams
y
 
A
nesthetics
 
B
enzocain: various
 
Dibucaine: Nupercainal cream and ointment
y
 
A
stringent or protectant
 
Zinc oxide: various
y
 
Depigmenting agents
 
Hydroquinone cream:
E
ldoopaque cream
y
 
S
cabicides
 
L
indane: Kweel cream
y
 
S
unscreen agent
 
Dioxybenzone:
S
olvar cream and oxybenzoneGels
y
 
S
emisolid system consisting of small or large moleculesin an aqueous liquid vehicle rendered jelly like by theaddition of a gelling agent.
y
 
Gelling agent used:
 
S
ynthetic
 
M
acromolecules
y
 
S
ometimes called jellies
y
 
Gelling agents: carbomer 934, cellulose derivatives(carboxymethyl-cellulose) and natural gums (tragacanth)
S
ingle-Phase Gels
y
 
M
acromolecules uniformly distributed throughout aliquid
y
 
E
xample: Na C
M
C and tragacanth gelTwo-Phase
S
ystems
y
 
Gel mask consists of floccules of small distinct particles
y
 
E
xample:
M
ilk of 
M
agnesia (often referred as magma)Characteristics of Gels
y
 
Thickens on standing, forming a thixotrope, shaken before use to liquefy the gel and enable pouring
y
 
Remain fairly uniform upon standing and does notreadily settle because of high degree of attraction between the dispersed phase and water medium
y
 
A
luminum hydroxide gel
y
 
F
ormulated to contain drug substance:
 
S
olvents (alcohol and/or propylene)
 
A
ntimicrobial preservatives (methylparaben or chlorhexidine gluconate)
 
S
tabilizers (edentate disodium)
U
ses of Gels
y
 
L
ubricant for catheters
y
 
B
ases for patch testing
y
 
E
xamples:
 
 NaCl gel for electrocardiography
 
F
loucinonide Gel for anti-inflammatorycorticosteroid
 
 Na
F
luoride & Phosphoric acid gel ± dental care prophylactic
 
Tretionoin Gel for treatment of acneGels and
M
agmas
y
 
Considered colloidal dispersion since they contain particles of colloidal dimensions
A
 pproriate Names (Colloidal Dispersion)
y
 
S
O
LS
: term to designate a dispersion of solid in either aliquid, solid or gas dispersion medium
 
Prefix hydro: water as dispersion medium so calledhydrosol
 
Prefix alco: alcohol as the dispersion medium socalled alcosol
 
A
erosol: dispersion of solid or liquid in gaseous phasePreparation of Gels
y
 
B
y freshly precipitating the disperse phase upon reachingan inorganic agent, a gelatinous precipitate results
y
 
E
xample: Preparation of 
A
l(OH)3 gel
A
lCl
3
+ Na
2
CO
3
 
p
NaHCO
3
 
 
B
y direct hydrating the inorganic material in water 
A
l
2
O
3
+ H
2
O
p
 
A
l(OH)
3
 
y
 
E
xamples:
A
luminum Hydroxide Gel,
A
lugel,
A
mphogel, Ce-lu-gel, Cremalin, Hydroxal,
V
anogel,
A
luminum Phosphate Gel (Phosphagel): antacid
E
xamples of Topical Gels
y
 
E
rythromycin and benzoyl peroxide topical gel:
B
enzamycin

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