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Uy, Alyssa V.

Chapter 10 -OINTMENTS, CREAMS, GELS d. They do not change noticeably
upon aging
e. Insoluble in water
f. Not water-washable
Ointments, Creams, and Gels – TOPICAL APPLICATION
g. Anhydrous
 to the skin
h. Will not absorb water
 place on the surface of the eye
i. Emollient
 vaginally, nasally, rectally j. Occlusive
TOPICAL DERMATOLOGICAL designed to deliver drug into the skin – dermal k. Greasy
disorders (SKIN AS TARGET ORGAN) l. Nonirritating
TRANSDERMAL designed to deliver drug through skin (percutaneous absorption) – m. Inexpensive, non reactive
general circulation – SKIN NOT BEING THE TARGET ORGAN - Sources Of Hydrocarbon Bases
NOTE: SYSTEMIC ABSORPTION – always considered a. Vegetable Oil - Mineral oil
b. Animal Fat - Oleic oil
OINTMENTS c. HC from Petrolatum
- 3 Forms of HC
 Unguents are semisolid preparations for external application of such a. Liquid hydrocarbon - Mineral oil
consistency that they maybe readily applied to the skin with or b. Semi-solid HC petrolatum –
without inunction (rubbing) Vaseline
 Ointments should be of such composition that they soften but not c. Solid HC - Paraffin
necessarily melt when applied to the body. - Examples
 General Uses Of Ointments a. White Petrolatum
1. Acts as protective or protectant - serve as physical barrier b. White Ointment
to environment c. Vegetable shortening
2. Acts as emollient - softens skin and makes it pliable d. Vaseline
3. Carrier of medicament - vehicle - Examples Of Hydrocarbon Bases
 Types Of Ointments >Petrolatum, NF - mixture of semisolid HC
1. Medicated - those with medicaments for treatments of obtained from petroleum
cutaneous (skin diseases). Properties: An unctous mass,
Examples: Sulfur Ointment, Zinc Oxide color yellowish to light amber,
Ointment and Compound Resorcinol melts between 380C -600C
2. Non-medicated - also referred to as “ointment bases” and Synonyms: Yellow petrolatum,
use as such for their emollient or lubricating effect or use Petroleum jelly
as vehicles in medicated ointments. Commercial Product: Vaseline
Example: White Ointment >White Petrolatum, USP - is petrolatum that
 The USP and NF Classify Ointment Bases into Four General Groups has been decolorized
a. Hydrocarbon bases or Oleaginous bases Uses: diaper rash, dry skin
b. Absorption bases Synonym: White Petroleum Jelly
c. Water removable bases or Emulsion Ointment bases Commercial Product: White
d. Water soluble bases Vaseline
 Factors of selecting ointment bases >Yellow Ointment - Each 100 g contains 5 g
a. Physicochemical properties of the medicaments as yellow wax and 95 g of petroleum. Yellow wax
stability in the base or influence on consistency is purified wax obtained from honeycomb of
b. Patient’s conditions – as to the desired release rate of the the bee (Apis mellifera)
drug from the base Synonym: Simple Ointment
c. Intended site of application – ability of occlusion of >White Ointment, USP - 100 g contains 5% of
moisture from the skin by the base white wax (bleached purified beeswax) and
d. Characteristics of the various vehicles available – use the 95% white petrolatum
one which provided the majority of essential attributes >Paraffin, NF - is a purified mixture of solid HC
 Types of bases obtained from petroleum
1. HYDROCARBON BASES Characteristics: colorless or white,
- are water-free, and aqueous preparations may only more or less translucent mass that
be incorporated into them in small amounts and may be used to harden or stiffen
then with difficulty oleaginous semisolid ointment
- USES: HC are use mainly for their emollient bases.
effect and not intended for >Mineral Oil, USP - is a mixture of liquid HC
penetration into the skin. They aredifficult to obtained from petroleum. Useful in levigating
wash off. They do not “dry out” or change of substances insoluble in it in the preparation
noticeably upon aging. of ointment base e.g. Salicylic acid, Zinc oxide
- Characteristics Synonym: Liquid Petrolatum
a. Retained on the skin for prolong >Olive Oil, USP - from crushed olives- also
period of time called sweet oil
b. Do not permit the escape of
moisture to the skin to the 2. OFFICIAL ABSORPTION BASES
atmosphere - 2 TYPES
c. Difficult to wash as such they acts >Those that permit the incorporation of
as occlusive dressing
aqueous solutions resulting in the
formation of water-in-oil emulsion. wax, white wax, mineral oil, sodium borate,
(Anhydrous absorption bases) and purified water
i. Insoluble in water Examples: Eucerin cream - is a
ii. Not water washable W/O emulsion of petrolatum,
iii. Anhydrous mineral oil, mineral wax, wool
iv. Can absorb water wax, alcohol and bronopol. Cold
v. Emollient cream - emollient and base.
vi. Occlusive
Examples: Hydrophilic Petrolatum and Are oil-in-water emulsion that are capable of being
Anhydrous Lanolin washed from skin or clothing with water. For this
>Those that are already water-in-oil reason, they are frequently referred to as “water-
emulsion (emulsion base) that permits the washable” ointment base.
incorporation of small additional quantities WATER REMOVABLE BASES
of aqueous solution - Characteristics
- Characteristics a. Resemble creams in their appearance
a. Insoluble in water b. May be diluted with water or with
b. Not water washable aqueous solution
c. Contains water (limited) c. From therapeutic viewpoint, no ability to
d. Emollient absorb serous discharge in dermatologic
e. Occlusive conditions
f. Greasy d. Certain medicinal agents may be better
Examples: Lanolin and Cold cream; water absorbed in the skin
soluble drugs: Gentamycin Sulfate e. Insoluble in water
- Characteristics f. Water washable
a. Not easily removed from skin g. Contains water
with water washing h. Can absorb water
b. May possess some power of i. Non-occlusive
penetration into the deepest j. Non-greasy
layers of the skin - Example:
c. Used for “endodermic” ointment Hydrophilic Ointment, USP - is “water
- USES loving”. It contains sodium lauryl sulfate as
>As emollient but do not provide the the emulsifying agent, with stearyl alcohol
degree of occlusion and white petrolatum representing the
>Incorporates aqueous solutions into oleaginous phase of emulsion and
oleaginous bases propylene glycol and water representing
- EXAMPLES OF ABSORPTION BASES the aqueous phase. Methyl and Propyl
a. Hydrophilic Petrolatum, USP - parabens are used as preservatives
composed of cholesterol, stearyl a. Hydrophilic Ointment
alcohol, white wax and white b. Vanishing Cream
petrolatum c. Dermabase
Example: Aquaphor d. Velvachol
b. Anhydrous Lanolin, USP - may contain e. Unibase
NMT 0.25% water. - USE: employed as water removable vehicle for
Characteristics: It is insoluble in medicinal substances
water but mixes without
separation with about 2x its 4. WATER SOLUBLE BASE
weight in water. The Unlike water-removable bases, which contains both
incorporation of water results in water soluble and water insoluble components. Like
the formation of a W/O water-removable bases, however, water soluble bases
emulsion are water washable and are commonly referred to as
Synonym: Refined Wool Fat “greaseless” because of the absence of any oleaginous
c. Lanolin, USP - is a semisolid fat like materials
substance obtained from the wool of sheep - Characteristics
(Ovis aries) a. Because they soften greatly with the
Characteristics: It is a W/O addition of water, aqueous solutions are
emulsion that contains between not effectively incorporated into these
25 to 30% water. Additional bases. Rather, they are better used for the
water may be incorporated into incorporation of non-aqueous or solid
lanolin by mixing substance.
Synonym: Hydrous Wool Fat b. These penetrated the skin and better used
d. Cold Cream, USP - is a semi solid white for absorption of medicament and
W/O emulsion prepared with cetyl esters therefore used for “diadermic ointment”.
c. Water soluble
d. Water washable quite suitable for the absorption and
e. May contain water incorporation of the aqueous solution.
f. Can absorb water (limited) - In case of of hydrophobic base and an
g. Non-occlusive aqueous solution is to be added, a
h. Non-greasy portion of the hydrophobic base is
i. Lipid-free replaced by a hydrophilic base.
- Example: Polyethylene Glycol Ointment, USP is a 2. FUSION METHOD
combination of 400 g of polyethylene glycol 4000 - By this method, all or some of the
(solid) and 600 g of polyethylene glycol 400 components of an ointment are combined by
(liquid) to prepare 1000 g of base. melting together and cooled with constant
 SELECTION OF THE APPROPRIATE BASE stirring until congeal.
1. The desired release rate of the particular drug substance - Those components not melted are generally
from the ointment base. added to the congealing mixture as it is
2. The desirability for enhancement by the base of the cooled and stirred.
percutaneous absorption of the drug. - The heat labile substances and volatile
3. The advisability of occlusion of moisture from the skin constituents are added last when
by the base. temperature is low enough not to cause
4. The short term and long term stability of the drug in the decomposition.
ointment base  Packaging and Storage Of Ointments
5. The influence, if any, of the drug on the consistency or Semisolid pharmaceuticals frequently either in jars or in tubes.
other features of the ointment base. The jars may be made of glass, uncolored, colored green, amber
 Preparation of Ointment or blue or opaque and porcelain white. Plastic jars are used in
1. INCORPORATION limited extent. The tubes are made of tin or plastic. These are
The components of the ointment are mixed together called “collapsible tube”.
by various means until a uniform preparation has been  TESTS REQUIREMENTS FOR OINTMENTS
attained. 1. Microbial Content
In small scale or in extemporaneous compounding of - Meet acceptable standard for microbial
the Rx, the pharmacist may use 2 means: - Must contain antimicrobial preservatives
i. Mixing ingredients in a mortar with Preservatives: methylparaben, propyl paraben,
pestle until smooth ointment phenols, benzoic acid, sorbic, quaternary ammonium
produced salts
ii. Use a spatula and an ointment slab (a Example: Betamethasone Valerate Ointment – must
large glass or porcelain plate) to rub be absence of Staphylococcus aureus and
the ingredients together (spatulation) Pseudomonas aeriginosa
a. Incorporation Of Solid
In preparing ointment by spatulation, the pharmacist 2. Minimum Fill Test – net weight and volume
works the ointment with a stainless steel spatula but if 3. Packaging, Storage, and Labeling
the components react with metal (such as iodine, a. metal, plastic tubes, jar
tannins, mercuric salts) the hard rubber is used b. Well close containers, light sensitive, light
1. The ointment base is placed on one resistant
side of the working surface. c. Labeling- type of base used (water soluble or
2. The powdered components insoluble)
(previously reduced into fine powders) 4. Additional Standards
are placed on the other side. a. Examine the viscosity
3. Then a portion of the powder is mixed b. Vitro drug release to ensure within lot and lot-to-
with a portion of the base lot uniformity
until uniform.  Tubes May Be Filled By The Following Steps
4. Repeat until all portions of the 1. The prepared ointment is rolled into a cylinder
product and based are combine. shape of a piece of parchment paper; the
5. The portions of prepared ointment are diameter is smaller than that of the tube.
then combined and thorough blended 2. With cap of the tube off to permit escape of air,
by continuous movement of the the cylinder of ointment with the paper is
spatula. inserted into the open bottom of the tube
b. Incorporation Of Liquids 3. The piece of paper covering the ointments is
- Liquid substances or solutions of drugs grasped in one hand, the other hand forces a
are added to an ointment only after heavy spatula down on the extreme end of the
due consideration of the ointment tube, collapsing it and retaining the ointment
nature. while the paper is slowly pulled from the tube.
- An aqueous solution would be added About one half (1/2) inch of the bottom is then
with difficulty to the oleaginous flattened with the spatula.
ointment, except in very small 4. About 1/8 folds are made from the flattened end
amount. However, water absorbable of the tube and sealed by pliers or sealing clip on
hydrophilic ointment bases would be foot operated “crimper” machine.
Note: Ointments made by fusion may be poured directly into the 13. Hydroquinone cream - Eldopaque cream (Depigmenting
tubes. Stored at temperatures below 30oC to prevent Agents)
softening. 14. Lindane - Kwell cream (Scabicides)
15. Dioxybenzone - Solvar cream and Oxybenzone (Sunscreening

Examples of Ophthalmic Ointment

Ointment Commercial Product Category

Chloramphenicol Chloromycetin Ophthalmic Antibacterial

Dexamethazone Na Decadrone Phosphate Anti-inflammatory phosphate

adrenocortical steroid

Gentamicin sulfate Garamycin Antibactrial

Isoflurophate Floropryl Sterile Cholinasterase

CREAMS inhibitor

 Are solid emulsion containing suspensions or solutions of Polymixin B-Bacitracin Polysporin Antimocrobial
medicinal agents for external application.
 Creams of the O/W type include foundation creams; hand Polymixin B –Bacitracin Neosporin Antimicrobial neomycin
creams; shaving creams; and vanishing creams.
Sulfacetamide Na Sodium sulamyd Antibacterial
 Creams of W/O type include cold creams; emollient creams
 Product referred to as creams may not actually conform to the
Tobramycin Tobrex Antibacterial
above definition.
 Many products that are creamy in appearance but do not have an Vidarabine Vira A Antiviral
emulsion-type base are commonly called creams
 Example:
- Bacitracin (Anti-bacterial)
- Nystatin- Mycostatin cream (Antifungal) GELS
- Tretinoin- Retin A Cream (Antiacne)
- Crotamiton- Eurax cream (Scabicides)  Are semisolid systems consisting of either suspensions made up of
- TIOCONAZOL – TROSYD small inorganic particles or large organic molecules in an liquid
- Luorouracil-Efudex Cream (Antineoplastic) vehicle rendered jelly like by the addition of a GELLING AGENT.
 Sometimes called JELLIES
 Examples of Gelling Agents
1. Carbomers 910; 934; 934P; 940; 941;1342
Examples of Ointments and Creams 2. Carboxymethylcellulose; natural gums
*0.5 to 2.0% concentration in water
Adrenocortical Steroids  Classes of Gel
1. 2 phase systems - separation between the insoluble
1. Betamethasone Valerate - Valisone cream and ointment
matter and liquid vehicle is observed. This type
2. Fluocinolone Acetonide - Synalar cream and ointment
contains inorganic materials
3. Hydrocortisone Acetate - Cortaid cream and ointment
Example: Al(OH)3 Gel
4. Triamcinolone Acetonine - Aristocort A cream and ointment
2. Single phase gel - consist of organic macromolecules
5. Tretinoin - Retin A cream and ointment (Antiacne Drug)
uniformly distributed throughout the liquid where no
6. Nitroglycerin - Nitro-Bid ointment (Antianginal drug)
apparent boundary is seen
7. Antibacterial/Anti-infectives
Example: Na CMC and Tragacanth Gel
a. Bacitracin - Baciguent ointment
3. Continuous phase - commonly aqueous where alcohol
b. Gentamicin Sulfate - Garamycin cream &
and gels may be use as continuous phase
Example: Mineral oil + polyethylene resin = oleaginous
c. Nystatin - Mycostatin cream and ointment
ointment base
d. Mupirocin - Bactroban ointment
 Characteristics of Gels
8. Antifungals
1. Gels may be thicken on standing, forming a
a. Nystatin - Mycostatin cream and ointment
THIXOTROPE, and must be shaken before use to
b. Miconazole Nitrate - Monistat-Derm cream
liquefy the gel and enable pouring – Aluminum
c. Naftidine HCl - Naftin cream
Hydroxide Gel
d. Tolnaftate - Tinactin cream
2. Because of high degree of attraction between the
9. Luorouracil - Efudex cream (Antineoplastic)
dispersed phase and water medium, the gels remain
10. Crotamiton - Eurax cream (Scabicides)
fairly uniform upon standing and does not readily
11. Anesthetics
a. Benzocaine - various
 Example of Gel
b. Dibucaine - Nupercainal cream and ointment
1. Clobetasol propionate- Termovate Gel (Dermatologic:
12. Zinc oxide – various (Astringent/Protectant)
2. Acetic acid- Aci-jel (Vaginal: Restoration and Preparation of Gels
maintenance of acidity)
3. Progesterone- Crinone Gel (Vaginal: Bioadhesive gel; 1. By freshly precipitating the disperse phase upon reacting an
Progesterone supplement and replacement) inorganic agents, a gelatinous precipitate results
 Uses of Gels Example: Preparation of Al(OH)3 gel is by reacting
1. Lubricant for catheters Al(Cl)3 + Na2CO3  NaHCO3
2. Bases for patch testing
3. NaCl gel for electrocardiography 2. By direct hydrating the inorganic material in water
4. Floucinonide Gel for anti- inflammatory corticosteriod
5. Na Fluoride & Phosphoric acid gel – dental care Al2O3 + H2O  Al(OH)3
Examples: Aluminum Hydroxide Gel; Alugel; Amphogel; Ce-lu-gel;
6. Tretionoin Gel for treatment of acne
Cremalin; Hydroxal; Vanogel; Aluminum Phosphate Gel
7. Prostaglandin Gel – intravaginal
(Phosphagel) – Antacid
 Gels and Magmas are considered colloidal dispersion since they
contain particles of colloidal dimensions
 Examples Of Topical Gels
a. Erythromycin and benzoyl peroxide topical gel -
SOLS – term to designate a dispersion of solid in either a liquid, solid or gas b. Clindamycin Topical gel - Cleocin T Topical Gel
dispersion medium c. Benzoyl Peroxide Gel - Desquam-X 10 Gel - acne
a. Prefix HYDRO – water as dispersion medium so called vulgaris
HYDROSOL d. Hydroquinone Gel - Solaquin Forte Gel - bleach for
b. Prefix ALCO – alcohol as the dispersion medium so hyperpigmented skin
called ALCOSOL e. Salicylic Acid Gel - Compound W Gel - keratolytic
c. AEROSOL – dispersion of solid or liquid in gaseous f. Desoximetasone Gel - Topicort - anti-Inflammatory,
phase antipruritic agent

Active Ingredient Proprietary Gelling agent Route & Use

Acetic acid Aci-jel Tragacanth, acacia Vaginal; restoration & maintenance of acidity

Becaplermin Regranex gel Na CMC Dermatologic

Benzoyl peroxide Desquam-X gel Carbomer 940 Acne vulgaris

Clindamycin Cleocin T gel Carbomer 934 Antipruritic

Cyanocobalamin Nascobal Methylcellulose Nasal: hematologic

Desoximetasone Topicort gel Carbomer 940 Anti-inflammatory; antipruritic

Metronidazole Metro-gel Carbomer 934P Vaginal-bacterial

Progesteron Crinone gel Carbomer 934P Progesterone supplement

Tretinoin Retin-A Hydroxypropyl cellulose Acne vulgaris

TRANSDERMAL PREPARATIONS b. Absorbs serous secretions and are preferred for acute
- Ointments, creams, gels designed to deliver a drug systematically lesions having a tendency to ooze
by addition of PENETRATION ENHANCERS to the topical vehicle c. Are less penetrating than ointment
- Examples of Penetration Enhancers d. Are less macerating than ointment
o Dimethyl sulfoxide (DMSO), ethanol, propylene glycol,  Types
glycerin, polyethylene glycol, urea, dimethyl a. Dermatologic Paste
acetamide, sodium lauryl sulfate, poloxamers, Spans, b. Paste for injection
Tweens, lecithin, and terpenes  Examples of Paste
o Example: PLURONIC lecithin organogel (PLO) – Pluronic a. Zinc Oxide Paste with acid - Lassar’s Paste - Salicylic
(Poloxamer) F127 gel (usually 20% to 30% acid 20 g; and ZnO paste q.s. to make 1000g
concentration) b. Zinc Oxide Paste - ZnO 250 g; Starch 250 g ; White
petrolatum 500 g to make 1000 g
PASTE c. Triamicinolone Acetonide Dental Paste
 Dermatologic paste are ointment like preparations employed in
practice of dermatology PLASTERS
 Usually stiffer, less greasy and more absorptive than ointments  Substances intended for external application, made of such
such as starch, ZnO, CaCO3 , and talc in the base materials and consistency as to adhere to the skin and thereby
 Characteristics attach as dressing
a. Stiffness and impenetrability, not suited for hairy parts  Purpose:
of the body a. To afford protection and mechanical support
b. To furnish an occlusive macerating action ulcers because of its ability to form pressure bandage
c. To bring medication into close contact with surface of known as “gelatin boot”.
skin General information
 Example of Plasters
Medicinal substance 100g
a. Adhesive plaster – consisting of vinyl resin, plasticizers,
and chemical additives Gelatin 150g
b. Modern Plasters – are practically all machine made and Glycerin 400g
are available in colors such as flesh, striped, and others
Purified water 350g
c. Medicated plasters - Salicylic Acid Plaster, Salonpas
d. BACK PLASTERS to make about 1000g
i. are made of heavy cotton or wool and
cotton backing to provide warmth and
support. DRESSINGS
ii. They are usually used for backache, sore  Dressings are external application resembling ointments in
shoulders, sore arms, and other muscular consistency, but remaining semisolid at body temperature, they
aches liquefy at 500C and remain pliable in thin films below 280C.
iii. The active constituents of back plaster is  Classes Of Dressings
OLEORESINS OF CAPSICUM a. Primary wound dressing or now as wet dressing
iv. EXAMPLES: Chilli Plaster; Hot Salonpas b. Absorbents - surgical cotton and gauze
c. Bandages
CERATES d. Adhesive tapes
 Examples of Dressings
 Are unctuous preparations of such consistency that may be easily a. Paraffin dressing, formerly official in the NF VI, was
spread at ordinary temperature upon muslin cloth or similar employed as an air-excluding, soft, pliable, analgesic, splint-
material with spatula yet not soft to liquefy and run when applied like covering for surface denuded by burns
to the skin b. Petrolatum Gauze, USP - is absorbent gauze saturated with
 Contents: oil, hard petrolatum and beeswax white petrolatum.
 Examples: Cantharides cerates; Rosin cerate; Camphor cerate; c. Furazone gauze pads-sterile - antibacterial dressings
Cerate of lead acetate; Compound Rosin Cerate containing nitrofurazone
d. Surgical dressing is any material used as covering,
CATAPLASM protective, or support for a diseased part
 Are viscous preparation intended for warm, external application 1. Adhesive bandage, USP
to a body for purpose of reducing inflammation 2. Gauze bandage
 Are soft semisolid, external applications which either stimulate a  Packaging Semi Solid Preparations
body surface or alleviate an inflamed area by supplying a. Topical dermatologic – jars or tubes
medication substance in the presence of heat and mixture. b. Ophthalmic, nasal, vaginal, rectal – tubes
Example: Numotizine c. Ointments – ointment jars – opaque glass or plastic; some
colored green, amber or blue
CEMENTS d. Ointment jars – about 0.5 ounce to 1 pound
 Are dental preparation employed primarily as temporary e. Jars and tubes – must be tested for compatibility and
protective coverings for exposed pulps; also for holding medicinal stability
agents in tooth cavities and re-basing of dentures. f. Ointment tubes – aluminum or plastic
 Methods of preparation and Ingredients g. Ophthalmic, rectal, vaginal, aural or nasal – packaged with
a. Mixing a powder consisting of ZnO, and other metallic special applicator
salts with a liquid consisting of either eugenol or clove h. Aluminum tubes – coated with epoxy resin, vinyl lacquer to
oil mixed with a bland oil. eliminate any interaction with the content
b. Zinc acetate and other metallic salts accelerate the i. Plastic tubes – High or low density polyethylene (HDPE or
settling time LDPE), polypropylene (PP), polyethylene terepththalate
c. The consistency of the cement may be altered by (PET), plastics, foil or paper laminate sometimes 10 layers
varying amount of the liquid. thick
j. LDPE – soft and resilient, provides good moisture barrier
GLYCEROGELATINS k. HDPE – less resilient but provides a superior moisture
 Are plastic masses intended for topical application and containing barrier
gelatin, glycerin, and water and a medicament suitable for l. 12. PP – has a high level of heat resistant
application in dermatological practice. m. 13. PET – transparency and high degree of chemical
a. Glycerogelatins are melted prior to application, cooled n. 14. Multiple dose tubes –continuous thread closures
to only slightly above body temperature, and applied o. 15. Single dose tubes – “tearaway tip”
to the affected area with a fine brush. After p. 16. Tubes – capacities of 1.5, 2, 3.5, 5,15,30,45,60,120g
application the glycerogelatins hardens, usually q. 17. Ophthalmic ointments- collapsible plastic or aluminum
covered with bandage.
b. Example: Zinc Gelatin Boot
c. Zinc Gelatin is a firm, plastic mass containing 10% zinc
oxide in a glycerogelatin base - treatment of varicose