Dosage - Chapter 10

7/30/2019 Dosage - Chapter 10

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Chapter 10: Ointments, Creams, and Gels

Ointments, Creams, and Gels

Semisolid dosage forms for topical application Applied to the: skin, surface of the eye, nasally, vaginally

or rectally

Used for therapeutic effects of the agents they contain(emollients, protective barriers, and vehicles)

Topical Dermatological Products

Drugs delivered into the skin for treatment of dermaldisorder

For local effects Skin as the target organ

Transdermal Products

Drugs delivered through the skin (percutaneousabsorption) to the general circulation

For systemic effects Skin not the target organ

Ointments

Semisolid preparations for external application to theskin or mucous membranes

Types of Ointments

Medicated For treatments of cutaneous (skin disease) For both local and systemic effects Systemic drug absorption considered since

drugs:

Enter the fetal blood supply Breast milk can be transferred to thefetus or nursing mother

Examples: Sulfur Ointment, Zinc OxideOintment and Compound Resorcinol

Non-medicated Referred to as ointment bases Use as for their physical effects: protectant,

emollient or lubricating effect or use as

vehicles in medicated ointments

Example: White OintmentOintment Bases

Used for medicated ointments: Physical effects Vehicles

Four general groups: Oleaginous bases Absorption bases Water-removable bases Water-soluble bases

Oleaginous or Hydrocarbon Bases

Uses: emollient effect Effective as occlusive dressing

Remain on the skin for long periods without drying out

Immiscibility with water (difficult to wash off) Characteristics

Retained on the skin for prolong period oftime

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

Levigating agent: liquid petrolatum when powderedsubstance is incorporated into HC bases

Petrolatum, USP (yellow petrolatum andpetroleum jelly)

Purified mixture of semisolid HCsobtained from petroleum

Product: Vaseline (Chesebrough-Ponds)

White Petrolatum, USP (white petrolatumjelly)

Wholly or nearly decolorizedpurified mixture of semisolid HCs

from petrolatum

Uses: diaper rash, dry skin Commercial product: White Vaseline

(Chesebrough-Ponds)

Yellow Ointment, USP (simple ointment) Purified wax obtained from thehoneycomb of the bee Apis mellifera Has slightly greater viscosity than

plain petrolatum

White Ointment Consists of white wax and white

petrolatum

Absorption Bases

2 types those that: Permit the incorporation of aqueous solutions

resulting in the formation of water in oil

emulsions

Examples: hydrophilicpetrolatum and anhydrous

lanolin

Water in oil emulsions that permit theincorporation of additional quantities of

aqueous solutions

Examples: lanolin (as emollient)and cold cream

Characteristics Not easily removed from the skin with water

washing

May possess some power of penetration intothe deepest layers of the skin

Therefore are used forendodermic ointment

Uses As emollient but do not provide the degree of

occlusion

Incorporates aqueous solutions intooleaginous bases

Types of Absorption Bases

Hydrophilic petrolatum Composed of stearyl alcohol, white wax,

cholesterol, and white petrolatum

Characteristics: ability to absorb water withthe formation of water in oil emulsion

Commercial product: aquaphor (variation ofhydrophillic petrolatum)


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Anhydrous lanolin, USP May contain no more than 0.25% water Characteristics:

Insoluble in water but mixeswithout separation with about

two times its weight in water

o incorporation of water resultsin the formation of a water in

oil emulsion

Synonym: refined wool fat Lanolin, USP

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 that

contains between 25% to 30%

water

o Additional water may beincorporated by mixing

Synonym: hydrous wool fat Cold cream, USP

Semisolid white water in oil emulsionprepared with cetyl esters wax, white wax,

mineral oil, sodium borate, and purified water

Uses: emollient and base Examples: Eucerin cream: a water in oil

emulsion of petrolatum, mineral oil, mineral

wax, wool wax, alcohol and bronopol

Water-Removable Bases (Water Washable Bases)

Oil in water emulsion resembling creams Aqueous external phase Easily washed from skin Can absorb serous discharges Characteristics:

Resemble creams in their appearance May be diluted with water or with aqueous

solution

Can absorb serous discharges Certain medicinal agents may be better absorbed

in the skin

Types of Water-Removable Bases (Water Washable Bases)

Hydrophilic ointment Sodium lauryl sulfate (emulsifying agent) Stearyl alcohol and white petrolatum (oleaginous

phase of the emulsion) Methylparaben and propylparaben (antimicrobial

preservatives)

USE: employed as water removable vehicle formedicinal substances

Water-Soluble Bases

Do not contain oleaginous components Water washable, referred to as greaseless Soften greatly with water, large amount of aqueous

solutions not effectively incorporated

Used for incorporation of solid substances Polyethylene Glycol Ointment

Polymer of ethylene oxide and water Combining PEG 3350 (solid) with PEG 400

(liquid), results in a very pliable semisolid

ointment

Selection of the Appropriate Base

Selection for use in the formulation of an ointmentdepends on 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

Stability of the drug in the ointment base Effect 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 Selected: base that provides the best

combination of the most desired attributes

Preparation of Ointments:

Incorporation Fusion

Incorporation

Components mixed until a uniform preparation isattained

On a small scale (extemporaneous compounding):components mixed using a mortar and pestle or spatula

to rub the ingredients together on an ointment slab

Non-absorbent parchment paper used to cover theworking surface

Incorporation of Solid

The particle size of a powder or crystalline material isreduced before incorporation into the ointment base for

the final product not to be gritty

Done by levigating (mineral oil) or mixing the solidmaterial in a vehicle in which it is insoluble to make a

smooth dispersion

Incorporation of Liquids

Small amounts of an aqueous solution may beincorporated into an oleaginous ointment

Bases, even if hydrophilic have limits to retain liquids,beyond: become too soft and semiliquid

Alcohol solution (small volume) may be added easily tooleaginous vehicle or emulsion bases

Large scale: roller mills force coarsely formed ointmentsthrough stainless steel rollers to produce ointments thatare uniform in composition and smooth in texture

Small ointment mills: used also in product developmentlaboratories and in small batch manufacture

Ointment Roller Mill

Suitable for grinding ointment, paste, paints, printersink, etc. in the pharmaceutical plastic industry

The machine is conducted on a closed sheet iron base,with in-built foot mounting, for floor positioning

Fusion Method

All or some of the components of an ointment arecombined by being meted together and cooled withconstant stirring until congealed


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The heat labile substances and volatile constituents areadded last when temperature is low enough not to

cause decomposition

Carried out: Small scale: porcelain dish or glass beaker Large scale: large steam-jacketed kettle

Prepared by fusion: Medicated ointments and ointment bases

(with beeswax, paraffin, stearyl alcohol, and

high molecular weight PEG)

Preparation of ointments with an emulsionbase: manufacturing involves melting and

emulsification

Stainless Steel Tank

Creams and ointments in batch sizes up to 1500 kilos aremanufactured in stainless steel tanks.

Compendial Requirements (USP Tests) for Ointments

Microbial content Topical applications are not required to be sterile

(except ophthalmic preparations)

Strict adherence to environment control andapplication of good manufacturing practices: to

minimize the microorganisms in unstrerilized

pharmaceutical products

Antimicrobial preservatives in topical preparations:methylparaben, propylparaben, phenols, benzoic

acid, sorbic acid amd quarternary ammonium salts

Must meet the requirements of the test forabsence of Stap. Aureus and Pseudomonas

aeruginosa

For rectal, urethral, vaginal use: tested for yeastand molds

Minimum fill Determination of the net weight or volume of the

contents of containers: to ensure proper contents

compared with labeled amount

Packaging, storage and labeling Packaging:

Ointments and other semisolid preparation:large-mouth ointment jars, metal or plastic

tubes

Light-sensitive preparations: opaque of light-resistant containers

Storage Well-closed containers to productcontamination

Labeling (USP): Include the type of base used

Additional Standards

USP requires manufacturer: examine semisolidpreparation for viscosity and for in vitro drug release

Creams

Semisolid preparations containing one or moremedicinal agents dissolved

Dispersed either in W/O emulsion or O/W emulsion orin another type of water-washable base

Vanishing cream: O/W emulsions containing largepercentages of water and stearic acid or other

oleaginous components

Primary application: Topical skin products used rectally and

vaginally

Easier to spread and remove, preferred thanointments

Examples of Ointments and Creams

Anesthetics Benzocain: various Dibucaine: Nupercainal cream and ointment

Astringent or protectant Zinc oxide: various

Depigmenting agents Hydroquinone cream: Eldoopaque cream

Scabicides Lindane: Kweel cream

Sunscreen agent Dioxybenzone: Solvar cream and oxybenzone

Gels

Semisolid system consisting of small or large moleculesin an aqueous liquid vehicle rendered jelly like by the

addition of a gelling agent.

Gelling agent used: Synthetic Macromolecules

Sometimes called jellies Gelling agents: carbomer 934, cellulose derivatives

(carboxymethyl-cellulose) and natural gums (tragacanth)

Single-Phase Gels

Macromolecules uniformly distributed throughout aliquid

Example: Na CMC and tragacanth gel

Two-Phase Systems

Gel mask consists of floccules of small distinct particles Example: Milk of Magnesia (often referred as magma)

Characteristics of Gels

Thickens on standing, forming a thixotrope, shakenbefore use to liquefy the gel and enable pouring

Remain fairly uniform upon standing and does notreadily settle because of high degree of attraction

between the dispersed phase and water medium

Aluminum hydroxide gel Formulated to contain drug substance:

Solvents (alcohol and/or propylene) Antimicrobial preservatives (methylparaben or

chlorhexidine gluconate)

Stabilizers (edentate disodium)Uses of Gels

Lubricant for catheters Bases for patch testing Examples:

NaCl gel for electrocardiography Floucinonide Gel for anti-inflammatory

corticosteroid

Na Fluoride & Phosphoric acid gel dental careprophylactic

Tretionoin Gel for treatment of acneGels and Magmas


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Considered colloidal dispersion since they containparticles of colloidal dimensions

Approriate Names (Colloidal Dispersion)

SOLS: 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

Aerosol: dispersion of solid or liquid in gaseousphase

Preparation of Gels

By freshly precipitating the disperse phase uponreaching an inorganic agent, a gelatinous precipitate

results

Example: Preparation of Al(OH)3 gelAlCl3 + Na2CO3 NaHCO3

By direct hydrating the inorganic material in waterAl2O3 + H2O Al(OH)3

Examples: Aluminum Hydroxide Gel, Alugel, Amphogel,Ce-lu-gel, Cremalin, Hydroxal, Vanogel, Aluminum

Phosphate Gel (Phosphagel): antacid

Examples of Topical Gels

Erythromycin and benzoyl peroxide topical gel:Benzamycin

Clindamycin topical gel: Cleocin T Topical Gel Benzoyl peroxide gel: Desquam-X 10 Gel-acne vulgaris Hydroquinone gel: Solaquin Forte Gel: bleach for

hyperpigmented skin

Salicylic acid gel: Compound W Gel: keratolytic Desoximetasone gel: Topicort: anti-Inflammatory,

antipruritic agent

Miscellaneous Semi-solid Preparation Pastes Plasters Glycerogelatins

Pastes

Semisolid preparation for application to the skin, for itsstiffness and impenetrability

Remain in place after application and effectivelyemployed to absorb serous secretions

Not suited for application to hairy parts of the body Example: zinc oxide paste (Lassars Plain Zinc Paste)

Types of Paste

Dermatologic paste Paste for injection

Examples of Paste

1. Zinc oxide paste with acid: Lassars Paste: Salicylic acid20g and ZnO paste q.s. to make 1000g

2. Zinc oxide paste: ZnO 250g, starch 250g, whitepetrolatum 500g to make 1000g

3. Triamicinolone acetonide dental pastePlasters

Solid or semisolid adhesive masses spread on a backingof paper, fabric, moleskin, or plastic

Nonmedicated plaster: for protection andmechanical support (Adhesive Plaster)

Medicated plaster: provide effects at the site ofapplication (Salicylic acid plaster removal of corns

on toes by the keratolytic action)

Purposes of Plasters

To afford protection and mechanical support To furnish an occlusive macerating action To bring medication into close contact with surface of

skin

Example of Plaster

Modern plasters are practically all machine made andare available in colors such as flesh, striped, and others.

Examples of Medicated Plasters

Salicylic acid plaster Salonpas

Back Plasters

Made of heavy cotton or wool and cotton backing toprovide warmth and support

Used to backache, sore shoulder, sore arms, and othermuscular aches

Active constituents of back plasters is oleoresins ofcapsicum

Examples: Chili Plaster, Hot SalonpasCerates

Unctouse preparations of such consistency that may beeasily spread at ordinary temperature upon muslin cloth

or similar material with spatula yet not soft to liquefy

and run when applied to the skin

Contents: oil, hard, petrolatum and beeswax Examples: Cantharides cerates, rosin cerate, camphor

cerate, cerate of lead acetate, compound rosin cerate

Cataplasm

Viscous preparation intended for warm, externalapplication to a body for purpose of reducinginflammation

Soft semisolid, external applications which eitherstimulate a body surface or alleviate an inflamed area by

supplying medication substance in the presence of heat

and mixture.

Example: numotizineCements

Dental preparation employed primarily as temporarycoverings for exposed pulps and also for holding

medicinal agents in tooth cavities and rebasing of

dentures

Glycerogelatins

Plastic masses containing 15% gelatin, 40% glycerin, 35%water and 10% added medicinal substance (zinc oxide)

For the long term application For treatment of varicose ulcers Official: zinc gelatin or zinc gelatin boot-form pressure

bandage (treatment of varicose ulcers)

Dressings

External application resembling ointments inconsistency, but remaining semisolid at body

temperature, they liquefy at 50C and remain pliable in

thin films below 28C

Classes of Dressing


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Primary wound dressing or now as wet dressing Absorbents: surgical cotton and gauze Bandages Adhesive tapes

Examples of Dressings

Paraffin Dressing: formerly official in the NF VI andemployed as an air-excluding, soft, pliable, analgesic,

splint-like covering for surface denuded by burns

Petrolatum Gauze, USP: absorbent gauzr saturated withwhite petrolatum

Fruazone Gauza Pads-sterile: antibacterial dressingscontaining nitrofurazone

Surgical dressing: any material used as covering,protective, or support for a diseased part: (1) Adhesive

bandages, USP; (2) Gauze bandage

Other Examples of Dressings

Bandages Paper tapes Surgical tapes

Packaging Semisolid Preparation

Topical dermatologic products Packaged in either jars or tubes

Ophthalmic Nasal, vaginal, and rectal semisolids products

Packaged in tubes Aluminum or plastic

Ophthalmic ointments Packaged in small aluminum or collapsible

plastic tubes holding 3.5g

Tubes: sterilizes before aseptically filled, fitted withnarrow-gauge

Plastic Tubes are made of:

High or low-density polyethylene (HDPE or LDPE) or ablend of each

Polypropylene (PP) Polyethylene terephthalate (PET) Various plastic, foil, and/paper laminates

Special features and Advantages of Plastic

LPDE: soft and resilient with good moisture barrier HPDE: with superior moisture barrier but less resilient PP: has high level of heat resistance

PET: offers transparency and high degree of productchemical compatibility

Laminates

With excellent moisture barrier because of the foilcontent, high durability, and product compatibility

Ointment jars

Clear or opaque glass or plastics Amber-colored, some are porcelain

Filling Ointment Jars

Small scale pharmacy: weighted amount of ointmenttransferred into the jar with a spatula

Filling and Crimping Machine

A small-scale fully automatic filling and crimpingmachine for collapsible metal tubes

Tube-filling Machine

This machine automatically fills 125 tubes a minute withproper amount, tightens cap, and orients each tube by

electric eye so that label faces forward then closes and

crimps the end.

Filling Ointment Tubes

Tubes filled from the open back end of the tubeopposite from the cap end

Manual filling of ointment tube requires: Prepare ointment on a wax or parchment: paper

rolled into a cylindrical shape, inserted into the

open end of the tube, pushed forward

The spatula pressing against the lower portion ofthe tube and making a crease below the ointment

full, the paper is slowly remove leaving the

ointment in the tube

The bottom of the tube is flattened, folded andsealed with a crimping tool or clip

Features and Use Dermatologic Preparations

Drug penetration into the skin depends on a number offactors:

Physiochemical properties of the medicinalsubstance

Characteristics of the pharmaceutical vehicle Condition of the skin itself Oleaginous bases

Greater occlusion and emollient effects thanhydrophilic or water-washable bases

Pastes Greater occlusion and more effective than

ointments at absorbing serous discharge

Creams O/W emulsions, spread more easily than

ointments and are easier to remove

Water-soluble bases Non-greasy and are easily removed

Features and Uses of Ophthalmic Ointments and Gels

Ophthalmic ointments must meet the: USP sterility tests Test for metal particles in ophthalmic

ointments

Steam sterilization or ethylene oxide methods: notcapable of penetrating the ointment

Dry heat sterilization: can penetrate the ointment base,the high heat may pose a threat to the stability of the

drug

Antimicrobial preservatives: methylparaben,prophylparaben, combination of phenylmercuric

acetate, chlorobutanol, benzalkonium chloride

Strict methods of aseptic processing: drug and non-drugcomponent is rendered sterile, aseptically weighed and

incorporated in a final product

Features and Use of Nasal Ointment and Gels

Introduce into the nasal passage for local effects on themucous membrane and underlying tissues

Nasal route of administration: also for the systemicabsorption of the numbers of drugs:

Butorphanol tartrate (Stadol NS, Bristol Myers,Squibb)


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An analgesic Cyanocobalamine (Nascobat gel, Schwartz)

A hematopoietic Narfaralin acetate (Synarel, Searle)

For txt of endometriosis Nicotine (Nicotrol NS, McNeil)

As an adjunct in smoking sensation

Features and Use of Rectal Preparation

For anorectal conditions: ointments, gels, creams, andcreamlike aerosol foams, solutions (for enema and

irrigation) and suppositories

Local condition of anorectal pruritus: inflammation, painand discomfort associated with hemorrhoids

Example: Prochlorperazine as suppositories Zinc oxide

Bases used in anorectal ointments and creams Combinations of polyethylene glycol 300 and

3350

Emulsion cream bases using cetyl esters wax,and butylated hydroxyanisole (BHA)

Features and Use of Vaginal Preparations

Treatment of Conditons and Disease of the vulvovaginalarea: ointments, creams, cream-like foams, and gels

Topical product to treat: Vulvovaginal infection, vaginitis,

conditions of endometrial atrophy

and for contraception with

spermatocidal agents.

Pathogenic organisms:o Trichomonas vaginaliso Candida (Monilia) albicanso Hemophilus vaginalis

Anti-infective agents are: nystatin,chlotrimazole, miconazole, clindamycin, and

sulfonamides

Endometrial atrophy treated locally with:hormones dienestrol and progesterone

Contraceptive preparations containedspermicidal agents such as: nonoxynol-9 and

octoxynol with cervical diaphragm

Vaginal gels are preserved with antimicrobialagents: E.g. Vulva (Mycelex-7 Vaginal Cream,

Bayer)

Table 10.1: Dermatologic Ointments and Creams by Therapeutic

Category Preparation

Adrenocortical steroids Aclometasone dipropionate cream and

ointment

o Corresponding commercial product:Aclovate Cream and Ointment

(GlaxoSmithKline)

o Usual strength of active ingredient:0.05% cream and ointment

o Use: relief of inflammatorydermatoses

Fluocinolone acetonide cream andointment

o Corresponding commercial product:Synalar Cream and Ointment

(Roche)

o Usual strength of active ingredient:0.025% cream and ointment


Hydrocortisone acetate cream andointment

o Corresponding commercial product:Cortaid Cream and Ointment

(Pharmacia & Upjohn)

o Usual strength of active ingredient:0.5% and 1%


Triamcinolone acetonide cream andointment

o Corresponding commercial product:Aristocort A Cream and Ointment

(Fujisawa)

o Usual strength of active: 0.01%ointment; 0.1%, 0.025%, 0.5% cream


Adrenocorticoid - antifungal combination Betamethasone, clotrimazole creamo Corresponding commercial product:

Lotrisone Cream (Schering-Plough)

o Usual strength of active ingredient:1% betamethasone, 0.05%

clotrimazole

o Use: relief, treatment ofinflammatory pruritic manifestations

that may be complicated by fungal

overgrowth

Analgesic Capsaicin cream

o Corresponding commercial product:Zostrix Cream (Medicis)

o Usual strength of active ingredient:0.025%

o Use: relief of arthritic pain Antiacne

Tretinoin creamo Corresponding commercial product:

Retin-A (Ortho McNeil)

o Strength: 0.025%, 0.05%, 0.1%o Usual strength of active ingredient:

derivative of Vitamin A for topical

treatment of acne vulgaris

Antianginal Nitroglycerin ointment

oCorresponding commercial product:Nitro-Bid Ointment (Hoechst Marion

Roussel)

o Usual strength of active ingredient:2%

o Use: reduces workload of heart bysmooth muscle relaxation of

peripheral arteries and veins

Antibacterial or anti-infectives Gentamicin sulfate cream, ointment

o Corresponding commercial product:Garamycin Cream and Ointment

(Schering-Plough)

o Usual strength of active ingredient:0.1%


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o Use: local treatment of skininfections by susceptible

microorganisms

Nystatin creamo Corresponding commercial product:

Mycostatin Cream (Apothecon)

o Usual strength of active ingredient:0.5% 100,000 U/g

o Use: local treatment of skininfections by susceptible

microorganisms

Polymyxin B sulfate, bacitracin zinc,neomycin ointment

o Corresponding commercial product:Neosporin Ointment

(GlaxoSmithKline)

o Usual strength of active ingredient:5,000 U/g polymyxin B, 400 U/g

bacitracin zinc; 3.5 mg/g neomycin

o Use: treatment of minor cuts,scrapes

Antifungals Miconazole nitrate cream

o Corresponding commercial product:Monistat-Derm Cream (OrthoMcNeil)


o Use: cutaneous candidiasis, tineainfections ofTrichophyton spp.

Tolnaftate creamo Corresponding commercial product:

Tinactin Cream (Schering-Plough)


o Use: topical treatment of tineapedis, tinea corporis, tinea manuum

Antineoplastic Fluorouracil cream

o Corresponding commercial product:Efudex Cream (Roche)


o Use: treatment of multiple actinic,solar keratoses

Antipruritic, analgesic Lidocaine ointment

o Corresponding commercial product:Xylocaine Ointment (Astra)

o Strength: 2.5%o

Use: relief of pain, itching of minorskin irritation, insect bites

Astringent, protectant Zinc oxide ointment

o Corresponding commercial product:Desitin Ointment (Pfizer)


o Use: topical astringent, protective inskin conditions such as diaper rash

Depigmenting agents Hydroquinone cream

o Corresponding commercial product:Eldopaque Cream (ICN)


o Use: temporary bleaching of skinwith freckles, old age spots,

chloasma

Scabicide Crotamiton cream

o Corresponding commercial product:Eurax Cream (Westwood-Squibb)


o Use: eradication of scabies,symptomatic treatment of pruritus


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Table 10.2: Examples of Topical Gels

Active Ingredient Proprietary Product Gelling Agent Route and Use

Acetic acid Aci-Jel (Ortho McNeil) Tragacanth, acacia Vaginal; restoration and

maintenance of acidity

Becaplermin Regranex Gel (Ortho McNeil) Sodium, CMC Dermatologic; recombinant

human platelet-derived growth

factor; promotes healing of

diabetic ulcers of lower

extremity

Benzoyl peroxide Desquam-X Gel (Westwood-

Squibb)

Carbomer 940 Dermatologic; acne vulgaris

Clindamycin Cleocin T Topical Gel (Pharmacia

& Upjohn)

Carbomer 934P Dermatologic; acne vulgaris

Clobetasol propionate Temovate Gel (GlaxoSmithKline) Carbomer 934P Dermatologic; antipruritic

Cyanocobalamin Nascobal (Schwartz Pharma) Methylcellulose Nasal; hematologic

Desoximetasone Topicort Gel (Medicis

Dermatologics)

Carbomer 940 Dermatologic; anti-inflammatory,

antipruritic

Metronidazole Metro-Gel Vaginal (Galderma) Carbomer 934P Vaginal; bacterial vaginosis

Podofilox Condylox Gel (Oclassen) Hydroxypropyl cellulose Rectal; anogenital warts

Progesterone Crinone Gel (Serono) Carbomer 934P Vaginal; bioadhesive gel for

progesterone supplementation

and replacement

Timolol maleate Timoptic-XE (Merck) Gelrite gellan gum Opthalmic gel-forming solution

used in treatment of elevatedintraocular pressure

Tretinoin Retin-A Gel (Ortho McNeil) Hydroxypropyl cellulose Dermatologic; acne vulgaris

o Table 10.3: Examples of Ophthalmic OintmentsCommercial Product Active Ingredient Category

Chloramphenicol ophthalmic Chloromycetin Opthalmic

Ointment (Parke-Davis)

1% Antibacterial, antibiotic

Dexamethasone sodium

phosphate ophthalmic

Decadron Phosphate Opthalmic

Ointment (Merck)

0.05% Anti-inflammatory,

adrenocortical steroid

Gentamicin sulfate ophthalmic Garamycin Opthalmic Ointment

(Schering-Plough)

0.3% Antibacterial, antibiotic

Isoflurophate ophthalmic Floropryl Sterile Opthalmic

Ointment (Merck)

0.025% Cholinesterase inhibitor

Polymyxin B-bacitracin

ophthalmic

Polysporin Opthalmic Ointment

(Monarch)

Per gram: polymyxin B sulfate,

10,000 U; bacitracin zinc, 500 U

Antimicrobial

Polymyxin B-bacitracin-neomycin

ophthalmic

Neosporin Opthalmic Ointment

(Monarch)

Per gram: polymyxin B sulfate,

5,000 U; bacitracin zinc, 400 U;

neomycin sulfate, 5 mg

Antimicrobial

Sulfacetamide sodiumophthalmic

Sodium Sulamyd OpthalmicOintment (Schering-Plough)

10%, 30% Antibacterial


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Tobramycin ophthalmic Tobrex Opthalmic Ointment

(Alcon)

0.3% Antibacterial, antibiotic

Vidarabine ophthalmic Vira-A Opthalmic Ointment

(Monarch)

3% Antiviral

o Table 10.4: Examples of Rectal and Vaginal Creams and OintmentsActive Ingredient Product Type Primary Use

Rectal

Anusol (GlaxoSmithKline) Starch Ointment Hemorrhoid treatment

Tronolane (Ross) Pramoxine HCl Cream Hemorrhoidal, analgesic,

antipruritic

Vaginal

Mycelex-7 (Bayer) Clotrimazole Cream Antifungal

AVC (Novavax) Sulfanilamide Cream Vulvovaginitis (Candida albicans)

Cleocin (Pharmacia & Upjohn) Clindamycin PO4 Cream Bacterial vaginosis

Terazol 7 (Ortho McNeil) Terconazole Cream Antifungal (Candida albicans)

Ogen (Pharmacia & Upjohn)

Premarin (Wyeth-Ayerst)

Estropipate

Conjugated estrogens

Cream

Cream

Estrogenic for vulvar, vaginal

atrophy

Atrophic vaginitis, kraurosis

vulvae

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Dosage - Chapter 10