CHAPTER 10

OINTMENTS CREAMS GELS

INTRODUCTION
Ointments, Creams, and Gels TOPICAL APPLICATION * to the skin * place on the surface of the eye * vaginally, nasally, rectally TOPICAL DERMATOLOGICAL designed to deliver drug into the skin dermal disorders (SKIN AS TARGET ORGAN) TRANSDERMAL designed to deliver drug through skin (percutaneous absorption) general circulation SKIN NOT BEING THE TARGET ORGAN NOTE: SYSTEMIC ABSORPTION always considered

OINTMENTS
are semisolid preparations for external application of such consistency that they maybe readily applied to the skin with or without inunction (rubbing) Ointments should be of such composition that they soften but not necessarily melt when applied to the body.
Unguents

General Uses Of Ointments

1. Acts as protective or protectant serve as physical barrier to environment 2. Acts as emollient - softens skin and makes it pliable 3. Carrier of medicament - vehicle

Types Of Ointments 1.Medicated - those with medicaments for treatments of cutaneous (skin diseases). Examples: Sulfur Ointment, Zinc Oxide Ointment and Compound Resorcinol 2.Non-medicated - also referred to as ointment bases and use as such for their emollient or lubricating effect or use as vehicles in medicated ointments. Example: White Ointment

The USP and NF Classify Ointment Bases into Four General Groups

1. Hydrocarbon bases or Oleaginous bases 2. Absorption bases 3. Water removable bases or Emulsion Ointment bases 4. Water soluble bases

Factors Of Selecting Ointment Bases

1. Physicochemical properties of the medicaments as stability in the base or influence on consistency. 2. Patient s conditions - as to the desired release rate of the drug from the base. 3. Intended site of application - ability of occlusion of moisture from the skin by the base. 4. Characteristics of the various vehicles available - use the one which provided the majority of essential attributes

HYDROCARBON BASES
Are

water-free, and aqueous preparations may only be incorporated into them in small amounts and then with difficulty. USES: HC are use 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
1. Retained on the skin for prolong period of time 2. Do not permit the escape of moisture to the skin to the atmosphere 3. Difficult to wash as such they acts as occlusive dressing 4. They do not change noticeably upon aging

Sources Of Hydrocarbon Bases 1. Vegetable Oil - Mineral oil 2. Animal Fat - Oleic oil 3. HC from Petrolatum 3 Forms of HC a. Liquid hydrocarbon - Mineral oil b. Semi-solid HC petrolatum Vaseline c. Solid HC - Paraffin

HYDROCARBONS BASES
Characteristics Insoluble in water Not water-washable waterAnhydrous Will not absorb water Emollient Occlusive Greasy Nonirritating Inexpensive, non reactive


Examples White Petrolatum White Ointment Vegetable shortening Vaseline



Examples Of Hydrocarbon Bases

Petrolatum,

NF - mixture of semisolid HC obtained from petroleum Properties: An unctous mass, color yellowish to light amber, melts between 380C -600C Synonyms: Yellow petrolatum, Petroleum jelly Commercial Product: Vaseline Petrolatum, USP - is petrolatum that has been decolorized Used: diaper rash, dry skin Synonym: White Petroleum Jelly Commercial Product: White Vaseline

White

Yellow Ointment - Each 100 g contains 5 g yellow wax and 95 g of petroleum. Yellow wax is purified wax obtained from honeycomb of the bee (Apis mellifera) Synonym: Simple Ointment

White

Ointment, USP - 100 g contains 5% of white wax (bleached purified beeswax) and 95% white petrolatum

Paraffin,

NF - is a purified mixture of solid HC obtained from petroleum Characteristics: colorless or white, more or less translucent mass that may be used to harden or stiffen oleaginous semisolid ointment bases. Oil, USP - is a mixture of liquid HC obtained from petroleum. Useful in levigating of substances insoluble in it in the preparation of ointment base e.g. Salicylic acid, Zinc oxide Synonym: Liquid Petrolatum

Mineral

Olive

Oil, USP - from crushed olives- also called sweet oil

OFFICIAL ABSORPTION BASES

2 TYPES Those that permit the incorporation of aqueous solutions resulting in the formation of water-in-oil emulsion. (Anhydrous absorption bases) Examples: Hydrophilic Petrolatum and Anhydrous Lanolin Those that are already water-in-oil emulsion (emulsion base) that permits the incorporation of small additional quantities of aqueous solution Examples: Lanolin and Cold cream; water soluble drugs: Gentamycin Sulfate

Characteristics 1.Not

easily removed from skin with water washing, 2.May possess some power of penetration into the deepest layers of the skin 3.And therefore are used for endodermic ointment. USES 1.As emollient but do not provide the degree of occlusion 2.Incorporates aqueous solutions into oleaginous bases

EXAMPLES OF ABSORPTION BASES 1. Hydrophilic Petrolatum, USP - composed of cholesterol, stearyl alcohol, white wax and white petrolatum Characteristics: It has the ability to absorb water with the formation of W/O emulsion Example: Aquaphor 2. Anhydrous Lanolin, USP - may contain NMT 0.25% water. Characteristics: It is insoluble in water but mixes without separation with about 2x its weight in water. The incorporation of water results in the formation of a W/O emulsion Synonym: Refined Wool Fat

3. Lanolin, USP - is a semisolid fat like substance obtained from the wool of sheep (Ovis aries) Characteristics: It is a W/O emulsion that contains between 25 to 30% water. Additional water may be incorporated into lanolin by mixing Synonym: Hydrous Wool Fat 4. Cold Cream, USP - is a semi solid white W/O emulsion prepared with cetyl esters wax, white wax, mineral oil, sodium borate, and purified water Examples: Eucerin cream - is a W/O emulsion of petrolatum, mineral oil, mineral wax, wool wax, alcohol and bronopol. Cold cream emollient and base.

1. Anhydrous Absorption Bases

Characteristics Insoluble in water Not water washable Anhydrous Can absorb water Emollient Occlusive Greasy


Examples Hydrophilic Petrolatum Lanolin Aquaphor Aquabase Polysorb



2. Water-in-oil Emulsion Water-inCharacteristics Insoluble in water Not water washable Contains water (limited) Emollient Occlusive Greasy


Examples Hydrous Lanolin Cold Cream Eucerin Hydrocream Rose Water Ointment


WATER REMOVABLE BASE

Are

oil-in-water emulsion that are capable of being washed from skin or clothing with water. For this reason, they are frequently referred to as water-washable ointment base.

WATER REMOVABLE BASES

Characteristics

1. Resemble creams in their appearance 2. May be diluted with water or with aqueous solution 3. From therapeutic viewpoint, no ability to absorb serous discharge in dermatologic conditions 4. Certain medicinal agents may be better absorbed in the skin

WATER REMOVABLE BASES

Example

Hydrophilic Ointment, USP - is water loving . It contains sodium lauryl sulfate as the emulsifying agent, with stearyl alcohol and white petrolatum representing the oleaginous phase of emulsion and propylene glycol and water representing the aqueous phase. Methyl and Propyl parabens are used as preservatives USE: employed as water removable vehicle for medicinal substances

Water Removable (O/W Emulsion)

Characteristics Insoluble in water Water washable Contains water Can absorb water NonNon-occlusive NonNon-greasy


Examples Hydrophilic Ointment Vanishing Cream Dermabase Velvachol Unibase



WATER SOLUBLE BASE

Unlike

water-removable bases, which contains both water soluble and water insoluble components. Like water-removable bases, however, water soluble bases are water washable and are commonly referred to as greaseless because of the absence of any oleaginous materials

Characteristics

1. Because they soften greatly with the addition of water, aqueous solutions are not effectively incorporated into these bases. Rather, they are better used for the incorporation of non-aqueous or solid substance. 2. These penetrated the skin and better used for absorption of medicament and therefore used for diadermic ointment . Example: Polyethylene Glycol Ointment, USP is a combination of 400 g of polyethylene glycol 4000 (solid) and 600 g of polyethylene glycol 400 (liquid) to prepare 1000 g of base.

WATER SOLUBLE BASES

Characteristics Water soluble Water washable May contain water Can absorb water (limited) NonNon-occlusive NonNon-greasy LipidLipid-free


Example Polyethylene Glycol Ointment



SELECTION OF THE APPROPRIATE BASE

1. 2. 3. 4. 5.

The desired release rate of the particular drug substance from the ointment base. The desirability for enhancement by the base of the percutaneous absorption of the drug. The advisability of occlusion of moisture from the skin by the base. The short term and long term stability of the drug in the ointment base The influence, if any, of the drug on the consistency or other features of the ointment base.

PREPARATION OF OINTMENT
1. INCORPORATION  The components of the ointment are mixed together by various means until a uniform preparation has been attained.  In small scale or in extemporaneous compounding of the Rx, the pharmacist may use 2 means: a. Mixing ingredients in a mortar with pestle until smooth ointment produced b. Use a spatula and an ointment slab (a large glass or porcelain plate) to rub the ingredients together (spatulation)

Incorporation

Of Solid

In preparing ointment by spatulation, the pharmacist works the ointment with a stainless steel spatula but if the components react with metal (such as iodine, tannins, mercuric salts) the hard rubber is used 1. The ointment base is placed on one side of the working surface. 2. The powdered components (previously reduced into fine powders) are placed on the other side. 3. Then a portion of the powder is mixed with a portion of the base until uniform. 4. Repeat until all portions of the product and based are combine. 5. The portions of prepared ointment are then combined and thorough blended by continuous movement of the spatula.

Incorporation

Of Liquids

Liquid substances or solutions of drugs are added to an ointment only after due consideration of the ointment nature. An aqueous solution would be added with difficulty to the oleaginous ointment, except in very small amount. However, water absorbable hydrophilic ointment bases would be quite suitable for the absorption and incorporation of the aqueous solution. In case of of hydrophobic base and an aqueous solution is to be added, a portion of the hydrophobic base is replaced by a hydrophilic base.

2. FUSION METHOD
By this method, all or some of the components of an ointment are combined by melting together and cooled with constant stirring until congeal. Those components not melted are generally added to the congealing mixture as it is cooled and stirred. The heat labile substances and volatile constituents are added last when temperature is low enough not to cause decomposition.

Packaging

and Storage Of Ointments

Semisolid pharmaceuticals frequently either in jars or in tubes. The jars may be made of glass, uncolored, colored green, amber or blue or opaque and porcelain white. Plastic jars are used in limited extent. The tubes are made of tin or plastic. These are called collapsible tube .

TESTS REQUIREMENTS FOR OINTMENTS 1.Microbial Content

Meet acceptable standard for microbial Must contain antimicrobial preservatives Preservatives: methylparaben,propyl paraben, phenols, benzoic acid, sorbic,quaternary ammonium salts Example: Betamethasone Valerate Ointment must be absence of Staphylococcus aureus and Pseudomonas aeriginosa

TESTS Requirements for Ointments

Minimum Fill Test net weight and volume Packaging, Storage, and Labeling metal, plastic tubes, jar Well close containers, light sensitive, light resistant Labeling- type of base used (water soluble or insoluble) 4. Additional Standards Examine the viscosity Vitro drug release to ensure within lot and lot-to-lot uniformity

May Be Filled By The Following Steps 1. The prepared ointment is rolled into a cylinder shape of a piece of parchment paper, the diameter is smaller than that of the tube. 2. With cap of the tube off to permit escape of air, the cylinder of ointment with the paper is inserted into the open bottom of the tube 3. The piece of paper covering the ointments is grasped in one hand, the other hand forces a heavy spatula down on the extreme end of the tube, collapsing it and retaining the ointment while the paper is slowly pulled from the tube. About one half (1/2) inch of the bottom is then flattened with the spatula. 4. About 1/8 folds are made from the flattened end of the tube and sealed by pliers or sealing clip on foot operated crimper machine. Note: Ointments made by fusion may be poured directly into the tubes. Stored at temperatures below 30oC to prevent softening.
Tubes

CREAMS
Are

solid emulsion containing suspensions or solutions of medicinal agents for external application.

Creams

of the O/W type include foundation creams; hand creams; shaving creams; and vanishing creams. Creams of W/O type include cold creams; emollient creams Product referred to as creams may not actually conform to the above definition. Many products that are creamy in appearance but do not have an emulsion-type base are commonly called creams

Example of Cream:
Bacitracin  Anti-bacterial Anti

Example of Cream
NystatinNystatin- Mycostatin cream  Antifungal


Example of Cream
TretinoinTretinoin- Retin A Cream  Antiacne drug


Example of Cream
CrotamitonCrotamiton- Eurax cream  Scabicides


Example of Cream
TIOCONAZOL TROSYD

Example of Cream
LuorouracilLuorouracil-Efudex Cream  Antineoplastic


Examples of Ointments and Creams

Adrenocortical Steroids 1. Betamethasone Valerate - Valisone cream and ointment 2. Fluocinolone Acetonide - Synalar cream and ointment 3. Hydrocortisone Acetate - Cortaid cream and ointment 4. Triamcinolone Acetonine Aristocort A cream and ointment

Examples of Ointment and Cream

Antiacne Drug 1. Tretinoin - Retin A cream and ointment Antianginal drug 1. Nitroglycerin - Nitro-Bid ointment Antibacterial/Anti-infectives 1. Bacitracin - Baciguent ointment 2. Gentamicin Sulfate - Garamycin cream and ointment 3. Nystatin - Mycostatin cream and ointment 4. Mupirocin - Bactroban ointment

Examples of Ointments and Creams

Antifungals 1. Nystatin - Mycostatin cream and ointment 2. Miconazole Nitrate - Monistat-Derm cream 3. Naftidine HCl - Naftin cream 4. Tolnaftate - Tinactin cream Antineoplastic 1. Luorouracil - Efudex cream Scabicides 1.Crotamiton - Eurax cream

Examples of Ointments and Creams

Anesthetics Benzocaine - various Dibucaine - Nupercainal cream and ointment Astringent/Protectant Zinc oxide various Depigmenting Agents Hydroquinone cream - Eldopaque cream Scabicides Lindane - Kwell cream Sunscreening Agent Dioxybenzone - Solvar cream and Oxybenzone

Examples of Ophthalmic Ointment Ointment Commercial Product Category

1. Chloramphenicol 2. Dexamethazone Na phosphate 3. Gentamicin sulfate 4. Isoflurophate 5. Polymixin B-Bacitracin 6. Polymixin B Bacitracin neomycin 7. Sulfacetamide Na 8. Tobramycin 9. Vidarabine

Chloromycetin Ophthalmic Decadrone Phosphate Garamycin Floropryl Sterile Polysporin Neosporin Sodium sulamyd Tobrex Vira A

Antibacterial Anti-inflammatory adrenocortical steroid Antibactrial Cholinasterase inhibitor Antimocrobial Antimicrobial Antibacterial Antibacterial Antiviral

Examples of Rectal and Vaginal Creams and Ointments Product RECTAL Anusol Tronolane VAGINAL Mycelex 7 AVC Cleocin Terazol 7 Ogen Premarin Clotrimazole Sulfanilamide Clindamycin PO4 Terconazole Estropipate Cream Cream Cream Cream Cream Antifungal Vulvovaginitis- Candida albicans Bacterial vaginosis Antifungal Candida albicans Estrogen for vulvar, vaginal atropy Atrophic vaginitis, kraurosis vulvae Starch Pramoxine Ointment Cream Hemorrhoidal Treatment Hemorrhoidal Analgesic, Antipruritic Active Ingredient Product Type Primary Use

Conjugated estrogen Cream

Gels
 Are

semisolid systems consisting of either suspensions made up of small inorganic particles or large organic molecules in an liquid 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 2. Carboxymethylcellulose; natural gums *0.5 to 2.0% concentration in water

Classes of Gel


2 phase systems - separation between the insoluble matter and liquid vehicle is observed. This type contains inorganic materials Example: Al(OH)3 Gel Single phase gel - consist of organic macromolecules uniformly distributed throughout the liquid where no apparent boundary is seen Example: Na CMC and Tragacanth Gel Continuous phase - commonly aqueous where alcohol and gels may be use as continuous phase Example: Mineral oil + polyethylene resin = oleaginous ointment base

Characteristics of Gels
Gels may be thicken on standing, forming a THIXOTROPE, and must be shaken before use to liquefy the gel and enable pouring Aluminum Hydroxide Gel Because of high degree of attraction between the dispersed phase and water medium, the gels remain fairly uniform upon standing and does not readily settle

Example of Gel


Clobetasol propionate- Termovate Gel propionateDermatologic: Antipruritic

Example of Gel


Acetic acid- Aci-jel acid- AciVaginal: Restoration and maintenance of acidity

Example of Gel


ProgesteroneProgesterone- Crinone Gel Vaginal: Bioadhesive gel; Progesterone supplement and replacement

Uses of Gels
Lubricant for catheters  Bases for patch testing  NaCl gel for electrocardiography  Floucinonide Gel for anti- inflammatory anticorticosteriod  Na Fluoride & Phosphoric acid gel dental care prophylactic  Tretionoin Gel for treatment of acne  Prostaglandin Gel intravaginal


Gels and Magmas

Are considered colloidal dispersion since they contain particles of colloidal dimensions APPROPRIATE NAMES (COLLOIDAL DISPERSION) SOLS term to designate a dispersion of solid in either a liquid, solid or gas dispersion medium A. Prefix HYDRO water as dispersion medium so called HYDROSOL B. Prefix ALCO alcohol as the dispersion medium so called ALCOSOL C. AEROSOL dispersion of solid or liquid in gaseous phase

Preparation of Gels 1.By freshly precipitating the disperse phase upon reacting an inorganic agents, a gelatinous precipitate results Example: Preparation of Al(OH)3 gel is by reacting Al(Cl)3 + Na2CO3 NaHCO3

Preparation of Gels 2. By direct hydrating the inorganic material in water Al2O3 + 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

1. 2. 3. 4. 5. 6.

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 - antiInflammatory, antipruritic agent

Examples of Topical Gel Active Ingredient

1. Acetic acid 2. Becaplermin Aci-jel Regranex Gel

Proprietary

Gelling agent

Route and Use

Tragacanth, acacia Na CMC

Vaginal: restoration and maintenance of acidity Dermatologic

3. Benzoly peroxide Desquam-X Gel 4. Clindamycin 5. Clobetasol Cleocin T Gel Termovate Gel

Carbomer 940 Acne vulgaris Carbomer 934P Acne vulgaris Carbomer 934 Antipruritic

6. Cyanocobalamin Nascobal 7. Desoximetasone Topicort Gel 8. Metronidazole 9. Progesteron 10. Tretinoin Metro-Gel Crinone Gel Retin A

Methylcellulose Nasal: hematologic Carbomer 940 Anti-inflammatory; antipruritic

Carbomer 934P Vaginal-bacterial Carbomer 934P Progesterone supplement Hydroxypropyl cellulose Acne vulgaris

TRANSDERMAL PREPARATIONS
Ointments, creams, gels designed to deliver a drug systematically by addition of PENETRATION ENHANCERS to the topical vehicle

Examples of Penetration Enhancers

Dimethyl sulfoxide (DMSO), ethanol, propylene glycol, glycerin, polyethylene glycol, urea, dimethyl acetamide, sodium lauryl sulfate, poloxamers, Spans, Tweens, lecithin, and terpenes Example: PLURONIC lecithin organogel (PLO) Pluronic (Poloxamer) F127 gel (usually 20% to 30% concentration)

Paste
Dermatologic paste are ointment like preparations employed in practice of dermatology  Usually stiffer, less greasy and more absorptive than ointments such as starch, ZnO, CaCO3 , and talc in the base


Characteristics
1. Stiffness and impenetrability, not suited for hairy parts of the body 2. Absorbs serous secretions and are preferred for acute lesions having a tendency to ooze 3. Are less penetrating than ointment 4. Are less macerating than ointment

Types of Paste
 Dermatologic

Paste  Paste for injection

Examples of Paste
1.

2.

3.

Zinc Oxide Paste with acid - Lassars Paste - Salicylic acid 20 g; and ZnO paste q.s. to make 1000g Zinc Oxide Paste - ZnO 250 g; Starch 250 g ; White petrolatum 500 g to make 1000 g Triamicinolone Acetonide Dental Paste

Plasters
 Substances

intended for external application, made of such materials and consistency as to adhere to the skin and thereby attach as dressing

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 Plasters


Adhesive plaster consisting of vinyl resin, plasticizers, and chemical additives.

Example of Plaster


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

Examples of Medicated Plaster 1. Salicylic Acid Plaster

2. Salonpas

BACK PLASTERS are made of heavy

cotton or wool and cotton backing to provide warmth and support. They are usually used for backache, sore shoulders, sore arms, and other muscular aches The active constituents of back plaster is OLEORESINS OF CAPSICUM EXAMPLES: CHILLI PLASTER; HOT SALONPAS

Examples of Medicated Plasters

Example of Medicated Plasters with 10 to 40% backing material

Backing materials used; Paper Cotton Felt, Plastic Linen, Moleskin Muslin silk

CERATES
Are unctuous preparations of such consistency that may be easily 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 Contents: oil, hard petrolatum and beeswax  Examples: Cantharides cerates; Rosin cerate; Camphor cerate; Cerate of lead acetate; Compound Rosin Cerate

Cataplasm


Are viscous preparation intended for warm, external application to a body for purpose of reducing inflammation Are soft semisolid, external applications which either stimulate a body surface or alleviate an inflamed area by supplying medication substance in the presence of heat and mixture. Example: Numotizine

Cements


Are dental preparation employed primarily as temporary protective coverings for exposed pulps; also for holding medicinal agents in tooth cavities and re-basing of redentures.

Methods of preparation and Ingredients



 

Mixing a powder consisting of ZnO, and other metallic salts with a liquid consisting of either eugenol or clove oil mixed with a bland oil. Zinc acetate and other metallic salts accelerate the settling time The consistency of the cement may be altered by varying amount of the liquid.

GLYCEROGELATINS
Are plastic masses intended for topical application and containing gelatin, glycerin, and water and a medicament suitable for application in dermatological practice.

ADMINISTRATON OF GLYCEROGELATIN Glycerogelatins are melted prior to application, cooled to only slightly above body temperature, and applied to the affected area with a fine brush. After application the glycerogelatins hardens, usually covered with bandage. Example: Zinc Gelatin Boot Zinc Gelatin is a firm, plastic mass containing 10% zinc oxide in a glycerogelatin base - treatment of varicose ulcers because of its ability to form pressure bandage known as gelatin boot

General Formula: Medicinal substance Gelatin Glycerin Purified water To make about 100 g 150 g 400 g 350 g 1000 g

DRESSINGS
Dressings are external application resembling ointments in consistency, but remaining semisolid at body temperature, they liquefy at 500C and remain pliable in thin films below 280C.

Classes Of Dressings
1. Primary wound dressing or now as wet dressing 2. Absorbents - surgical cotton and gauze 3. Bandages 4. Adhesive tapes

Examples of Dressings
1. Paraffin dressing, formerly official in the NF VI, was employed as an air-excluding, soft, pliable, analgesic, splint-like covering for surface denuded by burns 2. Petrolatum Gauze, USP - is absorbent gauze saturated with white petrolatum. 3. Furazone gauze pads-sterile - antibacterial dressings containing nitrofurazone 4. Surgical dressing is any material used as covering, protective, or support for a diseased part (1) Adhesive bandage, USP (2) Gauze bandage

EXAMPLES OF DRESSINGS: BANDAGES, PAPER TAPES, and SURGICAL TAPES

Packaging Semi Solid Preparations

1. Topical dermatologic jars or tubes 2. Ophthalmic, nasal, vaginal, rectal tubes 3. Ointments ointment jars opaque glass or plastic; some colored green, amber or blue 4. Ointment jars about 0.5 ounce to 1 pound 5. Jars and tubes must be tested for compatibility and stability 6. Ointment tubes aluminum or plastic

Packaging Semi Solid Preparations

Ophthalmic, rectal, vaginal, aural or nasal packaged with special applicator Aluminum tubes coated with epoxy resin, vinyl lacquer to eliminate any interaction with the content Plastic tubes High or low density polyethylene (HDPE or LDPE), polypropylene (PP), polyethylene terepththalate (PET), plastics, foil or paper laminate sometimes 10 layers thick LDPE soft and resilient, provides good moisture barrier HDPE less resilient but provides a superior moisture barrier

Packaging Semi Solid Preparations

12. PP has a high level of heat resistant 13. PET transparency and high degree of chemical compatibility 14. Multiple dose tubes continuous thread closures 15. Single dose tubes tearaway tip 16. Tubes capacities of 1.5, 2, 3.5, 5,15,30,45,60,120 g 17. Ophthalmic ointments- collapsible plastic or aluminum