ointments

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OINTMENTS, CREAMS, GELS -semi-solid dosage forms intended for topical application. Unmedicated – as protectants or lubricants Topical preps – both for local and systemic effects. Topical dermatological – drug INTO skin with the skin as target organ Transdermal – THROUGH skin, skin not target organ. OINTMENTS -semisolid prep intended for external applications to skin or mucous mem. Unmedicated ointments – protectant, emollient, lubricant OINTMENT BASES – physical effects, vehicles for medicated ointments 1. Oleaginous Bases / Hydrocarbon Bases 2. Absorption Bases 3. Water Removal Bases 4. Water Soluble Bases Ointment slab – large glass or porcelain plate/pill tile. Ointment mill – electronic mortar and pestle “Unguator” – device ingredients in plastic ointment jar COMPEDIAL REQUIRMENTS FOR OINTMENTS: Microbial Content – antimicrobial preservatives (methylparaben, propylparaben, phenols, benzoic acid, sorbic acid) Minimum fill Packaging – large-mouth ointment jars, metal plastic tubes Storage – cool place Labelling CREAMS -semisolid prep contains one or more medicinal agents dissolved or dispersed in either W/O or O/W emulsion. -topical skin product, rectally, vaginally -easier to spread and remove

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Pharmaceutical Dosage Forms

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Page 1: Ointments

OINTMENTS, CREAMS, GELS

-semi-solid dosage forms intended for topical application.

Unmedicated – as protectants or lubricants

Topical preps – both for local and systemic effects.

Topical dermatological – drug INTO skin with the skin as target organ

Transdermal – THROUGH skin, skin not target organ.

OINTMENTS

-semisolid prep intended for external applications to skin or mucous mem.

Unmedicated ointments – protectant, emollient, lubricant

OINTMENT BASES – physical effects, vehicles for medicated ointments

1. Oleaginous Bases / Hydrocarbon Bases2. Absorption Bases3. Water Removal Bases4. Water Soluble Bases

Ointment slab – large glass or porcelain plate/pill tile.

Ointment mill – electronic mortar and pestle

“Unguator” – device ingredients in plastic ointment jar

COMPEDIAL REQUIRMENTS FOR OINTMENTS:

Microbial Content – antimicrobial preservatives (methylparaben, propylparaben, phenols, benzoic acid, sorbic acid)

Minimum fill Packaging – large-mouth ointment jars,

metal plastic tubes Storage – cool place Labelling

CREAMS

-semisolid prep contains one or more medicinal agents dissolved or dispersed in either W/O or O/W emulsion.

-topical skin product, rectally, vaginally

-easier to spread and remove

Vanishing creams – O/W large percentage of water and stearic acid

GELS (Jellies)

-semisolid system consisting dispersion of small/large molecules in aqueous liquid vehicle rendered jellylike (gelling agent)

Gelling agents:

o Synthetic macromolecules – carbomero Cellulose derivatives –

carboxymethycelluloseo Natural gums – tragacanth

Single phase gels – macromolecules uniformly distributed throughout liquid w/ no apparent boundaries bet dispersed macromolecules and liquid.

Two phase system (magma) – gel mass consist floccules of small distinct particles

Page 2: Ointments

Penetration enhancers:

Dimethyl sulfoxide, ethanol, propylene glycol, glycerine, PEG, urea, Spans, tweens, terpenes.

Pluronic lecithin organogel – transdermal prep commonly compounded

PASTES

-semisolid prep intended for application on skin.

-contain larger portion of solid material (25%) than ointments. STIFFER.

-remain in place after application and employed to absorb serous secretions.

Zinc Oxide Paste (Lassar’s Plain Zinc Paste)

-very firm, better able to protect skin, absorb secretion that zinc oxide ointment.

PLASTERS

-solid/semisolid adhesive masses spread on backing of paper, fabric, moleskin, or plastic.

-for prolonged contact at site

Unmedicated plasters – protection or mechanical support

Medicated plasters – provide effects on site

Salicylic acid plaster – used on toes for removal of corns.

GLYCEROGELATINS

-plastic masses containing gelatin(15%), glycerin(40%), water(35%), medicinal subs(10%)(zinc oxide).

-applied to skin for long term

Zinc gelatin – treatment of varicose cancer

Ointment jars – green, amber, blue

Opaue jars – light sensitive products

-porcelain white, dark green, amber

TYPES OF PLASTIC:

o LDPE – soft, resilient, good moisture barrier

o HDPE – superior moisture barrier less resilient

o PP – high level heat resistanceo PET – transparent, high degree product

chemical compatibilityo Laminates – excellent moisture barrier,

foil content, high durability, product compatibility

Caulking gun system – semisolid filled into chamber and product is delivered into tube.

1000-6000 tubes per hour

Rotary Machines – tube feeding, cleaning, filling, closing

Stratum corneum – desquamating horny layer

-40% protein (keratin) 40% water

Cornea – major route of drug entering eye

-3 layer structure

Conjunctiva and sclera – alternative route

Pathogenic organisms of vulvovaginal infections – Trichomonas vaginalis, Candida (Monilia) albicans, Haemorphilus vaginalis