Chapter 10: Ointments, Creams, and Gels 1. 2. Semisolid preparations intended for topical application.

For skin, surface of the eye, nasally, vaginally or rectally. Used for the effects they contain.

Ointment mill unguator or electronic mortar and pestle, place ingr. In a plastic container jar w/ special lid that allows the mixing blade to be used to mix in the dispensing container. Manually or via computer software. INCORPORATION OF SOLIDS

Unmedicated ones - protectives and lubricants Topical Prep .- both local and systemic effects, but systemic absorption should be a consideration if pregnant or nursing becoz drugs can enter the fetal blood supply aand be transfeerde to the fetus or nursinf infant. Topical dermatological product treat dermal disorders with the skin as a target organ. Transdermal product through the skin (percutaneous absorption) to the general circulation for systemic effects. Skin not as the target organ. OINTMENTS External applications to skin or mucous membranes. SS If spatulation: with stainless steel spatula having a broad, long blade and removes the accumulation with a smaller one. If reacts with metal : (eg iodine) hard rubber spatulas Prepared by thoroughly rubbing and working the components on a hard surface until smooth and uniform Ointment base placed on one side, powdered components previously reduced to fine powders and thoroughly blend in a, mortar. Small portion of the powder is mixed w/ a portion of the base. Geom. Dilution is continued until done

Reduced particle size of powder or crystalline material- to be not gritty LEVIGATING mixing the solid material to a vehicle in w/c it is insoluble to make smooth dispersion.

MEDICATED or NON-MEDICATED protectants, lubricants, emollients OINTMENTS BASES- vehicle for medicated oint. OINTMENT BASES (see phardoselab lecture, only other details are here!) Water may be incorporated, but in small amts only. Liquid petrolatum (mineral oil) can be used as a levigating agent MAGBASA KNALNG HAHAHHAHAH SELECTION OF APPROPRIATE BASE Depends on some factors: see book page 274 Ointment dry and scaly skin Lotion intertriginous areas or where friction can occur, as between thighs and armpits Creams weeping and oozing surfaces PREPARATION OF OINTMENT 1. INCORPORATION Components are mixed until uniform,

Levigating agents Should be compatible with drug and base. Equal in volume with the solid material Mortar and pestle, w/c allows reduction of the particle size and dispersion in the vehicle After dispersion, the dispersion is incorporated in the ointment base by spatualion or M&P until uniform. Mineral oil- bases with oil as the external phase Glycerin water :D

M&P method- when large volumes to be the added coz liquid is more captive than on ointment slab. Incorporating gummy material (eg camphor) pulverization by intervention, SEE DETAILS IN THE BOOK page 276 INCORPORATION OF LIQUIDS Small amts of an aq. Soln may be incorporated in O.Oint :D Hydrophilic ointments readily accept aqueous soln If aq. Prep + hydrophobic base = soln + minimum amt of hydrophilic base and then add to the hydrophobicbase. If beyond the limts = too soft or semi liquid

Alcoholic solutions- small volume may be added to oleaginous vehicles or emulsion bases. Natural Balsams mixed w/ castor oil b4 incorporation of base (eg. Peru Balsam) w/c reduces the surface tension and allows the even distribution of balsam throughout the base. Ointment or roller mills force coarsely formed ointments thru stainless steel or ceramic rollers. Small ointment mills- product devt laboratories and small batch manufacture or compounding. 2. FUSION Combined by melting together and cooled with constant stirring until congealed. Components not melted - added to d congealing mixture.

Mortar and pestle small scale, extemporaneous compounding. Spatula to rub the ingr. Together in an ointment slab glass or porcelain plate or pill tile) Non-absorbent parchment paper to cover the working surface, eliminates the cleaning of the ointment slab. Ointment parchment pad not allow too long a contact of the ointment in the parchment coz it may soften and tear.

Heat labile substances/ volatile comp. added lastly when the temp. is low enough to cause decomposition or volatilization. Substances- added to the congealing mixture as solutions or insoluble powders levigated with a base.

CREAMS SS with one or more medicinal agents dissolved ordispersed in either a W/O emulsion or O/W emulsion ro another type of water washable base. O/W or vanishing creams contains large % of water or stearic acid or oleaginous base. After application, the water evaporates leaving behind a thin residue film of stearic acid or other oleaginous base. preferred than ointments bcoz easily spread

Small scale porcelain dish or glass beaker Large scale large steamer jacketed kettles Medicated ointments and ointment bases with beeswax, paraffin, stearyl alcohol and high molecular weight PEGs. GELS -

Highest melting pt. = lowest required temp to melt W/emulsion base both melting and emulsification Immiscible components- such as wax and oil, melted by steam bath at 70-75 degree Celsius Read book COMPENDIAL REQUIREMENTS 1. Microbial content Topical applc. Are not required to be sterile Preparations containing water tend to support microbial growth than water free preps. ( methylparaben, propylparaben,phenols,, benzoic acid, sorbic acids, quartenary ammonium salts.

SS consisting dispersion of small or large molecules in an aqueous vehicle rendered jellylike by the addition of gelling agent. (eg carboxymethy cellulose see others in the book :D) Viscosity depends on their polymeric composition JELLIES

Single phase gels- macromolecules are uniformly distributed truout a liquid w/ no apparent boundaries between the dispersed macromolecules and the liquid. Two-phase system- Gel mass of floccules of small distinct particles; often reffered as magma Milk og

Betamethasone Valerate Ointmenet free from Staphylococcus aureus and Pseudomonas aerunginosa ( impt because of their capacity to infect the skin. Microbiological attributes of Non- sterile Pharmaceutical products strict adherence on the envt. control and application of good manufacturing practices to minimize both the type and the no. of microorganisms n unsterilized PProduct. Testing of raw materials, acceptable water, in process controls, and final product testing Rectal, urethral, and vaginal use should be tested for molds and yeasts. MINIMUM FILL Net weight or volume of the contents of the filled containers to ensure the proper contents compared with the labeled amount. PACKAGING, STORAGE AND LABELING Large mouth ointment jars, metal or plastic tubes. Well-closed container to protect against contamination Cool placed to protect against separation heat. Opaque and light resistant containers- light sensitive preps Label: with the type of base used ADDITIONAL STANDARDS Viscosity and vitro drug release to ensure w/in lot and lot to lot uniformity.

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3. 4. -

Vitri drug release- diffudion cell studies to determine the drugs release profile from the semisolid product.