Ointments, creams, and gels dds ppt pjt


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Ointments, Creams, and Gels (Pharmaceutical Dosage Forms and Drug Delivery System)

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Ointments, creams, and gels dds ppt pjt

  1. 1. Ointments, Creams, and Gels
  2. 2. Topicals •Preparations applied to the skin either for their physical effects or for the specific effect of a medicinal agent •Protectants, lubricants, emollients, drying agents, astringents Transdermals •Designed to support the passage of drug substances from the surface of the skin, through its various layers, and even into the systemic circulation INTRODUCTION
  3. 3. Functions of Dermatologicals •Protect injured areas from the environment •Provide for skin hydration (emollient) •Vehicle for medication transport Drug Penetration Is Dependent Upon: •Amount of pressure and vigor of rubbing •Surface area covered •Condition of the skin •Base used •Occlusive dressing use Application Areas for Dermatologicals LOTIONS CREAMS OINTMENTS Intertriginous areas Moist, weeping lesions Dry, scaly lesions INTRODUCTION
  4. 4. Ointments •Semisolid preparations intended for external application to the skin or mucous membranes. •Semisolid plastic flow characteristics •Definite yield value •Resistance to flow drops as application continues
  5. 5. Compendial Requirements for Ointments •Microbial Content •Minimum Fill •Packaging, Storage, and Labeling •Additional Standards •Oleaginous Bases •Absorption Bases •Water-Removable Bases •Water-Soluble Bases Ointment Bases Preparation of Ointments •Incorporation •Fusion Ointments
  6. 6. Oleaginous Bases •Water insoluble •Not water washable •Can’t absorb water •Oily, occlusive, lack cosmetic appeal Examples: •Hydrocarbons (mineral oils, petrolatums, paraffins, waxes) •Animal fats/vegetable oils (castor oil, cottonseed oil, olive oil) •Synthetic esters (glyceryl monostearate, butyl stearate, isopropyl lanolate, stearyl alcohol) •WHITE PETROLATUM •WHITE OINTMENT Absorption Bases •Water insoluble •Not water washable •Can absorb water •Anhydrous •Oily, occlusive, lacks cosmetic appeal Examples: •Hydrophilic petrolatum •Aquaphor •Aquabase Ointments
  7. 7. Emulsion Base Water-in-Oil •Water insoluble •Not water washable •Can absorb water •Contains water Examples: •Cold Cream (Petrolatum-Rose Water Ointment) •Lanolin •Nivea •Eucerin Emulsion Bases Oil-in-Water •Water insoluble •Water washable •Can absorb water •Contains water Examples: •Hydrophilic Ointment •Velvachol •Unibase •Dermabase •Vanicream •Acid Mantle Ointments
  8. 8. Humectants •Glycerin •Propylene glycol •Sorbitol 70% Water-Soluble Bases •Water soluble •Water washable •Can absorb water •Anhydrous or hydrous •All water soluble, no oil phase Example: •Polyethylene Glycol Ointment •Biozyme Ointment, Desenex Ointment, Whitfields Ointment •Veegum 10% Dermatological base •Veegum 5% Thixotropic lotion Ointments
  9. 9. Selection of the Appropriate Base •Release rate •Topical or percutaneous drug absorption •Occlusion •Stability of drug •Effect of drug on ointment base •Easily removable? •Characteristics of surface for application Incorporation •Mortar and pestle •Pill tile and spatula •Ointment mill •Unguator •Incorporation of solids •Incorporation of liquid Ointment Preparation •Ointment Slab/Pill Tile •Mortar/Pestle •Ointment Mill •Fusion Heat highest melting point material first Water phase a few degrees higher W/O: add water slowly O/W: add oil slowly Ointments
  10. 10. Ointment Packaging •Jars: Glass, Plastic Do not pour in while hot! •Disp. Jars: Plastic •Tubes: Plastic, tin, aluminum •Syringes: Individually dosed, good protection of the product Labeling and Storage •Labeling Protect with tape Dual labels Creativity often required •Storage Store in a cool place Ointments
  11. 11. Creams •Opaque, soft solids, or thick liquids intended for external application. •Semisolid, pseudoplastic flow •Very little yield value •Won’t flow under force of gravity but small force will initiate flow •Viscous liquids or semisolid emulsions of either the O/W type or the W/O type •Term “cream” is most frequently applied to soft, cosmetically acceptable types of preparations.
  12. 12. Gels •Semisolid systems consisting of dispersions of small or large molecules in an aqueous liquid vehicle rendered jelly-like through the addition of a gelling agent •A semirigid system in which the movement of the dispersing medium is restricted by an interlacing network of particles or solvated macromolecules of the dispersed phase
  13. 13. Types of Gels •Single Phase Gels in which the macromolecules are uniformly distributed throughout a liquid with no apparent boundaries between the dispersed macromolecules and the liquid Usually involve organics •Two Phase When the gel mass consists of floccules of small distinct particles Usually involve inorganics Gels
  14. 14. Gel Composition •Gelling agent •Water •Cosolvents •Preservatives •Stabilizers Kinds of Gels •Hydrogels Silica, bentonite, pectin, sodium alginate, methylcellulose, alumina •Organic Gels Contain an organic liquid (e.g., Plastibase) •Carbomer Gels Aqueous dispersion neutralized with sodium hydroxide or triethanolamine •Methylcellulose Gels •Starch Glycerite •Aluminum Hydroxide Gel Gelation •As a hot, colloidal dispersion of gelatin cools, the gelatin macromolecules lose kinetic energy. •With a reduction of kinetic energy or thermal agitation. •Gelatin, agar, pectin, Irish moss, pectin, tragacanth form gels by this mechanism. Gels
  15. 15. Phenomena Associated with Gels •Syneresis - When the interaction between particles of the dispersed phase becomes so great that on standing, the dispersing medium is squeezed out in droplets and the gel shrinks •Swelling -The taking up of liquid by a gel with an increase in volume •Imbibition - The taking up of a certain amount of liquid without a measurable increase in volume •Thixotropy -A reversible gel-sol formation with no change in volume or temperature •Jelene/Plastibase - A combination of mineral oils and heavy hydrocarbon waxes with a MW of about 1300 •Carbomer 934 - A polymer of acrylic acid cross-linked with a polyfunctional agent; recognized as an official emulsifying and suspending agent Gels
  16. 16. Applications •Oral •Topical •Intranasal •Vaginal •Rectal Gelling Agents •Alginic acid •Bentonite •Carbomer •CMC •CMC Sod •Colloidal Silicon Dioxide •Veegum •Methylcellulose •Plastibase/Jelene •Poloxamer/Pluronic •Povidone •Propylene Glycol Alginate •Sodium Alginate •Tragacanth Gels
  17. 17. Quality Control •Appearance •Uniformity •Weight/Volume •Viscosity •Clarity •pH •Others Packaging/Storage/Labeling •Tight containers •Room or refrigerated temperatures, as appropriate •Prior to use, store in tight containers. Stability •Physical Stability - Shrinkage - Separation of liquid from the gel - Discoloration •Microbial Stability •BUD: Unless otherwise documented, 14 days when stored in a refrigerator (USP) Patient Counseling •Proper application •Proper storage •Keep tightly closed
  18. 18. Transdermal Preparations •Pastes •Plasters •Glycerogelatins •Packaging Semisolid Preparations - Filling Ointment Jars - Filling Ointment Tubes Features and Use of Dermatologic Preparations •Ointments •Creams •Gels •Pastes •Plasters •Topical or systemic effect Gels
  19. 19. Features and Use of Ophthalmic Ointments and Gels •Relative short residence time after application •Sterile •Nonirritating •Softening point close to body temperature •Application technique Features and Use of Nasal Ointments and Gels •Primarily local effects but some systemic also •Rich blood supply in nasal lining Gels
  20. 20. Features and Use of Rectal Preparations •Ointments, creams, gels •Perianal area and anal canal •Anorectal pruritus, inflammation, hemorrhoids •Proper instruction for use to patient Features and Use of Vaginal Preparations •Ointments, creams, foams, and gels •Anti-infectives, hormones, pH modifiers, spermicides Gels
  21. 21. Pastes •Thick, stiff ointments that do not ordinarily flow at body temperature, and therefore serve as protective coatings over the areas to which they are applied. Usually >20% solids. •Semisolid, dilatant flow •Definite yield value •Resistance to flow increased with increased force of application Lotions •Aqueous preparations with insoluble material for external application without friction •Fluid preparations, Newtonian flow •No yield value •Flow under gravity •“Lotions” actually also refers to fluid oil- in-water and water-in-oil emulsions. Others
  22. 22. Cerates •Semisolid preparations containing a relatively high wax content •Semisolid •High yield point •Not to be directly rubbed onto skin Plasters •Solid or semisolid preparations that cannot be spread at room temperature Cataplasms or Poultices •Wet masses of solid matter applied to the skin to reduce inflammation and act as counterirritants Others
  23. 23. Prepared By: Cerna, Divina Dipus, Sheenara Rabara, Starette