BPSA Compounding Ointments and Creams 2024 Student Slides PDF

Compounding Ointments and Creams Introduction to Compounding Solutions and Suspensions Beyond Use Date Non-Sterile Compounded Formulation BUD Storage Non-preserved aqueous dosage forms 14 days Refrigerator Preserved aqueous dosage forms 35 days Controlled room temperature or refrigerator Oral liquid...

Compounding Ointments and Creams Introduction to Compounding Solutions and Suspensions Beyond Use Date Non-Sterile Compounded Formulation BUD Storage Non-preserved aqueous dosage forms 14 days Refrigerator Preserved aqueous dosage forms 35 days Controlled room temperature or refrigerator Oral liquids (non-aqueous) 90 days Controlled room temperature or refrigerator Other non-aqueous dosage forms 180 days Controlled room temperature or refrigerator 1. 2. 3. 4. Does it contain water (ie. is it aqueous)? Does it contain a preservative (if aqueous)? Is it a liquid intended to be used orally (if non-aqueous)? The BUD should not exceed the expiration of any single ingredient in the compound** Examples of Components Term Definition Active Pharmaceutical ingredient (API) Manufactured tablets, capsules, or liquids. Bulk powder/liquid. Solvent Water, alcohol, glycerin, saline Suspending Vehicle Ora-Plus, Methylcellulose, PCCA-Plus, Fixed Oil (non-aqueous) Sweeteners Many options, Aspartame, Sucrose, Sorbitol Flavoring Many options, may be oil-based or water-based Base Vehicle Ora-Sweet, PCCA Suspendit, Cherry Syrup Preservatives Benzalkonium chloride , benzyl alcohol, sodium benzoate Learning Objectives 1. Compare and contrast o/w versus w/o emulsions 2. Compare and contrast ointments and creams 3. Identify the components of a non-sterile compounded ointment or cream formulation (active ingredient, inactive ingredient, wetting agent, base) and recognize common examples 4. Define common terms related to compounding ointments and creams 5. Understand percentage preparations and be able to use this when performing pharmacy calculations 6. Provide counseling points to patients using compounded topical formulations Compounding Ointments and Creams Topical Preparations Advantages Helpful when oral or other routes not available (vomiting) Non-invasive route of administration Avoids GI tract (including absorption, degradation, drug interactions with food/drink, and interactions with other orally administered drugs). Avoids first-pass effect May provided extended therapy with a single application, improving compliance Disadvantages Ability to deliver limited amounts of active ingredients may restrict use to more potent drugs Some patients develop contact dermatitis Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. Topical Preparations Primary Purpose of Topical Preparations: 1. Protective Preparations: protect skin from external factors such as moisture, air, sun, and chemicals and allow the skin to heal 2. Emollients: provide skin with hydration/soften skin surface 3. Drug Delivery: preparations that release an active drug to the application site either for local or systemic (transdermal) effect Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. Allen LV. The Art, Science, and Technology of Pharmaceutical Compounding. 6th Edition. American Pharmacist Association, 2020. Available at: https://doi-org.cowles-proxy.drake.edu/10.21019/9781582123578.ch21 Emulsions Term Definition Emulsions Mixtures of two essentially immiscible liquids. Most commonly used for topical administration. Foundational part of most lotions, creams, and ointments Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. Types of Emulsions Oil-in-water (o/w) Emulsion Water-in-oil (w/o) Emulsion Water is external (continuous) phase Oil is external (continuous) phase Not greasy Greasy Non-occlusive Occlusive Can wash with water Not washable with water 1. Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. 2. The Art, Science, and Technology of Pharmaceutical Compounding, 6th Edition 2020. https://doi-org.cowles-proxy.drake.edu/10.21019/9781582123578.ch21 3. https://www.ipsf.org/article/compounding-corner-april-2019-compounding-creams-and-gels 4. https://pharmaeducation.net/difference-between-cream-and-ointment/ Creams and Ointments Cream Ointment Topical dosage form for external use Topical dosage form for external use Liquid or semisolid Semisolid Opaque, tends to “vanish” with rubbing Has a more fluid-like consistency Soften or melt at body temperature, Spreads easily, not gritty Useful for moist, weeping lesions Useful for dry, scaly skin or lesions 1. Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. 2. The Art, Science, and Technology of Pharmaceutical Compounding, 6th Edition 2020. https://doi-org.cowles-proxy.drake.edu/10.21019/9781582123578.ch21 3. https://www.ipsf.org/article/compounding-corner-april-2019-compounding-creams-and-gels 4. https://pharmaeducation.net/difference-between-cream-and-ointment/ Clinical Use of Compounded Ointments and Creams Diaper rash ointment Hormone replacement therapy Topical pain management Veterinary medications Dermatologic preparations (acne, psoriasis, eczema, etc) Pediatric formulations Allergen-Free medications Components of a Formulation Term Definition Active ingredient Ingredients that have a therapeutic effect (drug) Base Vehicle that holds the active ingredient(s) together and the driver that gets the active ingredient where we want them to be in the body Examples: aquaphilic, aquaphor, Eucerin, white petrolatum Wetting agent Liquid chemicals used to wet a powder and facilitate uniform mixing into a liquid or semisolid (ie. Helps to incorporate the active ingredient into the base more evenly, avoiding clumping and improving content uniformity). Also known as the levigating agent. Examples: propylene glycol, glycerin, mineral oil USP, castor oil, water Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. Allen LV. The Art, Science, and Technology of Pharmaceutical Compounding. 6th Edition. American Pharmacist Association, 2020. Available at: https://doi-org.cowles-proxy.drake.edu/10.21019/9781582123578.ch21 https://www.pccarx.com/Blog/choosing-an-appropriate-wetting-agent-for-your-topical-compound https://communityclinicalrx.com/general-health/all-about-that-base-a-guide/ Components of a Formulation Term Definition Stiffening Agent Ingredient intended to make a preparation more viscous and/or solid Examples: White Wax Humectants Decrease evaporation rate of water from the preparation Examples: Glycerine, Polyethylene Glycol Penetration Enhancer Increase rate of penetration of drug through the skin Examples: Water, many others Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. Allen LV. The Art, Science, and Technology of Pharmaceutical Compounding. 6th Edition. American Pharmacist Association, 2020. Available at: https://doi-org.cowles-proxy.drake.edu/10.21019/9781582123578.ch21 Definitions Trituration – process of reducing the particle size of powder ingredients in a mortar and pestle. Video: https://www.youtube.com/watch?v=KcCp3dSzCgs Definitions Levigation: the process of reducing particle size of a powder by mixing it with a small amount of liquid (just enough to wet the powder) to make a smooth paste Geometric dilution: mixing process in which one starts with the ingredient in the smallest quantity, then adds additional ingredients in order of quantity required by approximately “doubling” the portion being mixed with each addition. The Art, Science, and Technology of Pharmaceutical Compounding, 6th Edition 2020. https://doi-org.cowles-proxy.drake.edu/10.21019/9781582123578.ch21 Levigation and Geometric Dilution Video: https://www.youtube.com/watch?v=G4vzxzk7Cqg Formulation for Lab Triamcinolone 0.1% in Aquaphilic Ointment Make 60 grams Ointment Formula Ingredients Active ingredient: Triamcinolone USP micronized powder Wetting agent: propylene glycol Enough to wet (draw up 1 mL) Base (delivery system): Aquaphilic ointment QS (quantity sufficient) to 60 grams Calculations Percentage Preparations: Percent weight-in-volume (% w/v): number of grams of an ingredient per 100 mL of product Percent weight-in-weight (% w/w): number of grams of an ingredient per 100 grams of product Percent volume-in-volume (% v/v): number of mL of an ingredient in 100 mL of product Example: Triamcinolone 0.1% ointment means there is ______ grams Triamcinolone powder for every _____ of that preparation you make If making 200 g of a 0.1% preparation, then you need _______g of Triamcinolone powder Calculations Triamcinolone 0.1% in Aquaphilic Ointment Make 60 grams Q: How many grams of triamcinolone are needed to make this formulation? Calculations Triamcinolone 0.1% in Aquaphilic Ointment Make 60 grams 0.1% = 0.1 grams 100 grams 0.1% = 0.1 grams = X grams x = 0.06g 100 grams 60 grams * Cross multiply and divide 0.1 grams x 60 grams / 100 grams = 0.06 grams 0.06 grams x 1000 mg/g = 60 mg Quick Refresher Omeprazole 1 mg/ mL Percent weight in volume = number of grams of ingredient per 100 mL of product 1 mg x 1 gram x 100 mL = 0.1 grams or 1 mL 1000 mg 100 mL 0.1% Quick Refresher Sodium bicarbonate 8.4% Percent weight in volume = number of grams of ingredient per 100 mL of product; therefore 8.4 grams / 100 mL 8.4 g = 100 mL 1 gram X mL X = 11.9 mL Ratio strength 1:11.9 Supplies Needed Electric scale Weigh boat Ointment slab / glass plate Spatulas Steps for Lab Triamcinolone 0.1% in Aquaphilic Ointment Make 60 grams Steps: 1. Weigh Triamcinolone powder 0.06 g or 60 mg 2. Place powder in center of glass plate 3. Draw up propylene glycol (1 mL) 4. Place a couple drops of propylene glycol on the powder and begin the process of levigation (incorporating the liquid with the powder to make a paste) 5. Incorporate base (aquaphilic ointment) with paste using geometric dilution 6. Run through ointment mill (if applicable) 7. Place ointment in jar (tapping out air bubbles) and label Ointment Mill Creates homogenous mixture Reduces particle size Rolls formulation between three porcelain rollers Gaps between rollers can be adjusted Want to make 10% more because will lose some ointment when running it through the ointment mill Safety measures MUST be followed No ties or loose clothing Never use a metal spatula (can chip rollers) Never stick spatula parallel to and between rollers Ointment Mill Video: https://www.youtube.com/watch?v=i35IC8aCjXE Packaging Take care to remove air pockets Smooth top to give a “finished” look Patient Counseling Instruct patients on quantity to use How and where to apply Wash hands thoroughly before and after applying ointment Use only the recommended site(s) and rotate locations within that site Apply to clean, dry skin Do not use lotion at the site of application Use sites that are not rubbed by clothing movement and/or sites not subject to being rubbed off on another person or pet Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. Patient Counseling Do not wash application site for a few hours after application Do not rub eyes or touch mouth while handling ointment Beyond use date Evidence of instability Separation of components Discoloration Dryness or shrinkage Shrewsbury RP. Applied Pharmaceutics in Contemporary Compounding. 4th ed. Englewood, CO. Morton Publishing, 2020. Lab Meet in HI 108 Work with partners to compound the ointment formulation discussed in lecture Quiz on BB with compounding calculations Compounding Resources Drake Compounding Elective (Fall) PCCA Institute: https://www.pccarx.com/PCCAEducation/institute Introductory Compounding Bootcamp, Fundamentals of Compounding Course, Veterinary Compounding Course Textbook: Allen LV. The Art, Science, and Technology of Pharmaceutical Compounding. 6th Edition. American Pharmacist Association, 2020. Available at: https://doi-org.cowlesproxy.drake.edu/10.21019/9781582123578.ch21 Compounding organizations: American College of Apothecaries (ACA) American Pharmacist Association (APhA) American Society of Health System Pharmacists (ASHP) National Community Pharmacists Association (NCPA) National Home Infusion Association (NHIA) United States Pharmacopia (USP) Questions?