Sterile Product Compounding Quiz

Formulation of Triamcinolone 0.1% in Aquaphilic Ointment

• Active ingredient: Triamcinolone USP micronized powder
• Wetting agent: Propylene glycol
• Base (delivery system): Aquaphilic ointment
• Quantity: 60 grams
• Calculations:
  • Percentage preparations:
    • % w/v: number of grams of an ingredient per 100 mL of product
    • % w/w: number of grams of an ingredient per 100 grams of product
    • % v/v: number of mL of an ingredient in 100 mL of product

Triamcinolone 0.1% Ointment Calculations

• 0.1% ointment means there are 0.1 grams of Triamcinolone powder for every 100 grams of preparation
• Making 200 g of a 0.1% preparation requires 0.2 grams of Triamcinolone powder

Clinical Use of Compounded Ointments and Creams

• Applications:
  • Hormone replacement therapy
  • Topical pain management
  • Veterinary medications
  • Dermatologic preparations (acne, psoriasis, eczema, etc.)
  • Pediatric formulations
  • Allergen-free medications

Components of a Formulation

• 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
• Wetting agent: Liquid chemicals used to wet a powder and facilitate uniform mixing into a liquid or semisolid
• Examples:
  • Aquaphilic
  • Aquaphor
  • Eucerin
  • White petrolatum
  • Propylene glycol
  • Glycerin
  • Mineral oil

Other Components of a Formulation

• 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 enhancers: Increase rate of penetration of drug through the skin
• Examples:
  • Water
  • Many others

Compounding Terms

• Levigation: 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

Compounding Ointments and Creams

• Introduction to compounding solutions and suspensions
• Beyond use date (BUD) for non-sterile compounded formulations
• 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)

Pharmaceutical Compounding

• Definition: Creation of a unique drug product to meet a specific patient need
• Critical sites in sterile product compounding:
  • Hub of needle
  • Shaft of needle
  • Hub of syringe
  • Exposed syringe plunger
  • Rubber stopper of vials
  • Ports of IV bags
• Aseptic technique:
  • Airflow direction
  • Reconstitution of vials
  • Appropriate distance within the hood
• Scope and components of UPS Chapter:
  • Sterile compounding
  • Category 1: Least controlled environmental conditions
  • Category 2: More environmental controls than Category 1
  • Category 3: Highest level of environmental controls
  • Immediate use CSPs
  • Single and multi-dose CSPs### USP Standards
• USP sets standards for compounding, which states may choose to enforce, with minimum requirements:
  • Everyone must undergo training, demonstrate competency, and have refreshers every 12 months
  • Core competencies: hand hygiene, garbing, cleaning and sanitizing, handling and transporting components and CNSPs, measuring and mixing, proper use of equipment, documentation

Compounding Regulations

• Compounded drugs are not FDA-approved; DQSA was created in 2013 to give FDA more authority to regulate and monitor compounding
• Helps regulate raw materials used in compounding
• Category 503A and 503B pharmacies

Compounding Non-Sterile Products

• Solutions: liquid preparations that contain active ingredients dissolved in a solvent
• Suspensions: liquid preparations that contain active ingredients suspended in a solvent
• Identify the components of a non-sterile compounded formulation:
  • Active ingredient: manufactured tablets, capsules, or liquids, bulk powder/liquid
  • Solvent: water, alcohol, glycerin, saline
  • Suspending Vehicle: Ora-plus, methylcellulose, PCCA-plus, fixed oil
  • Sweeter: aspartame, sucrose, sorbitol
  • Flavoring
  • Base vehicle: Ora-sweet, PCCA suspendit, Cheery syrup
  • Preservatives: benzalkonium chloride, benzyl alcohol, sodium benzoate

Ointments and Creams

• Compare and contrast o/w versus w/o emulsions:
  • O/w: oil in water
  • W/o: water in oil
• Compare and contrast ointments and creams:
  • Cream: topical dosage form for external use, liquid or semisolid, opaque, tends to vanish with rubbing, has more fluid-like consistency, useful for moist, weeping lesions
  • Ointment: topical dosage form for external use, semisolid, soften or melt at body temperature, spreads easily, not gritty, useful for dry, scaly skin or lesions

Sterile Compounding

• Identify critical sites in sterile product compounding:
  • Hub of needle
  • Shaft of needle
  • Hub of syringe
  • Exposed syringe plunger
  • Rubber stopper of vials
  • Ports of IV bags
• Establish appropriate aseptic technique, taking into consideration airflow direction, reconstitution of vials, and appropriate distance within the hood
• Determine the correct dosage and rate of compounded sterile products and prepare a label accordingly

UPS Chapter <797>

• Sterile compounding scope:
  • Category 1: least controlled environmental conditions
  • Category 2: more environmental controls than Category 1
  • Category 3: highest level of environmental controls
• Immediate use CSPs:
  • Not subject to the requirements for Category 1, 2, or 3 CSPs when all the following are met:
    • Processes are in place to minimize contact with nonsterile surfaces, conventionally manufactured products or CSPs
    • Prepared according to drug labeling
    • Preparation involves not more than 3 different sterile products
    • Any unused starting component is discarded after preparation
    • Administration begins within 4 hours from start of preparation
    • Must be labeled with names, amount of ingredients unless administration is performed by person who compounded

Parenteral Drug Administration

• Recommend appropriate needle gauge for various administration routes:
  • Smaller the number, larger the gauge (inside diameter)
  • Ranges from 27 (finest) to 13 (largest)
• Length is measured in inches from hub/shaft juncture to the tip of needle point
• Ranges from 3/8 to 3 ½ inches
• Route: muscle, IM; subcu tissue, SubQ (45); IV (25); ID (10)

Compounding Regulations

• State laws: in Iowa, pharmacy may request substitution of a lower-priced generic and TE drug for a higher-priced prescribed drug
• Pharmacy shall obtain the approval of the provider prior to requesting subs
• Pharmacy shall not subs an equivalent drug contrary to a prescription drug order that prohibits a subs### Calculations for Compounding
• To make 60 grams of 0.1% Triamcinolone in Aquaphilic Ointment, 0.06 grams of Triamcinolone powder is required
• The formula to calculate the amount of ingredient needed is: (concentration % x total weight) / 100
• In this case, (0.1% x 60g) / 100 = 0.06g

Definitions and Concepts

• Percent weight in volume: number of grams of ingredient per 100 mL of product
• Examples: 0.1% Triamcinolone = 0.1g/100mL, 8.4% Sodium bicarbonate = 8.4g/100mL

Compounding Ointments and Creams

• Advantages:
  • Helpful when oral or other routes are not available
  • Non-invasive route of administration
  • Avoids GI tract and first-pass effect
  • May provide extended therapy with a single application, improving compliance
• Disadvantages:
  • Limited amounts of active ingredients may restrict use to more potent drugs
  • Some patients may develop contact dermatitis

Topical Preparations

• Primary purposes:
  • Protective preparations: protect skin from external factors and allow skin to heal
  • Emollients: provide skin with hydration and soften skin surface
  • Drug delivery: release an active drug to the application site for local or systemic effect