Cert Exam 5e Chapter 6

[Audio] Welcome to the Certification Exam Review Fifth Edition presentation for chapter six..

[Audio] Chapter 6: Nonsterile Compounding. Chapter 6.

[Audio] At the end of this chapter, you will be able to: Discuss guidelines for nonsterile compounding processes in USP Chapter <795>. Know the documentation requirements for nonsterile compounding. Understand the steps of preparing a nonsterile compounded product. Know the commonly compounded nonsterile dosage forms and techniques used in nonsterile compounding. Identify the equipment and supplies for nonsterile compounding..

[Audio] Know how to use and maintain the balances used in nonsterile compounding. Understand how to determine a product's stability, including beyond-use dates and signs of incompatibility. Identify additional labeling requirements for nonsterile compounded products..

[Audio] Section six point one: Types of Nonsterile Compounding.

[Audio] For a high-grade, nonsterile compounded product, correct professional procedures and policies must be followed with quality control measures, documentation, and recordkeeping. To achieve this, compounding technicians must follow USP Chapter <795> for the preparation, dispensing, and administration of these products. USP Chapter <795> classifies nonsterile compounding into three categories: Simple nonsterile compounding is for making a preparation from a USPrecommended formulation record or from a peer-reviewed journal article in which the components, procedure, equipment, and stability data are clearly Specified. Moderate nonsterile compounding requires special calculations or procedures for preparing the individual product or individual dosage units, or for determining the stability data. Complex nonsterile compounding requires special technician training, facilities, equipment, and procedures..

[Audio] To ensure a high-quality product is produced each time, it is necessary to document the proper quantities and sequences used to make the product. From the Master Formulation Record, the technician generates the Compounding Record which is filled in with the specific information from that instance of compounding. This documentation is required each time a product is made, unique for each prescription. A specific prescription and/or extemporaneous compounding lot number must be assigned to each Compounding Record, so the compound can always be traced to its date and particular process. The Compounding Record contains the relevant calculations, notes on special equipment used, ingredient lot numbers and expiration dates, and the initials of the compounding technician and the pharmacist who checked the technician's work..

[Audio] A tablet is a solid dosage form made from dry powdered ingredients. The powdered ingredients are mixed together and then pressed together with a single punch tablet press. A capsule contains the active and inactive ingredients encased in a hard shell made of gelatin, sugar, and water. The capsule shell consists of two parts: (1) the body, which is the longer narrower part; and (2) the cap, which is the short part that fits over the body. A solution is a liquid dosage form in which an active ingredient, the solute, is dissolved in a liquid vehicle, the solvent. A solution may contain a liquid or powdered solute. The solvent can be aqueous (water based), alcoholic, or hydroalcoholic. A suspension is a liquid dosage form in which the solute is not dissolved in the solvent but dispersed throughout the liquid vehicle. Since the active ingredient may settle in a suspension, the pharmacy technician should always include a "Shake Well" auxiliary label on the compounded products label. A troche, which is also known as a lozenge, is used for buccal administration, or absorption by the mucous membranes into the blood vessels in the cheek. The active ingredients in powder form for troches gummies, and lollipops are slowly added to a liquid base with other formulated ingredients. An ointment is a water-in-oil emulsion that is usually greasy and not water washable. An occlusive ointment holds moisture in the skin for hydration. A cream is generally an oil-in-water emulsion that is nonocclusive, nongreasy, and water washable. A cream is best prepared using glass equipment. A lotion is generally a liquid suspension or an oil-in-water emulsion used topically where lubrication is desired, such as on the skin or scalp. A lotion is similar to a cream but thinner in consistency. Much like a suspension, a gel contains solid particles in a liquid, but the liquid thickened with gelatin or another agent, and the particles are fine or ultrafine. A suppository is a solid dosage form that has the active ingredient placed in a water-soluble base or oleaginous base. Suppositories are inserted into body orifices, such as the rectum, vagina, or urethra..

[Audio] A digital electronic analytical balance is the easiest to use and most accurate scale, but it is expensive and may not be available in some community pharmacies. Most pharmacies have a Class III prescription balance which is a two-pan mechanical balance that uses pharmaceutical weights of various sizes to weigh small amounts of materials. A spatula is used to transfer solid dosage forms to weighing pans and for other tasks, such as preparing ointments and creams or loosening material from the surface of a mortar and transferring to a container. Spatulas may be made of plastic, rubber, or stainless steel. Hard rubber is used for corrosive materials like iodine or mercuric salts. A compounding slab, or ointment slab, is a plate made of glass, which is smooth, hard, and nonabsorbent. The slab is used to evenly mix the ingredients of an ointment or cream by using a process called spatulation (see detailed definition below). A mortar and pestle is used for grinding and mixing pharmaceutical ingredients. Both the mortar and pestle can be made of glass or porcelain. Cylinders, pipettes, and beakers, which are made of glass or polypropylene, are used to measure liquids. They are calibrated in metric and apothecary units. Out of all the volumetric equipment, graduated cylinders are considered to be the most accurate for measuring..

[Audio] Typical weight sets include metric and apothecary weights, though the apothecary weights are rarely used. Metric weights vary in size, from 10 mg to 100 g. They should be stored in their original box and only handled with the forceps provided to prevent the transfer of hand oil that can result in inaccurate measurements. Pans should always be covered with weighing papers or boats to prevent damage that could cause inaccuracies..

[Audio] Section six point two: Compounding Calculations.

[Audio] After the product is compounded, a beyond use date must be determined according to the stability of the compound as determined by U-S-P guidelines and those of the manufacturer for each ingredient. Many compounded products have adequate stability information from the Master Formulation Record to allow for assignment of a B-U-D based on the expiration dates and stability of the manufactured ingredients. In the absence of stability data, U-S-P <795> has established maximum B-U-D recommendations for nonsterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperatures. The B-U-D may never be later than the expiration date on the label of any component of the preparation. For nonaqueous formulations: The B-U-D is not later than the time remaining until the earliest expiration date of the active ingredient or six months, whichever is earlier. • For water-based oral formulations: The B-U-D is not later than 14 days when stored at controlled cold temperature. • For water-based topical/dermal, and mucosal liquid, and semisolid formulations: The B-U-D is not later than 30 days..

[Audio] Section six point three: Completing Nonsterile Compounding.

[Audio] The technician is responsible for accurate and thorough documentation of each step on the Compounding Record. The pharmacist also verifies that the final product looks, smells, and feels correct. If it is an ointment cream, lotion, or gel, it should be pharmaceutically elegant. If it is a solution, it must not have clumps or precipitation. When the label is applied, it must include the necessary information. This includes: • the patient's name • the physician's name • the date of compounding • the name of the preparation • the prescription and/or extemporaneous compounding lot number.

[Audio] --the Beyond Use Date -- the initials of compounding technician and pharmacist --the directions for use, including any special storage conditions --the additional requirements of state or federal law Note: The pharmacist selects appropriate auxiliary labels..

[Audio] This concludes the Certification Exam Review Fifth Edition presentation for chapter six..