Pharmaceutical Compounding Exam Study Guide, Exams of Advanced Education

This study guide for PHA 6111, module 9, focuses on pharmaceutical compounding, covering key definitions, standards, and practices like extemporaneous compounding, ingredient sources, and inorganic salt properties. It addresses compounding factors with complex organic molecules, medication disposal, and pharmaceutical waste types. It details pharmacy balances and vessels, such as class II dispensing beam balances and conical measures, providing a comprehensive overview for pharmacy students. Designed to aid exam preparation, it offers a structured review of essential compounding concepts and techniques, emphasizing accuracy, safety, and regulatory compliance in compounding practices, making it a valuable resource for pharmacy education.

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2024/2025

Available from 07/16/2025

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PHA 6111 LEC: Module 9
Exam Study Guide
Compounding - ANSWER small-scale manufacture of medicines from basic ingredients
in the community or in
hospital pharmacy
medicines are not available commercially in the market - ANSWER extemporaneous
compounding should only be used when ________
Low demand
Requires an individualized dose
Requires an individualized formulation for a patient - ANSWER Medicines are not
available in the market because:
industrial methylated spirits (IMS) - ANSWER suitable solution for cleaning work area
floor
skin
refrigeration
supply of main (potable) water - ANSWER Premises standard
USP, NF or FCC - ANSWER recommended source of ingredients for compounding all
drug preparations.
analytical reagent (AR) or certified American Chemical Society (ACS) grade - ANSWER
Alternative high quality source of ingredients
manufactured products from containers labeled with a batch control number and a
future expiration date - ANSWER what are acceptable potential sources of active
ingredients?
more of the chemical should be weighed to obtain the actual active drug - ANSWER
more molecules of water present in the molecule ==
tight containers;
to prevent the loss or gain of moisture - ANSWER HYDRATES AND SOLVATES should be
packaged in _______ to _______
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PHA 6111 LEC: Module 9

Exam Study Guide

Compounding - ANSWER small-scale manufacture of medicines from basic ingredients in the community or in hospital pharmacy medicines are not available commercially in the market - ANSWER extemporaneous compounding should only be used when ________ Low demand Requires an individualized dose Requires an individualized formulation for a patient - ANSWER Medicines are not available in the market because: industrial methylated spirits (IMS) - ANSWER suitable solution for cleaning work area floor skin refrigeration supply of main (potable) water - ANSWER Premises standard USP, NF or FCC - ANSWER recommended source of ingredients for compounding all drug preparations. analytical reagent (AR) or certified American Chemical Society (ACS) grade - ANSWER Alternative high quality source of ingredients manufactured products from containers labeled with a batch control number and a future expiration date - ANSWER what are acceptable potential sources of active ingredients? more of the chemical should be weighed to obtain the actual active drug - ANSWER more molecules of water present in the molecule == tight containers; to prevent the loss or gain of moisture - ANSWER HYDRATES AND SOLVATES should be packaged in _______ to _______

to minimize exposure to high humidity levels - ANSWER why is storage at indicated temperature important? particle size, tendency to absorb or give off water and pH - ANSWER what characteristics of inorganic salts affect their physical and chemical properties? acid; original - ANSWER ________ salt corresponding to an insoluble salt will be more water soluble than the ________ salt Sulfides - ANSWER water insoluble except for their alkali metal salts alkali metal salts of sulfides - ANSWER what salts of sulfides are water soluble? to increase their aqueous solubility - ANSWER why are salts of drugs used? Salt forms - ANSWER may also be used to enhance stability and change other attributes of the drug to aid handling during compounding. for solubility and stability purposes, enhance resistance to degradation after administration for use as prodrugs - ANSWER why are esters prepared? if they precipitate and damage the surrounding tissue - ANSWER why do some drugs cause pain at the site of injection? prepare a drug with increased solubility - ANSWER how to overcome pain at the site of injection? suspension, in place of the solution - ANSWER when esters that are poorly soluble are prepared to increase stability, what dosage form is formed? suspension; solution - ANSWER A drug in ________ degrades at much slower rate than in ________. (Solution/suspension) Quantities required for dosing or compounding are too small for accurate weighing. Some items (e.g. nitroglycerin) are explosive and must be diluted for safe handling Many substances, such as acids & bases, are commercially available in percentage strengths that vary from one acid to another. - ANSWER Reasons for preparing aliquots, dilutions and concentrates: dried or anhydrous basis - ANSWER Determinations of potency are done on ____ mcg of activity per mg of substance - ANSWER potency of antibiotics is commonly expressed as Proteins - ANSWER inherently unstable molecules and require special handling, and their degradation profiles can be quite complex

Controlled substance waste Non-hazardous medical waste - ANSWER TYPES OF PHARMACEUTICAL WASTE Ignitable Corrosive Reactive Toxic - ANSWER Hazardous wastes Ignitable - ANSWER aqueous drug formulations containing >24% alcohol by volume, oxidizers or materials that readily supply oxygen to a reaction in the absence of air (e.g. AgNO3 applicators), and flammable aerosol propellants. Corrosive - ANSWER agents with pH<2 or >12.

  • include glacial acetic acid, NaOH Toxic - ANSWER include heavy metals like barium, selenium and thimerosal acutely hazardous - ANSWER ASHP: P list toxic - ANSWER ASHP: U list P (acutely hazardous) or U list (toxic) drugs Chemotherapy agents Drugs with LD50 of <50 mg/kg Endocrine disruptors Immunosuppresants Drugs meeting NIOSH or OSHA criteria Drugs with potential toxicity due to chromium, selenium or cadmium - ANSWER ASHP list of dangerous pharmaceutical waste Regulated medical waste - ANSWER biohazardous waste or infectious medical waste Regulated medical waste - ANSWER waste contaminated by blood, body fluids, or other potentially infectious material Regulated medical waste - ANSWER include sharps Universal waste - ANSWER commonly generated hazardous waste like batteries, pesticides, mercury-containing products and bulbs/lamps. disposal by sink or toilet - ANSWER has resulted in increased levels of pharmaceuticals

in rivers, streams and drinking water supplies. pharmaceutical drug diversion - ANSWER Disposal of medications in the trash can lead to accidental exposure of children, pets and wildlife, and can also lead to ______

**- Controlling inventory levels

  • Using just** -in-time dispensing and compounding practices **- Dispensing smaller quantities
  • Reconsidering 3** -month supplies or automatic refills **- Using available tools to prevent ADRs and interacitons
  • Improving compliance
  • Minimizing prescription drug therapies, when appropriate** - ANSWER MINIMIZATION OF PHARMACEUTICAL WASTE poor record keeping - ANSWER can lead to dispensing errors which could result in the patient receiving a product other than that intended by the prescriber."

two; five - ANSWER Extemporaneous record sheets should be kept for a minimum of _______ years, although ideally _____ years would be advisable.

traditional Class II dispensing beam balance Modern electronic - ANSWER balance commonly found in pharmacies

50 mg - ANSWER CLASS A MINIMUM WEIGHT

100 mg - ANSWER CLASS B MINIMUM WEIGHT

1 g - ANSWER CLASS C MINIMUM WEIGHT

1 mg - ANSWER CLASS A INCREMENT

50 mg; 100 mg - ANSWER Minimum amounts that are weighed on Sensitive Electronic Balances balances are _______ for non potent substances, increasing to ______ for potent substances.

Balances for Weights Greater than 50 g - ANSWER balances are designed to weigh weights over the maximum weighable weight (i.e. 25 g) of a class II balance or electronic equivalent.

conical measures syringes - ANSWER two main types of vessel used within pharmacy

conical; cylindrical - ANSWER __________ rather than _______ are used in pharmacy

(conical/cylindrical)

They are easier to fill without spilling liquid on the sides above the required level.

- They are easier to clean after use. - ANSWER conical rather than cylindrical are used in pharmacy practice because:

harder to read the meniscus accurately

difficult to estimate volume between graduations. - ANSWER Compared to cylinders, with conical measures, it is:

parallax error - ANSWER •When reading, ensure that the eye is in line with the meniscus to avoid _____

reduce the particle size of powders.

- grind crystals into powder form

.• mix powders.

**- mix powders and liquids.

  • make emulsions.** - ANSWER Mortars and pestles are used to:

Mortar and Pestle - ANSWER used to reduce the size of powders, mix powders, mix powders and liquids, and make emulsions.

Glass Mortar and Pestle - ANSWER not usually used for the production of large quantity products as they are usually fairly small.

Glass Mortar and Pestle - ANSWER surfaces of a are very smooth, making them less suitable for size reduction of powders.

Glass Mortar and Pestle - ANSWER efficient when grinding crystals into powder form.

Glass Mortar and Pestle - ANSWER useful when dissolving small amounts of medicament or when incorporating substances that are absorbed by and stain porcelain

Porcelain Mortar and Pestle - ANSWER these lend themselves to larger scale production

Porcelain Mortar and Pestle - ANSWER are ideal for the size reduction of powders, for mixing powders with other powders, for mixing powders with liquids, and for the preparation of emulsions.

Glass mortar and pestle - ANSWER Generally small and therefore cannot be used for large quantities of material

Glass mortar and pestle - ANSWER Smooth surface of the glass reduces friction

drainage blow out - ANSWER Two types of pipette

metal - ANSWER traditional suppository molds are made of what

Metal moulds - ANSWER allow the suppositories to set quickly because of their efficient heat transfer.

1g mould - ANSWER mould used for suppositories

4 g and 8 g - ANSWER moulds used for pessaries.

FILTERS - ANSWER Used to clarify liquids

Coarse filtration or straining - ANSWER carried out by pouring the liquid through muslin.

Filter paper or sintered glass filters - ANSWER used when finer degree of filtration is required.

can introduce fibers into the filtrate and may also absorb significant amounts of active ingredients. - ANSWER Filter paper or sintered glass filters disadvantage

water bath - ANSWER heat supply is needed for the production of suppositories, pessaries, ointments and creams.

MIXING - ANSWER To ensure that even distribution of all the ingredients has occurred.

**- Solubility of solids

  • Particle size reduction** - ANSWER MIXING SOLIDS WITH LIQUIDS FACTORS TO CONSIDER

Light kaolin - ANSWER used in suspensions

Heavy Kaolin - ANSWER used in preparation of kaolin poultice

wool fat - ANSWER anhydrous lanolin

Hydrous wool fat - ANSWER lanolin

COUNTING DEVICES Manual method - ANSWER consists of pouring the product onto a piece of clean white demy paper which overlaps another piece

Counting triangles - ANSWER fast, accurate and simple way to count tablets

Made either of metal or plastic

Two rows of figures are printed or etched along the edge.

number of rows - ANSWER Counting triangles top row of figures

number of tablet contained in that number of row. - ANSWER Counting triangles numbers below

capsule counter - ANSWER Metal rows consisting of 10 rows of grooves.