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Ch. 11

Bulk Repackaging and Non-Sterile Compounding

QuestionAnswer
API Active pharmaceutical ingredients
Bulk Repackaging The process
Calibration Determining graduations(measurements) on a device such as a scale
Compounding The act of mixing, reconstituting, and packaging a drug
Compounding record (CR) The form that documents a non-sterile compounding process
Emulsion A mixture of two or more liquids that do not usually blend using a stabilizing agent; the process of making an emulsion is called emulsification
Excipient An inert substance added to a drug to form a suitable consistency for dosing
Formulation Record (FR) A document similar to a recipe that is used in the preparation of non-sterile compounds
Good Manufacturing Practices(GMP) Federal guidelines that must be followed by all entities that prepare and package medication or medical devices
Hydrophilic Having a strong affinity for water; any substances that easily mixes in water
Hydrophobic Lacking an affinity for water; any substances that does not mix or dissolve in water
Oleaginous Base An ingredient used in compounding that does not dissolve in water
Periodic Automated Replacement (PAR) levels Minimum set amounts of stock that must be kept on hand
Punch Method Manual Filling of capsules with powdered medication that has been premixed
Solute The ingredient that is dissolve into a solution
Solution A water base in which one or more ingredients are dissolved completely
Solvent The greater part of a solution that dissolves a solute
Suspension A solution in which the powder does not dissolve into the base; the solution must be shaken before use
Triturate To grind or crush powder, such as a tablet, into fine particles
Troches Flat, dislike tablets that dissolve
Unit dose packs or strip packs Strip of heat-sealed packets, each packet holding one tablet or capsule; used in the bulk repackaging process
USP 795 General chapter defining practices and guidelines for non-sterile compounding
Created by: Kianaortiz.RX
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