Compounding III: Documentation & Preparation Flashcards
BUD selection, preparing dosage forms, etc.
when preparing a product, how much product should be prepared?
calc and prep should be done for 10% excess
master formulation record should have
compound’s official or assigned name, strength and dosage form
calculations
ingredients and quantities
stability & compatibility data w references
equipment
prep/mixing instructions
labeling info
packaging and storage requirements
quality control (CQ) procedures
recommended BUD
description of final product
when reducing particle size in compounding, what size should the particles be? How do we verify this?
0.1-10 microns ; verified w a sieve
solution
definition
examples
solute dissolved in solvent
syrups, elixirs, tinctures, spirits
eutectic mixture definition
the combo of ingredients will melt at a lower temp than each of the individual components melting points
as capsule size increases, capsule capacity/volume _________
decreases
non-aqueous formulations should have a BUD of
no later than 6 months (180 days). store at room temp
water-containing topicals (cream or lotion) should have a BUD of
no later than 30 days stored at room temp
water-containing oral formulations should have a BUD of
no later than 14 days
unit-dose packaging has a BUD of
6 months after preparation
