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level: level 5 - RUBBER / LATEX SUPPOSITORY MOLDS

Questions and Answers List

level questions: level 5 - RUBBER / LATEX SUPPOSITORY MOLDS

Question	Answer
The mold requires __ before the melt is poured to facilitate clean and easy removal of the molded suppositories.	lubrication
1 Lubrication is usually necessary with __ 2 They do not need Mineral Oil	1 glycerinated gelatin. A thin coating of mineral oil applied with the finger to the molding surfaces usually suffices. 2 Cocoa Butter and PEG
Calibration of the Mold	1 Prepare molded suppositories from base material alone. 2 After removal from the mold, the suppositories are weighed and the total weight and average weight of each suppository are recorded (for the particular base used).
Determination of the Amount of Base Required	Amount of base = (Total volume of the mold) - (amount of drug substances)
The oldest and simplest method of suppository preparation Method of choice when only few suppositories are prepared in a cocoa butter base It has the advantage of avoiding the necessity of heating the cocoa butter	Hand Rolling Method
Generally prepared by Melt Fusion method Commercially automated equipment for melt fusion is available Process starts with two main components: packaging shell material and molten bulk drug product	Manufacturing Suppositories
Primary packaging in automated process:	a. Forming b. Dosing c. Cooling d. Sealing e. Finishing Mnemonics: FDCSF (or DCS FF)
USP 36-NF31 Identification, Assay, Loss on Drying, Disintegration and Dissolution Calculations for theoretical weight and actual weight , weight variation, colour, hardness, surface texture, overall appearance	Quality Control
IN quality control, observation for excessive softening and oil stains on packaging	Stability
QUALITY CONTROL 1 Physical Stability 2 Chemical Stability 3 Microbiological stability	1 softening, hardening, drying , cracking, separation, polymorphs, odor of rancidity 2 hydrolysis, epimerization, decarboxylation, dehydration, oxidation, photochemical degradation 3 do not contain preservatives
1 Beyond-Use Dating for Compounded suppository: 2 If the product is prepared from USP/NF, __ 3 If contains water: __	1) 25% of the time remaining on the expiration date or 6 months 2 A beyond-use date of 6 months is appropriate 3) 14 days when stored in a refrigerators
Expiration Dating for Manufactured Suppositories	> must bear expiration date > EXCESSIVE MOISTENING is the major indication of instability