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level: Level 8

Questions and Answers List

level questions: Level 8

QuestionAnswer
Types of drying methods1 Convective drying 2 Conductive drying 3 Radiation drying 4 Freeze drying CC RF
Principle involves in oven  Fixed bed __  FIXED BED OR STATIC, simply put the components in a tray dryer then let it dry with a heat  Dynamic __  PRINCIPLE BEHIND THE FLUIDIZED BED DRYER a type of dryingConvective drying
 With solid, INTERNAL CONTACT WITH HOT SURFACE and the bulk of HEAT TRANSFER OCCURS BY CONDUCTION or vacuum inside the equipment produced with the heat a type of dryingConductive drying
 With through the HEAT TRANSMISSION BY RADIATION and usually differs from heat transfer by conduction or convention in which there is NO TRANSFER MEDIUM or a SOLID, LIQUID or GAS TO be PRESENT  Ex. Microwave oven a type of dryingRadiation drying
 USE NITROGEN  A VERY LOW TEMPERATURE to REMOVE THE WATER or MOISTURE and as a result it will TURN IT INTO A POWDER FORM a type of dryingFreeze drying
FILLING 1 Solids (such as tablets and capsules): they are counted by __ 2 Powder or granular products: may be filled by volume using an __. 1 REVOLVING DISC, SLAT COUNTER OR BREAKING A BEAM OF LIGHT 2) 1 Auger or a Filling cup, 2 by weight using a Bulk Feed plus Trickle top up (same sap ag fill sa liquid preparation)
TABLET MANUFACTURING TECHNIQUES1. Dry methods: uses dry granulation technique 2. Wet methods: uses wet granulation technique 3. Direct compression: If want to make a tablet that has a weight of 50 mg
POWDER COMPRESSION VS COMPACTION1 Powder compression  Is defined as the REDUCTION IN VOLUME OF THE POWDER owing the application of a force 2 Powder compaction  Defined as the FORMATION OF A POROUS SPECIMEN OF DEFINED GEOMETRY by powder compression
THE PROCESS OF TABLETING CAN BE DIVIDED INTO THREE STAGES (COMPACTION CYCLE):1. Die filling 2. Tablet formation 3. Tablet ejection
TABLET PRESSES 1  Also known as eccentric press  Can weigh at least 200 tablets per minute 2  Used in manufacturing plant or a larger scale  Can produce 10,000 tablets per minute. 1 Single-punch press 2 Rotary press
TABLET PRESSES PARTS1 Hopper: store the materials for compression 2 Feed Frame: distributes the materials into the die 3 Dies: controls the size and shape of the tablet 4 Punches: compact the materials within the dies and shape 5 Cams: guide the punches
TABLET PROCESSING PROBLEMS:1 Capping 2 Lamination 3 Chipping 4 Picking 5 Sticking 6 Mottling 7 Weight variation 8 Hardness variation That is CAP, LAM, CHIP PICK STICK MOTT Weight var and hardness var
1 COMPLETE OR PARTIAL SEPARATION OF TOP OR BOTTOM of TABLETS from the main body 2 SEPARATION OF TABLET IN TWO or MORE DISTINCT LAYERS 3 SEPARATION OF SMALL PORTION in TABLET SURFACE1 Capping 2 Lamination 3 Chipping (these are TABLET PROCESSING PROBLEMS)
1  REMOVAL OF MATERIALS to the SURFACES of the tablets and ADHERENCE of the FACE OF THE PUNCH 2  The ADHESION OF THE GRANULATION OF THE DIE or the BUILD UP of the MATERIAL in the PUNCH 3  UNEQUAL COLOR DISTRIBUTION in SURFACE1 Picking 2 Sticking 3 Mottling (these are TABLET PROCESSING PROBLEMS)
1  Very unacceptable in processing since it has a difference in the tablets 2  Can be test through hardness testers which is the part of in-process test1 Weight variation 2 Hardness variation (these are TABLET PROCESSING PROBLEMS)
CHIPPING CAUSES: (STATE THE CAUSES & THEIR REMEDIES)1 AIR ENTRAPMENT AMONG GRANULES - The air escapes after the pressure is released so to prevent, make a light granulations - If too dry or more powder then less moisture - REMEDY: make a density or tracking materials and REDUCE THE AMOUNT OF POWDER and SOME WATER or hydroscopic materials 2 OVER LUBRICATION - REMEDY: to VALIDATE THE AMOUNT OF LUBRICANT 3 WORN AND IMPERFECT PUNCHES AND DIES - REMEDY: REPLACE PUNCHES 4 CARELESSNESS OF SETTING UP PRESSES - REMEDY: follow the SOP always
STICKING CAUSES: (STATE THE CAUSES & THEIR REMEDIES)1 LACK OF LUBRICANT - REMEDY: PROPER AMOUNT OF LUBRICANT 2 UNPOLISHED SURFACES OF PUNCHES AND DIES - REMEDY: USES PLATED PUNCH FACES with CHROMIUM to produce an smooth adherence face 3 EXCESSIVE MOISTURE - REMEDY: DRY THE GRANULATION 4 SOFT TABLETS - REMEDY: ADD MORE BINDER or FORMULATE powders or add dilution of low active melting ingredient or additives that with high melting materials. - To prevent the softening of granules due to heat of compression and may increase the tablet size.
MOTTLING CAUSES: (STATE THE CAUSES & THEIR REMEDIES)1 DIFFERENT COLORS OF INGREDIENTS - REMEDY: CHOOSE EXCIPIENTS that has the SAME COLOR with ACTIVE INGREDIENTS 2 COLORED DEGRADATION PRODUCTS OF THE DRUG - REMEDY: USE DIES to MASK THE DEGRADATION product 3 COLOR-DYE MIGRATION DURING DRYING OF GRANULES - REMEDY: REDUCE THE DRYING TEMPERATURE or change the solvent system