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level: Level 6

Questions and Answers List

level questions: Level 6

QuestionAnswer
GENERAL UNIT OPERATION INVOLVED IN MANUFACTURING1 MILLING 2 MIXING 3 GRANULATION 4 DRYING 5 FILLING
Process of reducing the particle sizeMILLING
MILLING 3 BASIC ACTIONS1) Attrition - Breaking down of materials by rubbing action between two surfaces 2) Rolling - The use of heavy rollers to crush ang pulverize the materials 3) Impact - Involves the operation of hammers or bars at high speed; In here, they strike the lamps against each other or against the wall of the chamber ARI
1 Breaking down of materials by RUBBING ACTION BETWEEN TWO SURFACES 2 The use of HEAVY ROLLERS TO CRUSH ang PULVERIZE the materials 3 Involves the operation of HAMMERS OR BARS AT HIGH SPEED; In here, they strike the lamps against each other or against the wall of the chamber1 Attrition 2 Rolling 3 Impact
MIXING - Uses several equipment:1 Tumbling Mixers or Blenders 2 High Speed Mixer Granulators 3 Fluidized-bed Mixers 4 Agitator Mixers
COMMONLY USED for GRANULES and FREE-FLOWING POWDERS; Their containers are GENERALLY MOUNTED so that they can be ROTATED ABOUT AN AXISTumbling Mixers or Blenders
Aside from mixing, this can also be USED FOR GRANULATION OF PRODUCTSHigh Speed Mixer Granulators
MAIN USE is to DRY THE GRANULES or DECOATING THE MULTIPARTICLESFluidized-bed Mixers
Usually depend on the motion of the BLADE OR PADDLE through the product; Main mechanism is CONVECTIVE MIXING (inversion of the powderbed using blades or paddles in which the large mass of material moves from one place to another.); Using this equipment, DEADSPOTS MAY NOT BE ELIMINATED during the process, SOME OF THE PARTICLES WILL NOT BE MIXEDAgitator Mixers
A process in which the POWDER PARTICLES are made to ADHERE TO FORM A LARGER MULTIPARTICLE ENTITIES Typically, the size of these granules are from 0.2 TO 4 MM while for granules intended for tableting purposes and capsulation are from 0.2 TO 0.5 MMGRANULATION
GRANULATION 1 Typically, the size of these granules are from __ 2 while for granules INTENDED FOR TABLETING PURPOSES and CAPSULATION are from __1) 0.2 TO 4 MM 2) 0.2 TO 0.5 MM
GRANULATION METHODS1 Wet Granulation 2 Dry Granulation 3 Direct Compression
 Involves the MASSING OF A MIX OF DRY PARTICLES using a GRANULATING FLUID  OLDEST AND WIDELY USED METHOD which involves WET MASSING  The WET MASS IS FORCED THROUGH A SEIVE to PRODUCE GRANULES which are then dried  The granulating fluids usually used are volatile solvents (Ethanol, Isopropranol, and Water) (STATE THE ADV & DISADV)Wet Granulation ADV: 1 Improves COHESIVENESS & COMPRESSIBILITY of powders with formulation of granules 2 SUITABLE for high dosage drugs with POOR FLOW or COMPRESSIBILITY 3 GOOD DISTRIBUTION and UNIFORM CONTENT for soluble low-dosage drugs 4 GOOD COLOR DISTRIBUTION 5 Ensures fixed composition of each granule during processing, transport, and handling 6 IMPROVES the DISSOLUTION RATE of HYDROPHOBIC DISADV: 1 Very costly 2 time and labor-consuming 3 NOT USEFUL for WATER and HEAT-SENSITIVE DRUGS
Wet Granulation GENERAL STEPS:1. Milling of raw materials. 2. Weighing of raw materials. 3. Dry mixing of milled raw materials by adding the active ingredient, diluent, and internal disintegrant. 4. Wet mixing: incorporating of binder solution (granulating fluid) 5. Granulation and screening of the damp mass using 6-12 mesh screen. 6. Drying. 7. Dry screening through small mesh screen (no. 14-20). 8. Final mixing: addition of lubricant and external disintegrant; From there, it is now ready for further processing either to be encapsulated or to be compressed into powders. 9. Compression.
 The PRIMARY POWDER PARTICLES are AGGREGATED under a HIGH PRESSURE  Usually DONE THROUGH SLUGGING (a heavy-duty tablet press is used and the resulting product is a large tablet that is broken down into smaller pieces) or ROLLER COMPACTION (the powder is squeezed between 2 rollers to produce sheet of materials that will be broken down into smaller pieces)  This method may be USED FOR DRUGS THAT DO NOT COMPRESS WELL AFTER WET GRANULATION or those which are SENSITIVE TO MOISTURE  Active tablets are usually Thiamine, Thiamine hydrochloric, Aspirin, Ascorbic acid, and Magnesium hydroxide (STATE THE ADV & DISADV)Dry Granulation adv: Very useful for water and heat-sensitive materials disadv: 1 NOT permit uniform color distribution 2 tendency to CREATE MORE DUST (NO GRANULATING FLUID)
Dry Granulation 1 Active tablets are usually1 Thiamine 2 Thiamine hydrochloric 3 Aspirin 4 Ascorbic acid 5 Magnesium hydroxide
Dry Granulation GENERAL STEPS1. Milling. 2. Weighing. 3. Mixing: AI, diluent, and a portion of lubricant. 4. Slugging or precompression. 5. Granulation and Sieving. 6. Final mixing: Lubricant and Disintegrant. 7. Compression.
 The PREFERRED METHOD IN GRANULATION  TABLETS are COMPRESSED DIRECTLY from powder blends of active and suitable ingredients  USES DIRECTLY COMPRESSIBLE VEHICLE such as Anhydrous lactose, Spray-dried lactose, Crystalline sorbitol, Dicalcium phosphate dihydrate, Granular mannitol, and Avicel  The ingredients incorporated here SHOULD POSSESS INHERENT COHESIVENESS & GOOD FLOW PROPERTIES (STATE THE LIMITATIONS)Direct Compression LIMITATIONS: - Stratification-variation in content with differences in size and density - Drug limited to 30% of tablet weight unless directly compressible - Interaction between amine drugs and spray-dried lactose - Development of static charges which prevents uniform distribution
Direct Compression USES DIRECTLY COMPRESSIBLE VEHICLE such as1 Anhydrous lactose, 2 Spray-dried lactose, 3 Crystalline sorbitol, 4 Dicalcium phosphate dihydrate, 5 Granular mannitol, 6 Avicel
Direct Compression GENERAL STEPS1. Milling 2. Weighing 3. Mixing 4. Compression