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level: Level 7

Questions and Answers List

level questions: Level 7

QuestionAnswer
EQUIPMENT USED IN GRANULATION1 Wet Granulators 2 Dry Granulators
Wet Granulators list1 Sheer Granulators 2 High-speed Mixers/Granulators 3 Fluidized-bed Granulators 4 Spray-driers 5 Sphenoronizers/Pelletizer 6 Rotor Granulation (Freund Granulator) SSSH FR
Wet Granulator - include a PLANETARY MIXER (The rotation of the mix is in circular motion) and an OSCILLATING GRANULATOR (mechanical process in which the product is pressed through a sieve with a specially shaped rotor arm to obtain a desired particle and a drying oven; 3in1 equipment that has a mixer, granulator, and a drying oven)Sheer Granulators
Sheer Granulators 1 The rotation of the mix is in circular motion 2 (mechanical process in which the PRODUCT IS PRESSED THROUGH A SIEVE with a specially shaped rotor arm to obtain a desired particle and a drying oven; 3in1 equipment that has a mixer, granulator, and a drying oven). 1 PLANETARY MIXER 2 OSCILLATING GRANULATOR
High-speed Mixers/Granulators list1 Diosna/Felder 2 Collete-Gral Mixer
High-speed Mixers/Granulators list 1 A STAINLESS STEEL MIXING BOWL WITH A THREE-BLADED MAIN IMPELLER (usually revolves in a horizontal plane) and THREE-BLADED AUXILIARY CHOPPER (either revolves in a vertical or horizontal plane to ensure that every corners and particles are cut and mixed into their desired size) 2 BASED ON THE BOWL AND OVERHEAD DRIVE OF PLANETARY MIXER, but the SINGLE PADDLE is REPLACED BY TWO MIXING SHAFTS (One of the mixing shaft carries three blades which rotate in the horizontal plane at the base of the ball and the second shaft carries a smaller blade which acts as a chopper and rotates in the horizontal plane in the upper regions of the granulating mass). 1 Diosna/Felder 2 Collete-Gral Mixer
Wet Granulators A MULTIPURPOSE EQUIPMENT (3in1 mixer, granulator, and oven); Usually OPERATES IN A BUBBLING BED REGIMEFluidized-bed Granulators
Wet Granulators Are FOR GRANULES MADE FROM SOLUTION OR SUSPENSION OF DRUG ALONE or a single excipient or rather a complete formulation; ONLY USED when OTHER METHODS are NOT APPLICABLESpray-driers
Wet Granulators To produce pellets that are USED FOR CONTROLLED DRUG-RELEASE PRODUCTS following coating with a suitable polymer coat and also filling into hard-gelatin capsules; The PROCESS INVOLVED in this is EXTRUSION/SPHERONIZATIONSphenoronizers/Pelletizer (Spheronizers)
Wet Granulator - The process ALLOWS the DIRECT MANUFACTURE OF SPHERE FROM A DRY POWDERRotor Granulation (Freund Granulator)
 LATEST TECHNOLOGY IN MANUFACTURING SOLID DOSAGE FORM WITH CONTROLLED-RELEASE PROPERTIES  The particles are MADE INTO UNIFORM SPHERICAL SHAPE (pellets) by COATING IT WITH A THIN POLYMER (GIVE EXAMPLE)EXTRUSION/SPHERONIZATION  Example drug: Feosol (Has pellets that are enclosed in a capsule)
EXTRUSION/SPHERONIZATION MAIN STEPS1. DRY MIXING of ingredients to achieve homogenous powder dispersion. 2. WET MASSING to produce a sufficiently plastic wet mass. 3. EXTRUSION (pushing the wet mass into a dye) to form rod-shaped particles to form uniform size and diameter; The extrude produced must have enough plasticity to deform but not so much that the extruded particles adhere to other particles when collected or rolled in the spheronizer 4 SPHERONIZATION (transition from cylindrical particles into cylindrical particles with rounded edges, into dumbell shape, into ellipsoids, and finally into sphere) 5 DRYING to achieve the desired moisture content 6 SCREENING; achieve the desired narrow size distrib.
Dry Granulators - A LARGE HEAVY-DUTY WATER REPRESSES TO PRODUCE SLUGS or a VERY LARGE TABLETS with a 25 MM in diameter about to 10-15 MM THICK - After producing a larger tablets or slugs, a hammer mill is used to break the compacts then it will be sieved in an appropriate size After milling and mixing, it will be subjected to __ and water repress to subject in a large tablets or slug then it will undergo sieving processSluggers
1) 3 CLASSES OF EXTRUDERS BASED ON THEIR FEED MECHANISM 2) EXTRUSION/SPHERONIZATION Applications:1  Screw feed extruder  Gravity feed extruder  Piston feed extruder SGP 2) 1. Controlled drug release 2. Processing
Dry Granulators - ALTERNATIVE OR GENERAL METHOD - The POWDER MIX being SQUEEZED BETWEEN TWO ROLLERS TO FORM A COMPRESSED SHEET - Since the sheet is very thin, therefore it is weak and brittle which breaks immediately in to flakes - The flakes needs gentle treatment to break them in granules and can be usually achieved by screening aloneRoller Compaction
Desirable Properties of pellets: 1 Uncoated 2 Coated1 UNCOATED PELLETS: uniform spherical shape, uniform size, good flow properties, reproducible packing into hard gelatin capsules, high strength, low friability, low dust, smooth surface, ease of coating 2 ONCE COATED: o Desired drug-release characteristics o Once coated, they will maintain the properties in uncoated pellets
 It CONVERTS PRIMARY POWDERED PARTICLES INTO GRANULES using the application of pressure WITHOUT THE INTERMEDIATE USE OF LIQUID therefore to avoid the heat temperature combination that may cause degradation of other products  The granule sin here is to make another dosage form that will be subjected to compression or encapsulation to form a tabletDry Granulators
Dry Granulators Two pieces of equipment necessary1) A MACHINE FOR COMPRESSING the dry powders into COMPACTS OR FLAKES 2) A MILL FOR BREAKING UP these intermediate products into GRANULES