Rajaguru-PPT
- 1. PROCESS OF FORMULATION DEVELOPMENT Mr.R.RAJAGURU. M Pharm.,(Ph D).,PG.Pharmaceutical Petent Law ’s., Sr.Scientists FR &D Hyderabad Email.ID : rajaguru94mrv@gmail.com Cell No: 8098532413.,9014227983.
- 2. Filters CrystallizationOven drying Compression Finished products Imprinting Coating Blending Roller Compactor Rapid mixture Granulator -RMG Fluid bed dryer-FDB Blending Milling DRUG PRODUCT MANUFACTURE API Excipients
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- 5. 5 1. DRY MIX METHOD Manufacturing technology Mixing / Sifting Blending / Pre- Lubrication Lubrication Tablet compression Coating Packaging
- 6. Reference Product Details2.SLUG-DE-SLUG METHOD Manufacturing technology Mixing / Sifting Slug-de- slug Milling/ sizing Final blending (lubrication) Tablet compression Coating Packaging
- 7. 7 3. COMPACTION METHOD Manufacturing Technology Dispensing Sifting (40 # ) Blending Attrition (Mini Roller Compactor) Sieve (OG) Minimum 2 cycles based on the % yield Blending Compression Coating Packing
- 9. Reference Product Details 2. WET GRNUALATION METHOD Manufacturing Technology (Wet Granulation Method ) Dispensing Mixing / Sifting Binder Solution Preparation (Aqueous/ Non-Aqueous ) Rapid Mixture Granulator (RMG) Wet milling Drying Dry milling Blending (pre- Lubrication &Lubrication) Compression Coating Packing (Based on the product requirement packing
- 10. LIST OF EQUIPMENT in FRD LAB 1) Weighing balance 2) Vibro sifter 3) Moisture Analyzer 4) Rapid mixture granulator/ Mini Roll Compactor / Spherodizer /Extruder 5) Particle coater Granulator/Fluid bed drier 6) Lab co mill /Multi mill/ Pulverizer 7) Octagonal Blender 8) Tablet Compression Machine (Bi-Layer & Normal) 9) Capsule Filling Machine –Automatic/Manual 10)Tablet Coating System 11)Laboratory Blistering Machine 12)Induction Cap Sealer IPQC 1) Disintegration 2) Friability Tester 3) Hardness Tester 4) Vernier Caliper 5) Tap Density Tester 6) Electromagnetic Sieve Shaker 10
- 11. 11 Working principle: 1. Rapid mixer granulator formulation of granules occurs by rising whirling and tumbing motion of materials. 2. Dry mixing is done by adding all ingredients in the RMG by rotation of impeller and chopper at high speed Equipment Name: RAPID GRANULATOR MIXTURE - (RGM) Impeller Chopper
- 12. 12 Working principle: 1. Analyze sieves with an aim of improving the granulation process. 2. Focus on improving quality while reducing production cost 3.Select a right equipment that can produce a uniform blend and mixture. 4.Accurate control of particle hardness and improve dispersion rates 5.Control dust and flow properties of materials. Equipment Name: ROLL COMPACTOR
- 13. 13 Equipment Name: BLENDING Mixing is the process of thoroughly combining different materials to produce a homogenous product Powders are mixed using a suitable blender to obtain a uniform and homogeneous powder mix. The drug substance and excipients are mixed in geometric dilution. TYPE OF BLENDER Double con blender Octagonal blender Blender
- 14. 14 Equipment Name: COMPRESSION MACHINE In the tablet compression machine main principle is compressing of the upper and lower punch in a die hole, The hydraulic pressure plays a key role. This pressure is transmitted unreduced through the static fluid. Any externally applied pressure is transmitted via static fluid to all the direction in same proportion. It also makes it possible to multiply the force as needed. If we increase the hydraulic pressure more compressing force on tablet then it becomes more hard.
- 15. 15 Equipment Name: COATING MACHINE Tablets and granules are coated if there is need to mask the unpleasant taste/odour of some drug substance or to increase the aesthetic appeal of uncoated tablets as well as to modify the release or control the release of drug substance from tablets. This is achieved by enclosing or covering the core tablet or granules with coating solutions TYPE OF COATING; 1. Flim coating 2. Sugar coating 3. Enteric coating
- 16. 16 Equipment Name: BLISTER PACKING MACHINE Blister pack: Blister pack or bubble is a term for several types of per-formed plastic packaging used for small consumer goods, foods and for pharmaceuticals Blistering is the process of making blister or enclosing the tablets & capsules into preformed plastic packing Protects shelf life, temperature, moisture, & light Provides degree of temper resistance TYPE OF BLISTER PACK: Alu-Alu Blister pack PVC/PVdc pack Opaque pack Clear PVC/PVdc pack