Advance Non Sterile Solid Dosage form.pptx

Advanced Non sterile Solid Product manufa turing technology PMT Quality Assurance first year

1. 1 Guided By:- Dr. Ganesh B. Patil Professor & Head of QA Department Presented By :- Mr. Nitin K. More M. Pharm I st Year Quality Assurance Roll No. MQA0 6 Advance Non- Sterile Solid Product Manufacturing Department of Pharmaceutical Quality Assurance, H . R . Patel Institute of Pharmaceutical Education & Research, Shirpur. 06-04-2024

2. 06-04-2024 2 CONTENTS Process Automation in Pharmaceutical Industry Tablet Manufacturing Machines/Equipment Mixing Equipment Granulation Equipment Drying Equipment Tablet Defects and their Remedy SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

3. PROCESS ATOMATION IN PHARMACUETICAL INDUSTRY Basic Purpose of automation in the manufacturing industry is: To Increase Productivity The quality of the product improves as human input is minimized It causes a reduction in direct labour costs There is greater accuracy, more output, and greater speed Minimization of wastage 3 06-04-2024 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

4. “A tablet is a pharmaceutical solid dosage form containing medicaments with or without excipients.” 06-04-2024 4 TABLET SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

5. MANUFACTURE OF TABLETS: Steps :- 1. Mixing of the therapeutic agents with the excipients 2. Granulation of the mixed powders 3. Mixing of the powders or granules with other excipients (mostly lubricants) 4. Compression into tablets 5. Coating 06-04-2024 5 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

6. Granulation Granulation: process in which primary powder particles are made to adhere to form larger, multiparticle entities called granules. 06-04-2024 6 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

7. 1. Wet granulation 06-04-2024 7 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

8. 2. DRY GRANULATION When tablet ingredients are sensitive to moisture 06-04-2024 8 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

9. 3.Direct compression • Wet granulation and dry granulation methods having series of unit operations, both time consuming and potentially costly. T his method can be defined as basically  mixing and processing of formulation ingredients then compressing into tablets . 06-04-2024 9 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

10. Granulation Equipment's 1.Dry Granulator 2.Wet Granulator A. Sluggers. A. Shear mixer granulators. B. High speed granulators. B. Roller Compactors. C. Fluidized Bed granulators. D. Spray Dryers. 06-04-2024 10 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

11. 06-04-2024 11 Roller compactors used when- Drug is sensitive to heat or moisture or both. SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

12. 06-04-2024 12 Fluidized bed granulator • The powder is suspended by vertical flow of air from the bottom of the granulator. • The granulation fluid is sprayed on the powder from the top of the granulator. • Tangential air flow provides circular powder suspension. • Air applied with controlled temperature. SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

13. 06-04-2024 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR. 13 Rota granulation This process allow the direct manufacturing of spheres suitable for controlled release solid dosage forms from dry powder in one process. The powder mix is added to the bowl and wetted with granulating liquid from a spray . Rota granulation are manufacturing in size range between 45 L and 450 L capacity .

14. Continuous And Batch Mixing Batch Mixing In batch operation, all ingredients are loaded into the mixer together or in a pre-define sequence, and mixed until a homogenous material is produced and discharged from the mixer in a single lot. The output of a batch mixer is measured in kg/batch. Continuous Mixing Ingredients are continuously charged into the mixer in accordance with the formulation. The mixing take places the material travels from the charging port to the discharge nozzle, from where it is continuously discharged. The output of a continuous mixer is measured in kg/hr. 06-04-2024 14 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

15. 15 MIXING EQUIPMENTS 06-04-2024 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

16. Pelletization 06-04-2024 16 Pelletization can be defined as an size-enlargement process that converts fine powders or particles of bulk drugs and excipients into small, free-flowing, more or less spherical units, called pellets. Granulation is also known as pelletization SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

17. 06-04-2024 17 Pelletizers SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

18. 06-04-2024 18 Drying Equipments Drying the process that’s means eliminating or removing the moisture or water from the product. 1.Fluidized Bed Dryer. Fluidized bed dryer are the best and fastest drying systems for drying wet granulator solids which do not then tend to stick . At this stage the solids will not contact each other. 15-30 min for removing moisture by internal diffusion. SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

19. 06-04-2024 19 2) Spray Dryer Spray drying  is a method of producing a dry powder from a liquid or slurry by rapidly drying with a hot gas. Used for the thermal sensitive material. All spray dryers use some type of  atomizer  or  spray nozzle  to disperse the liquid or slurry into a controlled drop size spray. SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

20. 20 TECHNIQUE / METHODS USED IN TABLET PRODUCTION 06-04-2024 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

21. 06-04-2024 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR. 21 Problems In Tableting Capping Cracking Capping & lamination Mottling chipping

22. 06-04-2024 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR. 22 Capping Upper and lower part of the tablet are separated. Cases of Capping Insufficient lubricant moisture content in granules Remedies Dry the granules properly Increase the amount of lubricant 2.Cracking Splits throughout the tablet Causes of Cracking Insufficient amount of Binder Remedies Adding the sufficient amount of the binder Problems In Tableting

23. 06-04-2024 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR. 23 3. Picking Adherence of the tablet material from the surface of a tablet by a punch. Causes Insufficient lubricant Remedy Adding sufficient amount of lubricant 4. Mottling Unequal distribution of colour on the tablet surface Causes Drugs with degradation nature and have different coloured degraded product Remedy By using bright colouring agent that will mask all the colour variations of the ingredients

24. 24 References   Lachman L.  Lieberman H.A and Kanig J.L, “Theory and Practice of industrial pharmacy”, Lea & Febieger, Philadelphia,4th edition. Saikh, M.A.A., 2013. A technical note on granulation technology: a way to optimise granules.  International Journal of Pharmaceutical Sciences and Research ,  4 (1), p.55. Liberman A. Herbert, Lachman Leon, Schwartz B. Josep “Pharmaceutical Dosage Form; Tablets” Vol. 3,2 nd Edition Page No. 370-389. 06-04-2024 SES' H. R. Patel Institute of Pharmaceutical education & Research, SHIRPUR.

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