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Pilot plant for tablet dosage form

Pilot scale-up is defined as transforming a lab scale formula into a viable product by developing reliable, practical manufacturing procedures. The objectives are to produce stable dosage forms, review processing equipment, provide guidelines for production/control, evaluate/validate the process, and identify critical features. Personnel with experience in pilot operations and production are preferred. The presentation discusses raw materials handling, relevant equipment for blending, granulation, drying, size reduction, compression, coating, and evaluation parameters like appearance, weight variation, dissolution testing and more. GMP considerations and transfer of analytical methods to quality assurance are also covered.

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PILOT SCALE-UP FOR TABLET DOSAGE FORM Presented by Shikha singh MCOPS Manipal university
DEFINED AS A PART OF THE PHARMACEUTICAL INDUSTRY WHERE A LAB SCALE FORMULA IS TRANSFORMED INTO A VIABLE PRODUCT BY THE DEVELOPMENT OF LIABLE PRACTICAL PROCEDURE FOR MANUFACTURE Presentaionby-ShikhaYSingh R & D Pilot Plant Productio n PILOT SCALE-UP 2
OBJECTIVES Presentaionby-ShikhaYSingh To produce physically and chemically stable therapeutic dosage forms. Review of the processing equipment Guidelines for production and process control Evaluation and validation To identify the critical features of the process To provide master manufa- cturing formula 3
REPORTING RESPONSIBILITY:  Effective, economically, consistently reproducible on a production scale  Cost of manufacture: since low production costs provide a competitive advantage.  Each unit operation is optimised. Presentaionby-ShikhaYSingh 4
PERSONNEL REQUIREMENTS:  Scientists with experience in pilot plant operations as well as in actual production area are the most preferable.  As they have to understand the intent of the formulator as well as understand the perspective of the production personnel.  The group should have some personnel with engineering knowledge as well as scale up also involves engineering principles. 5 Presentaionby-ShikhaYSingh
SPACE REQUIREMENTS:  Physical testing area  Standard equipment floor space  Storage area  Space for cleaning of equipments 6 Presentaionby-ShikhaYSingh
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REVIEW OF FORMULA: Ingredients Quantity per tablet (mg) Aminophylline 100 Tricalcium phosphate 50 Pregelatinized starch 15 Water q.s. Talc 30 Mineral oil, light 2 9 Presentaionby-ShikhaYSingh
RAW MATERIALS:  Intermediate- or large-scale operations, materials handling- IMPORTANT  Prevent cross contamination.  Accurate delivery of drug  More sophisticated methods of handling materials  E.g-vacuum loading systems, metering pumps, screw feed system. Presentaionby-ShikhaYSingh 10
RELEVANT PROCESSING EQUIPMENTS:  Relevant processing equipment used in different stages of tablet operations:  Material handling  Dry blending  Granulation  Drying  Reduction of particle size  compression  Direct compression  Tablet coating Presentaionby-ShikhaYSingh 11
DRY BLENDING Presentaionby-ShikhaYSingh 12  To ensure good distribution  Inadequate blending- drug content variation  To ensure no lumps or agglomerates- otherwise flow problem  Screening, milling of the ingredients makes the process- more reliable and reproducible
EQUIPMENT USED Presentaionby-ShikhaYSingh 13  V-Blender  Double cone Blender  Ribbon Blender  Slant cone Blender  Bin Blender  Orbiting Screw Blenders vertical & horizontal high intensity mixers
Presentaionby-ShikhaYSingh 14Ribbon BlenderDouble Cone Blender Slant Cone Blender Bin Blender
GRANULATION  To impart good flow properties to the material  To increase the apparent density of the powders  To change the particle size distribution  Uniform dispersion of active ingredient  Equipment Used : 15 Presentaionby-ShikhaYSingh • Sigma blade mixer • Heavy duty planetary mixer Wet methods • Roller Compaction mill • Shear mill Dry methods
Presentaionby-ShikhaYSingh 16 Sigma Blade Mixer Planetary Mixer Roller Mill Rotary Shear
DRYING Presentaionby-ShikhaYSingh 17  Conventional method-hot air oven  Factors to be considered during scale-up:  Airflow  Air temperature  Depth of the granulation  Granulation bed Too deep Process-Inefficient Too dense
EQUIPMENT USED Presentaionby-ShikhaYSingh 18 TRAY DRYER (8 hour) FLUIDIZED BED DRYER (1 hour)
REDUCTION OF PARTICLE SIZE: (SIZING)  Compression factor gets affected by particle size distribution are  Followability  Compressibility  Uniformity of tablet weight  Content uniformity  Tablet hardness  Tablet colour uniformity 19 Presentaionby-ShikhaYSingh
Presentaionby-ShikhaYSingh 20 Hammer Mill Mechanical Sieving Oscillating Granulator EQUIPMENT USED Or some screening devices
COMPRESSION Presentaionby-ShikhaYSingh 21  FUNCTIONS:  Filling of empty die cavity with granulation  Pre-compression of granulation  Compression of granulation  Ejection of the tablet from the die cavity  ADVANCES- better control of  Feeder mechanism  Pre-compression  Compression force
Presentaionby-ShikhaYSingh 22 Single Rotary Press Double Rotary Press EQUIPMENT USED
TABLET COATING 3 important techniques involved in coating:  Sugar Coating modifications: conventional pan perforated pan/ FB columns  Film Coating  Enteric Coating 23 Presentaionby-ShikhaYSingh Sugar coating Solvent film coating Aq. Film coating
Presentaionby-ShikhaYSingh 24 Coating Pans Accela Coata Dria Coater Fluidized Bed Coating EQUIPMENT USED
PRODUCTION RATES:  Timescale for a pharmaceutical tablet to be produced-fraction of a second  Production rate is around 10,000 tablets/minute  Technical innovations- improved production rates to more than 500,000 tablets/hour  High rate of tablet output of modern presses requires continuous tablet weight monitoring  Electronic monitoring devices such as Thomas Tablet Sentinel, Pharmakontroll or Killan control System-MC. 25 Presentaionby-ShikhaYSingh
PROCESS EVALUATION: 26 Presentaionby-ShikhaYSingh PARAMETERS General appearance Weight variation Disintegration test Dissolution Test Heating and cooling Rates Friability test Content uniformity test
PREPARATION OF MASTER MANUFACTURING PROCESS: Weight sheet Processing directions Manufacturing procedure 27 Presentaionby-ShikhaYSingh
GMP CONSIDERATIONS: General Sifting, Mixing and Granulation Compressions Coating Printing Packaging (Strip and Blister) 28 Presentaionby-ShikhaYSingh
TRANSFER OF ANALYTICAL METHOD TO QUALITY ASSURANCE:  Scale-up of a new product- analytic test methods developed  Steps involved in transfer process:  Review the process  Proper analytical instrumentation is available  Personnel are trained to perform the tasks  Recovery studies  Validation studies 29 Presentaionby-ShikhaYSingh
ANY QUERIES??? Presentaionby-ShikhaYSingh 30
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