Process Development in Pharma Industry : GRANULATION : GMP

Description

In pharmaceutical industry, powder mixture included active product ingredient (API) and other ingredients, can be compressed into a tablet or filled into a capsule.   

• The powder must possess a number of physical characteristics including flowability, cohesiveness, compressibility, and lubrication.  Some of the pharmaceutical materials already have these required physical characteristics, the all ingredients are mixed for tablet compression or capsule filling directly.  Since most pharmaceutical materials do not possess all of these required properties, granulation methods are commonly used to impart the required characteristics.

• Wet granulation and dry granulation are the two most common methods of preparing granules for tablet compression or capsule manufacture. 

  This course provides informations, evaluations, and explanations on the contents of mixing, wet granulation, spray granulation (fluid bed granulation) and dry granulation (roller compaction) manufacturing technologies in the scope of pharmaceutical industry.

• Besides defining of these powder technologies used for tablet / film coated tablet / capsule manufacturing, Quality Target Product Profile (QTPP), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs) and Critrical Quality Attributes (CQAs) of these manufacturing technologies have been also described in this course.   

COURSE CONTENT

1 INTRODUCTION

2 PHARMACEUTICAL EXCIPIENTS

2_1 Diluent

2_2 Binder

2_3 Disintegrants

2_4 Lubricants

3 PHARMACEUTICAL MANUFACTURING METHODS FOR PREPARATION OF COMPRESSIBLE POWDERS

4 DIRECT COMPRESSION (DRY MIXING)

4_1 General Definition of Direct Compression

4_2 Advantageous of Direct Compression

4_3 Disadvantageous of Direct Compression

5 QTPP, CMA, CPP AND CQA FOR DIRECT COMPRESSION (DRY MIXING)

5_1 Quality Target Product Profile for Direct Compression

5_2 Critical Material Attributes (CMAs) of Direct Compression

5_3 Critical Process Parameters (CPPs) of Direct Compression

5_4 Critical Quality Attributes (CQAs) of Direct Compression

6 GRANULATION

6_1 General Definition of Granulation

6_2 Advantageous of Granulation

6_3 Disadvantageous of Granulation

7 WET GRANULATION

7_1 General Definition of Wet Granulation

7_2 Wet Granulation Theory

7_3 Wet Granulator Equipment Design

7_4 Wet Granulation Process Steps

8 QTPP, CMA, CPP AND CQA FOR WET GRANULATION

8_1 Quality Target Product Profile for Wet Granulation

8_2 Critical Material Attributes (CMAs) of Wet Granulation

8_3 Critical Process Parameters (CPPs) of Wet Granulation

8_4 Critical Quality Attributes (CQAs) of Wet Granulation

9 SPRAY GRANULATION (FLUID BED GRANULATION)

9_1 General Definition of Spray Granulation (Fluid Bed Granulation)

9_2 Spray Granulation (Fluid Bed Granulation) Theory

9_3 Spray Granulation (Fluid Bed Granulation) Equipment Design

9_4 Spray Granulation (Fluid Bed Granulation) Process Steps

10 QTPP, CMA, CPP AND CQA FOR SPRAY GRANULATION (FBD GRANULATION)

10_1 Quality Target Product Profile for Spray Granulation (FBD Granulation)

10_2 Critical Material Attributes (CMAs) of Spray Granulation (FBD Granulation)

10_3 Critical Process Parameters (CPPs) of Spray Granulation (FBD Granulation)

10_4 Critical Quality Attributes (CQAs) of Spray Granulation (FBD Granulation)

11 DRY GRANULATION (ROLLER COMPACTION)

11_1 General Definition of Dry Granulation (Roller Compaction)

11_2 Dry Granulation (Roller Compaction) Theory, Equipment Design and Process Steps

12 QTPP, CMA, CPP AND CQA FOR DRY GRANULATION (ROLLER COMPACTION)

12_1 Quality Target Product Profile for Dry Granulation (Roller Compaction)

12_2 Critical Material Attributes (CMAs) of Dry Granulation (Roller Compaction)

12_3 Critical Process Parameters (CPPs) of Dry Granulation (Roller Compaction)

12_4 Critical Quality Attributes (CQAs) of Dry Granulation (Roller Compaction)

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