Overview

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 CONTENT1 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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