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 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)
