Pharmaceutical Manufacturing (Granulation)

Pharma, Manufacturing, Drug, Granulation, Tablet, Capsule, Process, Development, Formulation, QTPP, CMA, CPP, CQA, R&D

What you’ll learn
Understand and define roles of pharmaceutical ingredients such as diluents, binders, disintegrants and lubricants
Define general scope of pharmaceutical manufacturing processes in pharmaceutical industry
Define equipment, theory and process steps of wet granulation
Define equipment, theory and process steps of spray granulation (fluid bed granulation)
Define equipment, theory and process steps of dry granulation (roller compaction)
Evaluate important points for direct compression, wet granulation, spray granulation and dry granulation
Understand advantageous and disadvantageous of wet granulation, spray granulation and dry granulation manufacturing techniques
Define Quality Target Product Profile, Critical Material Attributes, Critical Process Parameters and Critrical Quality Attributes (CQAs) of these methods

Requirements
Require mobile/tablet/laptop/personal computer with internet
To be student, graduate and/or pharma professional

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)

Overview
Section 1: Introduction

Lecture 1 Introduction

Section 2: Pharmaceutical Excipients

Lecture 2 Diluent

Lecture 3 Binder

Lecture 4 Disintegrant

Lecture 5 Lubricant

Section 3: Pharmaceutical Manufacturing Techniques for Preparation of Compressible Powders

Lecture 6 Pharmaceutical Manufacturing Techniques for Preparation of Compressible Powders

Section 4: Direct Compression (Dry Blending)

Lecture 7 General Definition of Direct Compression

Lecture 8 Advantageous of Direct Compression

Lecture 9 Disadvantageous of Direct Compression

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

Lecture 10 Quality Target Product Profile for Direct Compression

Lecture 11 Critical Material Attributes (CMAs) of Direct Compression

Lecture 12 Critical Process Parameters (CPPs) of Direct Compression

Lecture 13 Critical Quality Attributes (CQAs) of Direct Compression

Section 6: GRANULATION

Lecture 14 General Definition of Granulation

Lecture 15 Advantageous of Granulation

Lecture 16 Disadvantageous of Granulation

Section 7: WET GRANULATION

Lecture 17 General Definition of Wet Granulation

Lecture 18 Wet Granulation Theory

Lecture 19 Wet Granulator Equipment Design

Lecture 20 Wet Granulation Process Steps

Section 8: QTPP, CMA, CPP AND CQA FOR WET GRANULATION

Lecture 21 Quality Target Product Profile for Wet Granulation

Lecture 22 Critical Material Attributes (CMAs) of Wet Granulation

Lecture 23 Critical Process Parameters (CPPs) of Wet Granulation

Lecture 24 Critical Quality Attributes (CQAs) of Wet Granulation

Section 9: SPRAY GRANULATION

Lecture 25 General Definition of Spray Granulation (Fluid Bed Granulation)

Lecture 26 Spray Granulation (Fluid Bed Granulation) Theory

Lecture 27 Spray Granulation (Fluid Bed Granulation) Equipment Design

Lecture 28 Spray Granulation (Fluid Bed Granulation) Process Steps

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

Lecture 29 Quality Target Product Profile for Spray Granulation (FBD Granulation)

Lecture 30 Critical Material Attributes (CMAs) of Spray Granulation (FBD Granulation)

Lecture 31 Critical Process Parameters (CPPs) of Spray Granulation (FBD Granulation)

Lecture 32 Critical Quality Attributes (CQAs) of Spray Granulation (FBD Granulation)

Section 11: DRY GRANULATION (ROLLER COMPACTION)

Lecture 33 General Definition of Dry Granulation (Roller Compaction)

Lecture 34 Dry Granulation (Roller Compaction) Theory, Equipment Design and Process Steps

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

Lecture 35 Quality Target Product Profile for Dry Granulation (Roller Compaction)

Lecture 36 Critical Material Attributes (CMAs) of Dry Granulation (Roller Compaction)

Lecture 37 Critical Process Parameters (CPPs) of Dry Granulation (Roller Compaction)

Lecture 38 Critical Quality Attributes (CQAs) of Dry Granulation (Roller Compaction)

Section 13: CONCLUSION

Lecture 39 Conclusion

Anyone who is looking to get entry in pharmaceutical industry,Anyone who is looking to learn pharmaceutical manufacturing,Existing pharma professionals who are looking to progress in their jobs