Pharmaceutical Granulation and Compression

Description

Granulation and compression are two very important processes that are carried out extensively by most pharmaceutical companies. However, the theory of granulation is little understood and the selection of a particular machine and granulation method, is often done on the basis of tradition, rather than by using strict scientific or cost-benefit criteria. The basic techniques have changed dramatically in recent years and granulation for controlled release, extrusion, spheronisation, fluidisation techniques, spray drying, melt extrusion, oral dispersion technology and roller compaction are new technologies that are increasingly being used in modern pharmaceutical production, which exhibit many advantages over previously available techniques. As with granulation, compression is also little understood and why some materials/formulations will compress well whilst others compact with difficulty, is slowly being elucidated. The Course will examine current granulation and compression theory and practice.

Emphasis will be made as to how this theory and practice relates to current pharmaceutical development and production, with special reference to the machinery used. Scale-Up, Transfer Technology and SUPAC will also be addressed. A particular feature of the Course will be the workshop on new melt extrusion technology.

Overview

Three Day Intensive Course with an Emphasis on High Speed and Fluid Bed Granulation, Layering, Pellet Manufacture, Roller Compaction, Oral Dispersion Technology, Scale-Up, Transfer Technology, Melt Extrusion, Spray Drying and Compression Machinery

The aims of the Course are to provide a comprehensive and sound understanding of the theory and practice of tablet granulation and compression and to appreciate the various processes batch or continuous, that are available. The importance of the granulation process in producing good quality tablets will be emphasised. The modern techniques of extrusion, spheronisation, powder layering, roller compaction, fluid-bed processing, spray drying, melt extrusion, oral dispersion technology and tablet compression will be covered. The Course will be taught primarily by industrial scientists who have been closely involved with investigating these granulation and compression processes and thus a pragmatic approach will be adopted throughout.

Summary of Key Benefits of Attending

At the end of the Course participants will have:

• An understanding of the fundamental principles of granulation and the advantages, disadvantages and potential of the various granulation, layering, spray drying, oral dispersion, extrusion and spheronisation methods
• An understanding of the techniques and processes available for granulation in relation to controlled release products
• Detailed knowledge on current ideas and thoughts on Scale-Up, Transfer Technology and SUPAC
• An appreciation of some of the compression problems that can arise and how they can be overcome
• A knowledge of the factors that should be taken into consideration when selecting granulation and compression equipment

Who Should Attend?

All who are working in pharmaceutical research, formulation, development, production, QA/QC and registration who require a sound understanding of the various granulation and compression methods and who wish to appreciate some of the advantages of the newer methods of granulation, spheronisation, roller compaction, layering, melt extrusion and compression that are now available.

Course Programme

Methods and Reasons for Granulating

• Overview of granulation and compression. Techniques available. Theory of granulation.

Excipients

• Review of available excipients; advantages and disadvantages. Rationale for selection

Properties of Granules

• Measurement of granule properties. Ideal granule characteristics.

Granulation for Controlled Release

• Review of current methods.

High Speed Granulation and End-Point Control

• Introduction and history. Machine design. Fixed bowl vertical; fixed bowl horizontal. Removable bowl. Operation. Practical experiences. Review of suppliers. Granulation end-point. Diosna probe. Review of techniques of monitoring impellor torque. Slip meter control. Automated control of whole process.

Integrated Mixer-Granulator Dryers

• Review. Advantages and disadvantages. Equipment available.

Fluid Bed Granulation

• Operation. Equipment selection. Fully automated systems. Rotary granulators. Comparison of methods.

Layering

• Solution, suspension and dry powder layering.

Spray Drying

• F.S.D. Spray Drying

Pellet Manufacture

• Techniques available. Spray drying. Drum granulation. Comparison of methods.

Extrusion and Spheronisation

• Extrusion theory. Basic rheological modelling/formulation indicators. Types of extruders. Commercial extruders. Development extruders. Melt Extrusion: Carriers for Melt Extrusion, Solid Dispersions, Examples of Extruders/Other Equipment, Parameters Affecting Melt Extrusion, Formulation and Process Design Problems. Laboratory modelling. Properties of extrudates. Moisture movement across extrudates. The role of microcrystalline cellulose. Spheronisation: spheronisation theory. Commercial equipment. Problems of spheronisation. Evaluation of pellets.

Hot Melt Extrusion

• Review of process. Why hot melt extrusion. Types of solid dispersions. Types of carrier. Equipment. Case study

Roller Compaction

• Review of the current state of roller compaction. Equipment available. Advantages and disadvantages.

Compression Theory

• Review. Why some materials compress satisfactorily whilst others compact poorly. Theory related to practice.

Compression Machinery

• Review of the current state of press design. Removable turrets and cleaning of presses

Compaction Simulators

• Review and uses

Tabletting and Tooling Problems

• A review of problems that arise in production and how to avoid producing poor quality tablets.

Oral Dispersion Tableting Technology

Review of methods. Advantages and disadvantages of the technology. Equipment required.

Scale-Up, Transfer Technology and Supac

Workshop

A workshop will be arranged on hot melt extrusion processes.

SPEAKERS (View profiles on 'Our Experts' page)

Prof Michael H. Rubinstein

Geert Verreck M.Eng., Ph.D.

Ian Smales PhD

Paul Burton C.Chem, M.R.S.C.

Terry Lewis

Harald Stahl Ph.D.

Jan Vogeleer B.Sc.

Ian Muir BSc., Ph.D

Gordon Prudhoe BSc

Marina Levina MSc., Ph.D.