Sprecher
Dr Wilfried Babel, Gelita
Dr Carsten Hüttermann, Dow
Marc Huysmans, Capsugel
Benedict Kleine-König, Bosch
Dr Christian Mühlenfeld, Ashland
Dr Martin Opitz, Bosch
Claudio Scialdone, Tillots
Dr Harald Stahl, GEA
Prof Sven Stegemann, University of Graz
Zielsetzung
We kindly invite you to the “Capsule Technology School”, an exclusive workshop on state of the art know-how of the different topics of central importance. On the first day, you will get among others an overview of the manufacture and development of hard capsule formulations and raw materials. Day two will be dedicated to the diverse filling technologies and the pharmaceutical application of these techniques. Pharmacists and suppliers will share their expert knowledge in their presentations for example on inhalation products, filling of liquids, containment as well as on the latest capsule filling technologies. Additionally, you will be trained on selected aspects of trouble shooting as well as on the implementation of GMP (Good Manufacturing Practice) in regard of scale-up and Qualification/Validation.
Hintergrund
Capsules offer a flexible Drug Delivery System and, thanks to the rapid development in the pharmaceutical industry, there are always new perspectives to be discovered. Especially in the combination of medicinal product and dosage form, many aspects of the manufacture - both technical and economic - play a significant role: expiring patents, increasing health expenditure, economic insecurities characterize the pharmaceutical industry on the one hand. On the other hand, the progress made in research and development - such as the availability of highly-potent APIs and innovative new production processes - are sustainably changing the business area.
Zielgruppe
This course addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control, as well as engineers, project/facility engineers, especially those involved in the implementation of new monitoring methods, risk-based scale-up models and process technology for capsule filling processes. The conference is also of interest for suppliers of excipients used for capsules.
Programm
From Raw Material to Final Drug Delivery
Market trends
- Pharmaceutical world market evolution and
- influencing factors
- Global capsule market development
- Future trends
- HPMC is an attractive alternative to gelatin for hard capsules
- Controlled changes in HPMC processing conditions allow targeted changes of morphology & chemical structure leading to desired design of specific properties
- The chemical structure diversity of HPMC provides unique innovative potential for new designs of tailor-made properties for future improvements and new opportunities
- General characteristics of two piece capsules
- Different capsule polymers and their specific performance parameter
- In-vitro studies of different types of two piece
- HPMC capsules
Formulation & Characterization
Formulation technologies - review of methods for pellet manufacturing
- Introduction of various processes
- Limitations of the various processes
- Guidance to selection of optimal process
- Superdisintegrants to promote rapid disintegration and dissolution
- Prerequisites for a decreased disintegration time
- Overview about the mostly used superdisintegrants
- Reason & Rational for developing capsules formulations
- Considerations for powder blend capsule formulation
- Selection of excipients in formulation
- Advanced dry capsule formulation
Quality & Troubleshooting in the Filling Process
Capsule filling technologies & Scale-up
- Reproducible dosage possibilities for each solid pharmaceutical Drug
- Requirements for a capsule filler and the manufacturing process
- Capsule design
- Defects & Diagnosis on capsule filling machines
- Trouble shooting
Technology & Innovation
Microdosing & New technologies
- Definition and Technologies of Microdosing; DPIs
- Capsule Filling Operations
- Case study of different Lactose types
- How much containment is required?
- Review of most critical process steps
- Solutions for handling highly potent APIs
- Capsule properties
- Liquid fill encapsulation (HGC vs. SGC)
- Challenges of liquid filling
- Lipid-based formulations
- Dosing systems for liquid and semi solid formulations
- Capsule sealing systems and technologies
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E-Mail: info@concept-heidelberg.de
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Seminarprogramm als PDF
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