Emulsions & Gels

Emulsions & Gels

Hamburg, Germany

Course No 17099


Costs

Non ECA Member: EUR 1790,--
ECA-Member: EUR 1590,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Michael Drechsler, GP Grenzach Produktions GmbH (Bayer AG)
Christian Lomb, Labor LS
Dr Thomas Meindl, Labor LS
Dr Claude Oelschlaeger, Karlsruhe Institute of Technology (KIT) )
Prof Dr Miriam Pein-Hackelbusch, University of Applied Sciences and Arts Ostwestfalen Lippe
Dr François-Xavier Simon, BASF

Objectives

A lot of pharmaceutical products, cosmetics and food products are emulsions & gels. Regarding the production of pharmaceutical semi-solid preparations, the common GMP (Good Manufacturing Practice) concepts of validation and qualification have to be applied (i.e. EU GMP guidelines including Annex 9 and 15).

Semi-solid products have some characteristics that are different compared to other dosage forms (e.g. solid oral dosage forms). Due to the intrinsic effect of the vehicle and the influence of the formulation on the release of active ingredients (and the subsequent absorption), the final formulation (including packaging) should be defined early in the pharmaceutical development process. Comprehensive analytical, microbiological and stability testing contributes to that.

Additionally, since August 2013, important tools for the biopharmaceutical characterization of drug release are contained in the United States Pharmacopeia (USP) Chapter <1724> “Semisolid Drug Products – Performance Tests“.

Furthermore, rheology plays a significant role in the determination of a formulation’s flow properties (and for the characterization of semi-solid raw materials, like for example petrolatum, lanolin), during development, in-process-control (IPC), final end-product testing & release as well as in stability testing. The knowledge of rheological properties is essential for the production and filling of semi-solid preparations. Moving forward, the USP recently published two drafts for new USP Chapters <915> “Measurement of Structural Strength of Semisolids by Penetrometry” and <1912> “Measurement of Hardness of Semisolids” regarding the characterization of viscoelastic properties of semi-solid preparations (Pharmacopeial Forum PF 43(2) [Mar.–Apr. 2017]).

These and other relevant topics will be presented and discussed in this training.

This training aims at explaining the pharmaceutical, biopharmaceutical and technological aspects of various semi-solid dosage forms for topical use.

Formulation concepts (including the use of emulsifiers and colloidal carrier systems), GMP aspects and the industrial manufacture/ filling of semi-solid formulations are clearly illustrated. The rheological characterization as well as microbiological and stability testing will be covered.

Target Group

This course is directed at specialists and executives in research, development, production, quality control and quality assurance involved in the manufacturing, packaging, testing, release and authorization of pharmaceutical semisolids and cosmetic preparations.

Programme

Industrial manufacturing of semisolids – GMP aspects
  • GMP
  • Validation
  • Risk assessment
  • Change control
Relevant Semisolids
  • Classification according to Ph. Eur.
  • Dispersions and phases
  • Examples of relevant excipients
  • What about nanocarriers?
Manufacturing of semisolids
  • Process
  • Mixer
  • CIP/SIP
  • IPC
Filling of semisolids
  • Process
  • Filling machines
  • Storage container
  • IPC
Biopharmaceutical aspects of semisolids
  • In vitro drug release
  • Drug penetration into the human skin
  • The interplay between vehicle and drug
Rheology of emulsions
  • Basic phenomena
  • Experimental characterization techniques
  • Rheology and composition of emulsions and dispersions
  • Technical application examples
Microbiological tests and requirements
  • Regulatory requirements for pharmaceutical products versus cosmetics
  • Bioburden
  • Specific tests (aW value determination)
  • Challenges & Interpretation of test results
  • Efficacy of antimicrobial preservation
The Application and Use of Excipients – Insights and Challenges
  • Understanding the importance of emulsifiers/surfactants in formulations
  • Influence of excipient selection on performance
  • Chemical and physical stability of ingredients
  • Simple analytical techniques for evaluation
Stability testing
  • Design & Control of stability studies
  • In-use stability
Handling of OOS and OOT results
  • Microbiological tests: When is a result a OOS/OOT result?
  • How to handle OOS and OOT results?
  • How helpful are expert opinions in this context?

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