Emulsions & Gels - Development, Manufacture & Control of Dermatopharmaceutics and Cosmetics
Im Auftrag der ECA Academy

Emulsions & Gels - Development, Manufacture & Control of Dermatopharmaceutics and Cosmetics Im Auftrag der ECA Academy

Vienna, Austria

Seminar Nr. 16587


Kosten

Die Veranstaltung hat bereits stattgefunden. Suchen Sie nach Wiederholungsterminen und weiteren, themenbezogenen Seminaren auf der Seite GMP Seminare/-Konferenzen nach Thema.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Thomas Meindl, Labor L&S AG

Dr Christopher Müller, GP Grenzach Produktions GmbH (Bayer AG)

Prof Dr Reinhard Neubert, University of MLU Halle, IADP (Institute for Applied Dermatopharmacy)

Dr Frank Romanski, BASF

Prof Dr Norbert Willenbacher, Karlsruhe Institute of Technology (KIT)

Hintergrund

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> and <1912> 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.

Zielgruppe

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.

Programm

Industrial manufacturing of semisolids – GMP aspects

  • GMP
  • Validation
  • Risk assessment
  • Change contro
l
Relevant semisolid formulations
  • Technology of semisolid standard formulations relevant in Dermatopharmaceutics as well as in Cosmetics
  • Substantial excipients for the preparation of the semisolid formulations
  • Colloidal carrier systems to enhance penetration of highly lipophilic/ hydrophilic drugs and cosmetic actives (e.g. ceramides, peptides)
Manufacturing of semisolids
  • Process
  • Mixer
  • CIP/SIP
  • IPC
Filling of semisolids
  • Process
  • Filling machines
  • Storage container
  • IPC
Biopharmaceutical characterization of semisolid formulations
  • Methods and procedures to measure drug release from semisolid formulations
  • Methods for measuring drug penetration into the human skin
  • Real examples for each method
  • Regulatory aspects
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 results?
  • How to handle OOS and OOT results?
  • How helpful are expert opinions in this context?

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