Live Online Training: Emulsions & Gels

Live Online Training: Emulsions & Gels

Course No 17728

Please note: All times mentioned are CET.

Costs

ECA-Member: EUR 1590,--
Non ECA Member: EUR 1790,--
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, Bayer Consumer Care AG, Switzerland
Jürgen Martin, Martin-Consulting, Germany
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

This Live Online 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.

Background

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.

In 2018, the EMA published the draft Guideline on quality and equivalence of topical products. The guideline relates to locally applied and locally acting medicinal products for cutaneous use. Specific guidance is provided:
  • ƒOn the quality of topical products not covered by other guidelines.
  • ƒOn equivalence testing of topical products in lieu of therapeutic equivalence clinical trials.

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“. A reference to <1724> is made in USP <3> “Topical and Transdermal Drug Products - Product Quality 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 introduced two 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 (to be official on 1-May-2021).

These and other relevant topics will be presented and discussed in this Live Online Training.

Target Group

This Live Online Training 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.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Programme Day 1
 
Provisional timetable, the actual schedule may vary depending on the situation.
 
09.00 - 09.15 h Welcome/Introduction
 
09.15 - 10.00 h
Industrial Manufacturing of Semisolids – General Aspects
  • GMP
  • Validation
  • Scale-up
  • Risk assessment
  • Change control
10.00 - 10.45 h
Manufacturing of Semisolids – Practical Aspects
  • Process
  • Mixer
  • CIP/SIP
  • IPC
  • Troubleshooting
10.45 - 11.00 h Break
 
11.00 - 12.15 h Relevant Semisolids
  • Classification according to Ph. Eur.
  • Dispersions and phases
  • Examples of relevant excipients
  • What about nanocarriers?
12.15 - 12.45 h
Q&A Session 1
 
12.45 - 13.45 h Break
 
13.45 - 14.30 h
Filling of Semisolids
  • Process
  • Filling machines
  • Storage container
  • IPC
  • Troubleshooting
14.30 - 15.30 h
Biopharmaceutical Aspects of Semisolids
  • EMA Draft Guideline on quality and equivalence of topical products
  • In vitro drug release
  • Drug penetration into the human skin
  • The interplay between vehicle and drug
15.30 - 15.45 h Break
 
15.45 - 16.30 h
Stability Testing & Efficacy of Antimicrobial Preservation
  • Stability Testing
    • ICH requirements
    • Design of stability studies
    • Matrixing & Bracketing
    • Interpretation of test results & statistical analysis
  • Efficacy of antimicrobial preservation
    • Requirements according to Ph. Eur. and USP
    • Relationship between the efficacy of antimicrobial activity and in-use stability
    • Practical examples
16.30 - 17.00 h
Q&A Session 2
 
 
Programme Day 2
 
09.00 - 10.00 h
Rheology of emulsions
  • Basic phenomena
  • Experimental characterization techniques
  • Rheology and composition of emulsions and dispersions
  • Technical application examples
10.00 - 11.00 h
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
11.00 - 11.15 h Break
 
11.15 - 12.00 h
Handling of OOS and OOT Results
  • OOS-Results
    • Requirements according to the FDA-OOS-Guideline
    • What needs to be considered with regard to complexmatrices?
    • Examples
  • OOT & OOE-Results
    • Requirements for investigation
    • Example of a risk-based approach
  • Adverse Trends
    • Trends and possible root cause
12.00 - 12.30 h
Q&A Session 3

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