Emulsions & Gels - Live Online Training Development, Manufacture & Control of Dermatopharmaceutics and Cosmetics

Emulsions & Gels - Live Online Training

Seminar Nr. 20120

Dieses Seminar ist Bestandteil des GMP-Lehrgangs "ECA Certified Pharmaceutical Development Manager". Mehr über diesen GMP-Lehrgang erfahren.

Please note: All times mentioned are CEST.

Kosten

ECA-Member*: EUR 1690,--
Non ECA Member*: EUR 1890,--
EU/GMP Inspectorates*: EUR 945,--
APIC Member Discount*: EUR 1790,--

Alle Preise zzgl. MwSt.

* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

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

Sprecher

Dr Michael Drechsler, Bayer Consumer Care, Switzerland
Dr Ingrid Mecklenbräuker, Novartis Pharma Stein, Switzerland
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

Zielsetzung

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.

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.

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, 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”. In a draft version of chapter <1724>, published in PF 48(3), the scope has been expanded to include in vitro release test (IVRT) as well as in vitro permeation test (IVPT) methods, with discussions on experimental design, method development, and validation.

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 introduced two new USP Chapters <915> “Measurement of Structural Strength of Semisolids by Penetrometry” and <1912> “Measurement of Hardness of Semisolids” (an updated title was proposed in PF 48(3) to better describe the content of the chapter: Measurement of Yield Stress) regarding the characterization of viscoelastic properties of semi-solid preparations.

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

Zielgruppe

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

We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programm

Programme Day 1
 
 Relevant Semisolids
  • Classification according to Ph. Eur.
  • Dispersions and phases
  • Examples of relevant excipients
  • What about nanocarriers?
Industrial Manufacturing of Semisolids – General Aspects
  • GMP
  • Validation
  • Scale-up
  • Risk assessment
  • Change control
Manufacturing of Semisolids – Practical Aspects
  • Process
  • Mixer
  • CIP/SIP
  • IPC
  • Troubleshooting
Q&A Session 1
 
Filling of Semisolids
  • Process
  • Filling machines
  • Storage container
  • IPC
  • Troubleshooting
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
Microbiological Tests and Requirements
  • Pharmacopoeial requirements
  • Acceptance level & Interpretation of test results
  • Efficacy of antimicrobial preservation
    • Requirements according to Ph. Eur. and USP
    • Relationship between the efficacy of antimicrobial
Q&A Session 2
 
 
Programme Day 2
 
Rheology of emulsions
  • Basic phenomena
  • Experimental characterization techniques
  • Rheology and composition of emulsions and dispersions
  • Technical application examples
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
Aspects to Consider for Stability Testing
  • ICH requirements
  • Design of stability studies
  • Matrixing & Bracketing
  • What needs to be considered with regard to complex matrices?
Q&A Session 3

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