Discovery & Development Europe 2025: Formulation & Drug Delivery Congress
July 1-2, 2025
Basel, Switzerland

Invited lecture:
Oral Delivery Of Peptide And Protein Drugs – Oral Delivery of GLP-1 Analogues

Prof. Dr. A. Bernkop-Schnürch
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8th European Cyclodextrin Conference
September 9-12, 2025
Milano, Italy

Invited lecture:
Thiolated Cyclodextrins in Drug Delivery

Prof. Dr. A. Bernkop-Schnürch
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Stability Studies

Chemical stability

The evaluation of the intrinsic stability of molecules and the identification of decomposition products of drug candidates is essential for the right choice of drug candidate and dosage form. ThioMatrix is specialized on stress tests and stability screening to examine chemical stability of your drug candidates.

Enzymatic stability studies

ThioMatrix is well versed in the performance of enzymatic stability studies. The degradation of your drug (e.g. peptide drug or oligonucleotides) by various enzymes such as plasmatic enzymes [Werle M. and Bernkop-Schnürch A. (2006) Strategies to improve plasma half life time of peptide and protein drugs. Amino Acids. 30, 351-367], mucosal membrane bound enzymes or secreted intestinal enzymes can be determined within weeks after placing the offer. The gained information represents the basis for

• first bioavailability estimations
  
  
• slight chemical modifications of the molecule in order to improve its enzymatic stability (e.g. substitution or modification of certain amino acids in case of therapeutic peptides)
  
  
• choice of enzyme inhibitors as auxiliary agents if needed
  
  
• the design and development of highly efficient delivery systems

Storage stability studies

ThioMatrix designs and performs storage stability studies of new dosage forms with the final immediate packaging intended for marketing. Stability studies usually include long-term (12 months), intermediate (6 months) and accelerated (6 months) testing. Analyses include physical, chemical, biological, and microbiological tests. ThioMatrix is capable of testing all kinds of formulations according to ICH guidelines. Our climatic exposure test cabinets are frequently calibrated. An alarm system including SMS and e-mail alerts ensures that our climatic exposure test cabinets are permanently controlled. In case of any failure a back-up system including an emergency generator and additional climatic exposure test cabinets are available. Temperature and relative humidity (RH) are monitored continuously 365 days a year.

Available test conditions are:

• -20°C
  
  
• 5°C
  
  
• 25°C/ 60% RH
  
  
• 30°C/ 60% RH
  
  
• 30°C/ 65% RH
  
  
• 40°C/ 75% RH
  
  
• Photostability

Our service includes advice on:

• Selection of appropriate and validated analytical methods
  
  
• Chemical, physical and microbial aspects of stability studies
  
  
• Interpretation of test results
  
  
• Influence of formulation and packaging on stability
  
  
• Regulatory requirements

Thiomatrix joined the EU-project TENTACLE (101191747) focusing on the use of thiomers for in situ bioprinting.
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