How High Purity Excipients Address Parenteral Drug Formulation Challenges

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***Live: Tuesday, December 1, 2020 at 10am EST| 9am CST| 3pm GMT| 4pm CET***Formulators face special challenges with developing parenteral drugs to achieve the needed stability, efficacy and sterility. Learn how high purity excipients can be used to address formulation issues, while complying with regulatory requirements.*** On demand available after final airing until Dec. 1, 2021.***

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Event Overview: Demand for parenteral formulations is growing as the overall drug market expands and new therapies enter the pipeline. These drug forms require special formulation considerations related to chemical and physical stability, sterility, viscosity. Excipients play a crucial role in formulating a safe, effective drug.

In this webcast, experts will discuss key factors associated with formulating a parenteral drug including evaluating excipients to be used in sterilized drug products, understanding the chemical structure, evaluating grades of excipients, and more.

Important insights about the regulatory and quality aspects surrounding parenteral excipients such as elemental impurities, microbiological/endotoxin analytics, and compendial compliance, regulatory documentation will be shared.

The ways in which an excipient supplier can best support the drug product control strategy will be discussed.

Key Learning Objectives:

  • Understand the challenges associated with parenteral drug formulation
  • Review the global regulatory landscape around parenteral excipients, including ICH Q3D and microbiological/endotoxin analytics and the value for a drug product control strategy
  • Learn how various excipients can help resolve formulation challenges

Speakers: Dr. Lindsay Johnson, Global Technical Marketing Manager- Solubilization Portfolio, BASF

Dr. Dorothee Kriha, Regulatory Manager – Pharma Solutions, BASF

Time and Date: Tuesday, December 1, 2020 at 10am EST| 9am CST| 3pm GMT| 4pm CET

On demand available after final airing until Dec. 1, 2021

Sponsor: BASF

Register free:​ ​