Excipients selection for high-risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredients (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
In this webinar, you will learn:
- How to select the right excipients for high-risk formulation
- How low endotoxin and low bioburden limits are important aspects while selecting raw materials
- Strong regulatory support is crucial for high-risk formulation
Speaker
Smita Rajput, Ph.D.
Merck
Field Marketing Manager
Smita Rajput has a total of 8 years of experience in pharmaceutical product development. She is currently working as a field marketing manager for India, South East Asia, and Oceania.
Her expertise is in formulation development of complex injectable & ophthalmic segments, can direct users for selection of excipients. She has five patents and seven international publications in different complex formulation areas. She has professional experience with Dr. Reddy’s, Cadila Healthcare, and Johnson & Johnson.
Pharma and biopharma manufacturing
- Liquid Formulation Strategies
Duration:43min
Language:English
Session 1:presented May 25, 2021
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