Case Studies

Innovative Reformulation of a Complex, High-Drug-Load, Modified Release Dosage Form With Reduced Dosing Frequency

Innovative Reformulation of a Complex, High-Drug-Load, Modified Release Dosage Form With Reduced Dosing Frequency

Some reformulation projects are more challenging than others. Read this case study to see how we leveraged innovative processing equipment from Freund-Vector to develop an efficient — and effective — solution.

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How to Avoid Last-Minute CMC Roadblocks to Approval White paper

Opioid Reformulated for Abuse Deterrence – Filed as a CMC Supplement in Less Than a Year

The FDA wants you to reformulate your opioid oral controlled-release product to provide a level of abuse deterrence. A lengthy, expensive ordeal seems inevitable.

But what if you could limit and position the formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance?

We helped a client in exactly this position accomplish a complex reformulation and successful CMC supplement filing in less than a year. See the case study.

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