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.
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.