Newsletter | September 15, 2020

09.15.20 -- Flexible Solutions For Complex Formulations From Concept To Commercialization

How To Avoid Last Minute CMC Roadblocks To Approval

Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process is essential for success.

How To Achieve Different Release Profiles And Select Excipients For Formulation Development Of Modified Release Oral Solid Dosage Forms

Modified release formulation and manufacturing are challenging. To obtain the desired release profile — or release profiles if there are more than one active pharmaceutical ingredient (API) — a holistic approach is necessary. This article explains numerous considerations that enter into the planning and execution of a successful modified release oral solid dosage formulation.

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

A CDMO teams up with oral solid dosage processing innovator Freund-Vector to create an efficient, fast, high-quality drug manufacturing solution that allows for modular and tunable dosage strengths and release rates — despite the challenges of high drug loads, complex dissolution profiles, and incompatible APIs.