Quantifying tablet disintegration profiles in situ and in real time enables scientists to reliably understand the breakage and dispersion mechanisms that govern Active Pharmaceutical Ingredient (API) release rates. This essential process knowledge can support the prediction of in vivo drug release profiles during formulation development, and can help identify the root cause of inconsistencies during release testing.
The resulting mechanistic information complements traditional offline dissolution testing methods, and can support the development and release of bioavailable, stable, and manufacturable dosage forms.
In this white paper, the role of in process particle measurement to complement traditional API dissolution studies is presented. The use of in situ particle size and count measurement illustrates the potential for this to support scientists' efforts to develop process understanding for solid oral dosage form development. This is supplemented by case studies from various pharmaceutical companies who use this approach to support their work.
1. Use of In Process Particle Measurement During Drug Product Development
2. Evaluation of Dissolution and Disintegration Performance for Wet and Dry Granulated Tablets
3. Disintegration Case Studies from Amgen, Vertex Pharmaceuticals, and AstraZeneca
About the Author
Mark Menning has over 18 years of pharmaceutical development experience at Actera Pharmaceuticals, Tobira Therapeutics, Gilead Sciences, Amgen, and DuPont Pharmaceuticals. He led formulation/process development groups, participated in NDA authoring of multiple fixed-dose combination products for the treatment of HIV/AIDS, and is a co-inventor of several tablets. Mark received a BSChE from the Ohio State University and is completing a PhD in Chemical and Bioprocess Engineering at University College Dublin.