Case studies for the role of in-process particle measurement to complement traditional API dissolution studies

Featuring case studies from pharmaceutical companies, a new white paper discusses the role of in-process particle measurement to complement traditional Active Pharmaceutical Ingredient (API) dissolution studies. Scientists developed process understanding for solid oral dosage formulation.

METTLER TOLEDO has announced the availability of a new white paper – Monitor Tablet & Granule Disintegration for Solid Oral Dosage Form Development.

 

Quantifying tablet disintegration profiles in situ and in real time enables scientists to reliably understand the breakage and dispersion mechanisms that govern API release rates. This essential process knowledge can support the prediction of in vivo drug release profiles during formulation development, and 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 with Focused Beam Reflectance Measurement (FBRM) technology illustrates potential for this to support scientists' efforts to develop process understanding for solid oral dosage form development. This is supplemented by case studies from pharmaceutical companies, including Vertex, AstraZeneca, and Amgen, who use this approach to support their work.

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