The Journal of Industry and Technology

Industrial Analytical Instrumentation

Euro Technology

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Balances and weighing machines

New pharmaceutical solid dosage form development collaboration

Quantifying tablet disintegration profiles in situ and in real time enables the reliable understanding of 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.

METTLER TOLEDO has initiated a collaboration with Actera Pharmaceuticals, San Francisco, to expand the applications of Focused Beam Reflectance Measurement (FBRM) probes into pharmaceutical solid dosage form development. An FBRM
in situ particle size tracking instrument is located in Actera's product innovation labs at the California Institute for Quantitative Biosciences (QB3@953) in San Francisco. Mark Menning and Sean Dalziel are founding partners in Actera Pharmaceuticals, with pioneering expertise in pharmaceutical dosage form development.
"We find FBRM can elucidate the kinetics and mechanisms of tablet, granule, and particle deagglomeration in dosage forms, and is a more sensitive physical characterization method than compendial USP dissolution", said Menning. "The FBRM technology, where applied appropriately, can facilitate improved optimization of drug product formulation and process parameters, bridging of
in vitro to human bioavailability performance, and elucidate complex physical stability changes", said Dalziel. Actera provides this application as a service to pharmaceutical and biotech companies.

FBRM technology measures particles and droplets in concentrated suspensions and emulsions in real-time, without sampling and preparation. Unlike other offline particle size analysis techniques, FBRM can track changes in particulate systems capturing rapid or subtle kinetic events. FBRM has been extensively applied to Active Pharmaceutical Ingredient (API) crystallization. Expanding its utility to development and optimization of tablets and capsule products is a natural fit for FBRM technology. "We are delighted to collaborate with Actera Pharmaceuticals as we advance the applications for dissolution and solid dosage formulation" said Des O'Grady, METTLER TOLEDO Particle System Characterization Market Development Manager.

Actera Pharmaceuticals in profile
Located at qb3@953 in San Francisco, Actera Pharmaceuticals offers general CMC consulting services from API to drug product design. Actera Pharmaceuticals specializes in fixed-dose combination products that aid in simplified dosing regimens across therapeutic areas. The co-founders of Actera Pharmaceuticals each have over 18 years pharmaceutical development experience and have been involved in the launch of a combined 7 commercial pharmaceutical products

METTLER TOLEDO is a leading global supplier of precision instruments and services. The Company is the world's largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. METTLER TOLEDO also holds top-three market positions in several related analytical instruments and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. In addition, the Company is the world's largest manufacturer and marketer of metal detection and other end-of-line inspection systems used in production and packaging and holds a leading position in certain process analytics applications.

For further information, view website: 
Refer to page 156


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