Manufacturing Classification System: Rational Selection of Processes for Oral Solid Dosage Forms

Time: 2:30 pm - 3:00 pm

Date: 30 April 2019

30-april-2019 14:30 30-april-2019 15:00 Europe/London Manufacturing Classification System: Rational Selection of Processes for Oral Solid Dosage Forms

An international cross-industry and academia working group has proposed the development of a Manufacturing Classification System (MCS) for oral solid dosage forms based on processing route and properties of the API.  The Manufacturing Classification System discussed here is intended as a tool for scientists to rank the feasibility of different processing routes for the manufacture… Read more »

Making Pharmaceuticals

Synopsis

An international cross-industry and academia working group has proposed the development of a Manufacturing Classification System (MCS) for oral solid dosage forms based on processing route and properties of the API.  The Manufacturing Classification System discussed here is intended as a tool for scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the Active Pharmaceutical Ingredient (API) and the needs of the formulation, [1, 2].  The MCS will have many applications in pharmaceutical development, in particular, it will provide a common understanding of risk by defining what the “right particles” are (i.e. the physical properties of the particles that have been identified for each process route), enable the selection of the best process, and aid subsequent transfer to manufacturing.  The ultimate aim is one of prediction and modeling of product developability and processability based upon previous experience and API properties.

Leane M, Pitt KG, Reynolds G.  A  Proposal for a Drug Product Manufacturing Classification System (MCS) for Oral Solid Dosage Forms.  Pharmaceutical Development and Technology 2015; 20: 12-21

http://informahealthcare.com/doi/abs/10.3109/10837450.2014.954728

2) Leane M, Pitt KG, Reynolds GK, Dawson N, Ziegler I, Szepes A, Crean AM , Agnol RD. Manufacturing Classification System in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage formulations, case studies from industry and considerations for continuous processing.  Pharmaceutical Development and Technology 2018; 23, 10: 964-977. https://doi.org/10.1080/10837450.2018.1534863

 

Speakers

  • Kendal Pitt Senior Technical Director in Pharma Supply Chain - GlaxoSmithKline

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