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This paper proposes the development of a drug product Manufacturing Classification System (MCS) based on processing route. It summarizes conclusions from a dedicated APS conference and subsequent discussion within APS focus groups and the MCS working party. The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the API and the needs of the formulation. It has many applications in pharmaceutical development, in particular, it will provide a common understanding of risk by defining what the "right particles" are, enable the selection of the best process, and aid subsequent transfer to manufacturing. The ultimate aim is one of prediction of product developability and processability based upon previous experience. This paper is intended to stimulate contribution from a broad range of stakeholders to develop the MCS concept further and apply it to practice. In particular, opinions are sought on what API properties are important when selecting or modifying materials to enable an efficient and robust pharmaceutical manufacturing process. Feedback can be given by replying to our dedicated e-mail address (mcs@apsgb.org); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.

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Pharmaceutical powders are very prone to electrostatic charging by colliding and sliding contacts with walls and other particles. In pharmaceutical formulation processes, particle charging is often a nuisance and can cause problems in the manufacture of products, such as affecting powder flow, and reducing fill and dose uniformity. For a fundamental understanding of the powder triboelectrification, it is essential to study charge transfer due to a single contact of a particle with a target plane under well-defined physical, mechanical and electrical conditions. In this study, charge transfer due to a single impact of a particle against a stainless steel target was measured for alpha-lactose monohydrate, aspirin, sugar granules and ethylcellulose. The amount of transferred charge is expressed as a function of impact velocity and impact angle as well as the initial charge. The maximum contact area during impact between a particle and a target plane is estimated by an elastic-plastic deformation model. It is found that the transferred charge is a linear function of the contact area. For a given material, there is an initial particle charge for which no charge transfer occurs due to impact. This is found to be independent of impact velocity and angle, and is hence viewed as a characteristic property, which is related to the contact potential difference and tribo-electric series of the sample powders.