Developing an identified drug substance into a pharmaceutical product with well-defined and tightly controlled pharmacological performance is an exacting task. Here, Dr Paul Kippax, Product Group Manager, reviews how Malvern Instruments’ technology directly supports the development of oral solid dosage (OSD) forms by efficiently generating the data needed to drive formulation.

Over the past two decades the empirical processes which once characterized pharmaceutical development have steadily given way to the more systematic, knowledge-led approach enshrined in QbD. A QbD strategy builds quality into a product from the outset through the development of a detailed understanding of the factors that influence clinical efficacy, and of an effective control strategy for manufacture, based on the mitigation of risk.

The starting point for pharmaceutical product formulation is an identified, active drug substance. The goal of formulation development is to incorporate this substance in a product and to develop a manufacturing process that will deliver that product securely and consistently. In QbD terms, this relies on identifying the factors that will define the clinical efficacy of the product, and then learning to control the material and process attributes that will ensure consistent delivery to the resulting quality target performance profile (QTPP).

In this whitepaper we look at the steps involved in moving from a drug substance to a successful oral solid dosage (OSD) form, and at the analytical technologies that can be helpful. In particular, we focus on gathering the required information to progress pharmaceutical development within the context of the regulatory requirements and the application of QbD.

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