Focus on Pharma - Assessing in Vitro Bioequivalence: Oral Solid Dose Formulations

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Oral solid dose (OSD) drug products represent the largest class of products sold by the pharmaceutical industry, accounting for over 60% of global pharmaceutical sales. As a result, they represent a significant opportunity for generic companies. Within this, products which have a modified or sustained release profile represent a significant challenge, as the properties of the formulation and its components are critical in controlling the release of the drug. In response to this, regulators, including the US FDA, have released product-specific guidance aimed at advising generics manufacturers on the approaches which may be applied to prove bioequivalence in vitro.

In this webinar, we will consider how physicochemical analysis can aid the development of OSD products. In general, the guidance released by regulators for these products references the use of dissolution testing for in vitro bioequivalence assessments. However, specific knowledge of the properties of the active pharmaceutical ingredient (API), along with any functional excipients present within the formulation, can provide additional insight in order to aid prototype formulation development and optimization. We will introduce the typical workflows and regulatory frameworks associated with oral solid dose development and the techniques which are available to support these. We will then present case studies which confirm how development of a detailed physicochemical understanding of an API can enable more rapid formulation development.


Paul Kippax Ph.D.

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  • Who should attend?

- Researchers considering the requirements for deformulation of a reference listed drug (RLD) product

- Formulation scientists engaged in developing candidate generic drug product formulations

- Analytical scientists engaged in supporting in vitro bioequivalence studies

- Laboratory managers looking to understand the techniques required to support deformulation and in vitro bioequivalence assessments

  • What will you learn?

- You will gain an understanding of the physicochemical properties which are currently highlighted as important for in vitro bioequivalence studies for oral solid dose products such as tablets, powders and capsules

- You will learn about the range of analytical measurement methods available from Malvern Panalytical for assessing the properties of oral solid dose components and formulations

- You will see how techniques such as laser diffraction, Morphologically-Directed Raman Spectroscopy (MDRS), SEC, XRD and XRF can be used to aid formulation understanding and development