C. Seiler, R. Elkes, M.S. Beauchamp, S.R. Pygall, K. Bradley, A. Djemai, D.A. Thompson and S. Fitzpatrick
Development Laboratories, MSD, Hoddesdon EN11 9BU, UK Christian_seiler@merck.com
Hydrophilic matrix tablets continue to be the most popular oral controlled release (CR) technology in the market place, to a large part since they use established and cost-effective process technology that is equivalent to immediate release (IR) tablet products. Matrix tablets control the release of active pharmaceutical ingredients (APIs) via a pseudo-gel surface layer that forms upon tablet hydration. Dissolved API can diffuse through this layer, which can also erode to release non-dissolved API from the tablet. This provides opportunities for APIs with different physico-chemical attributes, whilst at the same time presenting specific limitations or challenges. The latter are the focus of this abstract, which makes reference to some recent in-house examples. The key topics are release rate sensitivity, ingredient segregation assessment and applications for low solubility APIs. The intent is to provide the audience with additional insight into matrix tablets to help focus experimental plans and technology decisions on key issues or risks.