Quality-by-Design (QbD) has revolutionized the pharmaceutical industry, challenging scientists to define performance design spaces during development. Process analytical technology (PAT) and lean manufacturing offer potential to improve product consistency and minimize both resource consumption and batch failures. Matrix tablets are the most prevalent modified-release (MR) dosage forms due to ease of development and low cost of manufacture compared to other MR dosage forms. Our research enables drug product manufacturers to address regulatory and sustainability initiatives from development through commercial production. One aspect entails modeling performance design space and rank-ordering how hypromellose functionality-related characteristics impact performance. Another aspect involves innovations around hypromellose morphology to enable direct compression, thus reducing processing and energy consumption costs by as much as 30%. Case studies will be presented demonstrating rank-order of hypromellose attributes, how hydroxypropyl (HP) substitution influences MR performance, and innovation of a hypromellose morphology enabling desired performance while eliminating granulation steps.

Innovative renewable cellulose-based materials for modified-release drug delivery

244th National Meeting (2012)

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