Scientific papers
The development of extended-release (ER) matrices has been widely studied, yet identifying the optimal drug release mechanism to achieve target release profiles remains a resource-intensive challenge in early formulation stages. This study focused on the initial development of ER hydrophilic matrix tablets using mirabegron as a model drug, investigating the effects of polymer type, diluent type, and polymer concentration on critical quality attributes (CQAs), such as tablet swelling and erosion behavior. A full factorial design was utilized to analyze interactions among control factors through multivariate regression, guided by quality by design (QbD) principles.
The swelling and erosion properties of 72 formulations were assessed, with swelling data modeled using the Vergnaud equation. Drug release profiles were evaluated in vitro for four selected formulations. Results demonstrated that polymer type, diluent type, and polymer amount significantly influenced the swelling and erosion behavior of the ER matrix tablets. Formulations with polyethylene glycol 8000 (P8000) exhibited greater swelling compared to those with isomalt (G720) or dextrate (DXT), with higher molecular weight polymers producing greater swelling within the same type. Hydroxypropylmethylcellulose (HPMC) and polyethylene oxide (PEO)-based matrices displayed the highest swelling rates, while polyvinyl alcohol (PVA-80) formulations showed the greatest erosion percentages.
The study underscores the importance of incorporating early-stage screening designs to improve efficiency and conserve resources, enabling a deeper understanding of drug release mechanisms in ER matrix tablet development.
Comments
No comments posted yet.
Add a comment
Articles you may like
Related products
Looking for additional information?
Let us help you