AAPS 2021: Pharmaceutical and clinical performance comparisons of modified release multiparticulates and matrix tablet formulations

Download our scientific poster from AAPS 2021, 'Pharmaceutical and clinical performance comparisons of modified release multiparticulates and matrix tablet formulations'.

The purpose of this study is to review practical experiences of head-to-head pharmaceutical and clinical comparisons of MUPs and matrix tablet platforms to identify an optimal MR formulation.

A wide variety of formulation technologies are available to control the in vivo release profile of drugs from solid oral dosage forms, whether to achieve a target systemic pharmacokinetic (PK) profile or deliver a therapeutic to a particular anatomical site for the treatment of local gastrointestinal (GI) disease. Multiparticulate systems (MUPs) and monolithic matrix tablets are two modified release (MR) technologies commonly used for the sustained delivery of a drug over a prolonged period. There are a variety of recognized pros and cons for these approaches.

Selection of a specific MR platform and optimization of the quantitative levels of critical to performance excipients in that formulation can be challenging based on surrogate nonclinical, in vitro, or silico data, and the recognized lack of predictability of these models to performance in humans. Traditional development also means the time and cost of taking multiple options into a clinical PK study can be prohibitive.

An integrated development program with in-study protocol flexibility can enable real-time optimization of key formulation variables based on clinical data, enabling multiple technology platforms to be assessed in parallel to identify the best technology to achieve the desired target product profile (TPP).

The purpose of this study is to review practical experiences of head-to-head pharmaceutical and clinical comparisons of MUPs and matrix tablet platforms to identify an optimal MR formulation.