Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; Manoj Gundeti2, MPharm; Nagarjun Rangaraj1, MPharm, PhD, MPharm; Anup Avijit Choudhury1, MPharm; Tausif Ahmed2, MPharm, PhD; Venkat Ramana Naidu1, MPharm, PhD

Introduction: In this work, we present model guided development of a new Etoricoxib tablet formulation using a proprietary technology. Application of absorption modelling using GastroPlus to guide the product development process is presented. An integrated approach of using in vitro, modelling and in vivo pharmacokinetics (PK) data to demonstrate bioequivalence between newly developed formulation and the commercial formulation is presented.
Methods: The MiSTTM technology is a combination of wetting-solubilizing agents with suspension-spray granulation technique. Physiologically-based biopharmaceutics model (PBBM) coupled with population PK and virtual bioequivalence were employed to guide the product development process. Commercially available GastroPlus 9.8 software was used for this purpose.
Results: Based on the simulation outcome, it was concluded that the new cost-effective formulation manufactured using MISTTM technology could be bioequivalent against the marketed formulation. This was further confirmed from the in vivo PK studies in normal healthy volunteers.
Conclusion: The simulated data were in line with the observed PK data obtained from the in-house bioequivalence study. This work demonstrates application of predictive modelling and simulation tools to accelerate new product development.

Developing new drug products is a resource intensive process. The model-informed drug development (MiDD) is an approach where biological, mathematical, and statistical models are applied to the drug development process to save time and cost of development [1]. On a broader level, this approach has three fundamental pillars: (1) Understanding of pharmacokinetics (PK) and pharmacodynamics (PD) of the drug; (2) Developing mathematical models that integrate data from PK, PD (preclinical and clinical studies) and in vitro studies; and (3) Applying the knowledge from the models to make decisions at various stages of development [1]. This is applicable to development of both innovator and generic drug products. It can accelerate development and help in effective regulatory decision-making [2].

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