Alternative drug delivery methods are an important part of the current global pharmaceutical market and its diverse patient profiles and needs. Drug manufacturers and patients are increasingly looking for innovative and diverse delivery methods to meet the needs of a broader demographic.
Consideration of alternative routes of administration early in the development process can be useful in enabling new molecular entities (NMEs) that come along with challenging properties (extensive first-pass metabolism, unfavorable physicochemical properties, gastrointestinal adverse effects) or suboptimal pharmacokinetic profiles identified in preclinical studies.
Reformulation of a drug with an alternative delivery route is one strategy of product life cycle management. However, a new formulation of an already approved drug may also improve bioavailability, optimize drug delivery profiles, reduce dosing frequency or improve the patient experience.
In general, alternative routes of administration have the potential to provide a faster return on investment than the development of an entirely new drug and they have proven their success as a life cycle management strategy. In the development of transdermal therapeutic systems (TTS) or oral thin films (OTF), early assessment of the potential of an active ingredient in terms of diffusion through the epithelium is one of the most important factors in applying the right formulation strategies early in the development process, which can help avoid costly late-stage failures.
In this presentation we will show you different useful and efficient in-silico and in-vitro tools for a fast and de-risking evaluation of a new API regarding its potential as a candidate for a TTS or OTF formulation. During this 45-minute webinar plus interactive Q&A session, you will learn which tools can be used for the evaluation of new APIs to have fast and strong result and a first milestone for initiating a full development project for transdermal patches or oral thin films as specific dosage form.
