At the heart of developments in drug design and delivery technologies lies the goal of improving patient outcomes and the patient experience, which, in turn, can reduce medical spending, improve health and increase pharmaceutical sales. This goal is achievable if the right molecule form, the ri ght formulation and the right dosage form can all be brought together to create a product that suits the patient’s needs.
A survey conducted by eyeforpharma in 2014 revealed that 86% of pharma executives feel that patient-centricity is key to profitability and the development of personalised or targeted medicines represents a major opportunity for the pharmaceutical sector, especially as their benefits are increasingly recognised by patients and payors.1 But, although the pharma industry is aware of the need for patient-centric drug design, progress still falls short of aspirations.
Catalent’s Applied Drug Delivery Institute has been at the forefront of the drive to make industry’s drugs more patient-centric. One of the fundamental beliefs of the Catalent Institute is that patient-centric design starts with a clear understanding of the factors driving patient outcomes during medicinal chemistry, ensuring that the optimal form of the molecule progresses forward. It is then a matter of identifying and optimising the best formulation approach — along with early dose form selection — always with a view to enhancing patient outcomes.
But research conducted by the Catalent Institute suggests that few formulation scientists receive patient-focused input to influence design choices made during development; often, the information that they receive comes during Phase III, which is too late to affect most drug substance and drug product design decisions.
According to a recent study by Tufts, companies spend an additional $300 million in post-approval studies to test new indications, new formulations and new dosage strengths and regimens.2 By investing more — and earlier — in dose design that incorporates patient and prescriber concerns, some of this cost could be avoided. Catalent has a long legacy of drug development and the application of advanced drug delivery technologies to develop dose forms that support more effective therapies.
A broad portfolio of advanced drug delivery technologies is combined with a data-driven approach to development to ensure that the resulting dose form meets all stakeholder requirements. For example, this may involve using a parallel screening platform to ensure the most suitable bioavailability technology for a molecule’s physiochemical characteristics, customising the dosage form with formulation technologies such as the RP Scherer softgel platform to improve bioavailability and reduce food effects, employing OptiDose CR technology or OptiShell technology for controlled release or Zydis orally disintegrating tablets (ODTs) and FlexDoseSM services for added patient convenience.
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