You do not know if the API can be used for transmucosal, dermal or transdermal delivery? You do not want to ask your board for a multimillion dollar budget for a product development without a hint that it might work? We offer a feasibility program with the target to provide you with enough data to convince your board to abandon the idea or to start the development of your next block buster product.
Starting with arrival of the API, the analytical specialists setup analytical test methods common and special methods for patch and film dosage forms. The analytical experts screen the API for certain properties vital to assess the probability of success for a product development. In case of the delivery of the API across or into a barrier, e.g. skin or mucosal tissue, a dedicated team uses customized, fully automated Franz-cell chamber systems with ex-vivo human skin or ex-vivo porcine mucosa to answer the question of penetration and permeation.
Formulation specialists will develop first product concepts based on the general understanding of the API and a first design idea. Those first prototypes will be challenged in various tests to evaluate if they meet the design criteria, e.g. transmucosal or transdermal permeation or penetration, stress stability testing, determination of adhesion and more.
In a final step, all the data will be summarized in an extensive report, including a suggestion whether a product development is unlikely to succeed or a promising undertaking. To inform your board a presentation is compiled, illustrating the rational the decision was based on, in an easy to understand way.