Fast onset of action

Category

Cross-category 

Description

We are seeking a liquid or semi-liquid formulation that has been proven to be absorbed directly into the bloodstream through mucosa (buccal mucosa) or skin (transdermal) to get faster onset of action for patients vs. standard oral route.

We are looking for a transdermal or transmucosal (mouth) drug delivery system that could be a formulation (e.g. sub-lingual ODT), an oral spray or patch (e.g. microneedle) or others.

Background

Standard formulations marketed so far are mainly delivered by oral route providing similar onset of action (around 1 hour). In addition poor bioavailability is observed by oral route (e.g. tablet, or suspension).

Sanofi Consumer Healthcare is looking for a breakthrough innovation able to answer to a real consumer/patient need for faster action that can disrupt the OTC market and gain differentiation vs. competition.

Key Success Criteria

Must-have requirements

In vitro data to substantiate good permeability profile

Preliminary in vivo Pharmacokinetics data to substantiate faster onset of action for this new route of administration vs. oral route with at least 6H of lasting effect (effective plasma drug concentration)

Avoid non permitted ingredients (FDA, Prop 65 compliance, ANVISA, EMA)

Good Preliminary stability profile of the final product suitable for all ICH zones

Preliminary Industrial feasibility assessment available

Solution that could be leveraged globally

Preferred Requirements

Supportive data to substantiate physical and chemical characteristics of the formulation and the delivery system

Directional or proof of concept data for efficacy (clinic or in-vitro/in-vivo)

Target Group

Adults

Approaches not of interest

Formulation containing first generation of oral antihistamine. Nasal formulation sprays.