Co-Formulate Limited, a division of Quotient Clinical, a leading provider of early stage drug development services, has been contracted by Proveca to perform paediatric formulation development work on several additional off-patent compounds.
This agreement follows Co-Formulate’s successful development of an age-appropriate, taste-masked formulation of Proveca’s first paediatric medicine, Sialanar, in line with regulatory requirements.
Proveca recently announced a positive EMA opinion for its Sialanar glycopyrronium bromide oral solution, and subsequent approval of an EU-wide Paediatric Use Marketing Authorization (PUMA). Co-Formulate contributed to the authoring of the drug product sections of the Paediatric Investigation Plan (PIP) and PUMA.
Proveca is a specialist pharmaceutical company engaged in the development of paediatric medicines. Co-Formulate is applying its expertise in formulation development, allied with its capabilities in analytical and stability testing, scale-up and regulatory support, to develop a range of alternative formulations for children of different age groups across a range of dose formats.
Huw Jones, Director and founder, Co-Formulate, said: “We are delighted to extend our agreement with Proveca, following the success of Sialanar, and look forward to working on the new compounds. Following the acquisition of Co-Formulate by Quotient Clinical in December 2015, the company is now able to offer customers end-to-end services covering formulation development, taste masking, clinical pharmacokinetic and taste assessments, and GMP clinical trial manufacturing and global supply, all under the umbrella of a single organisation.”
Simon Bryson, Director and cofounder, Proveca, commented: “We were very pleased with the outcome of the Sialanar formulation project, and are now delighted to be working with Co-Formulate on a range of further products.”