Nottingham, U.K, 24 July 2012 – Quotient Clinical, part of Quotient Bioresearch (“Quotient”) today announced the publication of results, in the journal Pharmaceutical Research, of a RapidFACT™ program conducted for Eli Lilly. The integrated pharmaceutical development and clinical program was designed to develop an optimal controlled release (CR) formulation for the molecule LY545695 – a new potential medicine for the treatment of persistent pain.
The RapidFACT program achieved all of its objectives. An optimised drug product was delivered that matched the target exposure profile, and at a dose reduced by 30% in comparison with the drug product(s) that had been used in the earlier stages of development. Consequently, the cost of goods was significantly reduced for the drug product entering later stages of development. The entire program of work was delivered in less than nine months, resulting in significant timeline savings to the development project team. The program incorporated an innovative formulation design space to enable real-time optimisation of drug release rate with a high level of precision, in direct response to emerging clinical data. Candidate formulations were also radiolabelled to allow real-time in vivo imaging of the dosage forms and confirmation of their location within the human gastrointestinal tract.
Mark Egerton, Managing Director of Quotient Clinical, said: “This program of work is an excellent case study on how our innovative RapidFACT service can support and expedite a development program. Timelines were shortened, drug substance consumption was reduced, and the fact that all formulation selection decisions were based on human clinical data significantly increased precision. This RapidFACT program also incorporated scintigraphic assessment, which provided invaluable insights into formulation performance when GI location was integrated with pharmacokinetic data.”
The reference for the publication is Lobo ED, Argentine MD, Sperry DC, Connor, AL, McDermott JC, Stevens, LA, Almaya, A. Optimization of LY545694 Tosylate Controlled Release Tablets Through Pharmacoscintigraphy, Pharm Res. 2012; Online First™, 14 June 2012
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About Quotient Clinical
Quotient Clinical, part of Quotient Bioresearch, “Quotient”, has over 20 years’ experience delivering high quality data to provide innovative early drug development solutions to pharmaceutical and biotechnology clients worldwide, including 17 of the top 20 pharmaceutical companies. Our expertise in Exploratory Clinical Pharmacology, Drug Product Optimisation, and 14C Enabled Drug Development, underpinned by our unique Translational Pharmaceutics™ and Synthesis-to-Clinic™ delivery platforms, adds significant value to client programs.
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About Quotient Bioresearch
Quotient Bioresearch is a leading provider of early stage and specialist drug development services to life science clients worldwide. We provide tailored solutions for pharmaceutical, biotechnology and agrochemical clients, using state-of-the-art technologies underpinned by unparalleled medical, chemical and biological expertise. Our consultative, science-driven approach ensures the highest quality service to support and accelerate new product development. Our extensive range of capabilities spans Chemistry and Metabolism, Bioanalytical Sciences, and Clinical. These can be provided independently or integrated into bespoke work programmes.
For additional information or to discuss your specific needs, contact us on firstname.lastname@example.org or visit www.quotientbioresearch.com