Dr Peter Scholes, Vice President Pharmaceutical Sciences at early clinical drug development specialists, Pharmaceutical Profiles Ltd (Nottingham, UK), gave a soapbox session at the 35th Annual Meeting & Exposition of the Controlled Release Society, held in New York City, 12 – 16 July 2008. By combining the benefits of in-human imaging technology and pharmacokinetic (PK) data early in formulation development, pharmacoscintigraphy can provide information critical to effective drug formulation strategy. Dr Scholes’ presentation: ‘Human Drug Absorption Studies for Defining the Modified Release Formulation Roadmap’, was followed by a podium presentation of a study that illustrates how Pharmaceutical Profiles’ technologies and clinical expertise support efficient and effective formulation development.
The study: ‘A Pharmacoscintigraphic Study to Assess the Performance of Novel Gastroretentive Pulsatile Formulations of Esomeprazole in Humans’, carried out by Depomed, Inc. (Menlo Park, CA), demonstrates the advantages of combining scintigraphic imaging and pharmacokinetic (PK) analysis to evaluate and compare formulations. Using Pharmaceutical Profile’s unique, EnterionTM capsule technology, Depomed was able identify the formulation that delivered the right release characteristics, explain the differences in PK between formulations and compare and validate the performance of their product against the market comparator.
Pharmaceutical Profile’s knowledge and expertise in human absorption studies has contributed to the development of more than 100 small molecules, proteins and peptides. With a focus on the needs of the pharmaceutical industry, this event is one of many in an ongoing programme of presentations, workshops and seminars to take place throughout the coming year.
For further details on upcoming opportunities to benefit from the experience of experts, visit: www.pharmprofiles.co.uk
About Pharmaceutical Profiles:
Pharmaceutical Profiles provides drug development support to most of the top pharmaceutical and biotechnology companies around the world.
The company specializes in early clinical drug development, with innovative technologies and expertise to optimize drug delivery and performance in the clinic.
World leading expertise in oral drug development has assisted the development of over 100 small molecules, peptides and protein therapeutics, including over 40 marketed drugs.
Unrivalled knowledge and experience in inhaled drug development has supported the development of the majority of inhaled drug delivery devices and formulations on the market today.
Pharmaceutical Profiles has around 100 highly qualified staff with a broad range of expertise.
Facilities include a phase I clinical unit, a GMP facility for the manufacture of Investigational Medicinal Products (IMPs), and formulation R&D facilities all under one roof, just south of Nottingham in the UK.