Greenwich, CT, February 28, 2013 – Stuart Needleman, President and Chief Operating Officer, Aptuit LLC, announced that Aptuit provides integrated product development of inhaled dosage forms through its Chemistry Manufacture and Control (CMC) group located at The Aptuit Center for Drug Discovery & Development in Verona, Italy.
Mr. Needleman said, “There are a number of distinct advantages for clients who choose Aptuit as a partner in developing inhaled dosage forms. The assurance that they are working with a team of highly experienced, multidisciplinary respiratory technology experts who take an open, transparent and honest approach is paramount, of course; but there are other factors to be considered. Adverse effects in the development of inhaled dosage forms are known to be common, resolved only by the collaboration of a diverse team such as ours. Additionally, our multidisciplinary team is co-located within the CMC group in Verona, making it beneficial for clients who need to overcome the challenge of working with several CRO partners from various locations.”
It was explained that Aptuit develops a strategy at the start of every inhaled project, defining the critical characteristics of the API, excipients, blend and process to be developed, along with other parameters such as the dose range, shelf life and in vitro performance.
“Understanding and identification of critical processing requirements are essential, and knowing which of these needs to be controlled should be clarified at the start. We employ a Quality by Design approach to support the strategy, conducting experiments throughout the process. We are focused on reviewing what prior knowledge has told us about predicting variables that could influence processing and analysis,” said Paul Bilson, CMC’s Technical Service Manager.
Mr. Bilson described the scope of Aptuit’s integrated product development services for inhaled dosage forms. He cited “best in class” capabilities for physical properties and solid state characterization; formulation development; analytics; clinical trial supply and packaging.
“A GMP analytical laboratory, custom designed for inhalation testing, conducts all testing of dosage forms such as DPIs, pMDIs, nasal sprays and nebulizers,” said Mr. Bilson. He added that dedicated inhalation suites within manufacturing pilot plants for inhaled dry powder production are in place and have been approved by AIFA (Italian Medicines Agency) for clinical trial supply.
For more information, please contact Paul Bilson at paul.bilson@aptuit.com. For press inquiries or to request an interview, please contact Maria Garvey, Delfino Marketing at 914-747-1400 or maria@delfino.com.
Aptuit LLC provides the most complete set of integrated early to mid-phase development services in the pharmaceutical industry. Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Sterile Fill Finish & Formulation Development, Oral Dosage Form Development & Manufacture, Clinical Sciences, Consulting and Aptuit INDiGOÒ (a program that accelerates drug development) are offered as stand alone or integrated services. Fully integrated drug discovery & development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. The company maintains five global facilities with approximately 800 employees in Europe and the United States, and has a strategic relationship with Laurus Labs in India. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.
For more information about Aptuit, visit www.aptuit.com
