CRO Offers Integrated Product Development for Inhaled Dosage Forms

Stuart Needleman, President and Chief Operating Officer, Aptuit, has 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.

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.

Paul Bilson, CMC’s Technical Service Manager, said: “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."

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 characterisation, 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 nebulisers,” said 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.

Aptuit LLC, +1 203 660 6600, paul.bilson@aptuit.com, www.aptuit.com.