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Article / Jun 01, 2013

Bridging API manufacturing and formulation through particle design

European Industrial Pharmacy, June 2013

The interface between the Active Pharmaceutical Ingredients (API) manufacturing and formulation development is of paramount importance in the pharmaceutical world. Chemists, engineers and formulators are not exposed, by training, to the same challenges. As presented in Figure 1, on the one hand there are API suppliers, characterized by a service orientation mindset, used to addressing synthesis route issues (e.g. impurities, yields), solid state characterization (e.g. polymorphs, polymorph control), raw material sourcing, etc); on the other hand, formulators are used to a different type of language and daily concerns (e.g. bioavailability, patience compliance, administration route, efficacy and processibility).

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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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