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Article / Jul 31, 2010

Scale-up methodology for pharmaceutical spray drying

Chemistry Today, July/August 2010

The use of spray drying in the pharmaceutical industry is growing at a fast pace. The need for robust scale-up methods is essential in order to control critical quality attributes and improve powder properties during drug development. Moreover, poor scale-up is likely to lead to considerable losses of expensive materials. Process understanding and simulation is a very powerful tool to support the scale-up of spray drying processes. A scale-up methodology based on scientific principles is proposed in this study. The method is divided in two steps: thermodynamic and atomization & particle formation. The method is relatively straightforward to apply and has been tested in numerous spray-dried formulations across all production scales. An illustrative example is also shown covering the main steps of the proposed methodology.

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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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