Pharmaceutical and cosmetic foam

Pharmaceutical and cosmetic foam

FOCUS preterm lambs were randomized to receive CPAP (continuous positive airway pressure) alone or CPAP plus either 10, 20, 30 or 90 minutes of Aerosu...

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FOCUS preterm lambs were randomized to receive CPAP (continuous positive airway pressure) alone or CPAP plus either 10, 20, 30 or 90 minutes of Aerosurf exposure at a maintained CAG output rate of 22.5 mg of total phospholipids/minute. Lung function, lung structure and lung tissue inflammatory markers were assessed across groups. Key observations include treatment with Aerosurf resulted in a dose-dependent improvement in lung function and decrease in lung interleukin-8, an established marker of respiratory inflammation, with marked differences following 20 minutes of aerosol exposure and with no further improvement following 30 and 90 minutes of exposure. Improvement in oxygenation was observed to a greater degree in the 10, 20 and 30 minute dosing groups compared with CPAP alone or the 90 minute dosing group. Improvements were also observed at reduced dose exposures compared with previous studies in this non-clinical model. Treatment with Aerosurf preserved lung structural integrity in all Aerosurf exposure groups. Aerosurf appeared to be well tolerated and interfaced effectively with CPAP respiratory support. CPAP is increasingly being employed to support preterm infants in order to avoid endotracheal intubation, but precludes the timely administration of surfactant in conventional dosage forms and has a limited success rate; combining CPAP with aerosolized surfactant may improve this. In related news, DLI has been awarded Phase I of a Fast Track Small Business Innovation Research Grant from the National Institutes of Health to support the development of its programme for aerosolizing KL4 surfactant for neonatal RDS. The grant provides $580,000 to support the development of DLI’s proprietary capillary aerosol generating device technology. Potential Phase II funding, up to an additional $1.8 M, would support a clinical trial of aerosolized KL4 surfactant in preterm infants with or at risk for RDS. In addition, DLI is continuing its efforts, with the collaboration of the US Food and Drug Administration (FDA) to gain FDA marketing authorization for its developmental Surfaxin product for the prevention of RDS in preterm 6

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infants [see also Focus on Surfactants, Jan 2010]. Press releases from: Discovery Laboratories Inc, 2600, Kelly Road, Suite 100, Warrington, PA 18976 3622, USA, tel: +1 215 488 9300, fax: +1 215 488 9301, website: http://www.discoverylabs.com (7 & 16 Dec 2010 & 10 Jan 2011)

PATENTS Pharmaceutical and cosmetic foam Foamix Ltd has been granted US Patent No 7,820,145 B2 for its oleaginous pharmaceutical and cosmetic foam. The foamable therapeutic formulation comprises 70-96.5% of a solvent phase that has a hydrophobic solvent, a silicone oil or a mixture thereof and optionally, an emollient, a co-solvent or a mixture thereof; a therapeutically effective amount of at least once active agent; 0.1-10wt% of a nonionic surfactant; a gelling agent; and at least one gas propellant. The formulation produces breakable foam when dispensed and collapses upon application of shear force. HAPPI, Household & Personal Products Industry, Dec 2010, 47 (12), 36

Shave gel patented by Gillette Gillette has been awarded US Patent No 7,820,152 B2 for its post-foaming gel shaving formulation. The composition comprises a volatile postfoaming agent, glyceryl acrylate/acrylic acid copolymer, water, waterdispersible surface active agent, and a gelling aid or thickening agent. HAPPI, Household & Personal Products Industry, Dec 2010, 47 (12), 36

Discovery Labs receives US patent Discovery Laboratories Inc (DLI) has been granted US Patent Number 7,863,241 for compositions that employ a combination of certain pulmonary surfactants with a broad array of protease inhibitors, administered as either a liquid or aerosol, for treating pulmonary inflammation. The Scripps Research Institute has granted DLI exclusive licensing rights for this patent. Several protease inhibitors are approved for use in serious pulmonary conditions. Inhaled protease inhibitors are currently under development, but

no such therapy is believed to be approved for use in aerosolized form for direct delivery to the lung. DLI’s KL4 surfactant may function as an advantaged pulmonary drug delivery system given its novel liposomal structure, completely synthetic composition and ability to be delivered as an aerosol. Additionally, the immune modulatory properties of KL4 surfactant may complement the pharmacologic activity of protease inhibitors. Press releases from: Discovery Laboratories Inc, 2600, Kelly Road, Suite 100, Warrington, PA 18976 3622, USA, tel: +1 215 340 4699, fax: +1 215 340 3940, website: http://www.discoverylabs.com (19 Jan 2011)

LITERATURE Applied Surface Thermodynamics Published by CRC Press, this second edition of Applied Surface Thermodynamics contains 40% new material and reorganized content. It begins by presenting a generalized Gibbs theory of capillarity, including discussions of highly curved interfaces. Concentrating on drop-shape techniques, the book discusses liquidfluid interfacial tension and its measurement. Next, the authors focus on contact angles with chapters on experimental procedures, thermodynamic models and the interpretation of contact angles in terms of solid surface tension. The book discusses theoretical approaches to determining solid surface tension as well as interfacial tensions of particles and their manifestations. It concludes by discussing drop size dependence of contact angles and line tension. New material includes the latest developments and applications in Axisymmetric Drop Shape Analysis (ADSA), recent studies of contact angle hysteresis, and contact angles on inert fluoropolymers. The volume aims to provide students and researchers with fundamental, state-ofthe-art knowledge and practical guidelines in solving real-world problems related to the measurement and interpretation of interfacial properties. AW Neumann, Robert David and Yi Zuo (eds), 2nd edn, 2010, CRC Press, 6000 NW Broken Sound Parkway, Suite 300, Boca Raton, FL 33487, USA, email: [email protected], website: http://www.crcpress.com. ISBN (hardback) 0849396875, 765 pp, $199.95

MARCH 2011