Aptalis Pharmaceutical Technologies Announces Approval
Aptalis Pharmaceutical Technologies recently announced that the European Commission granted marketing authorization for a new pediatric indication of a new oral granule formulation of Gilead Sciences, Inc.’s Viread (tenofovir disoproxil fumarate) for HIV-1 infected children aged 2 to less than 6 years, and for HIV-1 infected children above 6 years of age for whom a solid dosage form is not appropriate.
This authorization, which covers all 27 countries of the European Union (EU), follows the January 2012 US FDA New Drug Application (NDA) approval of Viread oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2 to 5. The oral powder, which utilizes Microcaps taste-masking formulation technology, will be manufactured and supplied to Gilead by Aptalis Pharmatech, Inc. Gilead will be responsible for product commercialization.
“The FDA and European Commission approvals of the oral granule formulation of Gilead’s Viread for use in the US and Europe respectively, are examples of how our company’s turnkey business model differentiates our services in the drug development process. We leverage our breadth of capabilities, experience and expertise to provide a comprehensive resource for our partners to establish effective pathways to commercialization. To this end, we are pleased to have had the opportunity to co-develop the pediatric oral powder formulation of Viread with Gilead using our Microcaps proprietary technology,” said John Fraher, President of Aptalis Pharma.
The microencapsulation technology known as Microcaps employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation. This includes taste- and odor-masking, customized release profiles, conversion of liquids to solids and the separation of incompatible materials. Microcaps can also be combined with the company’s AdvaTab technology to provide an orally disintegrating tablet with superior mouth-feel attributes.
Aptalis Pharmaceutical Technologies, formerly known as Eurand Pharmaceutical Technologies, offers a broad portfolio of oral drug delivery technology platforms: Customized Drug Release, Bioavailability Enhancement, and Taste Masking for ODTs (orally disintegrating tablets) and other dosage forms. For more information, visit www.AptalisPharmaTech.com.
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