Aptalis Pharma Announces NDA Approval of Oral Powder Formulation of Viread
Aptalis Pharma recently announced the US FDA has approved an NDA for Gilead Sciences, Inc.’s Viread (tenofovir disoproxil fumarate) oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2 to 5. Co-developed by Aptalis and
“We are delighted to have the opportunity to use our Microcaps proprietary technology to co-develop the oral powder formulation of Viread with Gilead, which was the result of an Aptalis program referred to as EUR-1030,” said John Fraher, President of Aptalis Pharma.
The Aptalis 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 Aptalis AdvaTab technology to provide an orally disintegrating tablet with superior mouth-feel attributes.
Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs, including cystic fibrosis and gastrointestinal disorders. Aptalis, formed from the recent combination of Axcan Pharma and Eurand, has manufacturing and commercial operations in the US, the European Union, and Canada, and its products include ZENPEP, CANASA, CARAFATE, PYLERA, LACTEOL, DELURSAN, PANZYTRAT, and SALOFALK. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms, including bioavailability enhancement of poorly soluble drugs, custom-release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations.
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