Wednesday, October 04, 2006

SkyePharma: Lodotra Phase III trial showed positive results

LONDON-- U.K. pharmaceutical SkyePharma said Wednesday that a Phase III clinical trial for Lodotra modified release tablets designed to optimize the efficacy of orally administered low-dose prednisone in Rheumatoid Arthritis showed positive results. Lodotra provides all the benefits of standard immediate release prednisone but has the additional, clinically important advantage of significantly reducing morning symptoms combined with a convenient dosing regimen, the company said.

AND here what it is......
GeoClock tablets have an active drug loaded inside an outer tablet layer consisting of a mixture of hydrophobic [water hating] wax and brittle material in order to obtain a pH-independent lag time prior to core drug delivery at a predetermined release rate.

This dry coating approach is designed to allow the timed release of both slow release and immediate release active cores by releasing the inner table first after which time the surrounding outer shell gradually disintegrates.

Using this novel technology, the pharma firm has been developing the new RA drug on behalf of another pharma company, Nitec.

According to SkyePharma, the drug, called Lodotra, will deliver the undisclosed active pharmaceutical ingredient (API) at the most appropriate time of day to treat the disease.

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