Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Polymer from ethylenic monomers only
Reexamination Certificate
2009-11-18
2010-12-07
Wax, Robert A (Department: 1615)
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
Polymer from ethylenic monomers only
C528S393000
Reexamination Certificate
active
07846425
ABSTRACT:
Disclosed herein is an improved process for preparation of Sevelamer hydrochloride having phosphate binding capacity of 4.7 to 6.4 mmol/g. Further, the invention discloses Sevelamer hydrochloride compositions and a novel process for preparation of said compositions comprising high shear non-aqueous granulation.
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Foreign Priority document 1402/MUM/2006 (filing date Sep. 1, 2006), retrieved from the WIPO site, pp. 1-22.
J.R. Mazzeo et al., “A Phosphate Binding Assay for Sevelamer Hydrochloride by Ion Chromatography,” J. Pharm. Biomed. Anal. (1999) 19, pp. 911-915.
“(logo) Renegal® Tablets (sevelamer hydrochloride) 400 and 800mg,” Package insert (downloaded from http://www.fda.gov/cder/foi/label/2000/21179lbl.pdf).
Bhide Yogesh Sharad
Choudhary Varsha Shashank
Hegde Deepak Anant
Pharmaceutical Patent Atty's LLC
Sasan Aradhana
USV, Ltd.
Wax Robert A
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