Sustained Release Pharmaceutical Dosage Form of Entecavir
AssigneeAUCTA Pharmaceuticals
InventorsEnxian Lu, Shoufeng Li, Shaoqiong Lyu
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Abstract
This document discloses a sustained release dosage form for oral administration of entecavir in a subject. Also disclosed is a method of treating hepatitis virus B infection.
Claims23
A dosage form for oral administration in a subject, comprising entecavir or a pharmaceutically acceptable salt thereof in an amount from about 0.2 mg to about 25 mg and an sustained release component, wherein the dosage form achieves therapeutically effective plasma levels over a seven-day period when administered on a once weekly basis.
The dosage form of 1, which provides an in vitro release of:
- (a) from about 10% to about 80% of the entecavir within about 2 hours;
- and
- (b) more than about 60% the entecavir within about 12 hours,
- wherein the in vitro release of the entecavir is measured according to USP dissolution apparatus 1, in 900 ml of PBS solution at pH 6.8 at 100 rpm.
The dosage form of 8, wherein the ratio by weight between the entecavir and the HPMC ranges from about 1:1 to about 1:20.
Dependencies are inferred from the claim text.