Controlled absorption naproxen formulation for once-daily administration
DCFirst Claim
1. A naproxen formulation for once-daily oral administration comprising naproxen in a multi-particulate pellet form, each pellet having a core of naproxen or a pharmaceutically acceptable salt thereof in association with an organic acid, the naproxen or pharmaceutically acceptable salt thereof and the organic acid being present in a ratio of from 20:
- 1 to 1;
1, and a multi-layer membrane surrounding said core and containing a pharmaceutically acceptable film-forming, water insoluble polymer and optionally a pharmaceutically acceptable film-forming, water soluble polymer and having a dissolution rate which when measured in vitro in a type 1 dissolution basket apparatus according to U.S. Pharmacopoeia XXI in phosphate buffer at pH 7.2 and at 75 r.p.m. corresponds to the following dissolution pattern;
a) from 0 to 50% of the total naproxen is released after 1 hour of measurement in said apparatus;
b) from 20 to 70% of the total naproxen is released after 2 hours of measurement in said apparatus; and
c) not less than 50% of the total naproxen is released after a total of 4 hours of measurement in said apparatus.
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Abstract
A once-daily naproxen formulation for oral administration having a first portion of the naproxen as a multi-particulate pellet form, each pellet having a core of naproxen or a pharmaceutically acceptable salt thereof in association with an organic acid, the core being surrounded by a multi-layer membrane and optionally a second portion of naproxen formulated to release the drug promptly following oral administration.
144 Citations
17 Claims
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1. A naproxen formulation for once-daily oral administration comprising naproxen in a multi-particulate pellet form, each pellet having a core of naproxen or a pharmaceutically acceptable salt thereof in association with an organic acid, the naproxen or pharmaceutically acceptable salt thereof and the organic acid being present in a ratio of from 20:
- 1 to 1;
1, and a multi-layer membrane surrounding said core and containing a pharmaceutically acceptable film-forming, water insoluble polymer and optionally a pharmaceutically acceptable film-forming, water soluble polymer and having a dissolution rate which when measured in vitro in a type 1 dissolution basket apparatus according to U.S. Pharmacopoeia XXI in phosphate buffer at pH 7.2 and at 75 r.p.m. corresponds to the following dissolution pattern;a) from 0 to 50% of the total naproxen is released after 1 hour of measurement in said apparatus; b) from 20 to 70% of the total naproxen is released after 2 hours of measurement in said apparatus; and c) not less than 50% of the total naproxen is released after a total of 4 hours of measurement in said apparatus. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
- 1 to 1;
Specification