Extended release pharmaceutical tablet of metformin
AssigneeBiovail Laboratories, Inc.
InventorsPawan Seth, Benoit Schmidtt
Life of this patent
Estimating the term…
Abstract
The invention provides an extended release pharmaceutical tablet containing: (i) a core comprising by weight, based on the core weight, about 70% to about 99% metformin and pharmaceutically acceptable excipients; and (ii) a coating permeable to metformin. The extended release tablet of the invention exhibit a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released; after about 4 hours, from about 15% to about 90% of the metformin is released; after about 8 hours, from about 50% to about 100% of the metformin is released; after about 12 hours, more than about 75% of the metformin is released.
Claims81
An extended release pharmaceutical tablet comprising:
- (i) a core comprising by weight, based on the core weight, about 70% to about 99% metformin and pharmaceutically acceptable excipients;
- and
- (ii) a coating permeable to metformin,
- said extended release tablet exhibiting a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released;
- after about 4 hours, from about 15% to about 90% of the metformin is released;
- after about 8 hours, from about 50% to about 100% of the metformin is released;
- after about 12 hours, more than about 75% of the metformin is released.
An extended release pharmaceutical tablet comprising:
- (i) a core comprising by weight, based on the core weight, about 70% to about 99% metformin and conventional excipients;
- and
- (ii) a coating permeable to metformin consisting essentially by weight, based on the coating weight, of about 20% to about 85% of a water-insoluble, water-permeable film-forming polymer, of about 10% to about 75% of a water soluble polymer and about 3% to about 40% of a plasticizer,
- said extended release tablet exhibiting a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released;
- after about 4 hours, from about 15% to about 90% of the metformin is released;
- after about 8 hours, from about 50% to about 100% of the metformin is released;
- after about 12 hours, more than about 75% of the metformin is released.
An extended release extended release pharmaceutical tablet comprising:
- (i) a core comprising by weight, based on the core weight, about 70% to about 99% metformin and pharmaceutically acceptable excipients;
- and
- (ii) a coating permeable to metformin consisting essentially by weight, base on the coating weight, from about 50% to about 85% of a water-insoluble, water-permeable film-forming polymer, from about 10% to about 35% of a water soluble polymer and from about 3% to about 15% of a plasticizer,
- said composition exhibiting a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released;
- after about 4 hours, from about 15% to about 90% of the metformin is released;
- after about 8 hours, from about 50% to about 100% of the metformin is released;
- after about 12 hours, more than about 75% of the metformin is released.
An extended release tablet comprising:
- (i) a core comprising by weight, based on the core weight, 70 to 99% of metformin, an expanding agent and pharmaceutically acceptable excipients;
- and
- (ii) a coating permeable to metformin consisting essentially by weight, based on the coating weight, from about 20% to about 50% of a water-insoluble, water-permeable film-forming polymer, from about 35% to about 75% of a water-soluble polymer and from about 15% to about 40% of a plasticizer;
- said tablet exhibiting a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released;
- after about 4 hours from about 15% to about 90% of the metformin is released;
- after about 8 hours from about 50% to about 100% of the metformin is released;
- and after about 12 hours, more than about 75% of the metformin is released.
An extended release pharmaceutical tablet comprising:
- (i) a core comprising by weight, based on the core weight, 70 to 99% of metformin, a non-hydro colloid expanding agent and pharmaceutically acceptable excipients;
- and
- (ii) a coating permeable to metformin and free of monomeric pore forming agent consisting essentially by weight, based on the coating weight, from about 20% to about 50% of a water-insoluble, water-permeable film-forming polymer, from about 35% to about 75% of a water-soluble polymer and from about 15% to about 40% of a plasticizer;
- said tablet exhibiting a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released;
- after about 4 hours from about 15% to about 90% of the metformin is released;
- after about 8 hours from about 50% to about 100% of the metformin is released;
- and after about 12 hours, more than about 75% of the metformin is released.
An extended release pharmaceutical tablet comprising:
- (i) a core comprising by weight, based on the core weight, 70 to 99% of metformin, crospovidone, glyceryl behenate, polyvinyl alcohol, silicon dioxide;
- and
- (ii) a coating permeable to metformin and free of monomeric pore forming agent consisting essentially by weight, based on the coating weight, from about 20% to about 50% of a water-insoluble, water-permeable film-forming polymer, from about 35% to about 75% of a water-soluble polymer and from about 15% to about 40% of a plasticizer;
- said tablet exhibiting a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released;
- after about 4 hours from about 15% to about 90% of the metformin is released;
- after about 8 hours from about 50% to about 100% of the metformin is released;
- and after about 12 hours, more than about 75% of the metformin is released.
An extended release pharmaceutical tablet comprising:
- (i) a core comprising by weight, based on the core weight, 70 to 99% of metformin, crospovidone, glyceryl behenate, polyvinyl alcohol, silicon dioxide;
- and
- (ii) a coating permeable to metformin and free of monomeric pore forming agent consisting essentially by weight, based on the coating weight, from about 20% to about 50% of ethylcellulose, from about 35% to about 75% of polyvinylpyrrolidone and from about 15% to about 40% of stearic acid;
- said tablet exhibiting a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released;
- after about 4 hours from about 15% to about 90% of the metformin is released;
- after about 8 hours from about 50% to about 100% of the metformin is released;
- and after about 12 hours, more than about 75% of the metformin is released.
An extended release pharmaceutical tablet comprising:
- (i) a core comprising by weight, based on the core weight, 70 to 99% of metformin, crospovidone, glyceryl behenate, polyvinyl alcohol, silicon dioxide;
- and
- (ii) a coating permeable to metformin and free of monomeric pore forming agent consisting essentially by weight, based on the coating weight, from about 20% to about 50% of ethylcellulose, from about 35% to about 75% of polyvinylpyrrolidone and from about 15% to about 40% of dibutyl sebacate;
- said tablet exhibiting a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released;
- after about 4 hours from about 15% to about 90% of the metformin is released;
- after about 8 hours from about 50% to about 100% of the metformin is released;
- and after about 12 hours, more than about 75% of the metformin is released.
Dependencies are inferred from the claim text.