Formulations and dosage forms for controlled delivery of topiramate
First Claim
1. A controlled release therapeutic composition comprising about 50-60% of an active agent, about 5-15% of a structural polymer carrier and about 15-40% of a solubilizing surfactant adapted to release the active agent over a prolonged period of time.
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Accused Products
Abstract
Dosage forms and devices for enhancing controlled delivery of lowly soluble active agents including topiramate by use of a drug core composition that increases the solubility of the pharmaceutical agent are described. The present invention provides a drug core composition for delivering high doses of lowly soluble topiramate in solid oral drug delivery systems that are convenient to swallow, for once-a-day administration. The drug core composition contains topiramate, a surfactant and a carrier in ratios for optimal solubility and delivery.
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Citations
53 Claims
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1. A controlled release therapeutic composition comprising about 50-60% of an active agent, about 5-15% of a structural polymer carrier and about 15-40% of a solubilizing surfactant adapted to release the active agent over a prolonged period of time.
- 2. A controlled release therapeutic composition comprising topiramate, a structural polymer carrier and a solubilizing surfactant adapted to release the topiramate over a prolonged period of time.
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14. A controlled release therapeutic composition comprising topiramate, a structural polymer and a solubilizing surfactant adapted to increase the solubility of the topiramate.
- 15. A dosage form for controlled release of a therapeutic composition comprising topiramate, a structural polymer and a solubilizing surfactant adapted to release topiramate over a prolonged period of time.
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22. A controlled release oral dosage form for once-a-day administration of topiramate comprising:
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(a) A core which comprises;
i. Topiramate;
ii. a structural polymer;
iii. a solubilizing surfactant;
(b) a semipermeable membrane at least partially surrounding the core; and
(c) an exit orifice through the semipermeable membrane which communicates with the core so as to allow release of the topiramate to the environment;
wherein the dosage form releases the topiramate over a prolonged period of time. - View Dependent Claims (23, 24, 25, 26, 27)
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28. A controlled release oral dosage form for once-a-day administration of topiramate comprising:
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(a) A core which comprises;
i. Topiramate;
ii. polyvinylpyrrolidone; and
iii. no solubilizing surfactant;
(b) a semipermeable membrane at least partially surrounding the core; and
(c) an exit orifice through the semipermeable membrane which communicates with the core so as to allow release of the topiramate to the environment;
wherein the dosage form releases the topiramate over a prolonged period of time.
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29. A method for treating a condition responsive to topiramate comprising orally administering a capsule shaped tablet core dosage form containing topiramate, a solubilizing surfactant and a pharmaceutically acceptable structural polymer carrier wherein the dosage form releases the topiramate at a substantially ascending release rate for a prolonged period of time.
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30. A method for treating a condition responsive to topiramate comprising orally administering a capsule shaped tablet core dosage form containing about 50-60% topiramate, about 5-15% of a structural polymer carrier and about 15-40% of a solubilizing surfactant wherein the dosage form releases the topiramate at a substantially ascending release rate for a prolonged period of time.
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31. A method for administering an active agent to a subject comprising:
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Administering a dosage from to the subject wherein the dosage form comprises;
(a) a capsule shaped tablet core comprising a plurality of layers wherein a composition containing about 50-60% of an active agent, about 5-15% of a structural polymer carrier and about 15-40% of a solubilizing surfactant is contained in at least one layer and at least one other layer comprises a suitable fluid-expandable polymer;
(b) a semipermeable membrane at least partially surrounding the capsule shaped tablet core to form a compartment having an osmotic gradient to drive fluid from an external fluid environment contacting the semipermeable membrane into the compartment; and
(c) an orifice formed through the semipermeable membrane and into the capsule shaped tablet core to permit the active agent to be released from within the compartment into the external fluid environment;
wherein the dosage form releases the active agent at a substantially ascending release rate for a prolonged period of time. - View Dependent Claims (32, 33, 34, 35, 36, 37)
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- 38. A method for delivering an active agent, the method comprising orally administering a capsule shaped tablet dosage form containing a composition having about 50-60% of an active agent, about 5-15% of a structural polymer carrier and about 15-40% of a solubilizing surfactant wherein the dosage form releases the active agent from the dosage form at a substantially ascending release rate for a prolonged period of time.
- 46. A capsule shaped tablet dosage form containing a composition having about 50-60% of an active agent, about 5-15% of a structural polymer carrier and about 15-40% of a solubilizing surfactant wherein the dosage form, following oral administration to a subject, releases the active agent from the dosage form at a substantially ascending release rate for a prolonged period of time.
Specification