Controlled release tablet
First Claim
1. A controlled release tablet consisting essentially of a single homogeneous mixture of a pharmaceutical agent selected from the group consisting of nifedipine, diclofenac sodium, salicylic acid, theophylline anhydrous, sulfapyridine, sulfadrazine, propranolol hydrochloride, diltiazem hydrochloride, glipizide, and sulfathiazole, a solubilizing agent, and an excipient, wherein said excipient comprises:
- polyethylene oxide and a lubricant; and
wherein the pharmaceutical agent is released from the tablet at a rate expressed as Mt /MT =ktn where;
t is time,Mt is the amount of the pharmaceutical agent which has been released at time t,MT is the total amount of the pharmaceutical agent contained in the tablet,k is a constant, andn is the release kinetics exponent; and
wherein the molecular weight and the solubility, respectively, of said polyethylene oxide and the pharmaceutical agent are selected such that n is about 0.89 to 1.0.
1 Assignment
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Accused Products
Abstract
A controlled release tablet including a pharmaceutical agent and an excipient. The excipient includes at least about 60% of a water swellable polymer and a lubricant. The water swellable polymer is chosen such that the swelling rate of the polymer is equal to the dissolution rate of the swollen polymer. The excipient may also include such other ingredients as diluents, fillers, binders, solubilizers, emulsifiers, and other pharmacologically inactive compounds. The polymer is chosen with the pharmaceutical agent in mind such that the tablet will be fully dissolved at the same time that the last of the pharmaceutical agent is released.
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Citations
25 Claims
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1. A controlled release tablet consisting essentially of a single homogeneous mixture of a pharmaceutical agent selected from the group consisting of nifedipine, diclofenac sodium, salicylic acid, theophylline anhydrous, sulfapyridine, sulfadrazine, propranolol hydrochloride, diltiazem hydrochloride, glipizide, and sulfathiazole, a solubilizing agent, and an excipient, wherein said excipient comprises:
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polyethylene oxide and a lubricant; and wherein the pharmaceutical agent is released from the tablet at a rate expressed as Mt /MT =ktn where; t is time, Mt is the amount of the pharmaceutical agent which has been released at time t, MT is the total amount of the pharmaceutical agent contained in the tablet, k is a constant, and n is the release kinetics exponent; and wherein the molecular weight and the solubility, respectively, of said polyethylene oxide and the pharmaceutical agent are selected such that n is about 0.89 to 1.0. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A controlled release tablet consisting essentially of a single homogenous mixture of a pharmaceutical agent and an excipient, wherein said excipient comprises:
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19 to 43% by weight polyethylene oxide; up to 3% by weight magnesium stearate; and 55to 80% by weight acacia; and wherein said pharmaceutical agent is nifedipine and is present in an amount of from 9 to 13% by weight of said tablet.
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11. A controlled release tablet consisting essentially of a single homogeneous mixture of a pharmaceutical agent nifedipine, a solubilizing agent, and an excipient, wherein said excipient comprises:
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polyethylene oxide and a lubricant; and the swelling rate of said polyethylene oxide is equal to the dissolution rate of said polyethylene oxide when the polyethylene oxide is swollen. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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- 22. A controlled release pharmaceutical tablet consisting essentially of a single homogeneous mixture of the pharmaceutical agent nifidipine, a solubilizing agent selected from the group consisting of polyethylene glycol, acacia, lecithin gelatin, casein, and tragacanth, and an excipient, wherein said excipient comprises polyethylene oxide and a lubricant and at least 50 percent by weight of said excipient is polyethylene oxide having a molecular weight of from 900,000 to 5,000,000.
Specification