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Water dispersible gemfibrozil compositions
| Details |
Inventors: Ghebre-Sellassie, Isaac; Gordon, Robert H.; Iyer, Uma; Fawzi, Mahdi B.;
Assignee: Warner-Lambert Company (Ann Arbor, MI)
Primary Examiner: Page; Thurman K.
Assistant Examiner:
Attorney, Agent or Firm: Mathews, Woodbridge & Collins
A water-dispersible formulation of gemfibrozil comprising finely divided particles of pure gemfibrozil uniformly coated with a mixture of a wax and at least one hydrophilic material, the coated particles in turn being overcoated with a minor amount of a surfactant. |
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DETAILED DESCRIPTION What is claimed is: 1. A water-dispersible formulation of gemfibrozil comprising finely divided particles of pure gemfibrozil uniformly coated with a mixture of a wax and at least one hydrophilic material selected from the group consisting of fatty acid alcohols, fatty acid esters, polyols, cellulose derivatives, and vinyl derivatives, the ratio of wax to hydrophilic material being from about 1:0. 1 to about 0. 1:1, said coated particles in trun being overcoated with an amount of a surfactant sufficient to improve the dispersibility of the formulation in water. 2. A water-dispersible formulation of gemfibrozil according to claim 1 wherein a first portion of the finely divided particles of pure gemfibrozil uniformly coated with a mixture of a wax and stearyl alcohol to provide relatively immediate release and a second portion of the finely divided particles of pure gemfibrozil uniformly coated with a mixture of a wax and hydrogenated castor oil to provide relatively sustained release. 3. A water-dispersible formulation of gemfibrozil according to claim 1 wherein the hydrophilic material is stearyl alcohol. 4. A water-dispersible formulation of gemfibrozil according to claim 1 wherein the surfactant is sodium lauryl sulfate.
Description:
The present invention relates to a water-dispersible formulation of gemfibrozil. Background Gemfibrozil, or 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, is a widely used antihyperlipoproteinemic agent which, because of the required large dose, generally is administered several times a day in the form of multiple capsules. Although it would be desirable to administer the agent in a water-dispersible formulation, this approach heretofore has been unattainable because of the unpleasant burning after-taste which it produces in the buccal mucosa. It also would be beneficial to provide such water-dispersible formulations with sustained release properties so as to reduce the number of times the drug must be administered. British Application No
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