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Details for Patent: 5,169,639

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Details for Patent: 5,169,639

Title: Controlled release verapamil tablets
Abstract:Controlled release verapamil tablets are disclosed. The tablets include an excipient having a hydrophilic material, preferably containing a mixture of xanthan gum/locust bean gum, and an inert diluent.
Inventor(s): Baichwal; Anand R. (Wappingers Falls, NY), Staniforth; John N. (Bath, GB2)
Assignee: Edward Mendell Co., Inc. (Patterson, NY)
Filing Date:Jul 25, 1991
Application Number:07/736,031
Claims:1. A tablet for the controlled release of verapamil in the gastro-intestinal tract, comprising:

a controlled release excipient comprising a hydrophilic gum matrix comprising a xanthan gum and locust bean gum in a ratio of from about 3:1 to about 1:3, and an inert diluent selected from the group consisting of a monosaccharide, a disaccharide, a polyhydric alcohol, and mixtures thereof, the ratio of said inert diluent to said hydrophilic gum matrix being from about 4:1 to about 0.67:1; and an effective amount of verapamil to render a desired therapeutic effect, the ratio of verapamil to said hydrophilic gum matrix being from about 3:1 to about 1:3.

2. The tablet of claim 1, wherein the verapamil is dry granulated with said controlled release excipient prior to tableting.

3. The tablet of claim 1, wherein the verapamil is wet granulated with said controlled release excipient prior to tableting.

4. The tablet of claim 1, wherein a first portion of the verapamil is dry granulated with a first portion of said controlled release excipient, and a second portion of the verapamil is wet granulated with a second portion of said controlled release excipient, said dry granulated portion and said wet granulated portion being combined prior to tableting.

5. The tablet of claim 1, wherein the ratio of xanthan gum to locust bean gum is about 1:1.

6. A tablet for the controlled release of verapamil in the gastro-intestinal tract, comprising:

from about 45 to about 70 percent of a controlled release excipient comprising from about 25 to about 55 percent of a hydrophilic gum matrix comprising a xanthan gum and locust bean gum in a ratio of about 1:1, and an inert diluent selected from the group consisting of a monosaccharide, a disaccharide, a polyhydric alcohol, and mixtures thereof; and an effective amount of verapamil to render a desired therapeutic effect.

7. The tablet of claim 6, wherein the ratio of verapamil to said hydrophilic material is from about 1.0:0.4 to about 1.0:0.7.

8. A method for preparing a controlled release verapamil formulation, comprising:

preparing a hydrophilic gum matrix comprising xanthan gum and locust bean gum in a ratio of about 1:1;

mixing said hydrophilic gum matrix with an inert diluent selected from the group consisting of a monosaccharide, a disaccharide, a polyhydric alcohol, and mixtures thereof, in a ratio of said inert diluent to said hydrophilic gum matrix from about 4:1 to about 0.67:1;

combining the mixture of hydrophilic gum matrix/inert diluent with verapamil, such that the ratio of verapamil to said hydrophilic gum matrix/inert diluent mixture is from about 1.0:0.4 to about 1.0:0.7; and

compressing the resultant mixture to form solid tablets having a desired dosage of verapamil to render a desired therapeutic effect, the verapamil being released according to a desired dissolution profile when exposed to gastric fluid.

9. The method of claim 8, wherein verapamil is combined with the mixture of hydrophilic gum matrix/inert diluent via wet granulation.
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