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Claims for Patent: 5,679,685

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Claims for Patent: 5,679,685

Title: Accelerated release composition containing bromocriptine
Abstract:Disclosed herein is a solid oral dosage form comprising bromocriptine and one or more pharmaceutically acceptable excipients. The oral dosage form has a dissolution rate in excess of 90% in 5 minutes in 500 ml of 0.1N HCl aqueous medium at 37 C and is useful for adjusting the plasma prolactin profile of a patient.
Inventor(s): Cincotta; Anthony H. (Andover, MA), Cincotta, Jr.; Manuel (Tiverton, RI), Pelloni; Christopher Louis (Louisville, CO), Runice; Christopher Eric (Denver, CO), Tigner; Sandra Louise (Broomfield, CO)
Assignee: Ergo Science, Incorporated (Charlestown, MA) Geneva Pharmaceuticals, Inc. (Broomfield, CO)
Application Number:08/459,021
Patent Claims: 1. A solid oral dosage form comprising bromocriptine (B) as the sole pharmaceutically active ingredient and physiologically acceptable inert excipients including a group of excipients that affect the rate of bromocriptine release from said dosage form wherein said release affecting excipients consist of citric acid (C) and a disintegrating agent (D).

2. The dosage form of claim 1 wherein the disintegrating agent (D) comprises cornstarch, and the dosage form further comprises the inert excipients lactose, colloidal silicon dioxide and magnesium stearate.

3. The dosage form of claim 2 wherein the relative amounts of said bromocriptine and said release affecting excipients are 0.8 mg bromocriptine; 1.35 mg of citric acid; and 9 mg corn starch, and the relative amounts of the inert excipients are 77 mg anhydrous lactose; 0.45 mg colloidal silicon dioxide; and 0.675 mg magnesium stearate.

4. The solid oral dosage form of claim 1 further comprising a low moisture content filler, a water-scavenging agent and a lubricant.

5. The oral dosage form of claim 4 wherein said dosage form has a total weight of about 90 mgs.

6. A solid oral dosage form consisting of bromocriptine (B); as an antioxidant, citric acid (C); a low moisture content filler, a disintegrating agent (D), a water-scavenging agent and a lubricant, wherein said B, C, and D are at a weight ratio B:C:D of 0.8:1.35:9.

7. The solid oral dosage form of claim 6 wherein (D) is cornstarch.
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