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Claims for Patent: 4,088,750

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Claims for Patent: 4,088,750

Title: Method and preparation for increasing bioavailability of digoxin
Abstract:Method and preparation for increasing the bioavailability of digoxin to treat cardiac insufficiency in a human, said method comprising the administration of a preparation comprising a capsule adapted to release a solution of digoxin in an amount sufficient to treat cardiac insufficiency.
Inventor(s): Cresswell; Ronald M. (Raleigh, NC), Holstius; Elvin A. (Greenville, NC)
Assignee: Burroughs Wellcome Co. (Research Triangle Park, NC)
Application Number:05/653,246
Patent Claims: 1. In the method of increasing the bioavailability of digoxin in a human suffering from cardiac insufficiency which comprises administering to the upper gastrointestinal tract of said human a capsule comprising a soft gelatin capsule shell containing a solution comprising digoxin in a solvent system, the improvement wherein the digoxin is in solution at a concentration of at least 0.25 mg digoxin/ml solution, said capsule containing the solution of the solvent system comprising the following ingredients in about the % amount set forth by weight:

polyethylene glycol 400 (90%)

absolute ethanol -- (6%)

propylene glycol -- (3%)

water -- (1%) and 0.2 mg digoxin

said solvent system being pharmaceutically acceptable to the gastrointestinal tract and able to dissolve digoxin to form a solution and is not substantially destructive of the capsule shell, the solution of said digoxin and solvent system being encapsulated in said shell and said capsule shell capable of being dissolved in the upper gastrointestinal tract of said human, said capsule with said solution providing a bioavailability of digoxin substantially equal to 0.25 mg digoxin administered in tablet form in the same manner as the capsule.

2. A method according to claim 1 wherein the capsule shell has a dissolution rate of substantially 100% at 1 hour.

3. The method of claim 1 in which the digoxin is in solution at a concentration of 0.25 to 0.6 mg digoxin/ml solution.

4. The method of claim 2 in which the digoxin is in solution at a concentration of 0.25 to 0.6 mg digoxin/ml solution.

5. A pharmaceutical capsule comprising a soft gelatin capsule shell containing a solution of 0.1 mg. or 0.2 mg. digoxin in said capsule shell, said capsule shell capable of dissolving in the upper gastrointestinal tract, said solution containing a solvent system which is pharmaceutically acceptable to the gastrointestinal tract and which will dissolve digoxin to form a solution and is not substantially destructive of the capsule shell, said capsule providing the same digoxin bioavailability as a comparable tablet while containing only about 80% of the amount of digoxin as in the comparable tablet, said digoxin present at a concentration of at least 0.25 mg digoxin/ml solution and said capsule containing the solvent system comprising the following ingredients in about the % amount set forth by weight:

polyethylene glycol 400 (90%)

absolute ethanol -- ( 6%)

propylene glycol -- ( 3%) and

water -- ( 1%).

6. The capsule according to claim 5 wherein the dissolution rate of the capsule shell is substantially 100% at 1 hour in the upper gastrointestinal tract.

7. The capsule according to claim 5 wherein the capsule shell at least partially dissolves in the stomach of a human.

8. The capsule of claim 5 in which the concentration is 0.25 to 0.6 mg. digoxin/ml solution.

9. The capsule of claim 7 in which the concentration of digoxin is 0.25 to 0.6 mg. digoxin/ml solution.
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