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Claims for Patent: 5,914,128

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Claims for Patent: 5,914,128

Title: Orally administrable solid dosage form
Abstract:An orally administrable solid dosage form containing a compacted ribavirin composition having an advantageously high tap density of at least 0.6 g/mL as well as surprisingly rapid disintegration and dissolution rates and wherein the ribavirin is substantially free of polymorphic forms of ribavirin is disclosed.
Inventor(s): Liebowitz; Stephen M. (Neshanic Station, NJ), Stupak; Elliot I. (West Caldwell, NJ), Chaudry; Imtiaz A. (North Caldwell, NJ), Vadino; Winston A. (Whitehouse Station, NJ), Bowen; Frank E. (Rutherford, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:08/997,172
Patent Claims: 1. An orally administrable solid dosage form comprising a rapidly dissolving ribavirin compacted composition comprising ribavirin and a pharmaceutically acceptable disintegrant wherein said composition has a tap density of at least about 0.6 g/mL and wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

2. The orally administrable solid dosage form of claim 1 wherein the composition comprises about 200 mg of ribavirin.

3. The orally administrable solid dosage form of claim 1 wherein the disintegrant is selected from the group consisting of croscarmellose sodium.

4. The orally administrable solid dosage form of claim 1 wherein the ribavirin is substantially free of polymorphic forms of ribavirin.

5. A rapidly dissolving compacted ribavirin composition comprising:

(a) an antivirally effective amount of ribavirin;

(b) an effective amount of at least one filler selected from the group consisting of lactose anhydrous lactose monohydrate, sucrose, mannitol, microcrystalline cellulose, pregelatinized starches, dibasic calcium phosphate dihydrate, calcium sulfate dihydrate and calcium sulfate trihydrate;

(c) an effective amount of a pharmaceutically acceptable disintegrant selected from the group consisting of croscarmellose sodium, sodium starch glycolate, corn starch, pregelatinized starch, sodium carboxymethyl cellulose, potato starch, microcrystalline cellulose, cross-linked polyvinylpyrrolidone,magnesium aluminium silicate, bentonite, alginic acid and alginates; and;

(d) an effective amount of a lubricant selected from the group consisting of magnesium stearate, calcium stearate, zinc stearate, talc, propylene glycol, PEG 4000, PEG 5000, PEG 6000, and stearic acid;

and, wherein the tap density of the compacted composition is at least about 0.6 g/mL.

6. A rapidly dissolving compacted ribavirin composition comprising:

and wherein the tap density of the compacted composition is at least about 0.6 g/mL.

7. The rapidly dissolving compacted ribavirin composition of claim 6 wherein the ribavirin is substantially free of polymorphic forms of ribavirin.

8. The rapidly dissolving compacted ribavirin composition of claim 6 wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

9. The rapidly dissolving compacted ribavirin composition of claim 6 wherein the disintegration time of the composition is less than about 10 minutes.

10. The rapidly dissolving compacted ribavirin composition of claim 6 wherein the tap density of the composition is in the range of about 0.75 g/mL to about 0.85 g/mL.

11. A rapidly dissolving compacted ribavirin composition comprising:

wherein the tap density of the compacted composition is at least about 0.6 g/mL;

and wherein the ribavirin is substantially free of polymorphic forms of ribavirin; and

wherein more than about 80% by weight of the compacted composition dissolves in water in about 30 minutes.

12. The rapidly dissolving compacted ribavirin composition of claim 11 wherein said composition is in the form of a capsule.

13. The rapidly dissolving compacted ribavirin composition of claim 11 wherein more than about 90% by weight of the compacted composition dissolves in water in about 15 minutes.

14. The rapidly dissolving compacted ribavirin composition of claim 11 wherein the tap density of the compacted composition is in the range of about 0.75 g/mL to about 0.85 g/mL.
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