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Details for Patent: 5,916,594

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Details for Patent: 5,916,594

Title: Process of making solid ribavirin dosage forms
Abstract:A process of making 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 as determined 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 (N/A)
Filing Date:Dec 22, 1997
Application Number:08/997,169
Claims:1. A method of producing a rapidly dissolving compacted ribavirin composition which comprises the steps of:

(a) admixing an antivirally effective amount of ribavirin, an effective amount of a pharmaceutically acceptable disintegrant, and an effective amount of at least one filler for a time sufficient and at a temperature wherein the heat produced is insufficient; and to form a homogeneous mixture;

b) compacting the homogeneous mixture of Step (a) at a compressing force in the range of about 50 to about 75 kN for a time sufficient to produce an acceptable compact wherein the ribavirin is substantially free of polymorphic forms of ribavirin;

c) admixing the acceptable compact of Step (b) with an effective amount of a lubricant for a time sufficient to produce a uniform, rapidly dissolving compacted ribavirin composition having a uniformly high tap density of at least about 0.60 glmL and wherein 80% of the rapidly dissolving compacted ribavirin composition dissolves in water in about 30 minutes.

2. The method of claim 1 wherein the rapidly dissolving compacted ribavirin has a tap density in the range of about 0.75 g/mL to about .0.85 g/mL.

3. The method of claim 1 wherein more than about 90% of the rapidly dissolving compacted ribavirin composition dissolves in water in about 15 minutes.

4. The product produced by the method of claim 1.

5. The method of claim 1 wherein at least one filler is 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.

6. The method of claim 1 wherein one of the fillers is lactose monohydrate.

7. The method of claim 1 wherein the other fillers is microcrystalline cellulose.

8. The method of claim 1 wherein the disintegrant is 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.

9. The method of claim 1 wherein the disintegrant is croscarmellose sodium.

10. The method of claim 1 wherein the lubricant is selected from the group consisting of magnesium stearate, calcium stearate, zinc stearate, talc, propylene glycol, PEG 4000, PEG 5000, PEG 6000, and stearic acid.

11. The method of claim 1 wherein the lubricant is magnesium stearate.
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