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Details for Patent: 5,976,577

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Details for Patent: 5,976,577

Title: Process for preparing fast dispersing solid oral dosage form
Abstract:Process is provided for preparing an oral solid rapidly disintegrating freeze-dried dosage form of a pharmaceutically active substance having an unacceptable taste, wherein prior to freeze drying, a suspension of uncoated or coated coarse particles of a pharmaceutically active substance in a carrier material is cooled to reduce the viscosity and minimize release of the active substance during processing, as well as beyond the point of disintegration of the form in the mouth, to minimize bad taste from the drug.
Inventor(s): Green; Richard (Wiltshire, GB), Kearney; Patrick (Swindon, GB)
Assignee: RP Scherer Corporation (Troy, MI)
Filing Date:Jul 11, 1997
Application Number:08/891,205
Claims:1. A process for preparing an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance, comprising the steps of:

forming a suspension in a continuous phase of coarse particles of a pharmaceutically active substance in a carrier material, said carrier material being selected from the group consisting of water-soluble and water-dispersible carrier materials;

reducing the temperature of the suspension to form a cooled suspension of increased viscosity;

forming discrete units of said cooled suspension; and

removing the continuous phase to leave said rapidly disintegrating form in said carrier material.

2. A process according to claim 1, wherein said continuous phase comprises water.

3. A process according to claim 1, wherein said carrier material is gelatin.

4. A process according to claim 1, wherein said coarse particles are uncoated or coated with a coating which delays release of the pharmaceutically active substance beyond the point of disintegration of said form on the tongue.

5. A process according to claim 4, wherein said coating is selected from a group consisting of a polymeric material and a lipid material.

6. A process according to claim 5, wherein said polymeric material is selected from the group consisting of cellulose, a cellulose derivative, an acrylic derivative, polyglycolic--polylactic acid, polyvinylalcohol, gelatin, collagen and polyethyleneglycol.

7. A process according to claim 6, wherein said cellulose derivative is selected from the group consisting of ethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, methylcellulose, cellulose acetate, cellulose acetate phthalate and hydroxypropylmethylcellulosephthalate, and said acrylic derivative is a polymethacrylate.

8. A process according to claim 5, wherein said lipid material is selected from the group consisting of a wax, lanolin, stearic acid, a stearic acid derivative, a phospholipid and a glycolipid.

9. A process according to claim 8, wherein said stearic acid derivative is selected from the group consisting of a glycerol ester, a fixed oil and a fat.

10. A process according to claim 1, wherein said coarse particles have a size in the range of 50 .mu.m to 400 .mu.m.

11. A process according to claim 1, wherein a structure-forming agent is added to the suspension.

12. A process according to claim 11, wherein said structure-forming agent is selected from the group consisting of mannitol and sorbitol.

13. A process according to claim 11, wherein said structure-forming agent is added in an amount of 1 to 5% by weight.

14. A process according to claim 1, wherein the temperature of the suspension is reduced such that the viscosity is increased to a level sufficient to prevent sedimentation of the drug over a period of 5 minutes.

15. A process according to claim 1, wherein the temperature of the suspension is reduced to about 15-19.degree. C.

16. A process according to claim 1, wherein said continuous phase is removed by freeze drying.

17. A process according to claim 1, wherein said coarse coated particles contain about 10 to 95% by weight of pharmaceutical substance.

18. A process according to claim 1, wherein said dosage form disintegrates in water in less than 10 seconds.

19. A process according to claim 1, wherein said suspension has a solids content in the range of less than 50% by weight.

20. An oral solid rapidly disintegrating dosage form of a pharmaceutically active substance when prepared by a process according to claim 1.

21. A process according to claim 1, wherein said cooled suspension is formed into discrete units by introduction into a mold.

22. A process according to claim 21, wherein said mold comprises a plurality of depressions each of a shape and size for said oral dosage form.

23. A process according to claim 21, wherein said cooled suspension in said mold is frozen.
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