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Last Updated: March 28, 2024

Claims for Patent: 5,633,015


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Summary for Patent: 5,633,015
Title: Beads having a core coated with an antifungal and a polymer
Abstract:The present invention is concerned with beads comprising a 25-30 mesh core, a coating of a hydrophilic polymer and an antifungal agent, and a seal outer coating layer; pharmaceutical dosage forms comprising said beads and a method of preparing said beads. Preferred antifungal agents are lipophilic azole antifungals, such as itraconazole and saperconazole.
Inventor(s): Gilis; Paul M. V. (B-2340-Beerse, BE), De Conde ; Valentin F. V. (B-3920-Lommel, BE), Vandecruys; Roger P. G. (B-2260-Westerlo, BE)
Assignee:
Application Number:08/432,188
Patent Claims: 1. A bead comprising:

a) a central, rounded or spherical core;

b) a coating film of a hydrophilic polymer and an antifungal agent selected from the group consisting of itraconazole and saperconazole, and

c) a seal-coating polymer layer, characterized in that the core has a diameter of from about 600 to about 700 .mu.m (25-30 mesh).

2. A bead according to claim 1 comprising by weight based on the total weight of the bead:

a) 20 to 60 percent core material;

b) 25 to 50 percent hydrophilic polymer;

c) 10 to 25 percent antifungal agent; and

d) 2 to 5 percent seal-coating polymer.

3. A bead according to claim 2 wherein the core material is a 25-30 mesh sugar sphere, the hydrophilic polymer is hydroxypropyl methylcellulose and the antifungal agent is itraconazole.

4. A bead according to claim 3 wherein the weight to weight ratio of antifungal agent: hydrophilic polymer is about 1:1 to about 1:2.

5. A bead according to claim 2 wherein the seal-coating polymer is polyethylene glycol.

6. A bead according to claim 2 comprising approximately:

a) 26 to 38 percent sugar;

b) 32 to 33 percent hydroxypropyl methylcellulose 2910 5 mPa.s.;

c) 21 to 22 percent itraconazole; and

d) 3 to 4 percent polyethylene glycol 20000.

7. A pharmaceutical dosage form comprising an effective antifungal amount of beads as defined in claim 1.

8. A pharmaceutical dosage form comprising an effective antifungal amount of beads as defined in claim 2.

9. A pharmaceutical dosage form comprising an effective antifungal amount of beads as defined in claim 3.

10. A pharmaceutical dosage form comprising an effective antifungal amount of beads as defined in claim 4.

11. A pharmaceutical dosage form comprising an effective antifungal amount of beads as defined in claim 5.

12. A pharmaceutical dosage form comprising an effective antifungal amount of beads as defined in claim 6.

13. A pharmaceutical dosage form wherein the dosage form is a hard-gelatin capsule comprising an effective antifungal amount of itraconazole or saperconazole in the form of beads as defined in claim 1.

14. A pharmaceutical dosage form wherein the dosage form is a hard-gelatin capsule comprising an effective antifungal amount of itraconazole or saperconazole in the form of beads as defined in claim 2.

15. A pharmaceutical dosage form wherein the dosage form is a hard-gelatin capsule comprising an effective antifungal amount of itraconazole in the form of beads as defined in claim 3.

16. A pharmaceutical dosage form wherein the dosage form is a hard-gelatin capsule comprising an effective antifungal amount of itraconazole in the form of beads as defined in claim 4.

17. A pharmaceutical dosage form wherein the dosage form is a hard-gelatin capsule comprising an effective antifungal amount of itraconazole in the form of beads as defined in claim 5.

18. A pharmaceutical dosage form wherein the dosage form is a hard-gelatin capsule comprising an effective antifungal amount of itraconazole in the form of beads as defined in claim 6.

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