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Claims for Patent: 6,455,533

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Claims for Patent: 6,455,533

Title: Pharmaceutical compositions for oral administration, comprising an active substance and a cyclodextrin
Abstract:The invention concerns pharmaceutical compositions for oral administration, comprising an active substance belonging to the family of substituted benzhydrylpiperazines and at least a cyclodextrin.
Inventor(s): Fanara; Domenico (Wanze, BE), Berwaer; Monique (Ham-sur-Heure-Nalinnes, BE), Nolf; Philippe (Brussels, BE), Vranckx; Henri (Brussels, BE), Deleers; Michel (Linkebeek, BE)
Assignee: UCB, S.A. (Brussels, BE)
Application Number:09/446,735
Patent Claims: 1. A solid pharmaceutical composition for oral administration comprising a mixture of an active substance belonging to the substituted benzhydrylpiperazine family, an optically active isomer thereof or a pharmaceutically active salt thereof and at least one cyclodextrin, wherein said mixture does not contain any inclusion complexes.

2. Pharmaceutical composition according to claim 1, wherein it is in the form of a chewable tablet, a dry syrup, granules or a sublingual tablet.

3. Pharmaceutical composition according to claim 1, characterized in that the active substance is chosen from the group consisting of cetirizine, hydroxyzine, efletirizine, meclizine and buclizine, the optically active isomers thereof and the pharmaceutically acceptable salts thereof.

4. Pharmaceutical composition according to claim 1, characterized in that the cyclodextrin is chosen from the group consisting of .alpha., .beta. or .gamma. cyclodextrins and alkyl or hydroxyalkyl derivatives thereof.

5. Pharmaceutical composition according to claim 1, the molar ratio between the cyclodextrin and the active substance is between 1.0 and 4.0.

6. Pharmaceutical composition according to claim 1, wherein the cyclodextrin is heptakis(2,6-di-o-methyl)-.beta.-cyclodextrin, randomly methylated .beta.-cyclodextrin or hydroxylpropyl .beta.-cyclodextrin.

7. A method of making a solid pharmaceutical composition for oral administration comprising a mixture of an active substance belonging to the substituted benzhydrylpiperazine family, an optically active isomer thereof or a pharmaceutically active salt thereof and at least one cyclodextrin, wherein said mixture does not contain any inclusion complexes, comprising: providing an active substance from the substituted benzhydrylpiperazine family, an optically active isomer thereof or a pharmaceutically active salt thereof and at least one cyclodextrin; b) mixing said active substance and said at least one cyclodextrin to form a mixture, wherein said mixture does not contain any inclusion complexes; c) optionally adding to said mixture at least one non-complexing excipient or adjuvent; and d) drying said mixture to form a solid pharmaceutical composition.

8. The method of claim 7, wherein the pharmaceutical composition is in the form of a chewable tablet, a dry syrup or a sublingual tablet.

9. The method of claim 7, wherein the active substance is chosen from the group consisting of cetirizine, hydroxyzine, efletirizine, meclizine and buclizine, the optically active isomers thereof and the pharmaceutically acceptable salts thereof.

10. The method of claim 7, wherein the cyclodextrin is chosen from the group consisting of .alpha., .beta. or .gamma. cyclodextrins and alkyl or hydroalkyl derivatives thereof.

11. The method of claim 7, wherein the molar ratio between the cyclodextrin and the active substance is between 1.0 and 4.0.

12. The method of claim 7, wherein the cyclodextrin is heptakis(2,6-di-o-methyl)-.beta.-cyclodextrin, randomly methylated .beta.-cyclodextrin or hydroxylpropyl .beta.-cyclodextrin.

13. A method for orally administering an active substance belonging to the substituted benzhydrylpiperazine family, an optically active isomer thereof or a pharmaceutically active salt thereof comprising: orally administering a solid pharmaceutical composition comprising a mixture of an active substance belonging to the substituted benzhydrylpiperazine family, an optically active isomer thereof or a pharmaceutically active salt thereof and at least one cyclodextrin, wherein said mixture does not contain any inclusion complexes.

14. The method of claim 13, wherein the pharmaceutical composition is in the form of a chewable tablet, a dry syrup or a sublingual tablet.

15. The method of claim 13, wherein the active substance is chosen from the group consisting of cetirizine, hydroxyzine, efletirizine, meclizine and buclizine, the optically active isomers thereof and the pharmaceutically acceptable salts thereof.

16. The method of claim 13, wherein the cyclodextrin is chosen from the group consisting of .alpha., .beta. or .gamma. cyclodextrins and alkyl or hydroalkyl derivatives thereof.

17. The method of claim 13, wherein the molar ratio between the cyclodextrin and the active substance is between 1.0 and 4.0.

18. The method of claim 13, wherein the cyclodextrin is heptakis(2,6-di-o-methyl)-.beta.-cyclodextrin, randomly methylated .beta.-cyclodextrin or hydroxylpropyl .beta.-cyclodextrin.
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