COMPLEX FORMULATION FOR PREVENTING OR TREATING OSTEOPOROSIS WHICH COMPRISES SOLID DISPERSION OF VITAMIN D OR ITS DERIVATIVE AND BISPHOSPHONATE

1 - 22 . (canceled)

23 . A complex formulation for the prevention or treatment of osteophorosis, comprising:

(i) a solid dispersion comprising vitamin D or a derivative thereof and a cyclodextrin, and

(ii) a bisphosphonate.

24 . The complex formulation of claim 23 , wherein vitamin D or the derivative thereof is selected from the group consisting of cholecalciferol (vitamin D3), ergocalciferol (vitamin D2), calcitriol, ergocalcitriol and a mixture thereof.

25 . The complex formulation of claim 23 , wherein the cyclodextrin is represented by formula (II):

wherein n is 6, 7 or 8; and R is C 1-6 alkyl, hydroxy-C 1-6 alkyl, carboxy-C 1-6 alkyl or sulfo-C 1-4 alkyl ether.

26 . The complex formulation of claim 25 , wherein the cyclodextrin is selected from the group consisting of 2-hydroxyethyl-β-cyclodextrin, 2-hydroxypropyl-β-cyclodextrin, 2,6-dimethyl-β-cyclodextrin, sulfobutylether-7-β-cyclodextrin, (2-carboxymethoxy)propyl-β-cyclodextrin, 2-hydroxyethyl-γ-cyclodextrin, 2-hydroxypropyl-γ-cyclodextrin and a mixture thereof.

27 . The complex formulation of claim 25 , wherein the cyclodextrin is selected from the group consisting of 2-hydroxyethyl-β-cyclodextrin, 2-hydroxypropyl-β-cyclodextrin, 2,6-dimethyl-β-cyclodextrin, sulfobutylether-7-β-cyclodextrin and a mixture thereof.

28 . The complex formulation of claim 23 , wherein the weight ratio of vitamin D or a derivative thereof to a cyclodextrin ranges from 1:1 to 1:2,000.

29 . The complex formulation of claim 23 , which further comprises a stabilizing agent, a pharmaceutically acceptable additive or a mixture thereof.

30 . The complex formulation of claim 29 , wherein the stabilizing agent is selected from the group consisting of butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), erythorbic acid, ascorbic acid, tocopherol and a mixture thereof.

31 . The complex formulation of claim 23 , wherein the bisphosphonate is represented by formula (III):

wherein R 1 is chloro, methyl, 2-aminoethyl, 3-aminopropyl, 4-aminobutyl, 4-chlorophenylthio, 2-(N-methyl-N-n-pentyl)aminoethyl, 3-pyridylmethyl, cycloheptylamino, (1-imidazolyl)methyl or 1-pyrrolidinylethyl;

R 2 is hydrogen, chloro or hydroxy;

M is hydrogen or sodium; and

z is a positive number.

32 . The complex formulation of claim 23 , wherein the bisphosphonate is selected from the group consisting of alendronate, etidronate, clodronate, pamidronate, tiludronate, risedronate, incadronate, zoledronate, and pharmaceutically acceptable salts, hydrates and partial hydrates thereof.

33 . The complex formulation of claim 23 , wherein the amount of the bishphosphonate ranges from 0.5 to 90% by weight based on the total weight of the complex formulation.

34 . The complex formulation of claim 23 , wherein the amount of the solid dispersion ranges from 0.1 to 80% by weight based on the total weight of the complex formulation.

35 . The complex formulation of claim 23 , wherein the amount of vitamin D or the derivative thereof ranges from 0.0005 to 20% by weight based on the total weight of the complex formulation.

36 . The complex formulation of claim 29 , wherein the amount of the stabilizing agent ranges from 0.001 to 10% by weight based on the total weight of the complex formulation.

37 . A method for preparing the complex formulation of claim 23 , comprising the steps of:

(1) dissolving a cyclodextrin and vitamin D or a derivative thereof in a solvent, and removing the solvent from the resulting mixture to obtain a solid dispersion;

(2) compressing the solid dispersion obtained in step (1) to obtain a powder; and

(3) mixing the powder obtained in step (2) with a bisphosphonate, and formulating the dry-mixture into a complex formulation.

38 . The method of claim 37 , wherein the solvent employed in step (1) is water, an organic solvent or a mixture thereof.

39 . The method of claim 38 , wherein the organic solvent is selected from the group consisting of ethanol, isopropylalcohol, acetone, acetonitrile, dichloromethane, chloroform and a mixture thereof.

40 . The method of claim 37 , which further comprising the steps of coating the complex formulation obtained in step (3) with an enteric-coating material.

41 . The method of claim 40 , wherein the enteric-coating material is employed in an amount ranging from 0.5 to 30% by weight based on the total weight of the complex formulation.