Claims
- 1. A pharmaceutical dosage form comprising a therapeutically effective amount of particles consisting of a solid dispersion comprising(a) itraconazole, or one of its stereoisomers, or a mixture of two or three or four of its stereoisomers, and (b) one or more pharmaceutically acceptable water-soluble polymers; wherein the particle has a size of less than 600 μm; the solid dispersion is in the form of a solid solution comprising (a) and (b), or in the form of a dispersion wherein amorphous or microcrystalline (a) or amorphous or microcrystalline (b) is dispersed in a solid solution comprising (a) and (b) and the water-soluble polymer is a polymer that has an apparent viscosity of 1 to 100 mPa.s when dissolved in a 2% aqueous solution at 20° C. solution, and wherein the dosage form further comprises by weight based on the total weight of the dosage form: 21.65% itraconazole 32.48% HPMC 2910 5 mPa.s 30.57% spray-dried lactose monohydrate:microcrystalline cellulose (75:25) mixture 8.49% crospovidone 2.79% talc 0.93% hydrogenated vegetable oil Type I 0.28% colloidal anhydrous silica 0.24% magnesium stearate, yielding 97.43% tablet core, and 1.47% HPMC 2910 5 mPa.s 0.37% propyleneglycol 0.29% talc 0.44% titanium dioxide, yielding 2.57% film-coat.
- 2. A method of treating a fungal infection in a mammal comprising orally administering to the mammal an effective antifungal amount of itraconazole in a pharmaceutical dosage form as claimed in claim 1, wherein said pharmaceutical dosage form can be administered once daily.
- 3. The method of claim 2, wherein said pharmaceutical dosage form can be administered at any time of the day independently of the food taken in by said mammal.
Priority Claims (2)
Number |
Date |
Country |
Kind |
96201430 |
May 1996 |
EP |
|
97200698 |
Mar 1997 |
EP |
|
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a National Stage application under 35 U.S.C. §371 of PCT/EP97/02507 filed May 12, 1997, which claims priority from EP 96.201.430.4, filed May 20, 1996 and EP 97.200.698.5, filed Mar. 7, 1997.
PCT Information
Filing Document |
Filing Date |
Country |
Kind |
PCT/EP97/02507 |
|
WO |
00 |
Publishing Document |
Publishing Date |
Country |
Kind |
WO97/44014 |
11/27/1997 |
WO |
A |
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EP |
08092088 |
Apr 1996 |
JP |
WO 9405263 |
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WO |
9405263 |
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WO |
Non-Patent Literature Citations (4)
Entry |
CAPLUS Abstract, AN 1995: 729062, Takei et al. 1995.* |
Chiou et al., Pharmaceutical Applications of Solid Dispersion Systems, J. Pharmaceutical Sciences, vol. 60, No. 9 Sep. 1971. |
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