IP Library › Granted Patent US 9,029,582
Granted Patent B2
US 9,029,582 · App. 14/117,958 · Granted May 12, 2015

Pharmaceutical composition

Inventors: Jose Castillo (Santa Fe, AR); Jose B. Iturraspe (Santa Fe, AR); Jose L. Nunez (Entre Rios, AR)
Assignee: Capital, Business Y Gestion de Finanzas S.L.
A61K31/565A61K9/0019A61K9/19
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Quick Facts
Patent No.
US 9,029,582
App. No.
14/117,958
Granted
May 12, 2015
Kind
B2
Abstract

The invention relates to a solid pharmaceutical composition comprising solid amorphous fulvestrant, said composition being formulated in combination with a solubilizing composition. The invention also relates to a method for preparing said composition and a kit including the composition.

Claims (14)

1. A solid pharmaceutical composition comprising amorphous fulvestrant, wherein the amorphous fulvestrant has a broad X-ray diffraction image with a maximum in a 2θ from 15° to 20°.

2. The composition of claim 1 characterized in that said solid composition is lyophilized.

3. The composition of claim 2 characterized in that said solid composition is lyophilized from a solution of the pharmaceutical active principle fulvestrant in a lyophilization solvent selected from the group consisting of acetic acid, dimethylsufoxide, tert-butanol, and mixtures thereof.

4. The composition of claim 2 characterized in that said lyophilized composition has a purity of at least 95%.

5. The composition of claim 1 characterized in that said composition is soluble in a solution of castor oil, alcohol and no benzyl benzoate, over a time period of less than 180 seconds.

6. The composition of claim 1 characterized in that said composition is soluble in a solution of castor oil, alcohol and no benzyl benzoate, over a time period of less than 90 seconds.

7. A kit characterized by comprising: a first container containing the solid fulvestrant composition of claim 1 ; a second container containing a solubilizing composition for said solid fulvestrant composition; and a syringe.

8. The kit of claim 7 characterized in that said syringe is prefilled and comprises said first container and said second container.

9. A kit according to claim 7 and a transfer system connecting said containers with said syringe.

10. Process for obtaining the composition of claim 1 comprising the steps of:

a. dissolving the active pharmaceutical principle fulvestrant in a lyophilization solvent selected from the group consisting of acetic acid, dimethylsulfoxide, tert-butanol and mixtures thereof,

b. drying the resulting solution.

11. The process of claim 10 characterized in that step b comprises lyophilization.

12. The process of claim 10 characterized in that said solid composition contains less than 0.5% of organic solvents.

Priority Claims (2)
AR P110101751 · May 20, 2011 · national
AR P110103435 · Sep 20, 2011 · national
Continuity (1)
Related Publication 20140088061A1 · Mar 27, 2014