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Claims for Patent: 7,718,640

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Claims for Patent: 7,718,640

Title:Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Abstract: The present invention relates to pharmaceutical compositions, formulated for injectable administration, which comprises a testosterone ester, in particularly testosterone undecanoate, in a vehicle comprising castor oil and a co-solvent. Upon injecting the compositions according to a particular administration scheme, reliable levels of testosterone in serum in the normal physiological range is achieved for a long period. This allows for the use of the compositions in hormone replacement therapy and male contraception without concomitant monitoring of testosterone levels in serum by a physician.
Inventor(s): Hubler; Doris (Jena, DE), Fricke; Sabine (Jena, DE), Ingwersen; Jan-Peter (Berlin, DE), Kuhnz; Wilhelm (Berlin, DE)
Assignee: Bayer-Schering Pharma AG (Berlin, DE)
Application Number:10/798,780
Patent Claims: 1. A composition formulated for intramuscular injection in a form for single injection which contains 250 mg/ml testosterone undecanoate in a vehicle containing a mixture of castor oil and benzyl benzoate wherein the vehicle contains castor oil in a concentration of 40 to 42 vol %.

2. A composition formulated for intramuscular injection in a form for single injection according to claim 1, which contains 750 mg testosterone undecanoate.

3. The composition according to claim 1, which contains 1000 mg of testosterone undecanoate.

4. The composition according to claim 2, wherein the vehicle comprises the castor oil in a concentration of 25 to 30 vol %.

5. The composition according to claim 1, wherein the benzyl benzoate is in an amount of 55 to 65 vol % in the composition.

6. The composition of claim 1, wherein the vehicle consists of castor oil and benzyl benzoate.

7. The composition of claim 2, wherein the vehicle consists of castor oil and benzyl benzoate.

8. A composition formulated for intramuscular injection in a form for single injection which contains 250 mg/ml testosterone undecanoate in a vehicle containing a mixture of castor oil and benzyl benzoate, wherein the vehicle contains the castor oil in a concentration of about 40 vol %.

9. A composition according to claim 8, which contains 750 mg testosterone undecanoate.

10. The composition according to claim 8, which contains 1000 mg of testosterone undecanoate.

11. The composition of claim 8, wherein the composition contains no plant oil other than castor oil.

12. The composition of claim 9, wherein the composition contains no plant oil other than castor oil.

13. The composition of claim 8, wherein the vehicle consists of castor oil and benzyl benzoate.

14. The composition of claim 9, wherein the vehicle consists of castor oil and benzyl benzoate.
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