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Claims for Patent: 5,753,618

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Claims for Patent: 5,753,618

Title: Somatostatin analogue composition and use in treating breast cancer
Abstract:The invention provides a pharmaceutical composition containing a somatostatin analogue, and its use in the treatment of breast cancer. The pharmaceutical composition preferably contains lactic acid in addition to the somatostatin analogue and is better tolerated when administered by injection.
Inventor(s): Cavanak; Thomas (Biel-Benken, CH), Harris; Alan (Basel, CH)
Assignee: Novartis Corporation (Summit, NJ)
Application Number:08/471,706
Patent Claims: 1. A pharmaceutical composition consisting of octreotide acetate and 88% lactic acid, in the ratio of 1 part of octreotide to 5 parts of lactic acid, up to 1 part of octreotide to 60 parts of lactic acid, and with sodium hydrogen-carbonate to pH 4 to 4.5, and mannitol in isotonic sterile water, for parenteral administration.

2. The pharmaceutical composition of claim 1, in which the ratio of octreotide acetate to lactic acid is 1 to 5 up to 1 to 40.

3. The pharmaceutical composition of claim 1, in which the octreotide acetate is present at from 0.05 to 1 mg per ml, and the lactic acid is present at 3 mg per ml.

4. The pharmaceutical composition of claim 1, in which the pH is 4.2.

5. A method of treating breast cancer in a subject which comprises administering a therapeutically effective amount of the composition of claim 1 to a subject in need of such treatment.

6. A method of claim 5 in which the composition in co-administered with a dopamine agonist.
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