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Claims for Patent: 5,767,067

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Claims for Patent: 5,767,067

Title: Follicle stimulating hormone and pharmaceutical compositions containing same
Abstract:Purification of human FSH from post-menopausal urine gonadogropin using immunochromatography and reverse phase HPLC steps yelds a biologically active hormone which is free from detectable traces of LH and other urinary proteins.
Inventor(s): Arpaia; Guiseppe (Rome, IT), Serani; Serenella (Rome, IT), Sirna; Antonino (Rome, IT), Villa; Stefano (Rome, IT)
Assignee: Istituto di Ricerca Cesare Serono S.p.A. (Rome, IT)
Application Number:08/413,936
Patent Claims: 1. A substantially pure biologically active follicle stimulating hormone preparation free from traces of luteinizing hormone detectable at 1.5 mIU/ml, based on the 2nd IRP-HMG reference standard for luteinizing hormone, and substantially free from all other urinary proteins, comprising an alpha-subunit associated with a beta-subunit,

wherein the alpha-subunit comprises a heterogeneous population of glycosylated human gonadotropin alpha-subunits having (1) the following amino acid sequence .alpha.: ##STR3## (2) the amino acid sequence a but lacking the starting Ala and Pro at positions 1 and 2; and (3) the amino acid sequence .alpha. but lacking the starting Ala, Pro and Asp at positions 1-3, and

wherein the beta-subunit comprises a heterogeneous population of glycosylated beta-subunits having (1) the following amino acid sequence .beta.: ##STR4## (2) the amino acid sequence .beta. but lacking the starting Asn at position 1; and (3) the amino acid sequence .beta. but lacking the starting Asn and Ser at positions 1 and 2.

2. A preparation in accordance with claim 1, wherein the Asn at positions 7 and 24 of said beta-subunit and the Asn at positions 52 and 78 of said alpha-subunit are glycosylated.

3. A preparation in accordance with claim 1, having a specific activity when in the form of a lyophilized powder of about 6200 International units of follicle stimulating hormone per milligram of lyophilized powder.

4. A pharmaceutical composition for treating infertility containing a therapeutically effective amount of a preparation in accordance with claim 1, and a pharmaceutically acceptable excipient.

5. A pharmaceutical composition in accordance with claim 4, wherein said excipient is lactose.

6. A pharmaceutical composition in accordance with claim 4, in unit dosage form, which contains about 75 International units of follicle stimulating hormone per unit dose.

7. A pharmaceutical composition in accordance with claim 4, in unit dosage form, which contains about 150 International units of follicle stimulating hormone per unit dose.

8. A pharmaceutical composition in accordance with claim 4, further including human albumin as stabilizer.

9. A preparation in accordance with claim 1, having a specific activity when in the form of a lyophilized powder of 6200 International units of follicle stimulating hormone per milligram of lyophilized powder.

10. A pharmaceutical composition in accordance with claim 7, further including about 1 mg human albumin as stabilizer.
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