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Last Updated: September 27, 2020

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Claims for Patent: 7,087,248

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Summary for Patent: 7,087,248
Title:Pharmaceutical component based on human parathyroid hormone and a pharmaceutical composition for intranasal administration comprising the component
Abstract: A medical component comprising a human parathyroid hormone peptide or its derivative, and acetic acid contained at a concentration less than its chemical equivalent with respect to the human parathyroid hormone peptide or to its derivative. Since in the medical component acetic acid, which is present as a salt of or attached to the peptide or its derivative, has been reduced to an amount less than chemical equivalent with respect to the human parathyroid hormone peptide or its derivative, a medical component, which is highly stable and will ensure an excellent use feeling when introduced into a pharmaceutical composition, is obtained.
Inventor(s): Minamitake; Yoshiharu (Gunma, JP), Ono; Tetsu (Tatebayashi, JP), Kawanishi; Koji (Tatebayashi, JP), Suzuki; Yuji (Ashikaga, JP)
Assignee: Daiichi Asubio Pharma Co., Ltd. (Tokyo, JP)
Application Number:10/312,726
Patent Claims:1. A pharmaceutical component comprising a human parathyroid hormone peptide or its derivative, and acetic acid contained in an amount less than its chemical equivalent amount with respect to the human parathyroid hormone peptide or to its derivative, as calculated from the number of excess basic amino acid residues in the molecule of the human parathyroid hormone peptide or its derivative.

2. A pharmaceutical component as described in claim 1 comprising a salt of the human parathyroid hormone peptide or of its derivative with acetic acid wherein acetic acid is contained in an amount less than its chemical equivalent amount with respect to the human parathyroid hormone peptide or to its derivative.

3. A pharmaceutical component as described in claim 1, wherein the human parathyroid hormone peptide or its derivative is a peptide comprising the amino acid sequence of SEQ ID NO: 1.

4. A pharmaceutical component as described in claim 3, wherein the pharmaceutical component comprises 3 weight % or less acetic acid with respect to the weight of the peptide.

5. A pharmaceutical component as described in claim 1, wherein the pharmaceutical component is a lyophilized composition.

6. A pharmaceutical component as described in claim 1, wherein the pharmaceutical component is for intranasal administration.

7. A prior-to-use dissolvable pharmaceutical product comprising a lyophilized portion and a dissolving solution portion attached thereto wherein the pharmaceutical component as described in claim 1 is contained in the lyophilized portion.

8. A pharmaceutical component as described in claim 1, wherein the human parathyroid hormone peptide or its derivative is a peptide comprising the amino acid sequence of SEQ ID NO: 2.

9. A pharmaceutical component as described in claim 8, wherein the pharmaceutical component comprises 4 weight % or less acetic acid with respect to the weight of the peptide.

10. A pharmaceutical component as described in claim 8, wherein the pharmaceutical component comprises 6 weight % or less acetic acid with respect to the weight of the peptide.

11. A pharmaceutical composition for intranasal administration comprising a human parathyroid hormone peptide or its derivative and acetic acid contained in an amount less than its chemical equivalent amount with respect to the human parathyroid hormone peptide or to its derivative, as calculated from the number of excess basic amino acid residues in the molecule of the human parathyroid hormone peptide or its derivative.

12. A pharmaceutical component comprising a human parathyroid hormone peptide, and acetic acid contained in an amount less than its chemical equivalent amount with respect to the human parathyroid hormone peptide or to its derivative, as calculated from the number of excess basic amino acid residues in the molecule of the human parathyroid hormone peptide; wherein the human parathyroid hormone peptide is selected from the group consisting of SEQ ID NO: 1 and SEQ ID NO: 2.

Summary for Patent:   Start Trial

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2000-237717Jun 30, 2000
Japan2000-237718Jun 30, 2000
PCT Information
PCT FiledJune 29, 2001PCT Application Number:PCT/JP01/05674
PCT Publication Date:January 10, 2002PCT Publication Number:WO02/02136

Details for Patent 7,087,248

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Start Trial Daiichi Asubio Pharma Co., Ltd. (Tokyo, JP) 2020-06-30 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Start Trial Daiichi Asubio Pharma Co., Ltd. (Tokyo, JP) 2020-06-30 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23   Start Trial Daiichi Asubio Pharma Co., Ltd. (Tokyo, JP) 2020-06-30 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 004 2015-01-23   Start Trial Daiichi Asubio Pharma Co., Ltd. (Tokyo, JP) 2020-06-30 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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