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Last Updated: September 27, 2020

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Claims for Patent: 6,080,721

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Summary for Patent: 6,080,721
Title: Pulmonary delivery of active fragments of parathyroid hormone
Abstract:Systemic delivery of parathyroid hormone to a mammalian host is accomplished by inhalation through the mouth of a dispersion of an N-terminal fragment of PTH. It has been found that such respiratory delivery of the PTH fragment provides a pulsatile concentration profile of the PTH in the host\'s serum. PTH fragment compositions include dry powder formulations having the PTH present in a dry bulking powder, liquid solutions or suspensions suitable for nebulization, and aerosol propellants suitable for use in a metered dose inhaler.
Inventor(s): Patton; John S. (San Carlos, CA)
Assignee: Inhale Therapeutic Systems (San Carlos, CA)
Application Number:09/128,401
Patent Claims:1. A method for delivery of a biologically active N-terminal fragment of parathyroid hormone (PTH) comprising administering to a mammal a pharmaceutical composition comprising said PTH fragment together with a pharmaceutically acceptable dry bulking powder, wherein said PTH fragment is present in said pharmaceutical composition as a dry powder having a mean particulate size in the range from 0.5 .mu.m to 5 .mu.m; and

wherein said composition is administered by inhalation.

2. A method as in claim 1, wherein the bulking powder is composed of a material selected from the group consisting of sucrose, lactose, trehalose, HSA, glycine, cellobiose, dextran, maltotriose, pectin, sodium citrate, sodium ascorbate, and mannitol.

3. A pharmaceutical composition comprising a biologically active N-terminal fragment of parathyroid hormone (PTH) present as a dry powder having a mean particulate size in the range from 0.5 .mu.m to 5 .mu.m; and a pharmaceutically acceptable dry bulking powder, wherein the PTH is present at from 1% to 25% by weight, wherein the dry powder is present as an aerosol in a gas.

4. A pharmaceutical composition as in claim 3, wherein the bulking powder is composed of a material selected from the group consisting of sucrose, lactose, trehalose, HSA, glycine, cellobiose, dextran, maltotriose, pectin, sodium citrate, sodium ascorbate, and mannitol.

Details for Patent 6,080,721

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 Inhale Therapeutic Systems (San Carlos, CA) 2012-09-29 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Start Trial Inhale Therapeutic Systems (San Carlos, CA) 2012-09-29 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23   Start Trial Inhale Therapeutic Systems (San Carlos, CA) 2012-09-29 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 004 2015-01-23   Start Trial Inhale Therapeutic Systems (San Carlos, CA) 2012-09-29 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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