Stable pharmaceutical dosage forms of teriparatide
AssigneeNastech Pharmaceutical Company Inc.
InventorsSteven Quay, Henry Costantino, Ching-Yuan Li
Life of this patent
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Abstract
A parathyroid hormone (1-34) (PTH) dosage form is described that is suitable for multi-use administration. A dosage form of parathyroid hormone (1-34) (PTH) comprising an aqueous pharmaceutical formulation for aerosolized intranasal delivery of PTH having a bioavailability of about 5% or greater, wherein the formulation comprises a therapeutically effective amount of PTH and polysorbate, and wherein least 90% of the PTH can be recovered after storage for 24 weeks at 5° C.
Claims49
A dosage form of parathyroid hormone (1-34) (PTH) comprising an aqueous pharmaceutical formulation for aerosolized intranasal delivery of PTH having a bioavailability of about 5% or greater, wherein the formulation comprises a therapeutically effective amount of PTH and polysorbate, and wherein least 90% of the PTH can be recovered after storage for 24 weeks at 5° C.
A dosage form of parathyroid hormone (1-34) (PTH) comprising an aqueous pharmaceutical formulation for aerosolized intranasal delivery of PTH having a bioavailability of about 10% or greater, wherein the formulation comprises a therapeutically effective amount of PTH, methyl-β-cyclodextrin, didecanoylphosphatidyl choline, and ethylenediaminetetraacetic acid, and wherein least 90% of the PTH can be recovered after storage for 24 weeks at 5° C.
Dependencies are inferred from the claim text.