Nasal calcitonin formulations containing chlorobutanol
AssigneePar Pharmaceutical, Inc.
InventorsSteven C. Quay, Jorge C. de Meireles, Arati Deshpande, Zenaida O. Go, Anthony P. Sileno
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Abstract
An aqueous solution of calcitonin suitable for intranasal administration comprised of calcitonin, chlorobutanol at a concentration of less than 0.4% weight/weight, and water and having a pH of less than 4 with the proviso that benzalkonium chloride is not present in the solution. The aqueous solution of calcitonin can be used to treat osteoporosis, Paget's bone disease and hypercalcemia.
Claims17
A method for intranasal administration of calcitonin which comprises administering intranasally to an individual a solution of calcitonin comprising calcitonin, water, sodium chloride and only one preservative, wherein the preservative is chlorobutanol at a concentration equal to or greater than about 0.25% and less than about 0.4% weight/weight.
A composition comprising calcitonin, water, sodium chloride and only one preservative, wherein the preservative is chlorobutanol at a concentration equal to or greater than about 0.25% and less than about 0.4% weight/weight, and wherein the composition is suitable for intranasal administration in humans.
A composition consisting essentially of calcitonin, water, sodium chloride, a single preservative and optionally hydrochloric acid, wherein the single preservative is chlorobutanol at a concentration equal to or greater than about 0.25% and less than about 0.4% weight/weight, and wherein the composition is suitable for intranasal administration in humans.
A composition consisting essentially of a solution of (i) calcitonin, (ii) chlorobutanol at a concentration equal to or greater than about 0.25% and less than about 0.4% weight/weight, (iii) water, (iv) sodium chloride, and optionally (v) hydrochloric acid, wherein the composition has a pH of 4 or less, and wherein the composition is suitable for intranasal administration in humans.
Dependencies are inferred from the claim text.