Patent information
IP India · live recordAbstract
The present application relates to a method of treating migraine or cluster headache in a human patient said method comprising administering subcutaneously composition comprising sumatriptan or its pharmaceutically acceptable salt in an amount equivalent to 3 mg sumatriptan base.
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an aqueous solution of sumatriptan or its pharmaceutically acceptable salts thereof in an amount equivalent to 3 mg of sumatriptan base, and sodium chloride in an amount to maintain the osmolality of said solution between 275 to 315 mOsm/kg; wherein said sumatriptan and sodium chloride are present in a ratio of from about 0.80:1.00 to about 1.40:1.00; wherein said composition has a pH of about 4.2 to 5.3; wherein said composition is subcutaneoosly administered to the patient at a maximum recommended frequency according to the body mass index (BMI) of the patient; and wherein the subcutaneous administration of said composition to the patient results in a systemic exposure characterized by at least one of the following plasma profiles: c. Cma* of about 35 ng/ml to about 57 ng/ml; d. AUCo-2 of about 30 ng.hr/ml to about 50 ng.hr/ml; a. AUQ).jnf of about 43 ng.hr/ml to about 70 ng.hr/ml. 29. The composition of Claim 28, wherein the maximum recommended frequency of administration is not more than four times a day if the BMI is less than about 26. 30. The composition of Claim 28, wherein the maximum recommended frequency of administration is not more than four times a day if the BMI is greater than or equal to about 26.