Ready-to-infuse phenylephrine compositions
AssigneeAmneal Eu, Limited
InventorsPiyush Amrutlal Patel, Chiragkumar Girishbhai Siddhapara, Aditya Maheshchandra Patel, Amarender Reddy Donthidi, Srinivas Ramachandra Rao Kone
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Abstract
The present invention relates to stable ready-to-infuse sulfite free compositions of phenylephrine or a pharmaceutically acceptable salt thereof and methods for preparing the same.
Claims21
A ready-to-infuse, inert gas purged phenylephrine injection solution comprising a dose amount of phenylephrine or a pharmaceutically acceptable salt thereof, a pH adjusting agent, and a citrate buffer in an amount of from about 0.0001 mg/mL to about 0.15 mg/mL;
- wherein the solution is manufactured and packaged under inert gas purging and exhibits a pH of from 4.0-4.6;
- and wherein the solution upon storage for at least about 6 months at 25° C.±2° C./40%±5% relative humidity does not contain more than 0.2% wt/vol of phenylephrine citrate adduct impurity, based on the dose amount of the phenylephrine or-a pharmaceutically acceptable salt thereof.
(canceled)
A ready-to-infuse, inert gas purged phenylephrine injection solution comprising a dose amount of phenylephrine or a pharmaceutically acceptable salt thereof, a pH adjusting agent, and a citrate buffer in an amount of from about 0.0001 mg/mL to about 0.15 mg/mL;
- wherein the solution is manufactured and packaged under inert gas purging and exhibits a pH of from 4.0-4.6;
- and wherein the solution upon storage for about 6 months at 40° C.±2° C./not more than 25% relative humidity does not contain more than 0.2% wt/vol of phenylephrine citrate adduct impurity, based on the dose amount of the phenylephrine or a pharmaceutically acceptable salt thereof.
(canceled)
A ready-to-infuse, inert gas purged phenylephrine injection solution in a flexible plastic container packed in aluminium over pouch, and an oxygen scavenger between the bag and the aluminum over pouch, wherein the solution comprises 0.08 mg/mL or 0.16 mg/mL of phenylephrine hydrochloride, a pH adjusting agent, and a citrate buffer in an amount of from about 0.0001 mg/mL to about 0.15 mg/mL;
- wherein the solution is manufactured and packaged under inert gas purging and exhibits a pH of from 4.0-4.6;
- and wherein the solution upon storage for at least about 6 months under freezing storage condition does not contain more than 0.2% wt/vol of phenylephrine citrate adduct impurity, based on the dose amount of the phenylephrine hydrochloride;
- wherein the freezing storage condition comprises a temperature of about −20° C.±5° C.
Dependencies are inferred from the claim text.