Claims for Patent: 10,966,990

Summary for Patent: 10,966,990

Title:	Midazolam in flexible bags
Abstract:	Terminally sterilized, preservative-free aqueous midazolam solution comprising 0.25 to 1.5 mg/ml of midazolam, a tonicity adjusting agent to provide an osmolality of from 260 and 320 mosm/kg and sufficient acid and optionally a base to provide a pH of from about 2.5 to 3.5 with the remainder water for injection packaged in a flexible plastic container.
Inventor(s):	Dusci; Sergio (Tresivio, IT)
Assignee:	InfoRLife SA (Campascio, CH)
Application Number:	16/013,722
Patent Claims:	1. A ready-to-use terminally sterilized, preservative-free aqueous midazolam solution in an intravenous laminated flexible plastic bag, comprising 0.25 to 1.5 mg/ml of midazolam, sufficient tonicity adjusting agent to provide an osmolality of from 260 and 320 mosm/kg and sufficient acid and optionally a base to provide a pH of from about 2.5 to 3.5 with the remainder water for injection; wherein: the tonicity adjusting agent comprises at least one selected from the group consisting of sodium chloride, potassium chloride and calcium chloride; the acid comprises hydrochloric acid; the base, if present, comprises sodium hydroxide; and the midazolam content after accelerated storage at 40.degree. C. for six months is greater than 97% the intravenous laminated flexible plastic bag comprises from 3 to 7 layers and has an innermost layer comprises an ethylene-vinyl acetate coplymer. 2. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 1, wherein the tonicity adjusting agent is sodium chloride in an amount to provide an osmolality of from 260 and 320 mosm/kg. 3. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 2, wherein the amount of sodium chloride added is 9 mg/ml. 4. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 1 wherein the solution comprises from about 0.5 mg/ml to 1.25 mg/ml of midazolam. 5. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 4 wherein the solution comprises about 0.5 mg/ml of midazolam. 6. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 4 wherein the solution comprises about 1 mg/ml of midazolam. 7. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 1 wherein the pH is 2.5 to 3.5. 8. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 7 wherein the is 2.8 to 3.2. 9. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 8 wherein the pH is about 3. 10. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 1 wherein the midazolam content is about 0.5 mg/ml, the pH is about 3, the tonicity adjusting agent is sodium chloride, and acid is hydrochloric acid. 11. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 1 wherein the midazolam content is about 1 mg/ml, the pH is about 3, the tonicity adjusting agent is sodium chloride, and acid is hydrochloric acid. 12. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 11 wherein the amount of sodium chloride is about 9 mg/ml of solution. 13. The ready-to-use terminally sterilized, preservative-free aqueous midazolam solution of claim 1, wherein the solution consists essentially of the midazolam, the tonicity agent, water, the acid, and optionally the base.