Claims for Patent: 12,653,820

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Summary for Patent: 12,653,820

Title:	Hydromorphone formulations for multi-dose products
Abstract:	The present disclosure relates to a multi-dose vial presentation for hydromorphone. In particular, the present disclosure relates to terminally sterilized liquid formulations comprising hydromorphone hydrochloride packaged in a multi-dose glass vial. The present disclosure also relates to methods of treating patients by administration of such formulations and glass vials containing such formulations.
Inventor(s):	Nathan Puster, Rand H. Ahmad, Gyongyi Szakalas-Gratzl, Ragheb M. AbuRmaileh
Assignee:	Hikma Pharmaceuticals USA Inc
Application Number:	US18/152,303
Patent Claims:	1. A glass vial filled with a multi-dose parenteral liquid formulation, the liquid formulation comprising: (a) 2.0 mg/mL of hydromorphone hydrochloride; (b) 0.5 mg/mL of edetate disodium; (c) 1.8 mg/mL of methylparaben; and (d) 0.2 mg/mL of propylparaben; wherein the liquid formulation has a pH of 3.9 to 4.1, wherein the liquid formulation is substantially free of citrate buffer, wherein the liquid formulation has been terminally sterilized in a glass vial by autoclave wherein the terminal sterilization is characterized by an F0 value from 10 to 20, wherein the liquid formulation has not more than 0.3% w/w of 4-hydroxybenzoic acid and not more than 0.2% w/w of 7-hydroperoxylhydromorphone and 7-hydroxylhydromorphone after terminal sterilization and storage for up to 24 weeks at 25° C.±2° C. and 60% relative humidity (RH)±5% RH, wherein the glass vial contains a 20 mL fill of the liquid formulation, and wherein the vial has a headspace comprising not more than 8% oxygen. 2. The glass vial of claim 1, wherein the liquid formulation has not more than 0.1% w/w of 4-hydroxybenzoic acid after storage for up to 24 weeks at 25° C.±2° C. and 60% relative humidity (RH)±5% RH. 3. The glass vial of claim 1, wherein the liquid formulation retains at least 95% w/w of the hydromorphone hydrocholoride and has not more than 1% w/w of 2,2′-bishydromorphone and hydromorphone N-oxide after storage at 25° C.±2° C. and 60% RH±5% RH for up to 24 weeks. 4. The glass vial of claim 1, further comprising a pH adjusting agent. 5. A method of treating a patient in need of management of pain comprising parenterally administering to the patient the liquid formulation contained in the glass vial of claim 1. 6. The method of claim 5, wherein the pain is moderate to severe pain due to surgery, cancer, soft tissue and bone trauma, biliary colic, myocardial infarction, burns, or renal colic. 7. The glass vial of claim 1, wherein the liquid formulation has not more than 0.1% w/w of 2,2′-bishydromorphone after terminal sterilization and storage for up to 12 weeks at 40° C.±2° C. and 75% RH±5% RH. 8. The glass vial of claim 1, wherein the liquid formulation has not more than 0.4% 2,2′-bishydromorphone after terminal sterilization.