Claims for Patent: 12,622,903

Summary for Patent: 12,622,903

Title:	Drug products for intranasal administration and uses thereof
Abstract:	Provided herein are drug products adapted for nasal delivery comprising a device and a pharmaceutical composition comprising an opioid receptor antagonist, wherein the claimed invention provides a unit dose of an aqueous pharmaceutical solution, or aqueous pharmaceutical composition, housed in a device configured for intranasal administration to a patient, wherein the aqueous pharmaceutical solution consists of, or the aqueous pharmaceutical composition consists essentially of: (i) naloxone hydrochloride in an amount of about 9% by weight based on the total weight of the aqueous pharmaceutical solution; (ii) glycerin in an amount of about 1.4% by weight based on the total weight of the aqueous pharmaceutical solution; (iii) a citrate buffer system adjusted by hydrochloric acid and/or sodium hydroxide; and (iv) United States Pharmacopeia (USP)-grade Purified Water; wherein the pH of the aqueous pharmaceutical solution is from about 3.5 to about 4.7; and wherein the hydrochloric acid and the sodium hydroxide may each be independently present in the aqueous pharmaceutical solution, as required, to achieve the pH from about 3.5 to about 4.7.
Inventor(s):	Gregory G. Plucinski, Adrian T. Raiche, Kristi R. Sims
Assignee:	Summit Biosciences Inc
Application Number:	US18/602,972
Patent Claims:	1. A unit dose of an aqueous pharmaceutical solution housed in a device configured for intranasal administration to a patient, wherein the aqueous pharmaceutical solution consists of: (i) naloxone hydrochloride in an amount of about 9% by weight based on the total weight of the aqueous pharmaceutical solution; (ii) glycerin in an amount of about 1.4% by weight based on the total weight of the aqueous pharmaceutical solution; (iii) a citrate buffer system adjusted by hydrochloric acid and/or sodium hydroxide; and (iv) United States Pharmacopeia (USP)-grade Purified Water; wherein the pH of the aqueous pharmaceutical solution is from about 3.5 to about 4.7; and wherein the hydrochloric acid and the sodium hydroxide may each be independently present in the aqueous pharmaceutical solution, as required, to achieve the pH from about 3.5 to about 4.7; wherein the osmolality of the aqueous pharmaceutical solution is about 560 mOsm/kg; and wherein the device is configured to deliver the unit dose to the patient by a single actuation. 2. The unit dose of claim 1, wherein the pH of the solution is about 4.3. 3. The unit dose of claim 1, wherein the citrate buffer is in an amount of about 0.2% to about 0.4% by weight based on the total weight of the aqueous pharmaceutical solution. 4. The unit dose of claim 1, wherein the unit dose maintains at least 98 wt % of the naloxone hydrochloride upon storage under the conditions of 40° C. for at least 1 month. 5. The unit dose of claim 1, wherein the unit dose maintains at least 98 wt % of the naloxone hydrochloride upon storage under the conditions of 40° C. for at least 3 months. 6. The unit dose of claim 1, wherein the unit dose maintains at least 98 wt % of the naloxone hydrochloride upon storage under the conditions of 40° C. for at least 6 months. 7. The unit dose of claim 1, wherein the unit dose maintains at least 98 wt % of the naloxone hydrochloride upon storage under the conditions of 40° C. for at least 9 months.