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Last Updated: November 22, 2024

Claims for Patent: 11,040,032

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Summary for Patent: 11,040,032

Title:	Pharmaceutical compositions and methods of using the same
Abstract:	Novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those pharmaceutical compositions are described.
Inventor(s):	Moshal; Jeffrey M. (Allentown, PA), Libman; Michael (Allentown, PA)
Assignee:	GENUS LIFESCIENCES INC. (Allentown, PA)
Application Number:	16/174,567
Patent Claims:	1. A pharmaceutical composition for reducing sensation in a body region of a patient, the pharmaceutical composition comprising, by weight: about 4% cocaine hydrochloride; greater than 0 to less than 3% sodium citrate; and greater than 0 to about 2% benzoic acid; wherein a pH of the pharmaceutical composition is in a range of 3 to 4; and wherein greater than 90% of an original concentration of cocaine hydrochloride in the pharmaceutical composition remains in the pharmaceutical composition after the pharmaceutical composition has been stored for 6 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 2. The pharmaceutical composition of claim 1, wherein greater than 95% of an original concentration of cocaine hydrochloride in the pharmaceutical composition remains in the pharmaceutical composition after the pharmaceutical composition has been stored for 6 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 3. The pharmaceutical composition of claim 1, wherein greater than 97% of an original concentration of cocaine hydrochloride in the pharmaceutical composition remains in the pharmaceutical composition after the pharmaceutical composition has been stored for 6 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 4. The pharmaceutical composition of claim 1, wherein greater than 90% of an original concentration of cocaine hydrochloride in the pharmaceutical composition remains in the pharmaceutical composition after the pharmaceutical composition has been stored for 3 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 5. The pharmaceutical composition of claim 1, wherein greater than 95% of an original concentration of cocaine hydrochloride in the pharmaceutical composition remains in the pharmaceutical composition after the pharmaceutical composition has been stored for 3 months at a temperature ranging 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 6. The pharmaceutical composition of claim 1, wherein greater than 96% of an original concentration of cocaine hydrochloride in the pharmaceutical composition remains in the pharmaceutical composition after the pharmaceutical composition has been stored for 3 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 7. The pharmaceutical composition of claim 1, wherein greater than 90% of an original concentration of cocaine hydrochloride in the pharmaceutical composition remains in the pharmaceutical composition after the pharmaceutical composition has been stored for 12 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 8. The pharmaceutical composition of claim 1, wherein greater than 92% of an original concentration of cocaine hydrochloride in the pharmaceutical composition remains in the pharmaceutical composition after the pharmaceutical composition has been stored for 12 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%.

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