Claims for Patent: 10,894,012

Summary for Patent: 10,894,012

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:	16/903,558
Patent Claims:	1. A method of providing induction of local anesthesia of mucous membranes in an adult patient comprising: soaking four pledgets in about 4 mL of a pharmaceutical composition comprising about 36 mg/mL to about 44 mg/mL of cocaine hydrochloride, 1.2 mg/mL to 1.4 mg/mL citric acid, 0.7 mg/mL to 1.3 mg/mL sodium benzoate, and water; placing a maximum of two pledgets of the four pledgets in each nasal cavity of an adult patient for about 10 minutes to about 20 minutes, provided that the method results in an AUC.sub.inf in a range from about 25.0 ng*h/mL to about 370 ng*h/mL of cocaine in the adult patient; and performing a diagnostic or surgical procedure on or through the nasal cavities in the adult patient; provided that the method results in a reduction in pain equivalent to achieving a visual numeric rating score of 0 upon von Frey filament testing. 2. The method of claim 1, wherein the procedure is a nasal laryngoscopy. 3. The method of claim 1, wherein the procedure is a nasopharyngeal laryngoscopy. 4. The method of claim 1, wherein the procedure is a nasal endoscopy. 5. The method of claim 1, wherein a length of each of the four pledgets is about 3.0 cm. 6. The method of claim 1, wherein each of the four pledgets has an absorbency sufficient to absorb about 1 mL of the pharmaceutical composition. 7. The method of claim 1, wherein each of the four pledgets is removed from the nasal cavity and retains between about 70% and about 80% of the pharmaceutical composition. 8. A method of providing induction of local anesthesia of mucous membranes in an adult patient comprising: soaking four pledgets in about 4 mL of a pharmaceutical composition comprising about 36 mg/mL to about 44 mg/mL of cocaine hydrochloride, 1.2 mg/mL to 1.4 mg/mL citric acid, 0.7 mg/mL to 1.3 mg/mL sodium benzoate, and water; placing a maximum of two pledgets of the four pledgets in each nasal cavity of the adult patient for about 10 minutes to about 20 minutes, provided that the method results in an AUC.sub.inf in a range from about 25.0 ng*h/mL to about 370 ng*h/mL of cocaine in the adult patient; provided that the method results in a T.sub.max ranging from about 0.02 hours to about 1.00 hours; and performing a diagnostic or surgical procedure on or through the nasal cavities in the adult patient; provided that the method results in a reduction in pain equivalent to achieving a visual numeric rating score of 0 upon von Frey filament testing. 9. The method of claim 8, wherein the procedure is a nasal laryngoscopy. 10. The method of claim 8, wherein the procedure is a nasopharyngeal laryngoscopy. 11. The method of claim 8, wherein the procedure is a nasal endoscopy. 12. The method of claim 8, wherein a length of each of the four pledgets is about 3.0 cm. 13. The method of claim 8, wherein each of the four pledgets has an absorbency sufficient to absorb about 1 mL of the pharmaceutical composition. 14. The method of claim 8, wherein each of the four pledgets is removed from the nasal cavity and retains between about 70% and about 80% of the pharmaceutical composition.