Pharmaceutical compositions and methods of using the same
Novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those pharmaceutical compositions are described.
1. A method of providing induction of local anesthesia of mucous membranes in adult patients comprising:
soaking four cottonoid pledgets in the contents of one bottle containing about 4 mL of a pharmaceutical composition comprising about 36 mg/mL to 44 mg/mL of naturally derived cocaine hydrochloride, until each pledget absorbs about 40 mg of naturally derived cocaine hydrochloride,
contacting two pledgets in each nasal cavity against a septum of a patient for a period ranging from about 10 minutes to about 20 minutes, provided that the method results in a maximum plasma concentration C max in a range from about 19.7 ng/mL to about 54.3 ng/mL of cocaine in the patient; and
performing a procedure on the patient, the procedure selected from the group consisting of a nasal laryngoscopy, a nasopharyngeal laryngoscopy, and a nasal debridement,
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 debridement.
5. The method of claim 1 , wherein a length of each pledget is from about 3.0 cm to about 8.0 cm.
6. The method of claim 1 , wherein a height of each pledget is about 1.3 cm and a length of each pledget is about 4 cm.
7. The method of claim 1 , wherein the C max is about 37 ng/mL.
8. A method of providing induction of local anesthesia of mucous membranes in adult patients comprising:
soaking four cottonoid pledgets in the contents of one bottle containing about 4 mL of a pharmaceutical composition comprising about 36 mg/mL to 44 mg/mL of naturally derived cocaine hydrochloride, until each pledget absorbs about 40 mg of naturally derived cocaine hydrochloride;
contacting two pledgets in each nasal cavity against a septum of a patient in a range from about 10 minutes to about 20 minutes, provided that the method results in an AUC inf in a range from about 30.8 ng*h/mL to about 79.0 ng*h/mL of cocaine in the patient; and
performing a procedure on the patient, the procedure selected from the group consisting of a nasal laryngoscopy, a nasopharyngeal laryngoscopy, and a nasal debridement,
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 a length of each pledget is from about 3.0 cm to about 8.0 cm.
10. The method of claim 8 , wherein a height of each pledget is about 1.3 cm and a length of each pledget is about 4 cm.
11. The method of claim 8 , wherein the AUC inf is about 54.9 ng*h/mL.
12. The method of claim 8 , wherein the procedure is a nasal laryngoscopy.
13. The method of claim 8 , wherein the procedure is a nasopharyngeal laryngoscopy.
14. The method of claim 8 , wherein the procedure is a nasal debridement.
15. The method of claim 8 , wherein the achieved AUC inf ranges from about 30.8 ng*h/mL to about 54.9 ng*h/mL of cocaine in the patient.
16. The method of claim 8 , wherein the achieved AUC inf ranges from about 54.9 ng*h/mL to about 79.0 ng*h/mL of cocaine in the patient.