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 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° C. to 27° 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° C. to 27° 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° C. to 27° 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° C. to 32° 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° C. to 32° 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° C. to 32° 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° C. to 27° 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° C. to 27° C., and a relative humidity ranging from 55% to 65%.