Claims for Patent: 10,231,961

Summary for Patent: 10,231,961

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:	15/434,014
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,231,961
Patent Claims:	1. A packaged ready to use pharmaceutical product comprising: a pharmaceutical composition including, by weight, about 4% cocaine hydrochloride; greater than 0 to about 0.150% citric acid; and about 0.07% to about 0.20% sodium benzoate; in an aqueous solution at a pH of 2 to 4; and a container closure system comprising a 0.5 oz. boston round, amber glass bottle with a ribbed closure and a foam liner, and an observed spectral transmission for the glass bottle not exceeding 10% at any wavelength in the range of 290 nm to 450 nm; provided that a volume of the pharmaceutical composition is enclosed in the container closure system; and provided that the cocaine hydrochloride concentration in the volume of the pharmaceutical composition is greater than about 3.4%, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 3 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 2. The packaged ready to use pharmaceutical product of claim 1, provided that the cocaine hydrochloride concentration in the volume of the pharmaceutical composition is greater than about 3.4%, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 6 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 3. The packaged ready to use pharmaceutical product of claim 1, provided that the cocaine hydrochloride concentration in the volume of the pharmaceutical composition is greater than about 3.6% by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 4 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 4. The packaged ready to use pharmaceutical product of claim 1, provided that the volume of the pharmaceutical composition includes no more than 114 ppm methanol after the volume of the pharmaceutical composition has been stored in the container closure system for 6 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 5. The packaged ready to use pharmaceutical product of claim 1, provided that the volume of the pharmaceutical composition includes less than 50 ppm methanol after the volume of the pharmaceutical composition has been stored in the container closure system for 4 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 6. The packaged ready to use pharmaceutical product of claim 1, provided that the volume of the pharmaceutical composition includes no more than 100 cfu/g total aerobic microbial counts after the volume of the pharmaceutical composition has been stored in the container closure system for 6 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 7. The packaged ready to use pharmaceutical product of claim 1, provided that the volume of the pharmaceutical composition includes no more than 10 cfu/g total combined mold and yeast after the volume of the pharmaceutical composition has been stored in the container closure system for 6 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 8. The packaged ready to use pharmaceutical product of claim 1, provided that the volume of the pharmaceutical composition includes no more than about 8.8% benzoylecognine after the volume of the pharmaceutical composition has been stored in the container closure system for 6 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 9. The packaged ready to use pharmaceutical product of claim 2, provided that the volume of the pharmaceutical composition includes no more than about 5.9% benzoylecgonine after the volume of the pharmaceutical composition has been stored in the container closure system for 4 months at a temperature ranging from 38.degree. C. to 42.degree. C., and a relative humidity ranging from 70% to 80%. 10. A packaged storage stable pharmaceutical product comprising: a pharmaceutical composition including, by weight, about 4% cocaine hydrochloride; greater than 0 to about 0.150% citric acid; and about 0.07% to about 0.20% sodium benzoate; in an aqueous solution at a pH of 2 to 4; and a container closure system comprising a 0.5 oz. boston round, amber glass bottle with a ribbed closure and a foam liner, and an observed spectral transmission for the glass bottle not exceeding 10% at any wavelength in the range of 290 nm to 450 nm; provided that a volume of the pharmaceutical composition is enclosed in the container closure system; and provided that the volume of the pharmaceutical composition comprises no more than 4.1% of total impurities, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 6 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 11. The packaged storage stable pharmaceutical product of claim 10, provided that the volume of the pharmaceutical composition comprises no more than 5.5% benzoylecognine, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 9 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 12. The packaged storage stable pharmaceutical product of claim 10, provided that the volume of the pharmaceutical composition comprises no more than 7.1% benzoylecognine, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 12 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 13. The packaged storage stable pharmaceutical of product of claim 10, provided that the volume of the pharmaceutical composition includes no more than 251 ppm methanol after the volume of the pharmaceutical composition has been stored in the container closure system for 9 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 14. The packaged storage stable pharmaceutical of product claim 10, provided that the volume of the pharmaceutical composition includes less than 343 ppm methanol after the volume of the pharmaceutical composition has been stored in the container closure system for 12 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 15. The packaged storage stable pharmaceutical of product claim 10, provided that the volume of the pharmaceutical composition includes no more than 100 cfu/g total aerobic microbial counts after the volume of the pharmaceutical composition has been stored in the container closure system for 12 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 16. The packaged storage stable pharmaceutical product of claim 10, provided that the volume of the pharmaceutical composition includes no more than 10 cfu/g total combined mold and yeast after the volume of the pharmaceutical composition has been stored in the container closure system for 12 months at a temperature ranging from 28.degree. C. to 32.degree. C., and a relative humidity ranging from 60% to 70%. 17. A packaged storage stable pharmaceutical product comprising: a pharmaceutical composition including, by weight, about 4% cocaine hydrochloride; greater than 0 to about 0.150% citric acid; and about 0.07% to about 0.20% sodium benzoate; in an aqueous solution at a pH of 2 to 4, and a container closure system comprising a 0.5 oz. boston round, amber glass bottle with a ribbed closure and a foam liner, and an observed spectral transmission for the glass bottle not exceeding 10% at any wavelength in the range of 290 nm to 450 nm; provided that a volume of the pharmaceutical composition is enclosed in the container closure system; and provided that the volume of the pharmaceutical composition comprises no more than 4.3% of total impurities, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 12 months at a temperature ranging from 23.degree. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 18. The packaged storage stable pharmaceutical product of claim 17, provided that the cocaine hydrochloride concentration in the volume of the pharmaceutical composition is greater than about 3.6%, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 12 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 19. The packaged storage stable pharmaceutical product of claim 17, provided that the cocaine hydrochloride concentration in the volume of the pharmaceutical composition is greater than about 3.4%, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 18 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 20. The packaged storage stable pharmaceutical product of claim 17, provided that the volume of the pharmaceutical composition comprises no more than 4.3% benzoylecognine, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 12 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 21. The packaged storage stable pharmaceutical product of claim 17, provided that the volume of the pharmaceutical composition comprises no more than 5.8% benzoylecognine, by weight, after the volume of the pharmaceutical composition has been stored in the container closure system for 18 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 22. The packaged storage stable pharmaceutical product of claim 1, provided that the volume of the pharmaceutical composition includes a methanol content that is no more than 215 ppm after the volume of the pharmaceutical composition has been stored in the container closure system for 12 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%. 23. The packaged storage stable pharmaceutical product of claim 19, provided that the volume of the pharmaceutical composition includes a methanol content that is no more than 284 ppm after the volume of the pharmaceutical composition has been stored in the container closure system for 18 months at a temperature ranging from 23.degree. C. to 27.degree. C., and a relative humidity ranging from 55% to 65%.