EUTECTIC FORMULATIONS OF CYCLOBENZAPRINE HYDROCHLORIDE AND AMITRIPTYLINE HYDROCHLORIDE
The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.
1 . A pharmaceutical composition comprising a eutectic of mannitol and Cyclobenzaprine HCl.
2 . The pharmaceutical composition of claim 1 , comprising 60%-90% Cyclobenzaprine HCl and 40%-10% mannitol by weight.
3 . The pharmaceutical composition of claim 2 , comprising amounts of Cyclobenzaprine HCl and mannitol selected from: 60%±2% Cyclobenzaprine HCl and 40%±2% mannitol, 65%±2% Cyclobenzaprine HCl and 35%±2% mannitol, 70%±2% Cyclobenzaprine HCl and 30%±2% mannitol, 75%±2% Cyclobenzaprine HCl and 25%±2% mannitol, 80%±2% Cyclobenzaprine HCl and 20%±2% mannitol, 85%±2% Cyclobenzaprine HCl and 15%±2% mannitol, and 90%±2% Cyclobenzaprine HCl and 10%±2% mannitol by weight.
4 . The pharmaceutical composition of claim 3 , comprising 75%±2% Cyclobenzaprine HCl and 25%±2% mannitol by weight.
5 . The pharmaceutical composition of claim 1 , wherein the Cyclobenzaprine HCl:mannitol molar ratio is 1.76±0.1.
6 . The pharmaceutical composition of claim 1 , wherein the Cyclobenzaprine HCl is micronized Cyclobenzaprine HCl.
7 . The pharmaceutical composition of claim 1 , further comprising a basifying agent.
8 . The pharmaceutical composition of claim 7 , wherein the basifying agent is K 2 HPO 4 .
9 . The pharmaceutical composition of claim 7 , wherein the basifying agent is Na 2 HPO 4 .
10 . The pharmaceutical composition of claim 7 , wherein the basifying agent is trisodium citrate, anhydrous.
11 .- 53 . (canceled)
54 . The pharmaceutical composition of claim 7 , wherein the basifying agent is selected from the group consisting of potassium dihydrogen phosphate (KH 2 PO 4 ), dipotassium hydrogen phosphate (K 2 HPO 4 ), tripotassium phosphate (K 3 PO 4 ), sodium dihydrogen phosphate (NaH 2 PO 4 ), disodium hydrogen phosphate (Na 2 HPO 4 ), trisodium phosphate (Na 3 PO 4 ), trisodium citrate anhydrous, a bicarbonate salt, a carbonate salt, borate, hydroxide, silicate, nitrate, dissolved ammonia, bicarbonate, and sulfide.