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 eutectic of mannitol and cyclobenzaprine HCl, comprising 75%±2% cyclobenzaprine HCl and 25%±2% mannitol by weight.
2. The eutectic of claim 1 , wherein the cyclobenzaprine HCl is micronized cyclobenzaprine HCl.
3. A method of manufacturing the eutectic of claim 1 , said method comprising mixing cyclobenzaprine HCl and mannitol or milling cyclobenzaprine HCl and mannitol, wherein the eutectic comprises 75%±2% cyclobenzaprine HCl and 25%±2% mannitol by weight.
4. The method of claim 3 , comprising milling cyclobenzaprine HCl and mannitol.
5. The method of claim 4 , wherein, the cyclobenzaprine HCl and mannitol are milled in a high shear granulator.
6. The method of claim 3 , comprising mixing cyclobenzaprine HCl and mannitol.
7. The method of claim 6 , wherein the cyclobenzaprine HCl and mannitol are mixed via compression.
8. The method of claim 7 , wherein the cyclobenzaprine HCl and mannitol are compressed via roller compaction.
9. The method of claim 3 , wherein the cyclobenzaprine HCl is micronized cyclobenzaprine HCl.