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 method of manufacturing a eutectic of Cyclobenzaprine HCl and β-mannitol comprising 75%±2% Cyclobenzaprine HCl and 25±2% β-mannitol by weight, the method comprising mixing Cyclobenzaprine HCl and (β-mannitol or milling Cyclobenzaprine HCl and β-mannitol.
2. The method of claim 1 , comprising milling the Cyclobenzaprine HCl and β-mannitol.
3. The method of claim 2 , wherein, the Cyclobenzaprine HCl and β-mannitol are milled in a high shear granulator.
4. The method of claim 1 , comprising mixing the Cyclobenzaprine HCl and β-mannitol.
5. The method of claim 4 , wherein the Cyclobenzaprine HCl and β-mannitol are mixed via compression.
6. The method of claim 5 , wherein the Cyclobenzaprine HCl and β-mannitol are compressed via roller compaction.
7. The method of any one of claims 1 - 6 , wherein the Cyclobenzaprine HCl is micronized Cyclobenzaprine HCl.