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 making a pharmaceutical composition comprising a eutectic of mannitol and Amitriptyline HCl, wherein the eutectic comprises 75%±2% by weight Amitriptyline HCl and 25%±2% by weight mannitol, comprising mixing Amitriptyline HCl and mannitol or milling Amitriptyline HCl and mannitol.
2. The method of claim 1 , comprising milling Amitriptyline HCl and mannitol.
3. The method of claim 2 , wherein, the Amitriptyline HCl and mannitol are milled in a high shear granulator.
4. The method of claim 1 , comprising mixing Amitriptyline HCl and mannitol.
5. The method of claim 4 , wherein the Amitriptyline HCl and mannitol are mixed via compression.
6. The method of claim 5 , wherein the Amitriptyline HCl and mannitol are compressed via roller compaction.
7. The method of claim 1 , wherein the Amitriptyline HCl is micronized Amitriptyline HCl.
8. The method of claim 1 , further comprising the step of adding a basifying agent to the pharmaceutical composition.
9. The method of claim 8 , wherein the basifying agent is K 2 HPO 4 , Na 2 HPO 4 , or anhydrous trisodium citrate.