Eutectic formulations of cyclobenzaprine hydrochloride
The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol.
1. A eutectic comprising 65%±2% Cyclobenzaprine HCl and 35%±2% δ-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 , comprising mixing Cyclobenzaprine HCl and β-mannitol in the presence of a solvent.
4. The method of claim 3 , wherein said mixing is wet granulation mixing.
5. The method of claim 3 , wherein the solvent is a mixture of water and an alcohol.
6. The method of claim 5 , wherein said alcohol is methanol.
7. The method of claim 5 , wherein said alcohol is ethanol.
8. The method of claim 4 , further comprising drying the mixture after said wet granulation.
9. The method of claim 8 , wherein said wet granulation and drying are repeated one or more times.
10. The method of claim 4 , further comprising crystallization of the Cyclobenzaprine HCl-mannitol mixture after said wet granulation.
11. The method of claim 10 , wherein said wet granulation and crystallization are repeated one or more times.
12. A method of manufacturing the eutectic of claim 1 , comprising fluid bed drying a mixture of Cyclobenzaprine HCl, β-mannitol and a solvent.
13. The method of claim 3 , wherein the solvent is water.
14. The method of claim 12 , wherein a solution of Cyclobenzaprine HCl is sprayed onto β-mannitol particles inside of a fluid bed dryer.