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Last Updated: December 13, 2025

Claims for Patent: 10,117,936

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Summary for Patent: 10,117,936

Title:	Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride
Abstract:	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.
Inventor(s):	Marino Nebuloni, Patrizia Colombo
Assignee:	Tonix Pharma Holdings Ltd , Redox SRL
Application Number:	US14/776,624
Patent Claims:	1. A pharmaceutical composition comprising a eutectic of 25%±2% mannitol and 75%±2% Cyclobenzaprine HCl by weight, wherein the mannitol is β-mannitol or δ-mannitol. 2. The pharmaceutical composition of claim 1, wherein the Cyclobenzaprine HCl is micronized Cyclobenzaprine HCl. 3. The pharmaceutical composition of claim 1, further comprising a basifying agent. 4. The pharmaceutical composition of claim 3, wherein the basifying agent is K2HPO4. 5. The pharmaceutical composition of claim 3, wherein the basifying agent is Na2HPO4. 6. The pharmaceutical composition of claim 3, wherein the basifying agent is anhydrous trisodium citrate. 7. A method of manufacturing a pharmaceutical composition of claim 1, comprising mixing the Cyclobenzaprine HCl and the mannitol or milling the Cyclobenzaprine HCl and the mannitol. 8. The method of claim 7, comprising milling the Cyclobenzaprine HCl and the mannitol. 9. The method of claim 8, wherein, the Cyclobenzaprine HCl and the mannitol are milled in a high shear granulator. 10. The method of claim 7, comprising mixing the Cyclobenzaprine HCl and the mannitol. 11. The method of claim 10, wherein the Cyclobenzaprine HCl and the mannitol are mixed via compression. 12. The method of claim 11, wherein the Cyclobenzaprine HCl and the mannitol are compressed via roller compaction. 13. A method of manufacturing a pharmaceutical composition of claim 1, comprising spray drying a mixture of the Cyclobenzaprine HCl and the mannitol. 14. The method of claim 7, wherein the Cyclobenzaprine HCl is micronized Cyclobenzaprine HCl. 15. The method of claim 7, wherein the pharmaceutical composition further comprises a basifying agent. 16. The method of claim 15, wherein the basifying agent is K2HPO4. 17. The method of claim 15, wherein the basifying agent is Na2HPO4. 18. The method of claim 15, wherein the basifying agent is anhydrous trisodium citrate. 19. The pharmaceutical composition of claim 1, wherein the mannitol in the eutectic is β mannitol. 20. The pharmaceutical composition of claim 19, wherein the eutectic melts at 143.6±3° C. 21. The pharmaceutical composition of claim 1, wherein the mannitol in the eutectic is δ mannitol. 22. The pharmaceutical composition of claim 21, wherein the eutectic melts at 134° C±3° C. 23. The method of claim 7, wherein the mannitol in the eutectic is β mannitol. 24. The method of claim 23, wherein the eutectic melts at 143.6±3° C. 25. The method of claim 7, wherein the mannitol in the eutectic is δ mannitol. 26. The method of claim 25, wherein the eutectic melts at 134° C±3° C. 27. The method of claim 13, wherein the pharmaceutical composition further comprises a basifying agent. 28. The method of claim 27, wherein the basifying agent is K2HPO4. 29. The method of claim 27, wherein the basifying agent is Na2HPO4. 30. The method of claim 27, wherein the basifying agent is anhydrous trisodium citrate. 31. The method of claim 13, wherein the mannitol in the eutectic is δ mannitol. 32. The method of claim 31, wherein the eutectic melts at 134° C±3° C. 33. The method of claim 13, wherein the mannitol is β-mannitol. 34. The method of claim 13, wherein the spray drying converts the β-mannitol into δ-mannitol.

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