Eutectic formulations of cyclobenzaprine hydrochloride
Inventors
Lederman, Seth • Nebuloni, Marino
Assignees
Tonix Pharma Holdings Ltd • Redox SRL • Tonix Pharmaceuticals Inc
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Publication Number
US-10357465-B2
Publication Date
2019-07-23
Expiration Date
Abstract
The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol.
Core Innovation
The invention describes a Cyclobenzaprine HCl–mannitol eutectic comprising 65%2% Cyclobenzaprine HCl and 35%2% ̄-mannitol by weight. The disclosure characterizes eutectic formation and polymorphic phases using DSC and XRPD. It identifies the ̄-mannitol eutectic as having a lower melting point, enhanced dissolution, and greater stability than the ̂ form.
The disclosure reports improved stability of tablets containing mannitol compared with tablets containing sorbitol, which disintegrate within one week under the stated stability conditions. The ̄-mannitol eutectic is also reported as more stable than the ̂ form. The background problem addressed by the invention is not explicitly described in the provided content.
Claims Coverage
The provided relevant claims identify one independent claim and one inventive feature.
Cyclobenzaprine HCl–̄-mannitol eutectic
A eutectic comprising 65%2% Cyclobenzaprine HCl and 35%2% ̄-mannitol by weight.
The independent claim covers the specified Cyclobenzaprine HCl–̄-mannitol eutectic composition.
Stated Advantages
The disclosure reports improved tablet stability with mannitol compared with sorbitol.
The ̄-mannitol eutectic is described as having enhanced dissolution and greater stability than the ̂ form, as well as a lower melting point.
Documented Applications
The eutectic is described in connection with pharmaceutical tablets.
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