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-11026898-B2
Publication Date
2021-06-08
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 is a pharmaceutical composition comprising a eutectic of δ-mannitol and Cyclobenzaprine HCl. The claimed eutectic comprises 65%±2% Cyclobenzaprine HCl and 35%±2% δ-mannitol by weight. The disclosure also describes β-mannitol variants and pharmaceutical compositions containing additional components, including basifying agents, but the claim specifies the δ-mannitol eutectic and its proportions.
The disclosure reports improved stability relative to sorbitol formulations along with improved dissolution and tolerability for δ eutectics. The background section is not included in the text, so the specific problem identified in that section is not explicitly described. Characterization of eutectic formation and melting behavior is also reported, without further application details.
Claims Coverage
The claim coverage identifies one inventive feature across the claims.
Δ-mannitol and cyclobenzaprine HCl eutectic composition
A pharmaceutical composition comprising a eutectic of δ-mannitol and Cyclobenzaprine HCl, wherein the eutectic comprises 65%±2% Cyclobenzaprine HCl and 35%±2% δ-mannitol by weight.
The claim covers the specified pharmaceutical eutectic composition and its defined weight proportions.
Stated Advantages
The disclosure reports improved stability compared with sorbitol formulations.
The disclosure describes improved dissolution and tolerability for δ eutectics.
Documented Applications
The eutectic is described for inclusion in pharmaceutical compositions. No specific therapeutic indication or other use case is explicitly described.
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