CA3119755A1 — Eutectic formulations of amitriptyline hydrochloride and mannitol
Assigned to Tonix Pharma Holdings Ltd · Expires 2014-09-18 · 12y expired
What this patent protects
Both sublingual and oral formulations have issues with the stability of Active Pharmaceutical Ingredients, thus, a method or composition that increases the stability of Amnriptyline HC1 in a formulation would be useful. The present invention relates to pharmaceutical compositions…
USPTO Abstract
Both sublingual and oral formulations have issues with the stability of Active Pharmaceutical Ingredients, thus, a method or composition that increases the stability of Amnriptyline HC1 in a formulation would be useful. The present invention relates to pharmaceutical compositions and methods of manufacturing the same by mixing, milling or spray drying, in which the pharmaceutical composition comprises a eutectic of Amitriptyline HC1 and 13-mannitol. The eutectic comprises 75% 2% Amitriptyline HC1 and 25% 2% p-mannitol by weight. The pharmaceutical compositions further comprise a basifying agent. Eutectic compositions often have higher stability and/or dissolution rates than their non-eutectic counterparts and the present invention addresses this unmet need to stabilize Amitriptyline HC1.
Drugs covered by this patent
Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.
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