Pharmaceutically acceptable salts and polymorphic forms of hydrocodone benzoic acid enol ester and processes for making same

US10351574B2 · US · B2

Patent metadata
FieldValue
Publication numberUS-10351574-B2
Application numberUS-201715730885-A
CountryUS
Kind codeB2
Filing dateOct 12, 2017
Priority dateMar 8, 2013
Publication dateJul 16, 2019
Grant dateJul 16, 2019

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  1. Title

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  2. Abstract

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  5. First independent claim

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Abstract

Official abstract text for this publication.

Compositions comprising hydrocodone benzoic acid enol ester to form novel prodrugs including hydrocodone benzoic acid enol ester salts, and various polymorphs. Also provided are processes for the preparation of hydrocodone benzoic acid enol ester salts, and various polymorphs.

First claim

Opening claim text (preview).

The invention claimed is: 1. A compound comprising a polymorphic form of hydrocodone benzoic acid enol ester hydrochloride, wherein the polymorphic form is Form I, wherein Form I has an x-ray powder diffraction pattern comprising peaks at about the following 2θ values: 9.05, 12.32, 13.16, 14.94, and 18.57. 2. The compound of claim 1 , wherein Form I has an x-ray powder diffraction pattern further comprising peaks at about the following 2θ values: 6.16, 10.95, 11.91, 14.60, 17.04, 17.23, 17.80, 19.18, 20.66, 21.10, 22.15, 23.50, 26.07, and 28.39. 3. A solid pharmaceutical composition comprising a therapeutically effective amount of a polymorphic form of hydrocodone benzoic acid enol ester hydrochloride and a pharmaceutically acceptable excipient in a formulation for oral administration, wherein the polymorphic form is Form I, wherein Form I has an x-ray powder diffraction pattern comprising peaks at about the following 2θ values: 9.05, 12.32, 13.16, 14.94, and 18.57. 4. The solid pharmaceutical composition of claim 3 , wherein Form I has an x-ray powder diffraction pattern further comprising peaks at about the following 2θ values: 6.16, 10.95, 11.91, 14.60, 17.04, 17.23, 17.80, 19.18, 20.66, 21.10, 22.15, 23.50, 26.07, and 28.39. 5. A method for treating pain in a patient comprising the step of selecting a patient that is in need of pain treatment, administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of one or more polymorphic forms of hydrocodone benzoic acid enol ester hydrochloride the compound of claim 1 . 6. A method for treating pain in a patient comprising the step of selecting a patient that is in need of pain treatment, administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of one or more polymorphic forms of hydrocodone benzoic acid enol ester hydrochloride the compound of claim 3 .

Assignees

Inventors

Classifications

  • Morphinan derivatives, e.g. morphine, codeine · CPC title

  • Crystalline forms, e.g. polymorphs · CPC title

  • with oxygen atoms attached in positions 3 and 6, e.g. morphine, morphinone · CPC title

  • C07D489/04Primary

    Salts; Organic complexes · CPC title

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What does patent US10351574B2 cover?
Compositions comprising hydrocodone benzoic acid enol ester to form novel prodrugs including hydrocodone benzoic acid enol ester salts, and various polymorphs. Also provided are processes for the preparation of hydrocodone benzoic acid enol ester salts, and various polymorphs.
Who is the assignee on this patent?
Kempharm Inc
What technology area does this patent fall under?
Primary CPC classification C07D489/04. Mapped technology areas include Chemistry & Metallurgy.
When was this patent published?
Publication date Tue Jul 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time) (B2). Legal status and post-grant events are not shown on this page.
What related patents are in patentsdb?
We list 4 related publications on this page (citations in our corpus or others sharing the same primary CPC).