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Amantadine compositions, preparations thereof, and methods of use

A kind of technology of amantadine and composition, applied in the field of sustained-release oral pharmaceutical composition

Pending Publication Date: 2020-07-03
ADAMAS PHARMA LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] However, gastrointestinal side effects associated with the administration of immediate-release and known extended-release amantadine formulations remain a significant problem; therefore, improved compositions and methods are needed

Method used

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  • Amantadine compositions, preparations thereof, and methods of use
  • Amantadine compositions, preparations thereof, and methods of use
  • Amantadine compositions, preparations thereof, and methods of use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment I-1

[0224] Embodiment I-1. A kind of oral pharmaceutical composition, it comprises:

[0225] 137 mg to 500 mg of amantadine or a pharmaceutically acceptable salt thereof, and

[0226] at least one excipient which modifies the release of the drug,

[0227] wherein the pharmaceutical composition has a Tmax of amantadine of (i) 11 to 19 hours when administered to healthy individuals in a single dose, fasting human pharmacokinetic study, (ii) 44 AUC of amantadine to 72ng*hr / ml / mg of the drug 0-inf , and (iii) the pAUC of amantadine from 1.0 to 2.0 ng*hr / ml / mg of the drug 0-8 .

Embodiment I-2

[0228] Embodiment 1-2. A kind of oral pharmaceutical composition, it comprises:

[0229] 137 mg to 500 mg of amantadine or a pharmaceutically acceptable salt thereof, and

[0230] at least one excipient that modifies the release of said amantadine or said pharmaceutically acceptable salt thereof;

[0231] wherein the pharmaceutical composition has a Tmax of amantadine of (i) 11 to 19 hours when administered to healthy individuals in a single dose, fasting human pharmacokinetic study, (ii) 44 AUC of amantadine to 72ng*hr / ml / mg of the drug 0-inf , and (iii) the pAUC of amantadine from 0.3 to 0.9 ng*hr / ml / mg of the drug 0-6 .

Embodiment I-3

[0232] Embodiment 1-3. The oral pharmaceutical composition according to embodiment 1-1, wherein when administered to healthy individuals in a single dose, fasting human pharmacokinetic study, the oral pharmaceutical composition has a concentration of 0.3 to pAUC of amantadine at 0.9ng*hr / ml / mg of the drug 0-6 .

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Abstract

Provided herein are oral pharmaceutical compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and which have a low level of organic solvent. Provided are also methods of orally administrating a composition comprising amantadine, or a pharmaceutically acceptable salt thereof, to a subject, which has reduced gastrointestinal side effects or sleep disturbances. Further provided are extended release oral compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, that are suitable for once daily administration.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Application No. 62 / 549,921, filed August 24, 2017, the contents of which are hereby incorporated by reference in their entirety. technical field [0003] The present disclosure generally relates to oral pharmaceutical compositions comprising amantadine or a pharmaceutically acceptable salt thereof, and more particularly to sustained release oral pharmaceutical compositions comprising amantadine or a pharmaceutically acceptable salt thereof, Preparation of these compositions and methods of using these compositions. Background technique [0004] Amantadine is indicated for different conditions treatable by NMDA receptor antagonists, including the treatment of idiopathic Parkinson's disease (Parkinson's disease), post-encephalitic Parkinsonism and possible Symptomatic Parkinsonism with neurological damage caused by carbon monoxide poisoning. Amantadine also has ac...

Claims

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Application Information

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IPC IPC(8): A61K31/13A61K31/131A61K47/18
CPCA61K31/13A61P25/16A61P25/14A61K9/5078A61K9/5047A61K31/136A61K9/5026A61K9/501A61K9/5042A61K9/5015A61P25/28A61K9/0053A61K9/5031
Inventor G·T·温特T·J·富斯S·戈什N·麦克卢尔
Owner ADAMAS PHARMA LLC
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