发明名称 |
ORALLY EFFECTIVE METHYLPHENIDATE EXTENDED RELEASE POWDER AND AQUEOUS SUSPENSION PRODUCT |
摘要 |
An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile. |
申请公布号 |
US2017042873(A1) |
申请公布日期 |
2017.02.16 |
申请号 |
US201615215276 |
申请日期 |
2016.07.20 |
申请人 |
Tris Pharma, Inc. |
发明人 |
Mehta Ketan;Tu Yu-Hsing;Perumal Ashok |
分类号 |
A61K31/4458;A61K9/14;A61K9/00 |
主分类号 |
A61K31/4458 |
代理机构 |
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代理人 |
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主权项 |
1. A methylphenidate aqueous oral suspension, wherein said suspension has a pH of about 4.2;
(i) an immediate release methylphenidate component; (ii) a sustained release methylphenidate component comprising a water-insoluble, water-permeable, sustained release barrier coated methylphenidate-ion exchange resin complex-optional matrix, and (iii) water; wherein the aqueous oral suspension provides a pharmacokinetic profile in which d-methylphenidate has an area under the curve (AUC)0-∞ of about 114 ng-hr/mL to about 180 ng-hr/mL following a single oral administration of the aqueous oral suspension to adult subjects under fasted conditions at a dose equivalent to 60 mg racemic methylphenidate HCl. |
地址 |
Monmouth Junction NJ US |