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Pharmaceutical formulations of suvorexant

A preparation and drug technology, applied in the field of stable pharmaceutical preparations, can solve the problems of unpredictable, unpredictable onset, unpredictable plasma concentration, etc.

Inactive Publication Date: 2019-07-09
DRUGGABILITY TECH IP HOLDCO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The major pharmacokinetic issue associated with oral delivery of Suvorexan is the unpredictable absorption profile, which results in an unpredictable onset of action, unpredictable plasma concentrations throughout the evening and the next morning, resulting in second day sleepiness

Method used

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  • Pharmaceutical formulations of suvorexant
  • Pharmaceutical formulations of suvorexant
  • Pharmaceutical formulations of suvorexant

Examples

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Embodiment Construction

[0072]Disclosed herein are stable pharmaceutical formulations comprising suvorexan as an active compound, or a salt thereof, or a metabolite or derivative thereof, and at least one primary pharmaceutical excipient.

[0073] In one embodiment, said pharmaceutical formulation further comprises at least one secondary pharmaceutical excipient.

[0074] We have found that only selected combinations of primary and secondary pharmaceutical excipients disclosed in the present invention lead to stable pharmaceutical formulations with improved physicochemical characteristics and enhanced biological properties.

[0075] The primary pharmaceutical excipient by itself or together with the secondary pharmaceutical excipient has the function of forming a complex structure with suvorexan, or a salt thereof, or a metabolite or derivative thereof, through non-covalent secondary interactions. Secondary interactions can be formed through electrostatic interactions such as ionic interactions, hydr...

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Abstract

The present invention relates to pharmaceutical formulations comprising as active compound Suvorexant, or its salts, or its metabolites or derivatives, thereof and pharmaceutical excipients, process for the preparation thereof and pharmaceutical compositions containing them. The pharmaceutical formulations of the present invention possess instantaneous redispersibility, increased apparent solubility and permeability, no observable food effect with respect to immediate absorption and more predictable plasma concentration throughout the night and next morning. The invention also relates to methods of manufacturing the pharmaceutical formulations and pharmaceutical compositions containing them according to the invention, their uses and methods of treatments using the pharmaceutical formulations and their pharmaceutical compositions.

Description

technical field [0001] The present invention relates to a stable pharmaceutical formulation with controlled particle size, increased apparent solubility and increased dissolution rate, comprising as active compound Suvorexant or a salt thereof, or a metabolite thereof or derivatives thereof and are useful in the treatment of insomnia characterized by difficulty falling asleep and / or maintaining sleep. More specifically, the pharmaceutical formulations of the present invention are instantaneously redispersible, have increased apparent solubility and permeability, have no observable effect of food on their immediate absorption, and have the ability to Better predicted plasma concentrations. The invention also relates to processes for the manufacture of the pharmaceutical formulations according to the invention and pharmaceutical compositions containing them, their use and methods of treatment using these pharmaceutical formulations and pharmaceutical compositions thereof. Bac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/551C07D413/14A61K9/20
CPCA61K9/145A61K9/146A61K9/19A61K31/551A61P25/20A61K9/0053A61K9/1617A61K9/1635A61K9/1641A61K9/1652A61K31/5513B82Y5/00
Inventor R·安吉O·巴萨-德尼斯Z·奥特沃斯H·格拉维纳斯G·菲利普西
Owner DRUGGABILITY TECH IP HOLDCO
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