System and method for intranasal administration of lorazepam

Inactive Publication Date: 2006-07-06
UNIV OF KENTUCKY RES FOUND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0016] Yet another object of the invention is to provide such novel lorazepam compositions for intranasal administration in a relatively small and inexpensive, manually operated, self-contained hand-held disposable device that retains essentially no significant quantity of the therapeutic composition after administration of the one or more unit-doses as prescribed.
[0017] A further object of the invention is to provide a comprehensive method for providing a novel th

Problems solved by technology

It has been found that the addition of water to the

Method used

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  • System and method for intranasal administration of lorazepam

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Embodiment Construction

[0036] A suitable liquid composition for use in a spray device for intranasal administration includes a solvent in which the desired concentration of lorazepam can be attained to provide the desired unit-dose in a total sprayed liquid volume that can be delivered by the device and accommodated and absorbed by the subject's nasal mucosa. Lorazepam is insoluble in water. A commercially available injectable composition approved by the FDA and sold by Wyeth Laboratories under the brand name Ativan®, includes 2 mg of lorazepam in 0.18 mL of polyethylene glycol 400 in propylene glycol with 2.0% benzyl alcohol as a preservative. This composition was not acceptable for intranasal spray administration because benzyl alcohol is irritating to the mucosa.

[0037] A suitable composition for use in the invention was prepared as follows.

[0038] Lorazepam was formulated in a liquid composition for use in the practice of the invention. Since lorazepam is insoluble in water, the lorazepam was dissolve...

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Abstract

A therapeutic composition of lorazepam and its pharmaceutically acceptable derivatives are provided for intranasal administration of at least one predetermined volumetric unit dose in the form of a spray by means that delivers one or more therapeutically prescribed unit doses that are highly accurate as to the volume discharged and which leave no significant quantity of the composition in the delivery means.

Description

FIELD OF THE INVENTION [0001] The invention relates to pharmaceutical drug compositions and preparations of lorazepam. This invention also relates to pharmaceutical drug delivery devices, specifically to devices for the intranasal administration of lorazepam. BACKGROUND OF THE INVENTION [0002] Lorazepam preparations for the treatment of anxiety-related disorders and to induce sedation have been previously approved by the U.S. Food and Drug Administration (“FDA”) and have been long-used for oral, intra-muscular and / or intravenous administration. Lorazepam is currently marketed in injectable and tablet formulations. Marketers of these preparations have not sought regulatory approval from the FDA for liquid compositions of the same therapeutic compound for intranasal administration. This is surprising since it is well-known from the literature that the intranasal administration of a pharmacologically active compound generally results in a more rapid bioavailability of the compound, or ...

Claims

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Application Information

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IPC IPC(8): A61L9/04A61K9/12A61K9/00A61K31/485A61K31/55A61K31/5513A61K47/10A61K47/14A61K47/22A61K47/34A61K47/42A61L2/04A61M11/00A61P25/20A61P25/22
CPCA61K9/0043A61K31/485A61K31/55A61K47/10A61P25/20A61P25/22
Inventor WERMELING, DANIEL P.
Owner UNIV OF KENTUCKY RES FOUND
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