System and method for intranasal administration of lorazepam

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 ...

AI Technical Summary

Benefits of technology

[0013] It is a further object of this invention to provide an improved intranasal dosage composition and method of administration of lorazepam that exhibits a relatively rapid onset, moderate duration of therapeutic activity, minimal side effects, improved bioavailability, ease and safety of administration, and minimal physical discomfort and anxiety to the patient occasioned by administration.

[0017] A further object of the invention is to provide a comprehensive method for providing a novel therapeutic composition for intranasal administration that contains lorazepam in a form that exhibits the same pharmacological activity as lorazepam compositions that are approved for oral, IM and / or IV administration, the intranasal composition being available for delivery in highly accurate and reproducible predetermined unit-doses leaving essentially no significant quantity of the therapeutic composition after administration of the prescribed number of unit-doses.

[0023] The lorazepam compositions administered in accordance with the method and system of the invention exhibit systemic pharmacological effects following absorption from the nasal mucosa. As will be shown below, the novel pharmaceutical composition provide the lorazepam in a form that is readily absorbable by the nasal mucosa without damaging or irritating the mucosa, or producing an allergic, or other unacceptable reaction in the recipient.

[0026] The lorazepam composition of the invention is also compatible with the delivery system. The lorazepam compositions for use in the invention are formulated to deliver the dose within the foreseeable temperature ranges of exposure, e.g., without becoming too viscous to be administered in the proper form by the device, or crystallizing at lower temperatures; and without exceeding the internal pressure limits of the delivery system at higher temperatures.

Problems solved by technology

It has been found that the addition of water to the composition reduces the stability of the lorazepam.

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