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Intranasal benzodiazepine compositions

A composition and compound technology, applied in the direction of drug combination, active ingredient of heterocyclic compound, atomized substance, etc., can solve problems such as difficult absorption time, failure to improve patient compliance, inappropriate prevention or treatment, etc.

Inactive Publication Date: 2007-05-30
UNIV OF KENTUCKY RES FOUND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, certain intranasal benzodiazepine compositions are poorly absorbed or have a delayed time to peak plasma concentration, which may not be appropriate for the prevention or treatment of certain clinical conditions
Other prior art benzodiazepine formulations fail to improve patient compliance

Method used

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  • Intranasal benzodiazepine compositions
  • Intranasal benzodiazepine compositions
  • Intranasal benzodiazepine compositions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] This example compares 5.0 mg midazolam (MZ) following intranasal (IN), intramuscular (IM) and intravenous (IV) administration in 12 healthy male and female subjects.

[0060] subjects

[0061] After consent was obtained, 12 nonsmoking healthy subjects (6 males, 6 females) aged 20-29 years (mean age 22.3 years) and weighing 132-202 pounds (mean 157 pounds) Participate in this inpatient study. Eleven volunteers participating in the study were Caucasian and one was Asian. Study participants were selected based on inclusion / exclusion criteria, medical history, physical and nasal examination, vital signs, laboratory tests, and other procedures outlined in the protocol. Subjects were within ± 20% of ideal body weight for height and elbow width and weighed at least 60 kg (132 lbs). Subjects were in good health and had no previous clinically significant nasal surgery or polyps or other structural abnormalities of the nose, cardiovascular, gastrointestinal, renal, hepatic, ...

Embodiment 2

[0086] This study compared the pharmacokinetics of midazolam (MI) following administration of 2.5 mg and 5.0 mg intranasal (IN) MZ and 2.5 mg intravenous (IV) MZ in 18 healthy male and female subjects academic characteristics.

[0087] subjects

[0088] After obtaining consent, 18 non-smoking healthy subjects (9 males, 9 females) aged 20-29 years (average age 22.3 years) and weighing 60-92 kg (average 71 kg) participated in this study. An inpatient study. Seventeen of the volunteers participating in this study were Caucasian and 1 was African American. Seventeen subjects completed the study. Study participants were selected based on inclusion / exclusion criteria, medical history, physical and nasal examination, vital signs, laboratory tests, and other procedures outlined in the protocol. Subjects were within ± 25% of ideal body weight in relation to height and elbow width and weighed at least 60 kg (132 lbs). Subjects in the 18-45 age group are in good health and have no...

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Abstract

A pharmaceutical composition for intranasal administration to a mammal. The pharmaceutical composition comprises an effective amount of a benzodiazepine or pharmaceutically acceptable salt thereof; and a nasal carrier. In some embodiments, the pharmaceutical composition when administered intranasally produces a rapid physiological response. Pharmaceutical compositions may also include at least one or more sweeteners, flavoring agents, or masking agents or combinations thereof.

Description

[0001] This application is a continuation-in-part of U.S. Application Serial No. US10 / 418,260 filed April 15, 2003, which is U.S. Application Serial No. US09 / 790,199 filed February 20, 2001, the current U.S. Patent US6 , 610,271 continuation application. The disclosures of these applications are incorporated herein by reference in their entirety. technical field [0002] Benzodiazepines have been used in the prevention or treatment of a variety of clinical conditions based on their anxiolytic, hypnotic, anticonvulsant and antispasmodic properties. Certain benzodiazepines have also been shown to have antipanic, antidepressant, amnestic and anesthetic properties. Background technique [0003] The nascent benzodiazepines (chlorazepine and diazepam) had the traditional 1,4-diazepine ring structure and also had a 5-aryl substituent ring fused to the benzene ring. Numerous modifications of the 1,4-diazepine ring structure have produced compounds such as midazolam, which is a sho...

Claims

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Application Information

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IPC IPC(8): A61K31/55A61L9/14A61K9/00A61K47/10A61L2/04
CPCA61K9/0043A61K47/10A61K31/55A61P23/00A61P25/20A61P25/22A61P25/28
Inventor D·P·沃莫灵
Owner UNIV OF KENTUCKY RES FOUND