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Buccal, polar and non-polar spray containing zolpidem

a technology of zolpidem and zolpidem, which is applied in the directions of drug composition, aerosol delivery, nervous disorders, etc., can solve the problems of presenting their own problems, and achieve the effect of rapid absorption through the oral mucosa and fast onset of

Inactive Publication Date: 2006-09-28
MAGNA PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention relates to a buccal aerosol spray or soft bite gelatin capsule that can be used for transmucosal administration of a pharmacologically active compound. The invention provides a fast-acting solution for those who need a fast-acting medication. The spray or gelatin capsule can contain a polar or non-polar solvent, and may optionally contain a flavoring agent. The invention also provides a method for preparing the spray or gelatin capsule using a propellant. The invention allows for quick absorption of the active compound through the oral mucosal membrane, resulting in a faster onset of effect.

Problems solved by technology

However, formulations suitable for such administration by these latter routes present their own problems.

Method used

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  • Buccal, polar and non-polar spray containing zolpidem
  • Buccal, polar and non-polar spray containing zolpidem

Examples

Experimental program
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Effect test

example 1

Biologically Active Peptides Including Peptide Hormones

[0073]

A. Cyclosporine lingual spraymost preferredAmountspreferred amountamountcyclosporine 5-5010-3515-25water 5-207.5-50 9.5-12 ethanol 5-607.5-50 10-20polyethylene glycol20-6030-4535-40flavors0.1-5  1-42-3B. Cyclosporine Non-Polar lingual spraymost preferredAmountspreferred amountamountcyclosporine 1-50 3-40 5-30Migylol202530-40Polyoxyethylated202530-40castor oilButane25-8030-7033-50flavors0.1-5  1-42-3C. Cyclosporine non-polar bite caosulemost preferredAmountspreferred amountamountcyclosporine 1-35 5-2510-20olive oil25-6035-5530-45polyoxyethylated25-6035-5530-45oleic glyceridesflavors0.1-5  1-42-3D. Cyclosporine bite capsulemost preferredAmountspreferred amountamountcyclosporine 5-5010-3515-25polyethylene20-6030-4535-40glycolglycerin 5-307.5-25 10-20propylene glycol 5-307.5-25 10-20flavors0.1-10 1-83-6E. Sermorelin (as the acetate) lingual sprayAmountspreferred amountmost preferredsermorelin (as the.01-5  .1-3  .2-1.0acetate...

example 2

CNS Active Amines and Their Salts: Including but not Limited to Tricyclic Amines, GABA Analogues, Thiazides, Phenothiazine Derivatives, Serotonin Antagonists and Serotonin Reuptake Inhibitors

[0074]

most preferredAmountspreferred amountamountA. Sumatriptan succinate lingual spraysumatriptan succinate0.5-30   1-2010-15ethanol5-607.5-50 10-20propylene glycol5-307.5-20 10-15polyethylene glycol0-6030-4535-40water5-307.5-20 10-15flavors0.1-5  1-42-3B. Sumatriptan succinate bite capsulesumatriptan succinate0.01-5   0.05-3.5 0.075-1.75 polyethylene glycol25-70 30-6035-50glycerin25-70 30-6035-50flavors0.1-10  1-83-6C. Clozepine lingual sprayclozepine0.5-30   1-2010-15ethanol5-607.5-50 10-20propylene glycol5-307.5-20 10-15polyethylene glycol0-6030-4535-40water5-307.5-20 10-15flavors0.1-5  1-42-3D. Clozepine non-polar lingual spray with propellantclozepine0.5-30   1-2010-15Migylol20-85 25-7030-40Butanol5-8030-7560-70flavors0.1-5  1-42-3E. Clozepine non-polar lingual spray without propellantclo...

example 3

Sulfonylureas

[0075]

mostAmountspreferred amountpreferred amountA. Glyburide lingual sprayglyburide0.25-25  0.5-20 0.75-15  ethanol 5-60−7.5-50   10-20propylene glycol 5-307.5-20 10-15polyethylene glycol 0-6030-4535-40water2.5-30  5-20 6-15flavors0.1-5  1-42-3B. Glyburide non-polar bite capsuleglyburide0.01-10  0.025-7.5 0.1-4  olive oil30-6035-5530-50polyoxyethylated oleic30-6035-5530-50glyceridesflavors0.1-5  1-42-3

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Abstract

Buccal aerosol sprays or capsules using polar and non-polar solvents have now been developed which provide zolpidem for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprise formulation I: aqueous polar solvent, zolpidem, and optional flavoring agent; formulation II: aqueous polar solvent, zolpidem, optionally flavoring agent, and propellant; formulation III: non-polar solvent, zolpidem, and optional flavoring agent; formulation IV: non-polar solvent, zolpidem, optional flavoring agent, and propellant; formulation V: a mixture of a polar solvent and a non-polar solvent, zolpidem, and optional flavoring agent; formulation VI: a mixture of a polar solvent and a non-polar solvent, zolpidem, optional flavoring agent, and propellant.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of application Ser. No. 10 / 230,060, filed Aug. 29, 2002, pending, which is a continuation-in-part of application Ser. No. 09 / 537,118, filed Mar. 29, 2000 which is a continuation-in-part of the U.S. national phase designation of PCT / US97 / 17899 filed Oct. 1, 1997, the disclosures of which are incorporated by reference herein in their entirety.BACKGROUND OF THE INVENTION [0002] It is known that certain biologically active compounds are better absorbed through the oral mucosa than through other routes of administration, such as through the stomach or intestine. However, formulations suitable for such administration by these latter routes present their own problems. For example, the biologically active compound must be compatible with the other components of the composition such as propellants, solvents, etc. Many such formulations have been proposed. For example, U.S. Pat. No. 4,689,233, Dvorsky et...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61L9/04A61K9/00A61K9/40A61K31/437A61P25/20
CPCA61K9/0056A61K9/006A61K9/12A61K9/4866A61K31/437A61K31/4745A61P25/20A61K9/28
Inventor DUGGER, HARRY A. IIIABD EL-SHAFY, MOHAMMED
Owner MAGNA PHARMA INC
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