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Dissolving film for delivery of a clostridial derivative

一种生物降解膜、生物降解的技术，应用在溶出膜领域，能够解决增加患者感染或错误剂量给药的风险、周期性的护理难以始终如一的保持、患者忘记等问题

Inactive Publication Date: 2020-03-24
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, patients may forget or be unable to keep appointments, and physician schedules may make it difficult to maintain regular, cyclical care consistently over the years
In addition, the need for continuous 3-6 toxin injections per year increases patient risk of infection or wrong dosing

Method used

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  • Dissolving film for delivery of a clostridial derivative
  • Dissolving film for delivery of a clostridial derivative

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0138] film composition

[0139] Film compositions were prepared by adding the indicated amounts of each component to a suitable solvent.

[0140] Table 2: Membrane Composition

[0141]

[0142]

Embodiment approach

[0144] 1. A method of treating rhinitis or symptoms of rhinitis, comprising:

[0145] Administering a biodegradable or biocompatible film to the nasal cavity of a subject, thereby alleviating one or more symptoms of rhinitis, the film comprising:

[0146] A therapeutically effective amount of an active ingredient of a Clostridial toxin;

[0147] at least one polymer selected from hydrophilic polymers and bioadhesive / mucoadhesive polymers; and

[0148] At least one of the following:

[0149] (a) at least one mucosal penetration enhancer; and

[0150] (b) at least one dissolution controlling agent.

[0151] 2. The method of embodiment 1, wherein the film comprises at least about 0.0056-560 ng of the Clostridial toxin active ingredient.

[0152] 3. The method of embodiments 1-2, separately or in combination, wherein the film dissolves in less than about 10 minutes at the site of administration.

[0153] 4. The method of embodiments 1-3, separately or in combination, wherein ...

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Abstract

A biodegradable film comprising a therapeutically effective amount of a Clostridial neurotoxin is described. Methods for treating rhinitis and for treating a symptom of rhinitis by administering the biodegradable film to the nasal cavity are also described.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Application Serial No. 62 / 527,212, filed June 30, 2017, which is incorporated herein by reference in its entirety. technical field [0003] The subject matter described herein relates to dissolution films for delivery of active agents to mucosal surfaces, for local delivery or systemic delivery of active agents. In particular, dissolution films comprising Clostridial toxins as active ingredients are described. [0004] Background of the invention [0005] The anaerobic, Gram-positive bacterium Clostridium botulinum produces a potent polypeptide neurotoxin, botulinum toxin, which causes the neuroparalytic disease known as botulism in humans and animals. Clostridium botulinum spores are found in soil and can grow in improperly sanitized and sealed food containers in home cannery, which has caused many cases of botulism. The effects of botulism usually appear 18 to ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K38/48A61K47/10A61K47/14A61K47/18A61K47/26A61K47/42A61P11/02
CPCA61K9/006A61K47/186A61P11/02A61K9/0043A61K38/4893A61K47/10A61K47/14A61K47/26A61K47/42A61K9/7007A61K47/36A61K47/32A61K47/34
Inventor M·F·布林P·M·休斯陆光伟
Owner ALLERGAN INC