Injectable Botulinum Toxin Formulations

a technology of botulinum toxin and injection composition, which is applied in the direction of drug compositions, peptide/protein ingredients, immunological disorders, etc., can solve the problems of improper sterilization and sealing of food containers, unwanted paralysis in surrounding areas of the body, and dry skin, so as to reduce the tendency to undergo diffusion, reduce the effect of antigenicity and increase the duration of clinical efficacy

Inactive Publication Date: 2010-07-01
REVANCE THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0016]This invention provides injectable compositions comprising botulinum toxin non-covalently associated with a positively charged carrier molecule. In preferred embodiments, the compositions of the invention possess one or more advantages over conventional commercial botulinum toxin formulations, such as BOTOX® or MYOBLOC®. For instance, in certain embodiments, the composition

Problems solved by technology

When the horny layer loses its softness and flexibility it becomes rough and brittle, resulting in dry skin.
Spores of C. botulinum are found in soil and can grow in improperly sterilized and sealed food containers.
Botulism, which may be fatal, may be caused by the ingestion of the bacteria.
Its action essentially blocks signals that normally would cause muscle spasms or contractions, resulting in paralysis.
However, there are several problems associated with this approach.
The botulinum toxin may migrate from these subdermal wells to cause unwanted paralysis in surrounding areas of the body.
This problem is exacerbated when the area to be treated is large and many injections of toxin are required to treat the area.

Method used

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  • Injectable Botulinum Toxin Formulations
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Examples

Experimental program
Comparison scheme
Effect test

example 1

Duration Of Local Muscle Paralysis In A Murine Model

[0056]This example compares the duration of local muscle paralysis in mice injected with either RT003 or BOTOX®. RT003 is an exemplary injectable formulation according to the invention that contains type A botulinum toxin (purified to remove all endogenous non-toxin proteins) and positively charged carrier with the sequence RKKRRQRRRG-(K)15-GRKKRRQRRR. BOTOX® also contains type A botulinum toxin, but exogenous albumin is added to stabilize the type A botulinum toxin molecule.

[0057]The muscle paralysis was measured using digit abduction score (DAS) assay as reported by Aoki, K. R. in “A comparison of the safety margins of botulinum neurotoxin serotypes A, B, and F in mice”, Toxicon 2001; 39(12):1815-1820. In the DAS assay, a mouse is briefly suspended by its tail to cause a characteristic startle response in which the mouse extends its hind limbs and abducts its hind digits. The extent to which the mouse is able to exhibit this star...

example 2

Injectable Botulinum Toxin Formulations With an Improved Safety Profile

[0060]Over the last few decades, botulinum toxin has found use as a therapeutic agent for treating a variety of conditions, including wrinkles, hyperhidrosis, and muscle spasms. However, as botulinum toxin is the most potent naturally occurring toxin known to humans, improper administration of the toxin can be extremely dangerous. For instance, accidental systemic delivery of botulinum toxin can lead to paralysis, difficulty breathing, and even death. Moreover, even if botulinum toxin were properly delivered to a localized region of the body as a part of a therapeutic treatment, the toxin has a natural tendency to diffuse over time, thereby increasing the risk of unwanted paralysis in other parts of the body. For example, when botulinum toxin is injected around the eyes to treat wrinkles, it may diffuse to the muscles that control the movement of the eyelids. If this happens, the eyelid muscles may become partial...

example 3

Injectable Botulinum Toxin Formulations with Reduced Tendency to Generate Antibodies

[0072]When botulinum toxin is periodically injected into a patient to treat an unwanted condition such as wrinkles, it is often observed that efficacy of the botulinum toxin decreases with successive injections, even though the duration of the effects of the botulinum toxin may remain the same. This phenomenon is believed to be the result of the formation of antibodies to the botulinum toxin by the immune system of the patient. From a treatment perspective, the formation of antibodies to botulinum toxin by the patient is undesirable, because increasingly larger doses of botulinum toxin are then required to achieve the same effect, which presents serious issues related to both safety and cost.

[0073]In certain embodiments, this invention provides injectable botulinum toxin formulations that have a decreased tendency to induce antibody formation, as compared to currently available commercial injectable ...

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Abstract

This invention provides novel injectable compositions comprising botulinum toxin that may be administered to a subject for various therapeutic, aesthetic and/or cosmetic purposes. The injectable compositions contemplated by the invention exhibit one or more advantages over conventional botulinum toxin formulations, including reduced antigenicity, a reduced tendency to undergo unwanted localized diffusion following injection, increased duration of clinical efficacy or enhanced potency relative, faster onset of clinical efficacy, and/or improved stability.

Description

RELATED PATENT APPLICATION[0001]This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 61 / 142,063, filed Dec. 31, 2008, the contents of which are incorporated herein by reference in its entirety.FIELD OF THE INVENTION[0002]This invention relates to novel injectable compositions comprising botulinum toxin that may be administered to a subject for various therapeutic, aesthetic and / or cosmetic purposes.BACKGROUND OF THE INVENTION[0003]Skin protects the body's organs from external environmental threats and acts as a thermostat to maintain body temperature. It consists of several different layers, each with specialized functions. The major layers include the epidermis, the dermis and the hypodermis. The epidermis is a stratifying layer of epithelial cells that overlies the dermis, which consists of connective tissue. Both the epidermis and the dermis are further supported by the hypodermis, an internal layer of adipose tissue.[000...

Claims

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Application Information

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IPC IPC(8): A61K38/16A61K8/64A61P25/14A61P25/00A61P27/02A61P19/02A61P13/06A61P11/02A61P17/10A61P21/02A61P17/00A61P5/00A61Q19/08
CPCA61K8/64A61Q19/08A61K2800/91A61K2800/592A61P1/00A61P11/02A61P13/06A61P13/10A61P17/00A61P17/02A61P17/10A61P17/16A61P19/02A61P21/02A61P25/00A61P25/02A61P25/04A61P25/06A61P25/08A61P25/14A61P27/02A61P29/00A61P37/00A61P37/04A61P5/00Y02A50/30A61K9/08A61K39/08
Inventor RUEGG, CURTIS L.STONE, HONGRAN F.WAUGH, JACOB M.
Owner REVANCE THERAPEUTICS INC
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