Injectable Botulinum Toxin Formulations And Methods Of Use Thereof Having Long Duration Of Therapeutic Or Cosmetic Effect

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 embraced 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. According to the invention, single treatment of the compositions by injection affords significant clinical responses and at least a 6-month duration of effect in a subject undergoing treatment, as provided by the described treatment methods.

Description

FIELD OF THE INVENTION[0001]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. The injectable compositions and methods in which these compositions are used provide advantageous treatments which result in high responder rates and long duration of effect, for example, a duration of effect for over 20 to 24 weeks and longer.BACKGROUND OF THE INVENTION[0002]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.[0003]The e...

AI Technical Summary

Benefits of technology

This patent describes a new type of injectable composition that includes a modified form of the neurotoxin botulinum toxin, called non-covalently associated with a positively charged carrier molecule. This new composition has several advantages over existing commercial formulations of botulinum toxin, including reduced antigenicity, improved diffusion through tissues, and increased stability. The new composition can also be used in combination with other non-native molecules to enhance its diffusion through tissues. The patent also describes a method for reducing wrinkles and lines in the face using this new composition, which can provide a long-lasting effect for several months. Overall, this patent provides a new and improved approach for creating injectable compositions of botulinum toxin with improved efficacy and safety.

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.

Moreover, because the injected toxin complexes contain non-toxin proteins and albumin that stabilize the botulinum toxin and increase the molecular weight of the toxin complex, the toxin complexes have a long half-life in the body and may cause an undesirable antigenic response in the patient.

For example, some patients will, over time, develop an allergy to the albumin used as a stabilizer in current commercial formulations.

When this happens, subsequent injections must be carefully placed so that they do not release a large amount of toxin into the bloodstream of the patient, which could lead to fatal systemic poisoning, especially since the non-toxin proteins and albumin stabilize the botulinum toxin in blood.

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