US-12622860-B2 - Kits and methods of using ascorbates to modify polysaccharide fillers and delivery systems

Abstract

Embodiments of the present invention are directed to kits, compositions and methods for modifying and altering polysaccharide fillers and drug delivery systems with the application of an ascorbate.

Inventors

• Richard Burtt

Assignees

• ADVANCED AESTHETIC TECHNOLOGIES, INC.

Dates

Publication Date

20260512

Application Date

20201217

Claims (3)

1. 1 . A method of fluidizing an agarose gel mass solely with ascorbic acid, the method consisting of a step of administering in vivo an effective amount of a solution consisting of 500 mg/ml ascorbic acid directly to the to the agarose gel mass to fluidize the agarose gel mass to a desired fluidized form, wherein the ascorbic acid is injectable ascorbic acid, the agarose gel mass is solely fluidized by the ascorbic acid, and the fluidized form can be suctioned by needles.
2. 2 . The method of claim 1 wherein said mass is a dermal filler.
3. 3 . The method of claim 1 wherein said mass is a delivery vehicle for one or more drugs.

Description

RELATED APPLICATION INFORMATION This application is a divisional of U.S. patent application Ser. No.: 16/097,941, filed Oct. 31, 2018, which is a 371 U.S. National Phase of PCT/US2017/039506, filed Jun. 27, 2017, which claims priority to U.S. Provisional Application No. 62/355,086, filed Jun. 27, 2016. The contents of these applications are incorporated herein by reference in their entirety. STATEMENT REGARDING FEDERAL FUNDING Embodiments of the present invention were not conceived or reduced to practice with Federal sponsorship. BACKGROUND OF THE INVENTION Polysaccharides are used as cosmetic fillers and as a component of injectable drug delivery systems. When polysaccharides are placed in the body as a filler or as a drug delivery system, the polysaccharides may have a long period of time before such are resorbed into the body through metabolism or other means. SUMMARY OF THE INVENTION Embodiments of the present invention facilitate the use of polysaccharides, particularly as such polysaccharides are used as fillers and drug delivery vehicles. Embodiments of the present invention allow the polysaccharide to be modified in vivo or in vitro to impart special physical and chemical properties. For example, without limitation, the physical properties of texture, feel, resistance to pressure, viscosity and the like can be altered or modified, in vivo or in vitro. Similarly, the chemical properties, resistance to degradation and speed, of degradation can be modified or altered. The modification of physical and chemical features of a polysaccharide used as a filler or drug delivery system allows the health practitioner to modify the filler mass after it has been placed in the body or prior to placement in the body. As used herein, the term, “mass” refers to the polysaccharide material and the surrounding space it occupies. For example, polysaccharide fillers used for cosmetic purposes typically comprise solutions of 1.0 to 5.0%. These solutions may also comprise other materials to improve the flow or feel of the filler, such as hyaluronic acid, and anesthetic agents to address the potential discomfort during the administration of the filler. Anesthetic agents are well known in the art and include, without limitation, lidocaine. These fillers are administered to the deep layer of the skin. An example of a filler of this type is described in PCT/IB2014/060322 to Ghimas SPA, the entire content of which is incorporated herein by reference. One embodiment of the present invention is directed to a method of altering or modifying a mass comprising a polysaccharide held in the body of an animal. The method comprises the steps of administering an effective amount of ascorbate to the mass. The ascorbate can be administered to the mass prior to the mass being placed in the body or after the mass has been placed in the body. One embodiment of the method features a polysaccharide having one or more sugars selected from the group consisting of D-galactose and 3,6-anhydro-L-galactopyranose. These sugars are the constituents of agarose. Agarose is used as a dermal filler and as a drug delivery vehicle. As used herein, a “drug delivery vehicle” comprises a polysaccharide and one or more drugs. As used herein, the term “ascorbate” refers to ascorbic acid and its salts and oxidized forms such as dehydroascorbic acid. Ascorbic acid is commonly known as Vitamin C As used herein, ascorbate refers to both the levo and dextro forms. Ascorbate alters the form of the polysaccharide, increasing its dissolution, breaking down and fluidizing the mass. One embodiment of the present invention features an injectable ascorbic acid, such as Vitamin C As used herein, the term “an effective amount” refers to an amount to cause the polysaccharide to assume a desired fluidized form. The desired fluidized form refers to an more fluid form compared to agarose of same polymer composition and hydration without an ascorbate being present. Wherein the mass is a delivery vehicle for one or more drugs, the ascorbate has utility to facilitate removal of the polysaccharide, control the delivery or release of drug, address hardness, graininess or nodules in the mass and minimize the mark on the skin from the injection of drug. For example, without limitation, one embodiment of an invention directed to a drug delivery system comprises a polysaccharide and an ascorbate held in a vessel for reconstitution. Upon reconstitution, the ascorbate maintains the polysaccharide in a more fluid state. This fluid may continue after injection of the drug delivery system into a patient. As used herein, the term “drug” is used to refer to any compound or compounds used to effect a biological change or treat a medical condition. The drug may be incorporated into the polysaccharide prior to reconstitution or after reconstitution. Examples of drugs include without limitation, lidocaine, and other anesthetic agents, onabotulinemtoxin A (BOTOX®, Allergan) and other aesthetic agents.