Bioadhesive antibacterial wound healing composition

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

Reexamination Certificate

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C514S458000, C514S886000, C514S887000, C514S904000

Reexamination Certificate

active

06329343

ABSTRACT:

FIELD OF THE INVENTION
This invention pertains to therapeutic bioadhesive wound-healing compositions useful for treating wounds. More particularly, the bioadhesive wound-healing compositions comprise pullulan and wound-healing agents and/or metabolites thereof. This invention also pertains to methods for preparing and using the bioadhesive wound-healing compositions and the pharmaceutical products in which the therapeutic compositions may be used.
BACKGROUND OF THE INVENTION
Wounds are internal or external bodily injuries or lesions caused by physical means, such as mechanical, chemical, viral, bacterial, or thermal means, which disrupt the normal continuity of structures. Such bodily injuries include, e.g., contusions, wounds in which the skin is unbroken, incisions, wounds in which the skin is broken by a cutting instrument, and lacerations, wounds in which the skin is broken by a dull or blunt instrument.
A wide variety of products have been developed that enhance the body's ability to heal itself when wounded. These products typically function by medicating the wound, isolating the wound from infectious agents, and/or by binding the wound to prevent wound growth and to minimize the gap that the body's natural repair mechanisms must bridge to heal the wound.
For example, U.S. Pat. No. 5,856,364 to Martin discloses a therapeutic antiviral wound-healing composition comprising an antiviral agent and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin E acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,692,302 to Martin et al. discloses a razor cartridge comprising a wound-healing composition delivery system fixed to the cartridge. The wound-healing composition comprises effective amounts of pyruvate; an antioxidant, preferably Vitamin B acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,674,912 to Martin discloses a sunscreen wound-healing composition comprising a sunscreen agent, an anti-inflammatory agent and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin B acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,663,208 to Martin discloses an anti-fungal wound-healing composition comprising an anti-fungal agent and a wound-healing composition effective amounts of pyruvate; an antioxidant, preferably Vitamin B acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,658,957 to Martin discloses an immunostimulating wound-healing composition comprising an immunostimulating agent and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin E acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,658,956 to Leung and Martin discloses a bioadhesive wound-healing composition comprising a bioadhesive agent and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin B acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,652,274 to Martin discloses a therapeutic wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin E acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,648,380 to Martin discloses an anti-inflammatory wound-healing composition comprising an anti-inflammatory agent and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin E acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,646,190 to Martin discloses an acne treating wound-healing composition useful for the topical treatment of acne vulgaris tretinoin and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin E acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,641,814 to Martin discloses an antikeratolytic wound-healing composition comprising an antikeratolytic agent and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin B acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,633,285 to Martin discloses a cytoprotective wound-healing composition comprising a cytotoxic agent and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin B acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,614,561 to Martin discloses an antihistamine wound-healing composition comprising an antihistamine and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin E acetate; and a mixture of saturated and unsaturated fatty acids.
U.S. Pat. No. 5,602,183 to Martin et al. discloses a dermatological wound-healing composition useful to minimize and treat diaper comprising a therapeutically effective amount of a buffering agent to maintain the pH of the composition and a wound-healing composition comprising effective amounts of pyruvate; an antioxidant, preferably Vitamin B acetate; and a mixture of saturated and unsaturated fatty acids.
The foregoing Martin patents do not disclose wound-healing compositions comprising pullulan, unlike the following patents.
U.S. Pat. No. 5,722,942 to Tanaka et al. discloses wound covering materials suitable for protection and treatment of wounds. The materials comprise: (a) 1 part by weight of glucomannan; (b) 0.20-0.99 part by weight of a solubility modifier comprising pullulan or carrageenan; (c) 0.10-12 parts by weight of a physiologically acceptable adhesive polymer base; and (d) 0.20-20 parts by weight of at least one plasticizer selected from the group consisting of polyhydric alcohols, sugar alcohols, monosaccharides, disaccharides and oligosaccharides. The materials are provided in the form of a film or a laminate of a film and another sheet material.
U.S. Pat. No. 5,618,799 to Inagi et al. discloses a powder preparation for healing damaged skin, which comprises: (a)50-90 wt. % sucrose; (b) 0.5-10 wt. % povidone-iodine; and (c) a water-soluble polymer selected from the group consisting of polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid and salts thereof, pullulan, carboxyvinyl polymers, methylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, and carboxymethylcellulose and salts thereof.
U.S. Pat. No. 4,844,898 to Komori et al. discloses a wound-healing preparation which comprises 50-90 wt. % of a sugar, 0.5-10 wt. % of povidone-iodine, 1-20 wt. % of water, 0.1-5 wt. % of an agent for imparting an appropriate consistency and stability selected from polysaccharides and derivatives thereof, and a buffer in an amount sufficient to adjust the pH of the preparation to 3.5-6. The polysaccharide can be, e.g., dextrin, gum arabic, pullulan, chondroitin sulfate, methylcellulose, sodium carboxymethylcellulose and the like.
U.S. Pat. No. 5,518,902 to Ozaki et al. discloses high pullulan content products, such as ointments and cosmetic packs. The products can include a variety of ingredients in addition to pullulan, such as other polysaccharides, polyhydric alcohols, and antiseptics.
U.S. Pat. No. 5,411,945 to Ozaki et al. discloses a pullulan binder and products produced therewith, including a facial pack. The products can include a variety of ingredients in addition to pullulan, such as other polysaccharides, antibacterial agents, pharmaceutically active substances and biologically active substances.
Despite the existence in the prior art of wound-healing compositions containing pullulan, there is still room for improvement in such compositions, and in processes for making them.
All references cited herein are incorporated herein by reference in their entireties.
SUMMARY OF THE INVENTION
The invention provides a bioadhesive composition comprising pullulan, pyruvate, an antioxidant, and a mixture of saturated and unsaturated fatty acids adapted to resuscitate injured mammalian

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