Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Aftertreated polymer
Reexamination Certificate
2001-01-09
2002-09-03
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
Aftertreated polymer
C424S400000, C424S443000, C424S485000
Reexamination Certificate
active
06444199
ABSTRACT:
The present invention relates to amorphous solid borate-diol interaction products. More particularly, but not exclusively, the present invention relates to solid products formed by interaction of polymeric cis-1,2-diols with borate ion and suited for wound came and other uses.
BACKGROUND OF THE INVENTION
The reaction of sodium tetraborate with cis-1,2-diols to form amorphous solids has been well documented, notably for polyvinyl alcohol, but also for naturally occurring materials such as konjac, guar and locust bean gum. Examples of the use of this reaction to prepare products suited for medical and related purposes are extensive.
EP-A 056,420 describes an eye gel of at least one ophthalmic medicament, polyvinyl alcohol (1 to 3%), a borate gelling agent (0.1 to 1.0%), and sterile water. The gel is maintained at a pH of 6.5 to 8.5, preferably 6.9 to 8.5. The ophthalmic gel is said to be a long acting, topical medicament which has a pH that is compatible with injured eyes and has uniform release characteristics.
U.S. Pat. No. 4,624,868 relates to dried absorbent particles, where guar gum as an exemplification of cis-1,2-diol polysaccharides is first hydrated then thickened by cross-linking with borax and finally dried to a powder to flake form, preferably by freeze drying. The resulting particles can absorb up to 100 times their weight or more of aqueous fluids such as urine and are employed in disposable diapers, bandages, and the like.
U.S. Pat. No. 4,362,781 describes a premoistened wiper comprising a non-woven web impregnated with a modified guar gum (phosphated, 5 to 14% of fiber weight) and wet with an aqueous lotion containing borate ions. The lotion also contains an organic hydroxy or keto acid or salt thereof (such as potassium citrate) capable of completing with borate ions.
U.S. Pat. No. 3,998,215 describes an electrically conductive pad conformable to the surface of the human body and adapted to facilitate the transfer of electrical signals between the body and an electrode. The pad comprises a porous, fibrous carrier having a lightly adherent, conductive hydrogel carried thereby, the hydrogel impregnating and surfacing both sides of the earner and the hydrogel being more cohesive to the hydrogel than adhesive to the surface of the human body to enable residue-free removal from the skin. The hydrogel can comprise a mixture of water, polyvinyl alcohol, sodium borate decahydrate and a fungicide, the water being present in at least about 70% by weight.
PCT/WO 95/17147 relates to fibers coated with particles of a galactomannan, or derivative thereof, cross-linked with borate. Guar and its derivatives are preferred.
U.K. Patent 1,174,139 is concerned with a dilutent composition which comprises a solution comprising;
(A) water,
(B) from 0.5 to 10%, by weight, based on the weight of the solution, of a water-soluble polymer of vinyl alcohol or an ester thereof,
(C) from 0.001 to 5% by weight, based on the weight of the solution, of an alkali metal borate or hydrate thereof, and
(D) from 5 to 10%. by weight, based on the weight of the solution, of a polyol.
Soviet Union Patent 1.795.672 describes a composition which contains (by weight) water 100, polyvinyl alcohol 4.7 to 14.07, sodium tetraborate 0.16 to 0.45, aerosil or white silica 3.75 to 11.25 and an acetamide or acrylamide or saccharose additive 0.23 to 7.5. The product has a gel-like or rubbery consistency and is prepacked in sectioned polyethylene capsules. Prior to use, the prepacked material is chilled in the freezing compartment of a domestic refrigerator. It can produce skin temperatures down to −3 to −7° C. and can be recycled.
DE-A 4,007,668 is concerned with hydrogel foams based on gelatin and water optionally containing polyvinyl alcohol, together with a crosslinking agent which can be boric acid or a borate, and an organic or inorganic acid or salt, optionally with organic plasticizers and/or auxiliary agents and/or additives. The foam can be used for instance in the protection of wounds before drying out.
U.S. Pat. No. 5,071,648 relates to a composition comprising acetalized polyvinyl alcohol complexed with iodine, wherein the composition is capable of releasing free iodine in the presence of water. The acetalized polyvinyl alcohol may be further complexed with a borate. The acetalized PVA is preferably an hydroxylated polyvinyl acetal sponge.
PCT/WO 92/03172 is directed at a bandage, dressing or support matrix having a biocompatible open-pored plastic foam with a hydrogel embedded in the pores. The hydrogel is suitably formed from a borate-modified guar gum.
SUMMARY OF THE INVENTION
The present invention is directed at a different kind of interaction product which can be obtained from reaction of diols with borate. More especially, the present invention is concerned with amorphous solid products formed by interaction of polymeric cis-1,2-diols with borate ion and suited for wound care and other uses. Fluid handling and flow characteristics can be controlled and modified to fill specification needs.
PREFERRED EMBODIMENTS
At pH values between about 7.5 and 8.5, the borate ion from a borate salt or formed in situ from boric acid interacts with polymers containing cis-1,2-diols to form more viscous or amorphous solid systems. The polymeric diols can be synthetic, semi-synthetic, or natural. Some of the more common polymers undergoing this reaction are the polyvinyl alcohols and polysaccharides including galactomannans, such as guar and locust bean-gum, and glucomannans, such as konjac and Aloe (ace) mannans. Depending on the concentration of the polymer or polymers, the borate, and other additives, if any, the consistency can vary from somewhat viscous fluids to crisp amorphous solids. At selected concentrations of the components, the reaction products behave like self-restoring or healable solids that will flow at body temperatures. This property gives them possible value as wound-cavity fillers or wound putties. Other soluble and insoluble components can be added to impart desired properties, such as increased body-fluid absorption or fluid donation.
Although the principle use envisaged for the product of this invention is for the wound cavity-fillers, a number of other medical and non-medical markets can be envisioned. These possible uses include drug delivery, prosthetics and pads (fillers or in situ-formed coatings), and the toy and possibly executive stress-reliever markets.
For use as a wound cavity-filler, the product must be firm enough to handle, yet flow at body temperature to meet wound shape in about 10 to 30 seconds. The product needs to be easy to handle and either absorb or donate moisture, or both. Materials used must be biocompatible, non-toxic, and non-cytotoxic. In this respect, samples of PVA (5% and 20%) with added borate exhibited no cytotoxicity when tested on L929 mouse fibroblasts. Being sterilizable by gamma irradiation, autoclaving, or some other means is desirable.
Preparation of these amorphous solids preferably comprises forming a sol of the diol, and thermostable additives, if any, by dispersing the components in cool water, heating the mixture to boiling, adding hot aqueous sodium tetraborate, and allowing to cool. Other components can be added at suitable temperatures. If film preparation is desired, the hot sol can be distributed on a surface to form a film and the film is then used directly or is dried. For powders or granules, the solid diol can be triturated with a concentrated solution of sodium tetraborate or other borate source, with or without glycerol. For in situ-formed coatings, a sponge, cloth, gauze, or other material to be coated can be dipped into the hot mix, removed and drained, and optionally dried. Alternatively, the coatings can be applied by successively dipping the material to be coated into the borate solution, draining, blotting, blowing, or squeezing to remove the excess, if desired; dipping next into a cis-1,2-diol polymer solution, with or without additives; and finally again into the borate solution. If desired, this series can be repeat
Advanced Medical Solutions Limited
Fubara Blessing
Page Thurman K.
Woodard Emhardt Naughton Moriarty & McNett
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