Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2001-01-25
2003-05-06
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S422000, C424S078040, C424S423000, C424S426000, C424S428000, C424S400000, C424S078020
Reexamination Certificate
active
06558688
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to ocular tissue regeneration inducers. The present invention also relates to methods for inducing the regeneration of ocular tissues.
2. Discussion of the Background
Among the ocular tissues, there are three highly transparent tissues, namely the cornea, crystalline lens and vitreous body. Conventionally, when the transparency of such tissues is found to be decreased, the part in question is surgically cut out, followed by grafting of the cornea from a donor in the case of the cornea, insertion of an intraocular lens made of a polymethyl methacrylate material in the case of the crystalline lens, or injection of air or a silicone oil in the case of the vitreous body. In particular, in the treatment of cataracts in which the crystalline lens becomes opaque, the method which comprises excising the crystalline lens and inserting an intraocular lens into the lens capsule has become widespread owing to the advancement in technique and the advent of improved intraocular lens, which is substitute for the crystalline lens (cf. JP Kokai H02-255151 and JP Kokai H05-117399, among others).
SUMMARY OF THE INVENTION
However, the above-mentioned method which inserting an intraocular lens cannot realize that accommodative function which is intrinsic in the crystalline lens to a satisfactory extent but, instead, has drawbacks, such as, for example, the range of accommodation is narrowed and the time required for focusing is prolonged.
Under these circumstances, there remains a need for a technique capable of recovering the functions intrinsic in the crystalline lens after excision of the opacified crystalline lens.
Accordingly, it is one object of the present invention to provide novel agents capable of inducing the regeneration of ocular tissues such as the cornea, the crystalline lens, and the vitreous body.
It is another object of the present invention to provide novel methods for inducing the regeneration of ocular tissues such as the cornea, the crystalline lens, and the vitreous body.
As a result of intensive investigations made by the present inventors in search of a physiologically active substance which, when administered into ocular tissues, can induce the regeneration of ocular tissues, it was unexpectedly found that when a hydrophilic polymer mainly composed of alkylene glycol units or vinyl monomeric units having a nondissociating hydrophilic group is administered into ocular tissues, the ocular tissues can be regenerated. Based on that finding, the present invention has now been completed.
Thus, in a first embodiment, the present invention provides an ocular tissue regeneration inducer which comprises, as an active ingredient, a hydrophilic polymer mainly composed of alkylene glycol units or vinyl monomeric units having a nondissociating hydrophilic group.
In a second embodiment, the present invention provides a method for inducing ocular tissue regeneration inducer, which comprises, administering to a subject in need thereof a composition, which comprise, as an active ingredient, a hydrophilic polymer mainly composed of alkylene glycol units or vinyl monomeric units having a nondissociating hydrophilic group.
The ocular tissue regeneration inducer and method of the invention are clinically useful for inducing the regeneration of ocular tissues such as the cornea, crystalline lens and vitreous body.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Thus, in a first embodiment, the present invention provides an ocular tissue regeneration inducer which comprises, as an active ingredient, a hydrophilic polymer mainly composed of alkylene glycol units or vinyl monomeric units having a nondissociating hydrophilic group.
The ocular tissue regeneration inducer according to the invention comprises, as an active ingredient, a hydrophilic polymer mainly composed of alkylene glycol units or vinyl monomeric units having a nondissociating hydrophilic group (hereinafter, such polymer is sometimes referred to also as “hydrophilic polymer”).
In describing the present invention, the term “vinyl monomeric units having a nondissociating hydrophilic group” (hereinafter sometimes referred to also as “hydrophilic vinyl monomeric units”) means vinyl monomeric units free of dissociating groups capable of dissociating in the presence of water or moisture to generate an anion or cation (e.g. carboxyl group, sulfonic acid group, other acidic groups, salts thereof; alkaline groups such as amino group, or salts thereof) but having, within the molecule, a hydrophilic group or bond providing hydrophilic properties. As the nondissociating hydrophilic group, there may be mentioned a hydroxyl group, an amide bond, an acid anhydride group (group of the formula —CO—O—CO—) and the like. The hydrophilic vinyl monomeric units may have only one species selected from among a hydroxyl group, an amide group and an acid anhydride group or may have two or three of those species. Preferred as the hydrophilic group is a hydroxyl group and/or an amide bond.
The term “vinyl monomeric unit” as used herein means a monomeric unit derived from a monomer having a polymerizable double bond.
As the alkylene glycol units or hydrophilic vinyl monomeric units, which constitute the hydrophilic polymer mentioned above, there may be mentioned monomer units derived from alkylene glycols such as ethylene glycol and propylene glycol; vinyl alcohol; hydroxyl group-containing (meth)acrylic esters such as 2-hydroxyethyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2,3-dihydroxypropyl (meth)acrylate, polyethylene glycol mono(meth)acrylate, and polypropylene glycol mono(meth)acrylate; N-vinyllactams such as N-vinyl-2-piperidone, N-vinyl-2-pyrrolidone, N-vinyl-6-hexanelactam, N-vinyl-3-methyl-2-pyrrolidone, N-vinyl-3-methyl-2-piperidone, N-vinyl-3-methyl-6-hexanelactam, N-vinyl-4-methyl-2-pyrrolidone, N-vinyl-4-methyl-2-piperidone, N-vinyl-4-methyl-6-hexanelactam, N-vinyl-5-methyl-2-pyrrolidone, N-vinyl-5-methyl-2-piperidone, N-vinyl-5-methyl-6-hexanelactam, N-vinyl-6-methyl-6-hexanelactam, N-vinyl-3-ethyl-2-pyrrolidone, N-vinyl-4,5-dimethyl-2-pyrrolidone, and N-vinyl-5,5-dimethyl-2-pyrrolidone; (meth)acrylamides such as (meth)acrylamide, N,N-dimethyl(meth)acrylamide, N,N-diethyl(meth)acrylamide, N-hydroxymethyl(meth)acrylamide, N-(2-hydroxyethyl)(meth)acrylamide, and diacetone (meth)acrylamide; N-vinyl cyclic imides such as N-vinylsuccinimide and N-vinylmaleimide; N-vinylamides such as N-vinylformamide and N-vinylacetamide; 3-methylene-2-pyrrolidone; maleic anhydride; and so forth. These may be used singly or two or more of them may be used in combination. Preferred among these from the inducing ability of the ocular tissue regeneration are alkylene glycol units, vinyl alcohol units and N-vinyllactam units, more preferably vinyl alcohol units and N-vinyllactam units. Among the N-vinyllactam units, N-vinyl-2-pyrrolidone units are preferred.
The content of alkylene glycol units or hydrophilic vinyl monomeric units in the hydrophilic polymer is preferably within the range of 50 to 100 mole percent, more preferably within the range of 65 to 100 mole percent, still more preferably within the range of 75 to 100 mole percent. For adjusting the water solubility and/or viscosity, for instance, the hydrophilic polymer may contain hydrophobic monomeric units derived from alkyl (meth)acrylates such as methyl (meth)acrylate, butyl (meth)acrylate, and cyclohexyl (meth)acrylate; fluorine-containing (meth)acrylates such as trifluoroethyl (meth)acrylate; siloxane-containing (meth)acrylates such as tris(trimethylsiloxy)silylpropyl (meth)acrylate; vinyl esters such as vinyl acetate, vinyl butyrate, and vinyl hexanoate; and the like. The content of such hydrophobic monomeric units is preferably not more than 50 mole percent, more preferably not more than 35 mole percent, still more preferably not more than 25 mole percent.
From the viewpoint of the viscosity and ocular tissue regeneration inducing effect of the ocular tissue regeneration inducer, the
Fujitani Takumi
Higaki Tatsuhiko
Kakimaru Yoshimi
Makabe Takashi
Saishin Mototsugu
Bennett Rachel M.
Kuraray Co. Ltd.
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
Page Thurman K.
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