Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Patent
1998-04-13
1999-12-14
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
424494, 424426, 424423, A61K 914
Patent
active
06001394&
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The invention relates to an injectable composition for a biomaterial for filling supporting organic tissues, intended to give rise to a resorption/substitution function.
BACKGROUND OF THE INVENTION
Bony substitutes based on calcium phosphate particles and a biological adhesive are known from the state of the art.
Thus, G. Daculsi et al. have described in Ann. Oto. Rhino. Laryngol. 101:1992 the effectiveness of a calcium phosphate two-phase microporous composition for obliterating the mastoid cavity.
The same authors have also reported the effectiveness of a two-phase calcium phosphate macroporous composition for surgical repair of long bones (Journal of Biomedical Materials Research, Vol. 24, 379-396) and in vertebral arthrodeses (Clinical Orthopaedics and Related Research, 248, 1989, 169-175).
The usefulness of calcium phosphates in odontology has been demonstrated in a number of articles: A. Jean et al. in Cells and materials 1993; 3: 193-200. "Pulpal response to calcium phosphate materials. In vivo study of Calcium Phosphate materials in Endodontics"; B. Aliot-Licht et al. in Arch. Oral Biol. 1994; 39: 481-489 "Comparative effect of calcium hydroxide and hydroxyapatite on the cellular activity of human pulpal fibroblasts. An in vivo approach."
Furthermore, JP 3 011 006 describes a cement for hard tissues including an inorganic phase consisting of at least 60% of alpha tricalcium phosphate and of hydroxy-apatite and/or a calcium monophosphate, and a liquid phase including carboxymethyl cellulose.
However, such a composition exhibits the disadvantage, due to the excessive solubility of .alpha. tricalcium phosphate, of not being sufficiently stable to permit a process of resorption/substitution of the hard tissue. Furthermore, such a composition is liable to give rise to detrimental inflammatory processes. Furthermore, this mixture constitutes a calcium ionomer which is not suitable for injection after a few minutes, due to hardening of the mixture as soon as it is made up. This combination exhibits a double instability, a contraction in volume with release of water after several days and, above all, a drop in viscosity after sterilization of the mixture in the autoclave. It does not make it possible to produce a material which is "ready for use", sterile and injectable.
OBJECT OF THE INVENTION
The object of the present invention is to provide a biomaterial composition filled with mineral phase, capable of being reinhabited, injectable and curing in situ in the implantation site.
In particular, this composition must exhibit the following properties:
it must be sterilizable;
it must not be toxic in vivo;
it must have a high mineral filling inducing a mineralization front and/or a tissue cicatrization;
it must include a dispersing agent acting as a vector which carries the mineral filler into the operating site and which then holds it at this site until the tissue cicatrization, while acting as a matrix for composite material;
it must be capable of being introduced into a biological medium, especially by injection with a syringe or an apparatus of "lentula" type employed in dental surgery (a so-called lentulable composition), in the fluid or pasty state, before curing in contact with the buffered biological fluids;
it must be stable in order to be capable of being stored for a relatively long time before use;
it must be easy to use.
SUMMARY OF THE INVENTION
This objective has been attained by the present invention, the subject-matter of which is a composition for a biomaterial for resorption/substitution of supporting organic tissues, comprising:
20 to 75% by weight of an inorganic phase consisting of particles including either hydroxyapatite (A), optionally mixed with .beta. tricalcium phosphate (B), or calcium titanium phosphate (Ca(Ti).sub.4 (PO.sub.4 ).sub.6) (C), and
80 to 25% by weight of a liquid phase including an aqueous solution of a water-soluble, biocompatible polymer self-crosslinkable under the effect of the pH of the medium.
The inorganic phase based on particl
REFERENCES:
patent: 5717006 (1998-02-01), Daculsi et al.
Daculsi Guy
Dupraz Anne
Lapkowski Mieczyslam
Weiss Pierre
Benston, Jr. William E.
Centre National de la Recherche Scientifique (C.N.R.S.)
Page Thurman K.
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