Controlled-delivery system of pharmacologically active substances, preparation process and medical use thereof

摘要

The invention concerns a system for biocompatible drug release comprising: (i) a polymer matrix; (ii) an inorganic component located inside said matrix and characterized by a lamellar structure with a net positive or negative charge able to intercalate (iii) a pharmacologically active principle into said lamellar structure, by establishing an ionic type of bond with it and thereby obtaining an intercalation compound. The preparation process for the release system comprises the stages of: treating the lamellar solid in such a way as to give it a net positive or negative charge, then combining it with the chosen active principle, also in an ionic form, to obtain an intercalation compound which is then mixed with the polymer matrix. The release system can be employed in making medical devices, like sutures, membranes, osteosynthesis plaques, multilayered devices, gels and drug delivery systems.

主权项

1. A biocompatible delayed release system comprising:
(i) a polycaprolactone polymer matrix, wherein the biocompatible delayed release system comprises about 30% to 90% by weight of polymer matrix, and the polymer matrix formulated as a lamellar charged structure; and (ii) an intercalation compound dispersed inside the polycaprolactone polymer matrix, wherein the intercalation compound comprises:
(a) an inorganic hydrotalcyte component having a lamellar structure with a neutralized net positive or negative charge; and(b) a diclofenac intercalated within said hydrotalcvte lamellar structure and having an ionic bond with the inorganic hydrotalcyte component, wherein the intercalated combination of the inorganic hydrotalcyte component and of the diclofenac constitutes the intercalation compound, and the diclofenac is present in a quantity ranging from between about 1% to 50% by weight as compared to the inorganic hydrotalcyte component, and the concentration of the intercalation compound in the biocompatible delayed release system is between about 1% and 10%, and wherein the delayed release system has a two stage release profile.