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Modified release microparticles based on amphiphilic copolymer and active ingredient (s) and pharmaceutical formulations comprising the same
专利权人:
FLAMEL TECHNOLOGIES
发明人:
ALAIN CONSTANCIS,YOU-PING CHAN
申请号:
BRPI0714943
公开号:
BRPI0714943A2
申请日:
2007.07.30
申请国别(地区):
BR
年份:
2013
代理人:
摘要:
MODIFIED RELEASE MICROParticles based on amphiphilic copolymer and active principles and pharmaceutical formulas comprising the same. The present invention relates to novel microparticles formed of amphiphilic polyamino acids which carry active ingredient (s), PA (s), in particular protein active ingredient (s) and peptides, and to novel pharmaceutical release formulations. comprising said PA microparticles. The object of the invention is to develop novel PA-loaded microparticles obtained by aggregation of amphiphilic polyamino acid nanoparticles having improved properties, in particular in dry solid form, in relation to their dispersibility and, as regards suspension reconstituted, its stability and its ability to be easily manipulated and injected. The invention primarily relates to amphiphilic polyamino acid (PO) microparticles comprising at least one (non-covalently associated) PA which spontaneously forms a colloidal suspension of nanoparticles in water, pH 7.0, under isotonic conditions; whose microparticles a. are obtained by atomizing a colloidal solution or suspension of PO comprising at least one PA, b. they are between 0.5 and 100 microns in size, and are dispersible in colloidal suspension. The invention also relates to the process for preparing these microparticles, a liquid formulation comprising a suspension of these PO / PA microparticles, a reconstitution process and a kit for this formulation and a dry form of this formulation.MICROPARTÍCULAS DE LIBERAÇçO MODIFICADA BASEADA EM COPOLÍMERO ANFIFÍLICO E EM PRINCÍPIO(S) ATIVOS(S) E FORMULAÇOES FARMACÉUTICAS COMPREENDENDO AS MESMAS. A presente invenção se refere a novas micropartículas formadas de poliaminoácidos anfifílicos os quais transportam princípio(s) ativos(s), PA(s), em particular princípio(s) ativos(s) protéicos e peptídeos, e a novas formulações farmacêuticas de liberação modificada compreendendo as referidas micropartículas de PA. O objetivo da invenção é desenvolver novas micropartículas, c
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