Assuntos
Aprovação de Drogas , Descoberta de Drogas/tendências , Indústria Farmacêutica/tendências , United States Food and Drug Administration/tendências , Aprovação de Drogas/legislação & jurisprudência , Aprovação de Drogas/métodos , Descoberta de Drogas/legislação & jurisprudência , Descoberta de Drogas/métodos , Indústria Farmacêutica/legislação & jurisprudência , Indústria Farmacêutica/métodos , Humanos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudênciaRESUMO
Proprietary Rel-Ease (Praecis Pharmaceuticals) drug delivery technology uses biocompatible polymers as carriers to incorporate a drug into a polymer matrix through opposite charge interaction or complexation. The resulting low solubility complexes can be used to prepare sustained release depot injections or potentially sustained release formulations for oral administration. As a regulatory approved and commercialised drug delivery technology, Rel-Ease is used in abarelix for injectable suspension, a monthly depot injection for the treatment of patients with advanced prostate cancer. The technology offers high drug loading and minimal-to-no initial burst effect in vivo. It uses aqueous processes and is compatible for complexation with many peptide and protein therapeutics; its mechanism can also be applied to many small-molecule therapeutics and offers conventional and alternative methods for sustained release delivery via an oral route.