Composición farmacéutica de liberación prolongada de administración oral que contiene clorhidrato de hidromorfona

• Main Authors: YADA, Shuichi, YANO, Hideki, YOSHIDA, Kazuhiro, FUKUI, Sachiko
• Format: Patent
• Language: Spanish
• Published: 02.04.2019
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

Una composición farmacéutica de liberación prolongada que comprende (A) clorhidrato de hidromorfona o hidrato de clorhidrato de oxicodona, (B) succinato acetato de hidroxipropilmetilcelulosa que tiene un tamaño con mediana estadística (D50) de 40 μm o inferior, (C) hidroxipropilcelulosa y (D) un sacárido, en la que la relación de contenido del componente (C) con respecto al componente (B) en peso en la composición, (C)/(B), es de 10/4 a 7/7. An object is to provide a hydromorphone hydrochloride- or oxycodone hydrochloride hydrate-containing sustained-release pharmaceutical composition for oral administration that reliably exhibits its main pharmacological effect and has excellent formulation stability that avoids dose dumping of the principal drug, such as alcohol resistance. The present invention provides a sustained-release pharmaceutical composition comprising (A) hydromorphone hydrochloride or oxycodone hydrochloride hydrate, (B) hydroxypropyl methylcellulose acetate succinate having a median size (D 50 ) of 40 µm or smaller, (C) hydroxypropyl cellulose, and (D) a saccharide, wherein the content ratio of the component (C) to the component (B) by weight in the composition, (C)/(B), is 11/3 to 3/11.