PHARMACEUTICAL COMPOSITION CONTAINING ENTECAVIR HAVING ENHANCED STABILITY AND PREPARATION METHOD THEREOF

• Main Authors: LEE, YOU JIN, SONG, SE HYON, MO, SEI MYOUNG
• Format: Patent
• Language: English; Korean
• Published: 09.05.2013
• Subjects: CHEMISTRY; COMPOSITIONS BASED THEREON; COMPOSITIONS OF MACROMOLECULAR COMPOUNDS; DERIVATIVES THEREOF; HUMAN NECESSITIES; HYGIENE; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MEDICAL OR VETERINARY SCIENCE; METALLURGY; NANOTECHNOLOGY; ORGANIC MACROMOLECULAR COMPOUNDS; PERFORMING OPERATIONS; POLYSACCHARIDES; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; THEIR PREPARATION OR CHEMICAL WORKING-UP; TRANSPORTING

PURPOSE: A pharmaceutical composition containing entecavir with improved stability, and a method for manufacturing the same are provided to reduce the amount of impurity materials during a manufacturing process, and to stabilize an active ingredient which is instable to moisture. CONSTITUTION: A pharmaceutical composition contains entecavir and cyclodextrin and has improved stability for treating hepatitis B virus infection. The molar ratio of entecavir and cyclodextrin is 1:0.1 or more. A method for manufacturing the pharmaceutical composition comprises: a step of dissolving entecavir and cyclodextrin in a solvent and preparing a binding solution; a step of adding an pharmaceutically acceptable excipient into a mixing device; a step of adding the binding solution into the mixing device and making a granule; a step of drying the granule; a step of mixing the granule with the excipient and preparing a mixture; and a step of forming the mixture in a tablet, a capsule, a powder, or a granule. [Reference numerals] (AA) Total flexible material(ppm)