Lenaclotide dry suspension and preparation method thereof

• Main Authors: ZHANG JINHUI, ZHANG XIAOLEI, LIANG YUANJUN, GUO LILI, CHEN YOUJIANG, MA YINGCHAO, SUN XIUJIE, QUAN JINGJING, LIU XIAOLI
• Format: Patent
• Language: Chinese; English
• Published: 12.05.2023
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The invention discloses a linaclotide dry suspension and a preparation method thereof. The dry suspension comprises an active component linaclotide, a filler, a suspending aid, a disintegrating agent, a pH regulator, a stabilizer, a flavoring agent, a flow aid and a coloring agent. According to the linaclotide dry suspension, a powder mixing process is adopted, so that the influence of wet and hot conditions on active ingredients in a wet granulation process can be avoided; the preparation method is simple, the production efficiency is improved, the prepared dry suspension is good in taste and quick to release, the medication compliance of patients is improved, and the dry suspension is particularly suitable for patients with swallowing inconvenience or swallowing difficulty. The linaclotide dry suspension provided by the invention is good in stability, simple and convenient in preparation process and easy for industrial production. 本发明公开了一种利那洛肽干混悬剂及其制备方法。本发明干混悬剂包括活性成分利那洛肽、填充剂、助悬剂、崩解剂、pH调节剂、稳定剂、矫味剂、助流剂、着色剂。本发