Stable formulations containing anti-sclerostin antibodies, methods of making and uses thereof

• Main Authors: ZHAO JINKE, DENG QUANYU, ZHU YUANLUN, SUN JIAO, ZHOU RUOFEI
• Format: Patent
• Language: Chinese; English
• Published: 17.05.2024
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The present invention relates to a stable formulation containing a high concentration of an anti-sclerostin antibody, comprising a therapeutically effective dose of an anti-sclerostin antibody or antigen-binding fragment thereof, a histidine-hydrochloride histidine buffer and calcium chloride, said formulation having low viscosity, long term stability and good solubility. The invention also provides a preparation method of the preparation and application of the preparation in preparation of drugs for treating, preventing and/or improving any anti-scleroprotein related diseases or symptoms. 本发明涉及含有高浓度抗硬化蛋白抗体的稳定的制剂，该制剂包括治疗有效剂量的抗硬化蛋白抗体或其抗原结合片段、组氨酸-盐酸组氨酸缓冲剂和氯化钙组成，所述的制剂具有低粘度、长期稳定性和良好的溶解性。本发明还提供了所述制剂的制备方法，及其在制备治疗、预防和/或改善任何与抗硬化蛋白相关疾病或症状的药物中的用途。