Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-lun Road, Pudong District, Shanghai 201203, PR China.
School of Pharmacy, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-lun Road, Pudong District, Shanghai 201203, PR China.
Drug Discov Today. 2023 Sep;28(9):103696. doi: 10.1016/j.drudis.2023.103696. Epub 2023 Jul 5.
Lactose is one of the most widespread excipients used in the pharmaceutical industry. Because of its water solubility and acceptable flowability, lactose is generally added into tablet formulation to improve wettability and undesirable flowability. Based on Quality by Design, a better understanding of the critical material attributes (CMAs) of raw materials is beneficial in guiding the improvement of tablet quality and the development of lactose. Additionally, the modifications and co-processing of lactose can introduce more-desirable characteristics to the resulting particles. This review focuses on the functionality, CMAs, applications, modifications and co-processing of lactose in tablets.
乳糖是制药工业中使用最广泛的赋形剂之一。由于其水溶性和可接受的流动性，乳糖通常添加到片剂配方中以改善润湿性和不良的流动性。基于质量源于设计，更好地了解原料药的关键质量属性（CMA）有助于指导片剂质量的提高和乳糖的开发。此外，乳糖的改性和共加工可以为得到的颗粒引入更理想的特性。本文综述了乳糖在片剂中的功能、CMA、应用、改性和共加工。
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