Excipients in parenteral formulations: selection considerations and effective utilization with small molecules and biologics

赋形剂 活性成分 剂型 药品 制药技术 药物制剂 药物输送 生化工程 化学 药理学 医学 色谱法 有机化学 工程类
作者
Bindhu Madhavi Rayaprolu,Jonathan J Strawser,Gopal Anyarambhatla
出处
期刊:Drug Development and Industrial Pharmacy [Informa]
卷期号:44 (10): 1565-1571 被引量:70
标识
DOI:10.1080/03639045.2018.1483392
摘要

Excipients form a major component of pharmaceutical formulations and are classified as any ingredient other than the active ingredient which is included within the product formulation to improve drug product performance. Functional uses of excipients include improving solubility and stability, safety and efficacy, as bulking agents in lyophilized formulations, tonicity agents, and aiding in controlled or prolonged drug delivery. Parenteral formulations are sterile, pyrogen-free; free of particulate matter and by-pass the body’s natural defense mechanisms. Excipients may demonstrate a synergistic effect when combined with an active ingredient but may also lead to unwanted reactions with the drugs and packaging components. Ideal excipients are required to be considered safe, inert and multifunctional. Contrary to the past, safety of excipients needs to be well established in order for their use in the pharmaceutical formulations. Therefore, careful consideration should be given while selecting an excipient. This review article provides an overview of the excipients used exclusively in small molecule and biological parenteral products including solutions, suspensions, and lyophilized formulations, information on the possible drug-excipient and drug-packaging interactions and the regulatory requirements for the use of pharmaceutical excipients. The readers will be able to have a comprehensive understanding of the excipients used in parenteral formulations.
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