Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges

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• 作者：Hong Wen ; Huijeong Jung ; Xuhong Li
• 关键词：absorption ; distribution ; metabolism ; and elimination (ADME) ; adverse effects ; bioequivalence ; clinical pharmacology ; drug delivery ; formulation design ; local delivery ; long ; acting release ; modified release ; personalized medicine ; pharmacokinetic profiles ; prodrug ; quality ; regulatory ; targeted delivery ; therapeutic performance
• 刊名：The AAPS Journal
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：17
• 期：6
• 页码：1327-1340
• 全文大小：902 KB
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• 作者单位：Hong Wen (1)
  Huijeong Jung (1)
  Xuhong Li (2)
  
  1. Office of Generic Drugs, CDER, FDA, Silver Spring, Maryland, 20993, USA
  2. Office of Pharmaceutical Quality, CDER, FDA, Silver Spring, Maryland, 20993, USA
  
• 刊物主题：Pharmacology/Toxicology; Biochemistry, general; Biotechnology; Pharmacy;
• 出版者：Springer US
• ISSN：1550-7416

文摘

Various drug delivery approaches can be used to maximize therapeutic efficacy and minimize side effects, by impacting absorption, distribution, metabolism, and elimination (ADME) of a drug compound. For those drugs with poor water solubility or low permeability, techniques such as amorphous solid dispersion, liposomes, and complexations have been used to improve their oral bioavailability. Modified release (MR) formulations have been widely used to improve patient compliance, as well as to reduce side effects, especially for those drugs with short half-lives or narrow therapeutic windows. More than ten drugs using sterile long-acting release (LAR) formulations with clear clinical benefit have been successfully marketed. Furthermore, drug delivery systems have been used in delaying drug clearance processes. Additionally, modifying the in vivo drug distribution using targeted delivery systems has significantly improved oncology treatments. All the drug delivery approaches have their advantages and limitations. For both brand and generic drugs, the achievement of consistent quality and therapeutic performance using drug delivery systems can also pose serious challenges in developing a drug for the market, which requires close collaboration among industry, academia, and regulatory agencies. With the advent of personalized medicines, there will be great opportunities and challenges in utilizing drug delivery systems to provide better products and services for patients. KEY WORDS absorption, distribution, metabolism, and elimination (ADME) adverse effects bioequivalence clinical pharmacology drug delivery formulation design local delivery long-acting release modified release personalized medicine pharmacokinetic profiles prodrug quality regulatory targeted delivery therapeutic performance