藥品品質研究：口服固體劑型概論   全文下載

Pharmaceutical Product Quality Research: An Overview for Solid Oral Dosage Forms

藥品品質諸如安全性與有效性，是所有藥品核准製造之首要達到的基準。這基準甚至在藥品已被核准上市後也不能有所妥協。體外試驗方法的開發以預測藥品在體內的性能，是藥品品質研究的最具挑戰性目標。近年來本實驗室已參與多種藥品包括口服固體劑型、定劑量吸入劑、懸液、經皮吸收貼片及外用乳膏、軟膏、栓劑之研究。本文作者擬將上述劑型之研究經驗提出一系列綜論和研究議題供共同探討。本文首先介紹口服固體劑型之品質概論。

Product quality, like safety and efficacy, is a prerequisite for manufacturing approval of all pharmaceutical products. This requirement must not be compromised even after the product has been approved for marketing. Development of in vitro testing methods that are predictive for product in vivo performance is the most challenging goal in product quality research. In recent years, our Laboratory has been involved in this area of research for a variety of pharmaceutical products including oral solid dosage forms, metered dose inhalers, suspension products, transdermal patches and topical products including creams, ointments, and suppositories. The author intends to share some of his research experience in addressing product quality issues for the above mentioned dosage forms in a series of review and research articles. As the first in this series, an overview of the quality issue for oral solid dosage forms is presented.