A Guide to Particulate Science in Pharmaceutical Product Development
暫譯: 製藥產品開發中的微粒科學指南

粉體技術在製藥領域的應用早已廣為人知。然而，儘管許多書籍著重於粉體的形成與行為，探討如何運用顆粒科學（particulate science）來設計、製造及進行優質藥品品質管制的著作仍相當少。本修訂版介紹重要原理及其實務應用。作者涵蓋顆粒材料、顆粒的形態與製備、粉體堆體的取樣、粒徑描述與統計、顆粒與粉體的行為、儀器分析、粒徑測量與各種採用技術的協同效應，以及體外（in vitro）與體內（in vivo）性能評估標準。本新版並收錄多個案例研究。

本全面修訂版：

• 提供顆粒科學的完整介紹，並新增多個章節，討論多成分顆粒、法規考量及產品開發
• 涵蓋多元主題，從製藥領域粒徑已發表資料的品質，到晶體工程的未來發展
• 回顧粒徑測量方法，以及這些方法對特定應用的重要性
• 探討顆粒科學中的錯誤觀念與誤解，並介紹其他產業所帶來的經驗與啟示

Dr Margaret Louey is a pharmaceutical scientist with extensive experience in drug development and global health initiatives. She earned a Ph.D. from Monash University in Melbourne, Australia (2000), and then completed a post-doctoral fellowship at the University of North Carolina in Chapel Hill. Margaret entered the pharmaceutical industry and worked at GlaxoSmithKline for 15 years, primarily in product development of respiratory products. During this time, her interest evolved to increasing access to medicines in low- and middle-income countries. Margaret transitioned to the non-profit sector and joined the Clinton Health Access Initiative in 2018, where she has supported public-private partnerships to accelerate product development and regulatory submissions for high-priority pediatric products for the treatment and prevention of HIV and tuberculosis in low- and middle-income countries.

Dr Timothy "Timm" Crowder, Ph.D., is a pharmaceutical scientist and entrepreneur with deep expertise in particulate science and drug delivery, particularly in inhalation technologies. He earned his Ph.D. from the University of North Carolina at Chapel Hill, where his research focused on the design and development of innovative drug delivery systems. This work sparked a lifelong interest in the complex interplay between particle engineering, device design, and clinical outcomes.

Timm's career has spanned both industry and entrepreneurial ventures, with a particular focus on transforming cutting-edge research into practical, patient-centric therapies. As a co-founder of Oriel Therapeutics, Timm helped pioneer new approaches to dry powder inhaler technology. He went on to hold leadership roles across both large pharmaceutical companies and biotech startups, where he applied his expertise to advance inhaled therapies for respiratory diseases, rare conditions, and systemic delivery.

Throughout his career, Timm has remained passionate about bridging the gap between fundamental science and real-world product development. His work has encompassed everything from dry powder vaccine formulations to advanced inhaler technologies, always with an emphasis on delivering therapies that improve patient outcomes. In addition to his industry contributions, Timm has maintained a strong connection to academic research and training, co-authoring key publications on pharmaceutical particulate science and mentoring the next generation of scientists and innovators in the field.

Dr Anthony Hickey is Distinguished Fellow Emeritus at RTI International, Research Triangle Park, NC, Professor Emeritus of Pharmacoengineering and Molecular Pharmaceutics of the Eshelman School of Pharmacy, and Adjunct Professor of Biomedical Engineering of the School of Medicine at the University of North Carolina at Chapel Hill. He is a Fellow of the American Association for the Advancement of Science, the American Association of Pharmaceutical Scientists, the Academy of Pharmaceutical Sciences of Great Britain, the Royal Society of Biology, the Royal Society of Medicine and the National Academy of Inventors. He received the Research Achievement Award of the Particulate Presentations and Design Division of the Powder Technology Society of Japan, the David W Grant Award in Physical Pharmacy of the American Association of Pharmaceutical Scientists; Thomas T Mercer Joint Prize for Excellence in Inhaled Medicines and Pharmaceutical Aerosols of the American Association for Aerosol Research and the International Society for Aerosols in Medicine, the Ralph Shangraw Memorial Award for Excipient and Excipient Technology of the International Pharmaceutical Excipient Consortium Foundation. He is founder (and formerly President and CEO) of Cirrus Pharmaceuticals, Inc.; founder (formerly CSO) of Oriel Therapeutics, Inc; CEO of Astartein, LLC. and; Member of the Board of First Flight Venture Center, Inspiring Pty Ltd., and; KAER Biotherapeutics; Chair of the USP Joint Sub-Committee on Nanotechnology, Member of the USP Pharmaceutical Dosage Forms Expert Committee (DFEC) and Inhalation Sub-Committee of the DFEC of the United States Pharmacopeia. He consults on multidisciplinary research programs in the field of pulmonary drug and vaccine delivery for the treatment and prevention of a variety of diseases and serves on numerous editorial and scientific advisory boards.

Margaret Louey 博士是一位藥學科學家，在藥物開發與全球健康倡議方面擁有豐富經驗。她於 2000 年取得澳洲墨爾本 Monash University 的 Ph.D.，之後在 Chapel Hill 的 University of North Carolina 完成博士後研究。Margaret 進入製藥產業後，於 GlaxoSmithKline 任職 15 年，主要負責呼吸系統產品的產品開發。在此期間，她逐漸關注如何提升中低收入國家取得藥品的機會。2018 年，Margaret 轉入非營利部門，加入 Clinton Health Access Initiative，支援公私協力夥伴關係，以加速中低收入國家用於 HIV 與結核病治療及預防之高優先級兒科產品的開發與法規申請。

Timothy「Timm」Crowder 博士是一位藥學科學家與企業家，在微粒科學與藥物遞送方面擁有深厚專業，尤其專精於吸入技術。他在 University of North Carolina at Chapel Hill 取得 Ph.D.，研究聚焦於創新藥物遞送系統的設計與開發。這項研究激發了他一生對粒子工程、裝置設計與臨床結果之間複雜交互作用的興趣。

Timm 的職涯橫跨產業與創業事業，特別專注於將尖端研究轉化為實用、以病患為中心的治療方式。身為 Oriel Therapeutics 的共同創辦人，Timm 協助開創乾粉吸入器技術的新方法。之後，他在大型製藥公司與生技新創公司擔任領導職務，運用自身專業推動吸入式療法的發展，應用領域涵蓋呼吸道疾病、罕見疾病與全身性藥物遞送。

在整個職業生涯中，Timm 始終熱衷於彌合基礎科學與實際產品開發之間的落差。他的工作範圍涵蓋乾粉疫苗配方到先進吸入器技術，始終著重於提供能改善病患治療結果的療法。除了對產業的貢獻之外，Timm 也持續投入學術研究與培訓，合著多篇關於藥學微粒科學的重要論文，並指導該領域下一代的科學家與創新者。

Anthony Hickey 博士是 RTI International（位於北卡羅來納州 Research Triangle Park）的榮譽傑出院士，也是 Eshelman School of Pharmacy 的藥學工程與分子藥劑學榮譽教授，以及 University of North Carolina at Chapel Hill School of Medicine 的生醫工程兼任教授。他是 American Association for the Advancement of Science、American Association of Pharmaceutical Scientists、Academy of Pharmaceutical Sciences of Great Britain、Royal Society of Biology、Royal Society of Medicine 以及 National Academy of Inventors 的院士。

他曾獲得多項獎項，包括 Powder Technology Society of Japan Particulate Presentations and Design Division 的 Research Achievement Award；American Association of Pharmaceutical Scientists 的 David W. Grant Award in Physical Pharmacy；American Association for Aerosol Research 與 International Society for Aerosols in Medicine 共同頒發的 Thomas T. Mercer Joint Prize for Excellence in Inhaled Medicines and Pharmaceutical Aerosols；以及 International Pharmaceutical Excipient Consortium Foundation 頒發的 Ralph Shangraw Memorial Award for Excipient and Excipient Technology。

他是 Cirrus Pharmaceuticals, Inc. 的創辦人（曾任總裁兼執行長）；Oriel Therapeutics, Inc. 的創辦人（曾任首席科學長）；Astartein, LLC. 的執行長；並擔任 First Flight Venture Center、Inspiring Pty Ltd. 及 KAER Biotherapeutics 的董事會成員。他也是 United States Pharmacopeia（USP）奈米技術聯合小組委員會主席、USP Pharmaceutical Dosage Forms Expert Committee（DFEC）委員，以及 DFEC 吸入製劑小組委員會委員。

他為肺部藥物與疫苗遞送領域的多學科研究計畫提供顧問服務，研究目的在於治療與預防各類疾病；此外，他也擔任許多編輯委員會與科學顧問委員會的成員。