Fundamentals of Pharmaceutical Nanoscience

納米科學或稱極小尺度科學為製藥科學家提供了豐富的機會。通過在納米尺度上製造，可以對藥物活性進行前所未有的控制。本教科書將展示各種納米系統，從設計和構建到在藥物傳遞領域的應用。本書適用於藥物傳遞、物理和高分子化學以及應用製藥科學課程的研究生。

本文的目的是介紹合成高分子材料的物理化學和生物醫學特性，重點介紹它們在高分子治療學、藥物傳遞和生物性能方面的應用。本文有兩個主要目標。第一個目標是為高級研究生提供有關納米系統和高分子科學的原理知識，包括合成、結構和溶液和固態性質的表徵。第二個目標是描述高分子在藥物傳遞、靶向、反應調節劑以及監管問題方面的治療應用基礎。

這些課程通常被列為高級藥物傳遞和應用製藥學、高分子治療學或納米醫學，旨在為製藥科學研究生提供該領域的概述。然而，這些課程的內容也可能對相關生物醫學研究項目的研究生感興趣。

這些課程通常包括對高分子科學的主要原理和現代治療用高分子應用的基本概念的討論。所有課程都在逐漸遠離上述的課程名稱，而轉向「製藥納米科學或納米系統」。這個研究和技術發展領域在過去二十年間引起了極大的關注，並且預計它將繼續增長其重要性。然而，這個領域剛剛興起，課程有限但已提供。

Professor Ijeoma F. Uchegbu

Ijeoma Uchegbu FMedSci is UCL's Professor of Pharmaceutical Nanoscience, a fellow of the Academy of Medical Sciences, an honorary fellow of the Royal Society of Chemistry, a governor on the Wellcome board (one of the largest biomedical sciences research charities in the world), a member of the Academy of Medical Sciences Council and Chief Scientific Officer of Nanomerics Ltd. In 2024, Uchegbu will take up the position of President of Wolfson College, University of Cambridge having been elected to the position in 2023. Uchegbu has served as Chair of the Academy of Pharmaceutical Sciences and chaired the UK's Engineering and Physical Sciences Research Council and Science Foundation Ireland grant prioritisation panels.

Uchegbu has studied the mechanisms of drug transport across biological barriers and created transformational drug transport nanoparticles. She was the first to show that peptides could be delivered across the blood brain barrier to elicit a pharmacological response, when presented as peptide drug nanofibers and the first to demonstrate, via definitive pharmacology and pharmacokinetics evidence, peptide transport into the brain, using peptide nanoparticles delivered via the nose to brain route. These findings led to the development of the enkephalin pain medicine candidate Envelta(TM), which was designed to address the opioid crisis. In preclinical studies, Envelta(TM) showed no analgesic tolerance, reward seeking behaviour or potential to cause significant constipation. Envelta has been out licensed for clinical development.

The technology underpinning Envelta(TM) won first prize in the Royal Society of Chemistry's Emerging Technologies competition in 2017 and the Academy of Pharmaceutical Sciences Science Innovation Award in 2016. Three other medicine candidates based on this nanotechnology have further been out-licensed to pharmaceutical companies.

Uchegbu has also won numerous prizes for her work and these include: the UK Government's Women of Outstanding Achievement in Science, Engineering and Technology 2007, Royal Pharmaceutical Society Pharmaceutical Scientist of the Year 2012, Special Recognition Business of Science Leadership Award 2023 and others.

Uchegbu's scientific research work has been funded continuously for over two decades by the UK's Engineering and Physical Sciences Research Council and she serves on the Biotechnology and Biological Sciences Research Council's governing body.

Dr Andreas G. Schatzlein

Andreas Schatzlein has a track record of medicines development and translational research in industry and academia. His research interests focus on the discovery and preclinical/clinical development of targeted anti-cancer drugs and nanomedicines and the understanding of their underlying biology. Andreas is a veterinary surgeon by training and, after completion of his doctorate on transdermal nanomedicines delivery, joined the biotech start-up IDEA in Munich to develop this technology commercially.

In 1996 joined academia at the Cancer Research UK Beatson Laboratories at the University of Glasgow where became leader of the Experimental Therapeutics and Gene Medicines Group. There he was also responsible for setting up a unit that carried out analysis of pharmacokinetics and pharmacodynamics readouts from early phase translational oncology/nanomedicines trials using a good clinical laboratory practice framework. He currently is a Reader at the UCL School of Pharmacy and co-founder and CEO of Nanomerics Ltd, a UCL spinout company developing pharmaceutical nanotechnology.

Dr Aikaterini Lalatsa

Aikaterini Lalatsa is a Reader in Nanomedicines and the Deputy Director of Cancer Research UK (CRUK) Formulation Unit (a MHRA licensed manufacturing unit for sterile and oral new Investigational Medicinal Products for Phase I/II clinical trials) at Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS), University of Strathclyde. Katerina has a track record in development and translation of biologics, chemotherapeutics and nanomedicines working closely with industry towards translation into first in human studies. She leads the Bio-engineering, Biomaterials and Nanomedicine (BioN) laboratory (originally at University of Portsmouth and now at Strathclyde) that attracted funding from national and international government, charity or industrial sources. She is the inventor of 4 international patents and her work has led to a paradigm shift in the non-invasive delivery of peptides, proteins and antibodies and chemotherapeutics across the blood-brain barrier. Katerina is the MSc in Pharmaceutical Quality and Good Manufacturing Practise course leader at University of Strathclyde.

Porf. Dolores R. Serrano

Dolores received an European PhD with CUM LAUDE in 2013. After completing her doctorate studies, she worked as a postdoctoral Fellow at the School of Pharmacy and Pharmaceutical Sciences at Trinity College Dublin (Ireland) as part of SSPC consortium (Synthesis and Solid State Pharmaceutical Center). She was appointed as a lecturer in the Complutense University of Madrid in October 2015, and recently was promoted to Professor in 2023. She is the co-inventor of three patents and coauthor in over 80 publications. She received several scientific awards such as the Cantabria Labs Innovation Award in Dermatology in 2022, the Roche Institute Award in Digital Health in 2020, and the Research Pharmacy Award "Mario Martin Velamazan" in 2018. She has created one of the first 3D printing laboratory at the School of Pharmacy in Complutense University, being a referent on 3D printing of medicines. Her research team has also a consolidated background in 3D printing of microfluidic chips, especially for the manufacturing of nanomedicines, such as liposomes and nanoparticles.

教授Ijeoma F. Uchegbu

Ijeoma Uchegbu FMedSci是倫敦大學學院(UCL)的藥物納米科學教授，是英國醫學科學院的院士，英國皇家化學學會的名譽院士，威康基金會董事會的理事（威康基金會是全球最大的生物醫學科學研究慈善機構之一），是英國醫學科學院理事會的成員，也是Nanomerics Ltd的首席科學官。2024年，Uchegbu將擔任劍橋大學Wolfson學院的院長，她在2023年當選該職位。Uchegbu曾擔任英國藥學科學院主席，並主持過英國工程和物理科學研究委員會以及愛爾蘭科學基金會的資助優先順序評審小組。

Uchegbu研究了藥物在生物屏障中的運輸機制，並創造了具有轉化性的藥物運輸納米粒子。她首次證明了肽能夠通過血腦屏障傳遞，以引起藥理反應，當以肽藥物納米纖維的形式呈現時，並且首次通過明確的藥理學和藥物動力學證據，證明了肽通過肽納米粒子經由鼻腔進入大腦的運輸。這些發現促使了以解決阿片類藥物危機為目標的恩肯菲林疼痛藥物候選藥Envelta(TM)的開發。在臨床前研究中，Envelta(TM)顯示出無耐受性、無尋求報酬行為或引起明顯便秘的特性。Envelta已經被授權進行臨床開發。

支持Envelta(TM)技術在2017年獲得了英國皇家化學學會新興技術競賽的一等獎，並在2016年獲得了英國藥學科學院科學創新獎。基於這種納米技術的其他三個藥物候選藥物也已經被授權給製藥公司。

Uchegbu的工作獲得了許多獎項，包括：英國政府2007年的傑出科學、工程和技術婦女獎、2012年英國皇家藥學會藥物科學家年度獎、2023年特別表彰的商業科學領導獎等。

Uchegbu的科學研究工作連續二十多年得到了英國工程和物理科學研究委員會的資助，她還擔任生物技術和生物科學研究委員會的管理機構成員。

Dr. Andreas G. Schatzlein

Andreas Schatzlein在工業和學術界擁有藥物開發和轉化研究的豐富經驗。他的研究興趣集中在發現和臨床前/臨床開發靶向抗癌藥物和納米藥物，以及了解其潛在生物學。Andreas是一位獸醫，完成了有關皮膚穿透納米藥物傳遞的博士學位後，加入了位於慕尼黑的生物技術初創公司IDEA，以商業化開發這項技術。

1996年，他加入了位於格拉斯哥大學的英國癌症研究基金會比特森實驗室，成為實驗治療和基因藥物研究小組的負責人。在那裡，他還負責建立一個單位，該單位使用良好的臨床實驗室實踐框架，對早期轉化腫瘤學/納米藥物試驗的藥物動力學和藥效學結果進行分析。他目前是倫敦大學學院藥學院的讀者，也是Nanomerics Ltd的聯合創始人兼首席執行官，該公司是一家開發藥物納米技術的UCL創業公司。

Dr. Aikaterini Lalatsa

Aikaterini Lalatsa是納米藥物學讀者，也是英國癌症研究基金會（CRUK）配方單位的副主任（一個獲得英國藥物和保健產品規管局許可的製造單位，用於生產無菌和口服的新型調查藥物）。