Practical Pharmaceutics An International Guideline for the Preparation, Care and Use of Medicinal Products

Paul Le Brun, PharmD, PhD, is hospital pharmacist and clinical pharmacologist of the Department of Clinical Pharmacy and Toxicology of Leiden University Medical Center, The Netherlands since 2017. He also teaches pharmacy students in quality, preparation and innovative medicines as associate professor at the university of Leiden.

Paul obtained his degree in pharmacy from the Groningen University in 1982. He started his career at the Dutch Laboratory of Pharmacists (LNA), department of the Royal Dutch Association of Pharmacists (KNMP). From 1985 until 1988 he was trained and worked as a hospital pharmacist in the Central Hospital Pharmacy of The Hague. He joined Merck Sharp&Dohme as production pharmacist from 1989 to 1992. From 1992 until 2017 he was director of production of the Central Hospital Pharmacy in The Hague combined with clinical tasks in Haga teaching hospital.

In 2001 he obtained his PhD: "Optimization of antibiotic inhalation therapy in Cystic Fibrosis.Studies on nebulized tobramycin. Development of a colistin dry powder inhaler system. The research was valued in 2000 with the KNMP Innovation Award. To date, his main research themes are Aseptic preparation and Medicinal product development.

Paul published numerous scientific papers and was author/editor of the first edition of Practical Pharmaceutics.Sylvie Crauste-Manciet obtained her degree in Pharmacy (PharmD) in 1993, her PhD in 1997 and accreditation to supervise research (HDR) in 2013 from the University of Paris Descartes, France. Until 1999, she combines hospital pharmacy and academic activities as specialist in pharmaceutical technologies for preparation of sterile and not sterile drugs for hospitalized patients e.g. cytotoxic drugs, parenteral nutrition, paediatric capsules in Paris, Bordeaux and she recently moved to Angers. As professor of pharmaceutical technologies, she developed specific research in nanosytems design and characterization firstly at UPCGI Laboratory, UMR 8151 CNRS- U1022 INSERM at Paris Descartes University then at ARNA, ChemBioPharm team, INSERM U1212 UMR 5320 CNRS at Bordeaux University and since September 2022 at MINT laboratory UMR INSERM 1066 /CNRS 6021 at Angers University. She created in 2016 a master’s program dedicated for research on hospital pharmaceutical technology. Since 1998, she is the president of the European society of Hospital Pharmaceutical Technology (GERPAC) which is an association of European hospital pharmacists involved in the research and development of hospital preparations.

Sylvie Crauste-Manciet obtained her degree in Pharmacy (PharmD) in 1993, her PhD in 1997 and accreditation to supervise research (HDR) in 2013 from the University of Paris Descartes, France. Until 1999, she combines hospital pharmacy and academic activities as specialist in pharmaceutical technologies for preparation of sterile and not sterile drugs for hospitalized patients e.g. cytotoxic drugs, parenteral nutrition, paediatric capsules in Paris, Bordeaux and she recently moved to Angers. As professor of pharmaceutical technologies, she developed specific research in nanosytems design and characterization firstly at UPCGI Laboratory, UMR 8151 CNRS- U1022 INSERM at Paris Descartes University then at ARNA, ChemBioPharm team, INSERM U1212 UMR 5320 CNRS at Bordeaux University and since September 2022 at MINT laboratory UMR INSERM 1066 /CNRS 6021 at Angers University. She created in 2016 a master’s program dedicated for research on hospital pharmaceutical technology. Since 1998, she is the president of the European society of Hospital Pharmaceutical Technology (GERPAC) which is an association of European hospital pharmacists involved in the research and development of hospital preparations.

Irene Krämer, PharmD, PhD, is Director of the Pharmacy Department of the University Medical Center at the Johannes Gutenberg-University Mainz (Germany) and Professor of Clinical Pharmacy at the faculty of pharmacy at the same university.

She obtained her doctorate in pharmaceutical chemistry and continued her postgraduate education at the Pharmacy Department of the Johannes Gutenberg-University and went on to complete her postdoctoral thesis in Pharmaceutical Technology, entitled Development, Quality Assurance, and Optimization of Ready-to-Use Parenteral Solutions in the Integrated Cancer Care Concept .

The research projects of Prof. Kraemer focus on experimental studies of the physicochemical and microbiological stability of ready-to-administer parenteral preparations mainly used in oncology and intensive care patients. Other research projects deal with the development and evaluation of clinical pharmacy services and the improvement of medication safety by digitalization and automation of the medication process. She also performed numerous studies regarding medication adherence of special patient groups.

Prof. Krämer published numerous scientific papers and isauthor/editor of several clinical pharmacy and pharmaceutical technology textbooks. She received the German Federal Cross of Merit for her dedication to hospital pharmacy and patient care.

Julian Smith is a registered pharmacist, and a Qualified Person (QP) responsible for assuring the quality of medicines. He has been a hospital pharmacist for much of his professional career. His time in hospital was spent in “technical services”, mainly in Quality Assurance, where he was involved in the manufacture of Pharmaceutical “Specials” in licensed Production Units. His final role in the NHS was as the All-Wales Quality Assurance Pharmacist. During his career he has taken brief detours into both community pharmacy and academia. He was a lecturer in Pharmaceutics at Aston University in the UK. His PhD is in transdermal drug delivery, and this was where he developed a passion for formulation development which has driven his career. He became a director at Viridian Pharma where he wasinvolved in developing and applying for licensed pharmaceutical products. He is now a Director of JCS Pharma Consulting where he provides advice on product development, lectures in Quality Assurance, and acts as a contract Qualified Person.

Dr. H.J. (Herman) Woerdenbag is associate professor of pharmaceutical product care at the University of Groningen, Department of Pharmaceutical Technology and Biopharmacy. He is responsible for teaching activities (theory and practical) in pharmaceutical compounding and dispensing (small and medium scale, including quality management) and product care in the Pharmacy curriculum (BSc and MSc). He is teacher, coordinator and innovator of various compulsory and elective courses. He contributes to quality assurance in pharmacy education and curriculum renewal. Current research is mainly practice-oriented, in collaboration with (hospital) pharmacists in the Netherlands, and often linked with pharmacy education in galenics and compounding. His scientific and societal work covers publications on medicinal plants and herbal medicine, pharmaceutics and pharmaceutical product care.