Pharmacognosy II: phyto therapy

Academic year: 2010-2011 Course code module 1MFAR-FZ-006 Semester: 2nd semester Credits: 3 Study load (hours) 84 Theory (hours): 15,00 Practice/Exercises(hours): Other (hours): Part-time program: 2 Instructor(s) Sandra Apers Luc Pieters Language of instruction: Dutch Semester exam information: exam in the 2nd semester Contract restriction information: 1. Prerequisites *Algemene competenties The course on phytotherapy is part of the course on pharmacotherapy, but is specifically directed towards the treatment of mild to moderate symptoms of diseases, which are not life threatening. This course, however, differentiates from the classical pharmacotherapy, because herbal medicinal products can obtain a marketing authorization or registration using an alleged procedure based upon traditional and/or for well-established use.     Sequentiality Bachelor Pharmaceutical Sciences : Pharmacognosy I : Phytochemistry, Pharmacology and Applied Pharmacokinetics *Sequentiality Pharmacognosy I, part : Phytochemistry (3BFAR-02) AND Pharmacology and Applied Pharmacokinetics (3BFAR-08) 2. Objectives (expected learning outcomes) -          Transfer of current knowledge on the mostly used herbal medicinal products concerning their pharmaceutical quality, pharmacological activity and safety and their therapeutical activity according to clinical studies. -          Learn students to distinguish between herbal medicinal products which have obtained a marketing authorization or registration based upon clinical studies (WHO categories I and II), literature data (WHO category III) or traditional use (WHO category IV). -          Learn the students to compose herbal teas which can be used in the pharmacy for one of the acceptable indications of the lists. -          Learn the students to elaborate Community Monographs on herbal medicinal products according to the EMEA criteria. 3. Course content Until the end of 2006 herbal medicinal products could obtain a Belgian marketing authorisation according to an alleged procedure based upon lists of medicinal plants with mandatory therapeutic indications (27 lists containing about 180 plants). Since 2007, however, herbal medicinal products should be categorized into well-established and traditional herbal medicinal products according to the criteria determined by the European Medicines Agency (EMEA) in London. The most used herbal medicinal products in Europe will be discussed according to Community Herbal Monographs developed by the Committee on Herbal Medicinal Products (HMPC) of the EMEA. These monographs are intended to help pharmaceutical companies to obtain easier a marketing authorisation (MA) or registration of well-established or traditional herbal medicinal products. The monographs contain data on subsequently the qualitative and quantitative composition, pharmaceutical form, clinical particulars (therapeutic indications, posology and method of administration, contra-indications, special warnings and precautions for use, interactions, pregnancy and lactation, effects on ability to drive and use machines, undesirable effects, overdose) and pharmacological properties (pharmacodynamic, pharmacokinetic, and preclinical safety data). Moreover, both classes of herbal medicinal products should be distinguished. 4. Teaching method Direct contact: Lectures Seminars (possible question and answer sessions) Personal work: Assignments - in group Paper - in group Supervised self-study Project-based work - in group 5. Assessment method Continuous assessment: Assignments Participation in classroom activities Presentation 6. Compulsory reading – study material Own course. Handouts of ESCOP and BHC monographs Community Monographs of the HMPC via the website of EMEA   7. Recommended reading - study material ESCOP Monographs second edition, Thieme Verlag 2003 8. Tutoring laatste aanpassing: last update: 10/02/2011 11:38 luc.pieters

Pharmaceutical analysis: supplements

Academic year: 2010-2011 Course code module 1MFAR-GO-006 Semester: 2nd semester Credits: 6 Study load (hours) 168 Theory (hours): 22,50 Practice/Exercises(hours): 40,00 Other (hours): 12,00 Part-time program: 2 Instructor(s) Sandra Apers Magda Claeys Paul Cos Adrian Covaci Nina Hermans Language of instruction: Dutch Semester exam information: exam in the 2nd semester Contract restriction information: exam contract not possible 1. Prerequisites *Algemene competenties Basic knowledge on analytical techniques, pharmaceutical analysis and statistics. *Sequentiality Pharmaceutical Analysis III (3BFAR-03) AND Introduction to Medicinal Chemistry and Drug Development (3BFAR-06) AND Pharmacognosis I : medicinal plants and natural products (3BFAR-021) AND Food and Nutrition Theory I (3BFAR-04) 2. Objectives (expected learning outcomes) The aim of the course is to gain knowledge on sample preparation methods, analytical techniques and materials used in specific area's. The students will be trained in quality control and validation. 3. Course content The course contains several parts. In the first part different techniques and procedures to prepare and clean up samples will be discussed. An overview of the different columns available for HPLC and GC is given. The second part deals with analysis in different field, e.g. toxicology, microbiology, bromatology and pharmacognosy. In the part on the registration file, the requirements on the analytical part are summed up. The last part of the course is dedicated to quality control and validation. Quality guidelines, field of application and evaluation services are discussed. Method validation is thought during the practical course and seminars. International guidelines on validation are discussed, equipment is checked and methods are validated. The results obtained are evaluated by means of statistics (Excel). 4. Teaching method Direct contact: Lectures Exercise sessions Seminars (possible question and answer sessions) Practical sessions Personal work: Excursion(s) 5. Assessment method Exam: Written, without oral presentation Closed book Open book Practical exam 6. Compulsory reading – study material course 7. Recommended reading - study material Websites European Pharmacopoeia - EMEA - kwaliteitsnormen - commerciële sites chromatografisch materiaal (links blackboard) 8. Tutoring Coördinaten docenten: S. Apers:                     e-mail: sandra.apers@ua.ac.be Tel :     03 820 27 20 M. Claeys:                   e-mail: magda.claeys@ua.ac.be P. Cos :                       e-mail : paul.cos@ua.ac.be Adrian Covaci :            e-mail : adrian.covaci@ua.ac.be N. Hermans:                e-mail: nina.hermans@ua.ac.be laatste aanpassing: last update: 16/02/2011 17:04 adrian.covaci

Pharmaceutical Analysis I + II

Academic year: 2010-2011 Course code module 2BFAR-021 Semester: 1st and 2nd semester Credits: 12 Study load (hours) 336 Theory (hours): 52,50 Practice/Exercises(hours): 50,00 Other (hours): 30,00 Part-time program: 2 Instructor(s) Luc Van Vaeck Sandra Apers Language of instruction: Dutch Semester exam information: exam in the 2nd semester Contract restriction information: exam contract not possible 1. Prerequisites *Algemene competenties basic knowledge of general and organic chemistry *Sequentiality General Chemistry (1BFAR-02) AND Organic Chemistry I (1BFAR-06) AND Pharmaceutical Data Analysis (1BFAR-09) 2. Objectives (expected learning outcomes) - obtain insight in the fundamental concepts of analytical chemistry - capability to apply this knowledge to simple problems  - insight in the most important analytical techniques and their use - capability to use these techniques in simple experiments - acquire skills of accurate and precise working, order and organisation 3. Course content First the fundamental concepts and skills in analytical chemistry are dealt with.  The experimental methods, procedures and basic and analytical unit operations including calibration, uncertainty analysis, etc. are addressed.  The chemical equilibrium of solutions and its use in analytical applications such as pH calculations, precipitation reactions, separations and complex formation. The basics, methods and instrumentation of molecular spectrofotometry (UV-VIS absorption spectrometry, fluorimetry) are dealt with.  The fundamentals of distribution based separations and the most important methods (GC and HPLC) are addressed.  Then the more advanced analytical concepts, procedures and skills will be discussed.  Attention is paid to the range of volumetric determinations and in particular the way to adapt a given procedure to another application is treated.  Also additional separation methods including AFC, IC, SEC, TLC and CE as well as spectrometry for elemental analysis and electrochemical methods are covered.    4. Teaching method Direct contact: Lectures Exercise sessions Practical sessions Personal work: Exercises 5. Assessment method Exam: Written, with oral presentation Closed book Practical exam Continuous assessment: Exercises (Interim) tests Participation in classroom activities 6. Compulsory reading – study material Course available 7. Recommended reading - study material Fundamentals of Analytical Chemistry, 8th ed., D.A. Skoog, D.M. West, F.J. Holler, S.R. Crouch, Publ. Thomson Brooks/Cole, Belmont, CA, USA Quantitative Chemical analysis, 6th Ed. D.C. Harris, Publ. W.H. Freeman and Co. New York 8. Tutoring laatste aanpassing: last update: 30/01/2009 10:43 dorien.ivens

Pharmaceutical Analysis III

Academic year: 2010-2011 Course code module 3BFAR-03 Semester: 1st semester Credits: 6 Study load (hours) 168 Theory (hours): 15,00 Practice/Exercises(hours): 80,00 Other (hours): Part-time program: 2 Instructor(s) Sandra Apers Roger Kemel Language of instruction: Dutch Semester exam information: exam in the 1st semester Contract restriction information: exam contract not possible 1. Prerequisites *Algemene competenties Kandidaturen - proeven: Analytische scheikunde deel I en II Bachelor - master: Farmaceutische Analyse I en II *Sequentiality Pharmaceutical Analysis I + II (2BFAR-021) AND Organic Chemistry II (2BFAR-01) 2. Objectives (expected learning outcomes) The aim of this course is to learn every pharmacist to make use of, read and understand a pharmacopoeia. 3. Course content   Theory            The European pharmacopoeia forms the basis of the theoretical part of this course. The introductory chapters of this pharmacopoeia, i.e. apparatus, identification methods and purity tests, techniques and methods of analysis, will be dealt with. This course will include the techniques and methods used for the analysis of pure products or relatively simple mixtures that do not need extensive sample preparation. The knowledge obtained in the course of Pharmaceutical Analysis I&II will serve as the starting point of this course. Specific identification and test methods and methods of analysis of selected pharmaceutical excipients and drugs will be studied in more detail.   Practical course             In this practical course specific analyses related to toxicology, bromatology, pharmacognosy and pharmaceutical chemistry are performed according to well-described protocols. Techniques include HPLC and GC next to the classical titrations and spectroscopic methods. 4. Teaching method Direct contact: Lectures Personal work: Exercises Assignments - in group 5. Assessment method Exam: Written, with oral presentation Closed book Open questions Practical exam 6. Compulsory reading – study material Een cursus en practicumnota's opgesteld door de docent worden aangeboden via de cursusdienst. 7. Recommended reading - study material European Pharmacopoeia (available in PC room) 8. Tutoring Sandra Apers email: sandra.apers@ua.ac.be; tel: 03 820 27 20 Roger Kemel: email: roger.kemel@ua.ac.be; tel: 03 820 27 31 laatste aanpassing: last update: 29/09/2008 16:03 sandra.apers