Diploma in Pharmacy / Бакалавр (Diploma) в Области Фармацевтического Дела

Course Details

Course Information Package

Course Unit TitlePHARMACEUTICAL ANALYSIS II AND DRUG CONTROL
Course Unit CodePHA403
Course Unit DetailsInt.M. Pharmacy (Required Courses) - BSc Pharmacy (Required Courses) -
Number of ECTS credits allocated6
Learning Outcomes of the course unitBy the end of the course, the students should be able to:
  1. Identify various analytical techniques to drug analysis and control, e.g. spectroscopic, chromatographic, etc.
  2. Identify various analytical methods assessing the purity of formulations.
  3. State the stability of pharmaceutical products, active ingredients, excipients and compounds like preservatives, taste and smell improving agents.
  4. Analyse the reliability of various techniques in Pharmaceutical Analysis, including statistical processing.
  5. Analyse the application of analytical methods using biological fluids, so that they can be used in Clinical Pharmacy and Toxicology.
  6. Employ the Pharmacopoeia in drug analysis and control.
  7. Apply techniques for artificial ageing of pharmaceutical products or active materials, and accelerating ageing techniques.
  8. Apply the preparation of drugs containing active ingredients with narrow safety margin.
Mode of DeliveryFace-to-face
PrerequisitesPHA303Co-requisitesNONE
Recommended optional program componentsNONE
Course Contents·  Atomic absorption and inductively coupled plasma atomic emission spectroscopy. Chromatography in pharmaceutical analysis, theoretical basis and applications. Thin layer (TLC), Gas-liquid (GLC), High performance liquid chromatography (HPLC), HPLC conjugated to mass spectrograph. Reversed phase TLC and HPLC. Chromatographic systems, development and improvements. Assessment of chromatograms. Applications in pharmaceutical analysis. Purity, stability control. Determination of active materials, excipients and other additives. Statistical processing of results. Reliability of the applied methods. Comparison of chromatographic methods, as well as of these methods with other analytical techniques, e.g. spectroscopic. Validation of chromatogram quality. Development and optimisation of chromatographic results. Application of the above mentioned methods in the analysis of pharmaceutical forms or in biological fluids, in the service of Clinical Pharmacy and Toxicology.
·  Pharmacopeia and methods described and used in Pharmacy. Principles of quality assurance and reliability of analytical trials. Methods for quality and stability control of pharmaceutical products. Physical, chemical, microbiological control tests. Chemistry, technology, efficiency of packaging materials for pharmaceutical products (protection from air, light, humidity) and contamination of the pharmaceutical product by these materials. Technological studies on packaging materials. Chemistry and Technology of artificial ageing of drug products and quality control of ageing and stability.
·  Bioequivalence, bioavailability, criteria for comparative assessment of more pharmaceutical products.
·  Special care and study of bioactive compounds with narrow safety margin, e.g. lithium, diphenylhydantoins.
·  Laboratory: Two-dimensional thin layer chromatography for mixtures which cannot be easily separated, Combination of chromatographic and spectrophotometric techniques for the determination of the constituents of a pharmaceutical product (TLC-UV and HPLC-UV), Acceleration of ageing of a product by heat or radiation, Detection of the products of an aged pharmaceutical product (TLC, GLC, HPLC, UV-vis), Study and application of a determination of the European Pharmacopoeia, Determination of water in a technological product by the Karl Fischer method.
Recommended and/or required reading:
Textbooks
  • H.J. Roth, R. Troschutz, K. Eger, Ellis Horwood, Pharmaceutical Chemistry: Drug Analysis, 2003.
  • A. H. Beckett, J. B. Stenlake, D. Wilson, Practical Pharmaceutical Analysis, Continuum International Publishing Group, Ltd, 2001
References
    Planned learning activities and teaching methodsThe taught part of course is delivered to the students by means of lectures, conducted with the help of computer presentations. Lecture notes and presentations are available through the web for students to use in combination with the textbooks.
    Lectures are supplemented with laboratory work carried out in a Biology and Biochemistry laboratory.
    Assessment methods and criteria
    Tests20%
    Laboratory work20%
    Final Exam60%
    Language of instructionGreek
    Work placement(s)NO

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