Development of Pharmaceutical Products - GAF379
Title: Development of Pharmaceutical Products
Guaranteed by: Department of Pharmaceutical Technology (16-16210)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2024
Semester: winter
Points: 0
E-Credits: 4
Examination process: winter s.:written
Hours per week, examination: winter s.:0/32, C+Ex [HS]
Capacity: unknown / unknown (10)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: English
Teaching methods: full-time
Level:  
Is provided by: GF379
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: Mgr. Monika Smékalová, Ph.D.
Co-requisite : GAF346
Interchangeability : GAF288
Is interchangeable with: GAF320
Examination dates   WS schedule   
Annotation -
Elective course from a compulsory group of courses, 4th section of the Pharmacy study program, winter semester. The subject is related to the subjects Pharmaceutical Technology 1 and 2 and it is intended for students who would like to expand their knowledge in Pharmaceutical Technology, particularly in the development and formulation of pharmaceutical preparation including choice of active substance, dosage form, excipients, and final evaluation of the product. The subject is related to the subject Industrial Production of Pharmaceutical Products (GAF378) in the summer semester. The capacity limit is 10. The subject belongs to the area of specialization in Pharmaceutical Technology; the students enrolled in the specialization are preferred in case the capacity is exceeded.
Last update: Smékalová Monika, Mgr., Ph.D. (18.07.2024)
Course completion requirements -
The subject is concluded by passing the written exam. 70% of correct answers is necessary to pass.
Last update: Smékalová Monika, Mgr., Ph.D. (18.07.2024)
Literature -

Recommended:

  • . . In Gad, Shayne C., (ed.). Pharmaceutical manufacturing handbook : production and processes . Hoboken, N.J.: John Wiley & Sons, 2008, s. -. ISBN 978-0-470-25958-0..

  • . . In Allen, Loyd V.. Pharmaceutical dosage forms and drug delivery systems . Philadelphia: Wolters Kluwer, 2018, s. -. ISBN 978-1-4963-7291-8..

  • . . In Allen, Loyd V. (ed.). Remington : an introduction to pharmacy . London: Pharmaceutical Press, 2013, s. -. ISBN 978-0-85711-104-3..

  • . . In Swarbrick, James, (ed.). Encyclopedia of pharmaceutical technology . New York: Informa Healthcare, 2007, s. -. ISBN 0-8493-9399-X..

Last update: prepocet_literatura.php (19.09.2024)
Teaching methods -

Seminars and lectures

Teaching is provided by specialists from Zentiva.

Last update: Smékalová Monika, Mgr., Ph.D. (18.07.2024)
Requirements to the exam -
The subject is concluded by passing the written exam. 70% of correct answers is necessary to pass.
Last update: Smékalová Monika, Mgr., Ph.D. (18.07.2024)
Syllabus -
  • Development of pharmaceutical products
  • Analytical methods for solid state
  • Particle engineering
  • Dissolution methods
  • Formulation of solid dosage forms
  • Solid dosage forms – compression, coating
  • Modification of drug release
  • Evaluation of the preparation, bioequivalency studies 
Last update: Smékalová Monika, Mgr., Ph.D. (18.07.2024)
Learning resources -
Department of Pharmaceutical Technology | Intranet FAF (cuni.cz)
Last update: Smékalová Monika, Mgr., Ph.D. (18.07.2024)
Learning outcomes

  

The course Development of Pharmaceutical Products builds on the knowledge and skills acquired in the courses Pharmaceutical Technology I and II.

After completing the course, the student will be able to use the following terms (including their commonly used abbreviations): generic, active pharmaceutical ingredient (API), polymorphism, allotropy, crystal lattice, motif, monotropy, enantiotropy, crystal, amorphous substance, salt, cocrystal, solvate, electromagnetic spectrum, glass transition, tablet, solid dispersion, orodispersible film, multiple-unit pellet system (MUPS), sustained release, delayed release, osmotically controlled release (OROS), bioequivalence, biopharmaceutical classification system (BCS).

 

Learning outcomes:

Based on the knowledge and skills acquired, students will be able to:

Ø  explain the principles of methods for API characterization: NMR, IR spectroscopy, Raman spectroscopy, mass spectrometry, liquid chromatography, and dynamic vapor sorption.

Ø  understand the background of generic drug development, the process of screening and characterisation of API, and the development of methods for crystallisation of selected API, and explain the importance of polymorphism and its impact on bioavailability

Ø  explain the difference between crystal, amorphous substance, cocrystal, solvate, and salt, and evaluate their properties, advantages, and disadvantages of their use in dosage forms

Ø  explain the principles of solid phase characterisation methods: surface area analysis, optical microscopy, laser diffraction, focused beam reflectance measurement (FBRM), X-ray diffraction, differential scanning calorimetry, thermogravimetry

Ø  discuss new product development planning, dosage form selection, describe the steps in the formulation process, excipient selection, and quality assessment of the final product

Ø  describe the steps of stability studies and their evaluation

Ø  explain the principles of solubility enhancement methods, the choice of dissolution method, and propose the choice of instrument and conditions for characterising the release of different dosage forms

Ø  discuss the properties of a dosage form that affect the rate of drug release, and understand controlled release

Ø  explain the principles of techniques in the production of solid dosage forms: spray drying, melt extrusion, tablet production, tablet coating, pellet production

Last update: Smékalová Monika, Mgr., Ph.D. (28.03.2025)