SubjectsSubjects(version: 996)
Course, academic year 2026/2027
   
Pharmaceutical Technology I - GAF437
Title: Pharmaceutical Technology I
Form of teaching: lecture+seminar+practical classes
Guaranteed by: Department of Pharmaceutical Technology (16-16210)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2026
Duration in semesters: 1
Semester: summer
Points: 0
E-Credits: 6
Examination process: summer s.:
Hours per week, examination: summer s.:56/70, C [HS]
Capacity: unknown / unknown (unknown)
Maximum number of enrolled students: unlimited
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: not taught
Language: English
Teaching methods: full-time
Level:  
Repeated enrollment: 1 / 1 / - / 1
Note: deregister from the credit exam date if a requisite was not fulfilled
Guarantor: doc. PharmDr. Zdeňka Šklubalová, Ph.D.
Co-requisite : GAF308, GAF339, GAF341
Incompatibility : GAF310
Interchangeability : GAF188, GAF310
Schedule   
Annotation -
The course Pharmaceutical Technology I (PhT I) directly follows the course Methods of Pharmaceutical Technology. Its objective is to provide students with a comprehensive understanding of the preparation and manufacturing of traditional dosage forms with conventional drug release. Furthermore, the course emphasizes excipients employed in pharmaceutical products, formulation and stabilization processes, as well as quality assessment methods for medicinal preparations. The practical training is oriented towards acquiring the skills and habits necessary for extemporaneous preparation in pharmacies. The practical part also includes the application of pharmaceutical calculations required in the preparation of pharmaceutical preparations (including the verification of active substance doses), adjustment of preparations, and their proper labeling.
Last update: Vraníková Barbora, doc. PharmDr., Ph.D. (01.09.2025)
Course completion requirements -

The course Pharmaceutical Technology I is concluded with a credit (course completion). The requirements for obtaining the credit are as follows:

·         Completion of practical classes in the scope prescribed by the study plan. Full (100%) attendance at practical classes is mandatory.

·         Proper maintenance of laboratory reports from practical classes.

·         Achieving at least 75% correct answers in individual tests.

·         Correct preparation of the final credit medicinal product.

Last update: Vraníková Barbora, doc. PharmDr., Ph.D. (01.09.2025)
Literature -

Obligatory:

  • . . In Taylor, Kevin, Aulton, Michael E. (eds.). Aulton's pharmaceutics : the design and manufacture of medicines . [Velká Británie]: Elsevier, 2022, s. -. ISBN 978-0-7020-8154-5..
  • . . In Fahr, Alfred. Voigt's pharmaceutical technology . Hoboken, New Jersey: John Wiley & Sons Ltd., 2018, s. -. ISBN 978-1-118-97262-5..

Last update: Vraníková Barbora, doc. PharmDr., Ph.D. (01.09.2025)
Teaching methods -
  • Lectures
  • Practical classes, introduced by an explanatory session in the form of a seminar
Last update: Vraníková Barbora, doc. PharmDr., Ph.D. (01.09.2025)
Course assessment methods and requirements for successful completion, grading scheme -

The course Pharmaceutical Technology I is concluded with a credit. The exam is an integral part of the course Pharmaceutical Technology II.

Last update: Vraníková Barbora, doc. PharmDr., Ph.D. (01.09.2025)
Syllabus -

The course Pharmaceutical Technology I focuses on the following topics:

·         Biopharmaceutics, bioavailability, and bioequivalence

·         Pharmaceutical solutions

·         Pharmaceutical suspensions

·         Pharmaceutical emulsions

·         Semi-solid dosage forms (ointments, creams, pastes, gels)

·         Rectal dosage forms

·         Vaginal dosage forms

·         Powders (oral, dermal)

·         Granulated powders (granules)

·         Tablets

·         Coated tablets

·         Capsules

·         Pellets

·         Pharmaceutical packaging

·         Good Manufacturing and Pharmacy Practice

Last update: Vraníková Barbora, doc. PharmDr., Ph.D. (01.09.2025)
Learning resources -

Web FaF:

https://intranet.faf.cuni.cz/Study-materials/KFT/?path=pharmaceutical+technology

Last update: Navrátilová Lucie, Ing. (22.08.2025)
Learning outcomes -

Define and appropriately use the following terms in context: pharmaceutical technology, pharmaceutics, biopharmaceutics, dosage form, drug delivery system, Good Manufacturing Practice (GMP), Good Pharmacy Practice (GPP), immediate (conventional) release, active pharmaceutical ingredient (API), pharmaceutical excipient, technical excipient, functional characteristics of excipients, constitutive excipient, stabilizing excipient, dispersing system stabilizer, base, solvent, ointment base, suppository base, filler, binder, disintegrant, lubricant, drug release modifier, film-forming agent, antimicrobial additive, antioxidant, primary antioxidant, secondary antioxidant, peptizer, viscosity enhancer, surfactant, emulsifier, true emulsifier, pseudo-emulsifier (quasi-emulsifier), isotonic agent, buffer solution, flavoring agent, odorant, coloring agent, antimicrobial protection, prescription, formulation, manufacturing instructions, pharmaceutical packaging, adjustment, label, shelf life, expiration date, mass production of drugs and extratemporaneous preparation (compounding).

Summarize the biopharmaceutical aspects of oral, nasal, otic, vaginal, rectal, and dermal drug administration.

Discuss the differences between an active pharmaceutical ingredient and an excipient in a medicinal product. Summarize the functional characteristics of excipients. Classify excipients according to their origin. Classify excipients according to their function in the formulation. Discuss the differences between an excipient and a technical excipient, illustrating the differences with concrete examples. Classify constitutive excipients. Discuss the differences between a vehicle and a base. Classify stabilizing excipients. Classify organoleptic-modifying excipients. Provide at least three concrete representatives of each type of excipient, including a brief description of their properties. Identify the function of each component of a formulation. Describe the labeling and storage of APIs, excipients, and medicinal products in pharmacies; discuss labeling and storage using specific examples. Compare the labeling and storage of inoxiis, separands, venena, and narcotic or psychotropic substances. Discuss the handling of APIs and excipients in pharmacies. Discuss the differences between medicinal products and laboratory reagents/diagnostics.

Based on the composition of a preparation, identify the type of dispersed system. Assign individual components of a preparation to the respective phase (hydrophilic, lipophilic, solid, gaseous). Based on the composition, identify the type of dosage form/medicinal product. Recognize the corresponding type of dosage form among other dosage forms.

Describe the principles of the following pharmaceutical operations: weighing, heating/cooling, mixing, homogenization, granulation, dissolution, emulsification, and suspension. Schematically describe/draw the production/preparation of dosage forms. Propose/select a suitable method for the preparation/manufacturing of a medicinal product with respect to the type of dosage form. Propose/select suitable facilities for the preparation/manufacture of a medicinal product with respect to the type of dosage form. Discuss the differences between preparation of medicinal products in pharmacies and industrial pharmaceutical production.

Based on a prescription, evaluate the necessity of controlling the dose of the active substance. Where relevant, perform a dose control of the API in a medicinal product. Propose a procedure for preparing a specific medicinal product. Describe the preparation of a medicinal product according to a specific prescription. Prepare a medicinal product according to the prescription. Based on the prescription, propose a method for adjustment and storage of the medicinal product, including determination of shelf life, and justify your decision. Based on the intended use, decide on the color of the label for an individually prepared product and justify your decision. Fill in the basic label for a given preparation and decide on the use of supplementary labels. Describe and identify the tools used in the preparation of individually compounded products in a pharmacy setting.

Consult the Pharmacopoeia for information on the properties and solubility of APIs/excipients. Where relevant, perform a dose control of the API. Calculate the required amount of stock solution/ointment base/trituration for the preparation of a specific medicinal product.

Last update: Vraníková Barbora, doc. PharmDr., Ph.D. (01.09.2025)
 
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