Drug Form Technology I
1755-F3-TEPLL-J
Lectures introduce students to:
• Nomenclature of compounded medicines
• Basic technological processes
• Technology of galenic and extemporaneous preparations (solutions, drops, mixtures, emulsions, suspensions, powders, suppositories, ointments, ophthalmic preparations)
• Pharmaceutical phase interactions and solutions to incompatibilities
• Aseptic compounding requirements
• Stability factors and quality testing methods for extemporaneous medicines
Laboratory and practical classes focus on preparation of:
• Solutions, tinctures, syrups, drops, mixtures, emulsions, suspensions, powders, suppositories, ointments, and ophthalmic medicines.
Total student workload
1. Direct contact with academic teachers:
- Lectures: 35 h
- Laboratory: 125 h
- Practical classes: 20 h
- Consultations: 2 h
- Assessment/examination: 4 h
Total: 186 h = 6.1 ECTS
2. Overall student workload:
- Lectures: 35 h
- Laboratory: 125 h
- Practical classes: 20 h
- Preparation for labs/practical classes: 50 h
- Reading assigned literature: 36 h
- Consultations: 2 h
- Preparation for exam + exam: 7 h
Total: 275 h = 9 ECTS
3. Workload related to scientific research:
- Reading scientific literature: 10 h
- Research consultations: 2 h
- Participation in lectures with scientific aspects: 35 h
- Participation in labs/practical classes with research activity: 145 h
- Preparation for labs/practical classes with research activity: 20 h
- Preparation for exam in scientific aspects: 3 h
Total: 215 h = 7 ECTS
4. Workload for assessment and evaluation:
Preparation for labs + exam preparation + exam = 27 h (0.9 ECTS)
5. Mandatory practice: Not applicable
Learning outcomes - knowledge
The student:
• W1: Knows aseptic procedures and methods for ensuring sterility of medicinal products, substances, and materials (K_C.W31).
• W2: Knows types of packaging and delivery systems and how to select them to ensure the quality of compounded medicines (K_C.W32).
• W3: Knows types of physicochemical incompatibilities between ingredients of pharmaceutical preparations (K_C.W28).
• W4: Knows the scope of chemical-pharmaceutical studies required for drug registration documentation (K_C.W36).
• W5: Understands the impact of technological process parameters on properties of compounded dosage forms (K_C.W30).
• W6: Knows principles of compounding and quality control of extemporaneous medicines and storage conditions (K_C.W27).
Learning outcomes - skills
The student:
• U1: Assesses properties of compounded medicines, explains manufacturing methods, identifies stability factors, and selects appropriate packaging and storage conditions (K_C.U16).
• U2: Explains the significance of dosage form and product composition for therapeutic effect (K_C.U15).
• U3: Identifies and resolves problems in prescriptions, verifies composition, controls doses, and detects reportable quality defects (K_C.U17).
• U4: Uses pharmacopoeias, guidelines, and literature for quality evaluation of pharmaceutical substances and products (K_C.U4).
• U5: Prepares herbal preparations in laboratory conditions and evaluates their quality using pharmacopoeial methods (K_C.U18).
• U6: Evaluates functional properties of pharmaceutical excipients (K_C.U19).
• U7: Prepares standard operating procedures and protocols for compounding and pharmacy practice (K_C.U23).
• U8: Uses pharmacopoeias, formularies, technological guidelines, and literature related to dosage form technology and quality, especially for compounded medicines (K_C.U14).
• U9: Prepares ophthalmic medicines under aseptic conditions and selects sterilization methods (K_C.U20).
• U10: Searches for scientific information regarding pharmaceutical substances and medicinal products (K_C.U34).
Learning outcomes - social competencies
The student:
• K1: Develops the habit of using objective sources of information for excipient selection in compounding (K7).
• K2: Draws and formulates conclusions from measurements and observations of compounded medicines (K8).
Teaching methods
Lectures:
• Informative lecture (conventional)
• Problem-based lecture
Laboratories and practical classes:
• Classical problem-solving method
• Laboratory method
• Observation method
Expository teaching methods
- informative (conventional) lecture
Exploratory teaching methods
- experimental
- laboratory
- practical
- case study
- observation
Type of course
compulsory course
Prerequisites
Basic knowledge is required from the following courses:
General and Inorganic Chemistry
Physical Chemistry
Organic Chemistry
Mathematics
Course coordinators
Assessment criteria
•Written exam: W1–W6, U1–U10
•Observation: K1–K2
Grading scale:
• 2.0 (fail): 0–59%
• 3.0 (satisfactory): 60–69%
• 3.5 (satisfactory plus): 70–77%
• 4.0 (good): 78–83%
• 4.5 (good plus): 84–90%
• 5.0 (very good): 91–100%
Practical placement
Bibliography
1. Podstawy receptury aptecznej. Materiały do ćwiczeń dla studentów farmacji, eds. M. Sznitowska, M. Gajewska, Pro Pharmacia Futura, 2024.
2. Jachowicz R. (ed.): Receptura apteczna. Sporządzanie leków jałowych i niejałowych, PZWL, Warsaw, 2021.
3. Kamińska E.: Dawkowanie leków u noworodków, dzieci i młodzieży, PZWL, 2018.
4. Paediatric Formulary Committee (ed.): BNF for Children 2022-2023, Pharmaceutical Press, London, 2022.
5. Buckingham R. (ed.): Martindale. The Complete Drug Reference, 40th ed., Pharmaceutical Press, London, 2020.
6. Krówczyński L., Jachowicz R.: Ćwiczenia z receptury, 7th ed., Jagiellonian University Press, Kraków, 2000.
7. Kodym A.: Technologia leków recepturowych, Nicolaus Copernicus University, Bydgoszcz, 2006.
8. Sznitowska M.: Applied Pharmacy – Dosage Form Technology, PZWL, Warsaw, 2017.
9. Polish Pharmacopoeia IV, VI, XIII.
10. Therapeutic guides:
• Pharmindex Kompendium leków, Medimedia International, Warsaw, 2022.
• Podlewski J. K., Chwalibogowska-Podlewska A.: Leki współczesnej terapii. Encyklopedia, Medical Tribune Polska, Warsaw, 2021.
11. Krówczyński L., Rybacki E.: Interakcje w fazie farmaceutycznej, PZWL, Warsaw, 1986.
Supplementary:
1. Allen L. V. Jr.: Pharmaceutical Dosage Forms and Drug Delivery Systems, 11th North American ed., LWW, 2017.
2. Allen L. V. Jr.: Suppositories, Pharmaceutical Press, 2008.
3. Ghosh T. K., Jasti B. R.: Theory and Practice of Contemporary Pharmaceutics, CRC Press, 2005.
4. Bouwman-Boer Y., Fenton-May V., Le Brun P.: Practical Pharmaceutics, Springer, 2015.
5. Taylor K., Aulton M.: Aulton’s Pharmaceutics, Elsevier, 2017.
6. Allen L. V. Jr.: The Art, Science, and Technology of Pharmaceutical Compounding, APhA, 2016.
7. Remington: The Science and Practice of Pharmacy, Pharmaceutical Press, 2012.
Additional information
Additional information (registration calendar, class conductors,
localization and schedules of classes), might be available in the USOSweb system: