Pharmaceutical Technology (2)
Questions for the State exam in Pharmaceutical Technology
1. Systematic classification of drug products and dosage forms. Latin nomenclature of dosage forms. Drug product as a dispersion system. Administration routes of drug products.
2. Pharmaceutical excipients – constitutive excipients (bases). Water in dosage forms technology. Production of water for pharmaceutical use.
3. Pharmaceutical excipients – stabilizers of drug product composition, modifiers of sensual perception, technical excipients.
4. Excipients stabilizing liquid dispersion systems. Surfactants, surface activity, chemical structure, classification and examples of surfactants. Surface and interfacial phenomena in liquid systems.
5. Pharmaceutical solvents. Solutions. Solubility. Solubilization. Solubilizers. Dissolution rate of solid substances, relation to bioavailability. Aromatic waters, aromatic spirits. Syrups.
6. Drug products obtained by extraction methods. Physical and chemical aspects of drug extraction. Extraction methods. Dosage forms prepared from medicinal plant drugs – procedures, properties, evaluation.
7. Polymers as pharmaceutical excipients. Gels and gel structure. Soaps.
8. Dispersion systems liquid in liquid. Excipients. Preparation of emulsions. Medicinal emulsions. Instabilities.
9. Dispersion systems of solid substances in liquid. Wetting of solid substances. Excipients stabilizing dispersion systems. Kinetic and aggregate instability. Medicinal suspensions.
10. Powders as raw material and as a dosage form. Basic operations and general procedures during powder preparation (comminuting, mixing, sieving). Powders for cutaneous application.
11. Pulmonary drug products. Pressurized containers for aero dispersions, propellant gases. Biogalenic aspects of inhalation drug products.
12. Eye preparations. Physical and microbiological aspects of ophthalmic drug products, excipients, production, evaluation. Nasal and ear preparations. Bioavailability of active substances from ophthalmic, nasal and ear products.
13. Parenteral products. Sterility, sterilization, cleanroom areas. Manufacture of injections. Technology, classification and use of infusion solutions.
14. Rheology and flow properties of drug products. Viscosity. Apparent viscosity.
15. Semisolid preparations for cutaneous application, classification, definitions. Biogalenic aspects of semisolid preparations, transfer of a drug into and through the skin.
16. Ointments, creams, pastes. Ointment and cream bases. Manufacture of semisolid preparations. Solution, emulsion, suspension systems.
17. Preparation and quality control of rectal and vaginal products.
18. Granules. Creation of granules and compressed aggregates. Binding forces. Granulation, granulation methods.
19. Solid drug products for oral and peroral administration. Tablets. Quality control.
20. Coated tablets. Dissolution test.
21. Peroral capsules. Hard and soft gelatin capsules. (soft gelatin capsules with and without a seam).
22. Modified release drug products.
23. Dosage microforms. Excipients, production. Dosage forms containing microforms.
24. Therapeutic systems: peroral, transdermal, parenteral, ocular, intrauterine.
25. Stability and stabilization of drug products.
26. Pharmaceutical package and packaging.
27. Pharmaceutical bioavailability (absolute, relative). Main pharmacokinetics parameters and their consequences on developing of dosage forms. Chemical, biological and therapeutic equivalence of drug products.
28. Peroral and dermal liquid dosage forms. <s></s>
29. Targeted bio distribution of drugs. Colloidal carriers of drugs. Liposomes, microemulsions, nanoparticles.
30. Liberation and absorption of drugs in relation to dosage form.
Pharmaceutical technology II, Topics for a term exam
1. Principles of dosage form and the main types of excipients used in various dosage forms.
2. Rheology and the flow of liquids and semisolids.
3. Basic operations and general procedures in pharmaceutical technology.
4. Solutions and their properties, solubility and dissolution rate.
5. Solutions as dosage forms, vehicles, excipients used by preparation of solutions.
6. Extraction – theory, methods, preparations obtained by extraction, quality control.
7. Parenteral preparations – route of administration, types of parenterals, bioavailability, production of parenterals, quality control.
8. Parenteral preparations – preformulation and formulation, pH, osmolality, osmolarity, auxiliary materials, containers and closures.
9. Principles of sterilization, sterilization practice, sterility testing.
10. Eye preparations, excipients, formulation, quality control.
11. Aerosols – formulation, containers, manufacture and packaging, evaluation and quality control. Preparations for inhalation.
12. Suspensions – theory, wettability of solids, kinetic and aggregate instability.
13. Suspensions - evaluation of stability, stabilisation, preparation of suspensions.
14. Surfactants – characterization, their function in emulsions, HLB system.
15. Emulsions – theory, stability, preparation and evaluation.
16. Microemulsions – surface and interfacial phenomena, comparision with emulsions. Advantages and disadvantages of microemulsion use, examples.
17. Topical semisolids – classification, percutaneous absorption, constituents and methods of preparation (ointments, creams, gels, pastes, poultices, medicated plasters, cutaneous patches).
18. Transdermal delivery systems - types, formulation, penetration enhancers.
19. Rectal and vaginal preparations – bioavailability, excipients, methods of preparations, evaluation and quality control.
20. Granulation of powdered materials – constituents, methods, devices.
21. Tablets – excipients, methods of manufacture. The principle of tablet presses.
22. Coated tablets – theory and reasons of coating, methods of preparation, quality control.
23. Hard and soft gelatine capsules, excipients, methods of preparation, quality control.
24. Powders and granules as dosage forms, quality control.
25. Microforms – pellets, microcapsules, microspheres, microdragees. Auxiliary materials, methods of preparation.
26. Modified release dosage forms – delayed, prolonged, sustained, controlled release dosage forms, components and possibility of formulation
27. Drug targeting, passive, active targeting, colloidal drug delivery systems.
28. Stability of medicinal products – chemical stability, physical stability, stability testing, prediction of stability. Storage of medicinal products.
29. Pharmaceutical packaging – function, materials, types of containers.
30. Bioavailability, bioequivalence studies.
31. Liberation principles from different dosage forms.
32. Quality assurance, good manufacturing practice.
33. Parenteral preparations – intavenous infusions. Cathegories, excipients and components, their use.
34. Parenteral depot products – possibility of formulation, types, methods of production.
35. Pharmaceutical colloidal systems. Cathegories, characteristics, properties, methods of preparation.