Pharmaceutical Technology

Pharmaceutical Technology I. (5. semester)

Lecture topics/week:

1. The scope of pharmaceutical technology. History of pharmaceutical compounding.
2. Dosage forms as drug carrier systems. Classification of dosage forms and methods of administration.
3. Biopharmaceutical and pharmacokinetic bases of pharmaceutical technology.
4. Technological aspects of drug quality. Quality standards.
5. Physico-chemical principles in the pharmaceutical technology. Basic compounding procedures.
6. The guide for pharmaceutical compounding in Hungary. Storage of pharmaceuticals. Individual presciptions. Packaging materials in the pharmacy and their quality standards.
7. Liquid dosage forms. Solutions and solubility. Preparation of solution.
8. Ideal and colloid solutions, aromatic water, syrup, mucilage.
9. Elixire, mixture, gargles, enema preparations.
10. Drops for internal (Gutta) and external use (Oto-nasogutta). Microbiological preservatives.
11. Principles and practice of aseptic preparation. Eye drops.
12. Preparations made by extractions. Extractives, infusions, decoctions, tinctures.
13. Suspensions. Theory and preparation. Suspending agents. Apparatuses.
14. Emulsions. Theory and preparation. Emulsification, emulsifying agents, stability of emulsions.

Pharmaceutical Technology II. (6. semester)

1. Semi–solid preparations. Classification and preparation. Ointments, gels, pastes. Eye ointments.
2. Tests of semisolid preparations. Rheology and other characteristics.
3. Cosmetics in the pharmacy.
4. Rectal and vaginal preparations.
5. Preparation and tests of suppositories.
6. Dosage forms prepared by aggregation. Pills, boluses, sticks, foams, medicated chewing gums.
7. Comminution, powdering, sieving, mixing.
8. Compounding powder preparations.
9. Technological aspects of the pharmacopoeia ( Eur.Ph.,Ph.Hg.VIII.)
10. Technological aspects of veteriner preparations in the pharmacy.
11. Incompatibility problems I. Solutions.
12. Incompatibility problems II. Solid dosage forms.
13. Other dosage forms and role of excipients.

Pharmaceutical Technology III. (7. semester)

Lecture topics/week:

1. Theoretical background for the Pilot Plant laboratory practices. Introduction into industrial pharmaceutical technology.
2. Aspects of the pharmaceutical development. Preformulation. Theoretical background for the Parenteral laboratory practices.
3. Condition system of drug manufacturing. Good Manufacturing Practice (GMP). Industrial manufacturing and safety technique.
4. Stabilization possibilities of medicinal preparations. Principles of drug stability.
5. Chemical engineering, scaling-up, optimization principles. Stability testing.
6. Pharmaceutical unit operations. Particle size reduction, milling, sieving. Particle-engineering. Pharmaceutical unit operations. Aggregation, compaction and compression.
7. Critical manufacturing parameters. In-process-Control. Quality by design. Pharmaceutical unit operations. Heat transfer, evaporation, distillation.
8. Pharmaceutical unit operations. Drying. Pharmaceutical unit operations. Filtering, sedimentation, centrifugation, extraction by squeezing.
9. Pharmaceutical unit operations. Freeze-drying and lyophilized products. Pharmaceutical unit operations. Sterilization.
10. Pharmaceutical unit operations. Fluidization. Parenteral preparations. Factory design.
11. Validation. Large volume parenteral preparations.
12. Pharmaceutical unit operations. Crystallization. Pharmaceutical unit operations. Amorphization. Spray-drying.
13. Solution and dispersion type injections. Pharmaceutical unit operations. Mixing, dispersing.
14. Packaging technology and packaging materials I. Packaging technology and packaging materials II.

Pharmaceutical Technology IV. (8. semester)

Lecture topics/week:

1. Theoretical considerations of pilot plant practices. Theoretical considerations of parenteral preparations.
2. Classification and preformulation of solid dosage forms. Solid state characterization. Granulation I.
3. Granulation II. Inhaled preparations, aerosols.
4. Pellets and palletization. Particle systems and their characterization.
5. Tablets I. Tablets II.
6. Capsules I. Capsules II.
7. Coating I. Coating materials and procedures, film coating. Coating II. Traditional sugar coating.
8. Coating III. Solvent-free coating. Modern dosage form design: modified drug release.
9. Innovative pharmaceutical technological products. Generics and supergenerics. Quality by Design, PAT, nondestructive analysis.
10. Modern dosage form design: testing and evaluation of drug release profile. Modern dosage form design: improvement of dissolution and solubility.
11. Modern dosage form design: colloidal carrier systems, liposomes. Pharmaceutical technological aspects of Pharmacopoeias.
12. Modern dosage form design: transdermal therapeutic systems. Modern dosage form design: Molecular pharm. tech. microfabrication.
13. Guidelines of preparation. Galenic preparations. Surgical sutures, bandages, implants.
14. Pharmaceutical technology and quality assurance. Modern dosage form design: Delivery of biopharmaceuticals