Pharmaceutical Technology - Galenic Laboratory A - L
Module Pharmaceutical Technology

Academic Year 2022/2023 - Teacher: Rosario PIGNATELLO

Expected Learning Outcomes

  • Pharmaceutical Technology

The goal of the course is to provide the fundamental knowledge on the dosage forms, with particular emphasis on the role of the different components and quality controls on the final pharmaceutical form. The student will learn the nature and the classification of the excipients in order to understand the their role in the different dosage forms and administration ways. At the end of the coarse the student should be able to understand and describe the various approaches for optimizing the therapeutic efficacy of an active ingredient.

EXPECTED LEARNING RESULTS

At the end of the course the student will be able to:

- Acquire knowledge on the categories and properties of the excipients and how they influence the final characteristics of a medicinal product in terms of quality. Overview of some industrial procedures for the production of pharmaceutical forms. Basic knowledge of quality control tests to be applied to the finished product.
- Understand the difference between the different pharmaceutical forms (liquid, solid, semi-solid) and their therapeutic purposes.
- Use the acquired knowledge in the phase of completion of the compulsory pre-degree professional internship.

Course Structure

The course is organized in frontal lessons.

Detailed Course Content

  • Pharmaceutical Technology

MODULE 1 (5 credits)
Stability and biopharmaceutical (1 credit)
Stability and stabilization of medicinal products, storage, antimicrobials and antioxidants.
Biopharmaceutical concepts.
Influence of the type of pharmacutical product on the bioavailability and the activity of the drugs. Preformulation.

Conventional pharmaceutical forms (4 CFU)
Water for pharmaceutical use; Suspensions, emulsions, surfactants.
Liquid preparations for oral use (syrups, powders and granulates for syrups, solutions, emulsions, suspensions, powders for solutions or suspensions, drops, powder for drops).
Ophthalmic preparations (eye drops, eye baths, eye drops and eye baths, semi-solid ophthalmic preparations, eye inserts).
Parenteral preparations: classification, routes of administration, physico-chemical properties, excipients and controls.
Pulmonary pharmaceutical preparations; Pressurized preparations.
The solid pharmaceutical forms (powders; granules; capsules, tablets): classification, routes of administration, chemical-physical and biological requirements and controls of powders, granules, tablets and capsules. Tablet coating.
Semi-solid and topical pharmaceutical forms for skin application (ointments, creams, gels, pastes, cataplasms, medicated plasters).
Rectal Preparations (suppositories).
Vaginal preparations.
Nasal and Ear Preparations.


MODULE 2 (4 credits)
Unconventional and innovative pharmaceutical forms (3 credits)

Modified-release pharmaceutical forms
Drug Delivery System: Microemulsions. Vesicular systems (liposomes, niosomes). Micro and nanoparticulate polymeric systems. Lipid nanoparticulate systems (SLN and NLC).
Chemical approach for the improvement of the chemical-physical properties of drugs: Prodrug and polymeric prodrug; drug-polymer conjugates. Molecular inclusion systems (cyclodextrins).

Complementary sectors of pharmaceutical interest (1 credits)
Traditional and modern herbal drugs and herbal preparations.
Notes on the theoretical foundations and technology of homeopathic medicines.

Textbook Information

RECOMMENDED TEXTS
1. P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA - second edition - Ambrosiana Publishing House, 2015.
2. M. Amorosa - Principi di Tecnologia Farmaceutica- Libr. Univ. Tinarelli, Bologna 1998.
3. M.E. Aulton - PHARMACEUTICAL TECHNOLOGIES Design and preparation of medicines. EDRA editions, 2013.
4. Medicament VII Edition (1st vol.) - Pharmaceutical Cooperative, Milan.

TEXTS TO CONSULT
7. F.U.I. XII Ed. And related supplements and updates.
8. European Pharmacopoeia

9. T.A. Florence & D. Attwood - The chemical-physical bases of pharmaceutical technology - McMillan Press 2002.
10. Martin - Physical Pharmacy - Lea & Febiger, Philadelphia, London.
11. Remington's Pharmaceutical Sciences, 19th ed.
12. Livingstone - Pharmaceutics. The science of dosage form design - Ed. ME Aulton.

13. Teaching material made available online by the teachers.

Course Planning

 SubjectsText References
11 Stabilità e conservazione dei medicamenti P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – cap. 16; M.E. Aulton – TECNOLOGIE FARMACEUTICHE.
22 BiofarmaceuticaP. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione – Casa Editrice Ambrosiana, 2015; M.E. Aulton – TECNOLOGIE FARMACEUTICHE Progettazione e allestimento dei medicinali. Edizioni EDRA, 2013.
33 Acqua per uso farmaceutico; soluzioni acquose ed idroalcoliche; sospensioni, emulsioni; tensioattivi.P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione – Casa Editrice Ambrosiana, 2015; M.E. Aulton – TECNOLOGIE FARMACEUTICHE Progettazione e allestimento dei medicinali. Edizioni EDRA, 2013.
44 Forme Farmaceutiche ConvenzionaliDefinizione e Classificazione delle diverse forme farmaceutiche: FUI XII ed.; Eccipienti, processi e controlli: Colombo et al. - Principi di tecnologia Farmaceutica; M.E. M. AMOROSA a cura di (F. BARBATO): TECNICA FARMACEUTICA, PICCIN, 2021
55 Forme Farmaceutiche Non convenzionali ed InnovativeColombo et al. - Principi di tecnologia Farmaceutica; M.E. Aulton – TECNOLOGIE FARMACEUTICHE; Materiale di supporto fornito dal docente su Studium.
66 Preparazioni erboristiche e fitoterapicheP. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione 2015 (Cap. 39); Materiale di supporto fornito dal docente su Studium
77 Medicinali omeopaticiMateriale di supporto fornito dal docente.

Learning Assessment

Learning Assessment Procedures

The exam is done through a written test, which includes both multiple choice questions and open-ended questions.

The test can be integrated, at the suggestion of the teacher and at the student's discretion, by an oral interview.

The written test includes the theoretical topics envisaged in the Pharmaceutical Technology modules.