TECNOLOGIA FARMACEUTICA - LABORATORIO GALENICO - TECNOLOGIA COSMETICA CON ESERCITAZIONI A - L

Module TECNOLOGIA FARMACEUTICA

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

- Acquire knowledge on the categories and properties of excipients and how they influence the final characteristics of a medicine in terms of quality. Notes on some industrial processes for the creation of pharmaceutical forms. Basic knowledge of quality control tests to be applied to the finished product before its distribution.

- Understand the difference between the different pharmaceutical forms (liquid, solid, semi-solid) and the therapeutic purposes.

- Use the knowledge acquired during the compulsory pre-degree professional internship.

The A-L Pharmaceutical Technology module consists of lectures (9 CFU).

A small number of lessons may be dictated in English.

+ In-depth lessons (optional) will be provided on topics relating to the teacher's experimental research topics.

+ Additional and optional lessons (honor courses) will be provided for in-depth analysis of innovative topics of current research interest in the pharmaceutical technological field.

- Mathematic, Statistic and Informatic;

-General and Analitical Chemistry;

- Anatomy;

- Microbiology, Pharmacology and Physiology;

- Basic knowdledge of excipients for pharmaceutical use.

Attendance at the course is mandatory for at least 70% of the lectures.

The Pharmaceutical Technology course (9 credits) is divided into MODULE 1 (5 credits) and MODULE 2 (4 credits), as follows.

MODULE 1 (5 credits)

(1 credit) Fundamental operations in pharmaceutical technology: filtration, drying, freeze-drying, sterilization. Packaging and containers.

(4 credits) Conventional dosage forms

Solid dosage forms:

1. Powders and pulverization: definition, classification, technological properties, and controls;

2. Granules and granulation: definition, classification, excipients, requirements, and controls;

3. Tablets: definition, classification, excipients, manufacturing processes. Tablet coating (coating, film coating, gastrosoluble and gastro-resistant coatings);

4. Capsules: definition, classification, excipients, manufacturing processes for hard and soft capsules, controls;

5. Rectal Preparations and Vaginal Preparations: definition, classification, excipients, manufacturing processes, and controls.

Liquid dosage forms:

Aqueous and hydroalcoholic solutions. Suspensions. Emulsions. Focus on surfactants as excipients in different dosage forms. Liquid preparations for oral use: syrups. Ear preparations.

Semi-solid dosage forms: definition, classification, excipients. Semi-solid preparations for skin application.

Sterile dosage forms:

1. Pharmaceutical forms for ophthalmic use (definition, classification, excipients, chemical-physical and microbiological requirements, and controls);

2. Pharmaceutical forms for parenteral use (definition, classification, excipients, chemical-physical and microbiological requirements, controls).

Pressurized dosage forms:

1. Nasal dosage forms: definition, classification, excipients, requirements, and administration devices.

2. Pulmonary pharmaceutical forms: definition, classification, excipients, requirements, devices for their administration.

MODULE 2 (4 credits)

(1 credit) Complementary areas of pharmaceutical interest:

- Traditional and modern phytotherapeutic and herbal preparations

- Overview of the theoretical foundations and technology of homeopathic medicines.

(3 credits) Innovative dosage forms:

- Focus on polymeric materials and modified-release formulations

- Modified-release dosage forms for different routes of administration

- Advanced drug manufacturing technologies:

1. Microencapsulation

2. Molecular inclusion systems (Cyclodextrins)

3. Micro- and nanoemulsion systems

- Nanomedicine: Historical evolution, classification of nanoformulations in the preclinical and clinical phases for the delivery of small molecules. Types of nanoformulations: inorganic and organic nanoparticles, with particular attention to vesicular systems (liposomes, niosomes) and solid nanoparticles (polymeric, lipidic, hybrid).

SUGGESTED BOOKS

1. P.  Caliceti  - TECNOLOGIA FARMACEUTICA – prima edizione – Casa Editrice Ambrosiana, 2025.

2. M.E. Aulton – TECNOLOGIE FARMACEUTICHE Progettazione e allestimento dei medicinali. Edizioni EDRA, 2013.

3. P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione – Casa Editrice Ambrosiana, 2015.

4. Medicamenta VII Ed. (1° vol.) - Cooperativa Farmaceutica, Milano.

BOOKS TO CONSULT

4. F.U.I. in vigore e relativi supplementi e aggiornamenti.
5. Farmacopea Europea in vigore.T.A. Florence & D. Attwood – Le basi chimico-fisiche della tecnologia farmaceutica - McMillan Press 2002.
6. Martin - Physical Pharmacy - Lea & Febiger, Philadelphia, London.
7. Remington’s Pharmaceutical Sciences, 19th Ed.
8. Livingstone – Pharmaceutics. The science of dosage form design- Ed. ME Aulton.

The exam consists of a written test, which includes a preliminary section of multiple-choice questions and a section of open-ended questions.

The test may be supplemented, at the instructor's suggestion and the student's discretion, with an oral exam.

The written exam covers the theoretical topics covered in the Pharmaceutical Technology modules.

Information for students with disabilities and/or learning disabilities (LDs)

To ensure equal opportunities and in compliance with applicable laws, interested students may request a personal interview to plan any compensatory and/or dispensatory measures, based on their learning objectives and specific needs.
Professor Santina Chiechio is the CInAP (Center for Active and Participatory Integration - Services for Disabilities and/or Learning Disabilities) contact teacher at the Department of Pharmaceutical and Health Sciences.

1) To ensure the heat protection of a pharmaceutical substance or preparation, which of the following strategies can be adopted:

Add one or more antioxidants to the preparation.
Use dark or black glass containers.
Wrap the container in aluminum foil.
Store the intermediate preparation in the refrigerator between the various preparation stages.
* Work in temperature-controlled environments.*
2) What is meant by 'dilution' in homeopathic medicine?

a. The number of dilutions to which a given remedy has been subjected.

b. The degree of dilution of the alcohol used in the preparation of the TM.

c. * The degree of dilution and dynamization of the preparation, compared to the TM.*

d. The concentration of remedy with which the globules are impregnated.

e. This is not an important aspect in homeopathic preparations.

Open-ended questions:

1) Excipients for O/O creams.

2) Soft capsules.

3) Ophthalmic preparations: definition, classification, chemical-physical, and microbiological requirements.