PHARMACEUTICAL TECHNOLOGY/ PHARMACEUTICAL TECHNOLOGY LABORATORY
cod. 1000789

Academic year 2021/22
3° year of course - Second semester
Professor responsible for the course unit
BETTINI Ruggero
integrated course unit
12 credits
hub: PARMA
course unit
in ITALIAN

Course unit structured in the following modules:

Learning objectives

The objective of the first module The objective of the module is to give to the student the theoretical notions about exicpients, fabrication methods, controls, technological and biopharmaceutical properties of immediate release pharmaceutical forms.
Information about the key factors affecting absorption and bioavailability in relation to the pharmaceutical dosage form administered are given. The fundamentals of galenic production in pharmacy are treated as well.
The expected learning outcomes are:
1. Knowledge and understanding: knowledge of excipients, of fabrication methods, of controls, of technological and biopharmaceutical properties of immediate release pharmaceutical dosage forms and understanding of the different roles of excipient in the dosage forms
2. Applying knowledge and understanding: ability to apply, in an independent way, the knowledge acquired for the identification of excipients and the preparation methods more suitable for the development of a given dosage form.
3. Communication skills: ability to use the specific language for this specialist discipline.
4. Making judgements: the capability to face the professional responsibilities of a pharmaceutical technologist. To be able to evaluate the implication and the result of studies made to clarify the influence of the dosage form on the activity of the active molecule.
5. Learning skills: capability of using the knowledge and the basic elements acquired in the conduction of the work as a pharmaceutical technologist. Capability of upgrade, through the scientific publications in the field of pharmaceutical technology.
The objective of the course is to give to the student the practical notions about the preparations, controls and technological properties of most common immediate release dosage forms.
The expected learning outcomes are:
1) Knowledge and understanding: knowledge of excipients, fabrication methods, of controls, of technological properties of immediate release dosage forms.
2) Applying knowledge and understanding: ability to apply, in an independent way, the knowledge acquired for the preparation of a given dosage form.
3) Communication skills: ability to use the specific language for this specialistic discipline.
4) Making judgements: the capability to face the professional responsibilities of the galenical pharmacist
5) Learning skills: capability of using the knowledge and the basic elements acquired in the conduction of the work as galenical pharmacist. Capability of update, through the scientific publications in the field of pharmaceutical technology.
The objective of the second module is to give to the student the practical notions about the preparations, controls and technological properties of most common immediate release dosage forms.
The expected learning outcomes are:
1) Knowledge and understanding: knowledge of excipients, fabrication methods, of controls, of technological properties of immediate release dosage forms.
2) Applying knowledge and understanding: ability to apply, in an independent way, the knowledge acquired for the preparation of a given dosage form.
3) Communication skills: ability to use the specific language for this specialistic discipline.
4) Making judgements: the capability to face the professional responsibilities of the galenical pharmacist
5) Learning skills: capability of using the knowledge and the basic elements acquired in the conduction of the work as galenical pharmacist. Capability to update, through the scientific publications in the field of pharmaceutical technology.

Prerequisites

To take the exam, it is necessary to have passed the General Physiology and Organic Chemistry exams.

Course unit content

The first module deals with the modern approach at the preparation of medicines, at the comprehension of the characteristics of the different dosage forms, in particular with respect on the specific role of the various excipients as well as of the peculiarity of some administration route.
The content of the second module are related to the modern and appropriate pharmaceutical compounding and galenical development, in particular with respect to the practical preparation in pharmacy and the professional responsibility of the pharmacist.
The first part of the course will focus on the fundamentals of metrology and of the unit operations. In the second part the student will learn how to compound the different dosage forms
In agreement with the Pharmacopoeial requirements.

Full programme

First module:
Medicines and pharmaceutical dosage forms
Italian and European Pharmacopoeias
Pharmaceutical Processes: Particle size reduction, Mixing, Drying, Filtration, Sterilization, Dissolution, Granulation
Basic principles of biopharmaceutics
Pharmacokinetics
Pharmaceutical ingredients: active principles, excipients, packaging materials
Galenic development: pharmaceutical preformulation and formulation, packaging
Stability of pharmaceutical products
Conventional pharmaceutical dosage forms: Solid dosage forms (Powders, Granules, Capsules, Tablets, pellets, suppositories), liquid dosage forms (solutions, suspensions,e mulsions), semisolid dosage forms (ointments, gels, pastes, creams), sterile products
Administration routes and pharmaceutical dosage forms: oral, dermatological, parenteral, ocular, auricular, nasal, inhalation, rectal, vaginal.
Herbal Extracts

Second module
• Basic technological processes (e.g. mixing, granulation)
• Principles of pharmaceutical calculations
• Metrology
• Preparation and characterization, according to Italian Pharmacopeia, of conventional dosage forms:
o Oral powders
o Topical powders
o Tablets
o Capsules
o Liquid preparations for oral use
o Liquid preparation for topical use
o Topical semisolid dosage forms
• Legal issues concerning the preparation, packaging and pricing of galenical preparation according to the Italian Pharmacopeia

Bibliography

Farmacopea Ufficiale della Repubblica Italiana, XII Edizione, Istituto Poligrafico e Zecca dello Stato, Roma (2008);
-P. Colombo, P.L. Catellani, A. Gazzaniga, E. Menegatti, E. Vidale Principi di Tecnologie Farmaceutiche, Casa Editrice Ambrosiana, II Ed. Milano (2015)
-M. Amorosa, Principi di Tecnica Farmaceutica, Libreria Universitaria L. Tinarelli, Bologna (1998).
Letture consigliate:
A.J. Winfield, R.M.E. Richards, Pharmaceutical Practice second edition, Churchill Livingstone London (1998).

ENRICO RAGAZZI, «Galenica pratica, formulazione e tecnologia», Libreria Internazionale Cortina Padova
FRANCO BETTIOL, «Manuale delle preparazioni galeniche», Tecniche Nuove

Suggested reading:
US Pharmacopoeia
-Medicamenta, Cooperativa Farmaceutica Milano, VII ED. 1992
Approfondimenti:
International Journal of Pharmaceutical compounding

Teaching methods

The first module includes frontal lessons and video tutorials on the preparation mode of the main dosage forms.
In case of persistence of the health emergency, it may be necessary to integrate the lessons with the remote modality, we will proceed as follows:
lectures in mixed mode (part of the students in presence and part at a distance) or totally remote (in the case of the worst scenario).

The second module will be carried out through frontal lessons (2CFU) during which the fundamentals, the theoretical and practical aspects of the compounding will be presented and discussed.

3 CFU will be devoted, then, to the practical preparation of different dosage forms with particular emphasis to the physico- chemical as well as legal aspects of the different operations.
In case of persistence of the health emergency, it may be necessary to integrate the lessons with the remote modality, we will proceed as follows:
lectures in mixed mode (part of the students in presence and part at a distance) or totally remote (in the case of the worst scenario);
laboratory exercises in small groups of students or in remote modality in the worst-case scenario. In this latter case, the exercises can be integrated laboratory exercises in which students can participate on a voluntary basis as soon as the health conditions permit. In any case, the participation in these exercises will not affect the student's ability to take the exam.

Assessment methods and criteria

To acquire the final grade of the exam, the student must show to be have learned and to be able to use the basic concepts of each subject. In particular he/she should:
a) pass a practical exam at the end of practical works (Module of Laboratorio di Tecnologia Farmaceutica, weight 40% of the overall grade). The test consists in the preparation of a galenic recipe, or in the preparation of a pharmaceutical form and in the compilation of the processing sheet:
once the practical test has been passed, take a written exam, which focuses on pharmaceutical calculation exercises and the recognition of a pharmaceutical form, and an oral one, relating to the topics of pharmaceutical technology (Pharmaceutical Technology Module, (weight 60% of the overall grade) The oral exam can be taken after passing the written exam, in the same session.

The grade, expressed in thirtieths, will be based on the following criteria:
1. knowledge and comprehension (theoretical and practical) capability of the subjects studied;
2. making judgement ability
3. communication skills and appropriate use of the technical language;
4. ability to learn.

In case of persistence of the health emergency, it may be necessary to integrate the conduct of the exams with the remote modality, we will proceed as follows:
practical test replaced by a remote written test;
remote written test;
remote oral exam.

Other information

To attend the laboratory, it is mandatory the certificate of attendance for Module 3 (formazione specifica rischio medio - specific medium risk training) of the online course "Sicurezza nei luoghi di lavoro - Safety in the workplace".