OVERVIEW

The course provides the basic knowledge necessary for the understanding and formulation of pharmaceutical forms and also provides basic notions of pharmaceutical legislation concerning the responsibility in the preparation and distribution of medicines in pharmacies.

AIMS AND CONTENT

LEARNING OUTCOMES

Knowledge of the basic principles for the formulation and production of solid, liquid and semisolid dosage forms. Pharmaceutical dosage forms for rectal, vaginal, nasal and ocular administration together with the excipients and technologies used currently for their production.

Fundamentals on Italian low and regulation issues relevant to pharmacist professional practice in pharmacy

AIMS AND LEARNING OUTCOMES

Pharmaceutical Technology: basic knowledge necessary for the understanding and formulation of pharmaceutical forms. It is developed considering the technologies of their preparation, the methods for evaluating their quality and stability, the control assays required by the Pharmacopoeia and the technological advances in the sector.

Pharmaceutical Legislation: notions relating to the exercise of the profession of pharmacist in pharmacies open to the public and hospitals, as well as activities in industry. Main Italian laws that regulate the profession of pharmacist with particular regard to the management of narcotic drugs.

PREREQUISITES

The mandatory propaedeutics required are: Mathematics Physics General and inorganic chemistry Physical chemistry Organic chemistry I Organic chemistry II Pharmaceutical chemistry and toxicology I

TEACHING METHODS

The course is organized in classroom lectures in which the topics described in the program are presented and discussed, group work and projects. The lessons also include the contribution of specialist seminars by experts in the pharmaceutical industry and the creation of a project for the design of a drug not present on the market based on specific therapeutic needs. Work groups will be organized and students, in parallel with the lessons, will have to choose a case study and analyze it by applying the skills acquired in class. Through the application of the Project Based Learning teaching methodology, some topics covered will be explored in depth, in relation to the Open Badges "Social competence - basic level" and "Project creation competence - basic level". At the end of the course, each group will present its own case analysis project and proposals for improvement.

Any Student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturer(s) and to the dedicated SLD Representative in the Department ( Prof. Luca Raiteri, Luca.Raiteri@unige.it ) before class begins, in order to liaise and arrange the specific learning methods and ensure proper achievement of the learning aims and outcomes. VERY IMPORTANT: any request for compensatory tools and adaptations in the exam MUST be done within 10 working days before the date of the exam according to the instructions that can be found at https://unige.it/disabilita-dsa/comunicazioni

SYLLABUS/CONTENT

• Definition of medicines and dosage forms.
• Solid dosage forms: Powders; Granules; Tablets;  Capsules.
• Suppositories and pessaries.
• Fundamentals on Italian low and regulation issues relevant to pharmacist professional practice in pharmacy.

•   Liquid dosage forms: Solutions; Syrups.
• Disperse systems: interfacial phenomena, rheology, emulsions, suspensions.
•  Topical preparations.
• Ophthalmic preparations.
• Parenteral products.
• Patches.
• Technological controls of the pharmaceutical dosage forms.
• Preformulative studies and pahrmaceutical development.

RECOMMENDED READING/BIBLIOGRAPHY

• P.Colombo e coll. "Principi di Tecnologie Farmaceutiche" - Casa Editrice Ambrosiana
• M. Aulton, Kevin M.G. Taylor "Tecnologie Farmaceutiche"- Casa Editrice EDRA
• M.Minghetti e coll."Legislazione Farmaceutica"- Casa Editrice Ambrosiana
• Farmacopea Ufficiale Italiana 
• European Pharmacopoeia (EP), United States Pharmacopoeia (USP) 

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

See the teaching calendar on the web site of unige.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam is written and it consists of 10 open questions. 

The exam consists of a written test. The test is divided into 10 open questions on the topics included in the course program, of which:

-1 solving an exercise with a numerical answer (maximum 3 points)

-1 commentary on a pharmaceutical form (maximum 3 points)

-5 open-ended questions on a technological topic (maximum 3 points/answer)

-3 open-ended questions on a legislative topic (maximum 3 points/answer)

students have 2 hours available. To pass the exam, it is necessary to acquire a minimum total score of 18 out of 30. After correction, the papers are discussed publicly with the interested students.

ASSESSMENT METHODS

The objective of the exam is to verify and evaluate the level of achievement of knowledge of the topics covered in class. The written exam allows to verify the knowledge imparted in class focused on the formulation techniques of medicines and the regulatory provisions relating to their preparation and dispensing in the pharmacy. The parameters for evaluating the exam are: the mastery of technical vocabulary, the knowledge acquired, the quality of presentation of the topics covered.