The course aims to provide the theoretical and practical principles, relating to the development, marketing and distribution of drugs. The main learning objectives are the introduction to the basic principles of development, manufacturing, and quality control of pharmaceutical forms. At the end of the course, the student will be able to manufacture a pharmaceutical form (solid, semisolid, liquid) starting from the active ingredient based on the patient needs and on the route of administration. 

The student should also know the main Italian pharmaceutical legislation.

The knowledge acquired during the course are of fundamental importance to work in research & development and quality control both in pharmacy and industry together with the possibility to exercise the profession of pharmacist in Europe.

PHARMACEUTICAL TECHNOLOGY and PHARMACEUTICAL LEGISLATION (8 CFU)  
Chemico-physical principles and technology of pharmaceutical preparations: 

• Powders: methods for obtaining pharmaceutical powders. Properties of the powders. Powder as dosage forms, incompatibility; 
• Tablets: definition and classification. Compression methods and compressing machines. Physical phenomena of compression process. Controlled release tablets and coating. Specifications and final control tests. 
• Capsules: hard and soft capsules. Others capsules. Manufacturing process. Specifications and final control tests;
• Granules and pellets: granulation process. Production methods. Technological properties of the granules; 
• Liquid preparations:  properties of the solutions. Physical-chemical bases of dissolution. Dissolution rate and bioavailability. Factors affecting the solubility. Parenteral formulations: definition, general characteristics and routes of administration;
• Dispersed systems: colloidal systems, suspensions and emulsions. Stability and formulation. Surfactants: definition and classification. HLB. Wettability. Zeta potential; 
• Dermatological pharmaceutical forms: ointments, gels, creams, pastes, excipient and preparation; 
• Suppositories: classification, preparation of suppositories and ovules. Excipients. 

Design and production of dosage forms for the different routes of administration: 

• Pharmaceutical preformulation. Classification and characterization of the main oral, dermal, transdermal, ophthalmic, nasal, pulmonary, parenteral, rectal and vaginal dosage forms;
• Modified release drug delivery systems;
• Instruments and methods of preparation;
• Pharmaceutical stability;
• Specifications and final control tests.

Pharmaceutical legislation

• International legislation. European Medicines Agency (EMA);
• Italian health organization. National Health Service (SSN). Italian Medicines Agency (AIFA); 
• Italian Pharmacopoeia and European Pharmacopoeia (FUI);
• Territorial administrative system and pharmacies classification;
• Territorial and hospital pharmacy and service. Administrative classification of medicines;
• Medicinal products, industrial manufacturing authorization (AP), marketing authorization (AIC) dossier (CTD). Generic drugs and biosimilar. Supplemental oxigen and other medical gases;
• Drugs prepared in the pharmacy laboratory. Rules of Good Preparation of medicines in pharmacies (NBP);
• Dispensing discipline to the public of drugs. Prescription (human and veterinary). RR , RNR , RL and RMR. Drugs not subject to medical prescription (OTC and SOP).

PHARMACEUTICAL MANUFACTURING LABORATORY (4 CFU)

• Practical formulation of galenic dosage forms and industrial pre-formulation;
• Qualitative and quantitative control of pharmaceutical dosage forms;
• Main scientific search engines.

UNIURB students must follow the didactic regulation published on the University website.

To have access to the teaching laboratory, students must have passed Organic Chemistry I and attended Drug Analysis III and Organic laboratory techniques for the synthesis and extraction of drugs.

To take the exam, students must have passed Pharmaceutical Chemistry I, Drug Analysis I, and Drug Analysis II.

Erasmus students must follow the learning agreement.

D1 - KNOWLEDGE AND UNDERSTANDING
At the end of this training activity, the student must demonstrate that he is able to:
1) to know in depth the chemical-physical principles underlying pharmaceutical technology;
2) know the fundamental principles for the formulation and preparation of the different dosage forms;
3) know the most commonly used methods for the characterization of active ingredients and excipients, as well as the final formulation;
4) know the fundamental bases of pharmaceutical legislation;
5) to know the main databases of pharmaceutical, legislative and galenic technological interest.

D2 - ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING
At the end of this training activity, the student must demonstrate that he is able to:
1) describe the fundamental aspects of pharmaceutical technology;
2) classify and describe the different pharmaceutical forms;
3) prepare and dispense magisterial and officinal galenic preparations;
4) describe the main notions of pharmaceutical legislation;
5) describe the qualitative and quantitative aspects that allow us to correctly predict the experimental results.

D3 - AUTONOMY OF JUDGMENT
At the end of this training activity, the student must demonstrate that he is able to:
1) acquire the fundamental principles underlying pharmaceutical technology;
2) ability to apply the acquired knowledge and the understanding of the different formulation strategies;
3) evaluation of the formalities and correctness of the different types of medical prescriptions;
4) ability to prepare and dispense a galenic preparation;
5) ability to work in laboratories and to draw up a report.

D4 - COMMUNICATION SKILLS
At the end of the course, students will have to demonstrate that they are able to clearly describe the use of the various notions learned in the course of the training activity.

D5 - LEARNING SKILLS
At the end of this training activity, the student must demonstrate that he is able to find and apply new information, compared to that provided during the training activity, necessary to design, prepare and characterize all the different types of pharmaceutical forms. Furthermore, he / she must be able to find information and update his / her knowledge of pharmaceutical legislation.

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

The educational activities can be supported by experts in the field of pharmaceutical technology or legislation through seminars or dedicated lectures.

Teaching

Lessons and laboratorial activities

Innovative teaching methods

• Flipped classroom
• Cooperative learning
• Problem-based learning
• Debate

Attendance

Lectures are optional but recommended. Laboratorial activities are mandatory.

Laboratorial activities' reports must be produced at the end of the course to be admitted to the written exam.

It is mandatory to pass the written exam to access to the oral exam.

Course books

Pharmaceutical technology (Alternatives)

• Aulton M.E. -  Pharmaceutics - The design and manufacturing of medicines - Elsevier (English)
• Colombo P. - Principi di tecnologia farmaceutica - CEA Edizioni

Pharmaceutical legislation (Alternatives)

• Barberini G. - Legislazione farmaceutica nella pratica professionale - Piccin
• Minghetti P. - Legislazione farmaceutica - CEA Edizioni
• Loliscio N. - La Farmacia: un Campo Minato: Il Manuale del Farmacista - Società Editrice Esculapio

Pharmaceutical manufacturing laboratory (Alternatives)

• Frongia M. - Il Galenista e il Laboratorio - EDRA
• Bettiol F. - Manuale delle preparazioni galeniche - Ed. Tecniche Nuove 

Extra textbooks

• Ansel H. - Pharmaceutical calculations - Wolters Kluwer Health
• Ansel H. - Pharmaceutical Dosage Forms and Drug Delivery Systems XII edition
• Florence A.T. e Attwood D. - Physicochemical Principles of Pharmacy, 4th Edition - Pharmaceutical Press
• Felton L. - Remington: Essentials of Pharmaceutics - Pharmaceutical Press
• Gaisford S. e Saunders M. - Essentials of Pharmaceutical Preformulation - Wiley-Blackwell
• Perrie Y. and Rades T. - Pharmaceutics: Drug Delivery and Targeting - Pharmaceutical Press

Assessment

• Evaluation of laboratorial activities' reports + Practical exam with production of an extemporaneous formulation - 120 min
• Written exam: 5 multiple choice quiz (1 points for correct answer, 0 when not answered, -0.5 for wrong answer), 5 T/F quiz (0.4 points for correct answer, 0 when not answered, -0.2 for wrong answer) - 15 min. 5 units of measurement equivalences (4 out of 5 must be correct to pass the exam), 5 open questions (At least 2 about pharmaceutical legislation - maximum of 5 points each answer) -105 minutes.
• Oral exam: around 30 minutes to evaluate the student knowledge

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

Teaching

Following the program using course books. Mandatory laboratorial activities.

Attendance

Laboratorial activities are mandatory.

Laboratorial activities' reports must be produced at the end of the course to be admitted to the written exam.

It is mandatory to pass the written exam to access to the oral exam.

Course books

Pharmaceutical technology (Alternatives)

• Aulton M.E. -  Pharmaceutics - The design and manufacturing of medicines - Elsevier (English)
• Colombo P. - Principi di tecnologia farmaceutica - CEA Edizioni

Pharmaceutical legislation (Alternatives)

• Barberini G. - Legislazione farmaceutica nella pratica professionale - Piccin
• Minghetti P. - Legislazione farmaceutica - CEA Edizioni
• Loliscio N. - La Farmacia: un Campo Minato: Il Manuale del Farmacista - Società Editrice Esculapio

Pharmaceutical manufacturing laboratory (Alternatives)

• Frongia M. - Il Galenista e il Laboratorio - EDRA
• Bettiol F. - Manuale delle preparazioni galeniche - Ed. Tecniche Nuove 

Extra textbooks

• Ansel H. - Pharmaceutical calculations - Wolters Kluwer Health
• Ansel H. - Pharmaceutical Dosage Forms and Drug Delivery Systems XII edition
• Florence A.T. e Attwood D. - Physicochemical Principles of Pharmacy, 4th Edition - Pharmaceutical Press
• Felton L. - Remington: Essentials of Pharmaceutics - Pharmaceutical Press
• Gaisford S. e Saunders M. - Essentials of Pharmaceutical Preformulation - Wiley-Blackwell
• Perrie Y. and Rades T. - Pharmaceutics: Drug Delivery and Targeting - Pharmaceutical Press

Assessment

• Evaluation of laboratorial activities' reports + Practical exam with production of an extemporaneous formulation - 120 min
• Written exam: 5 multiple choice quiz (1 points for correct answer, 0 when not answered, -0.5 for wrong answer), 5 T/F quiz (0.4 points for correct answer, 0 when not answered, -0.2 for wrong answer) - 15 min. 5 units of measurement equivalences (4 out of 5 must be correct to pass the exam), 5 open questions (At least 2 about pharmaceutical legislation - maximum of 5 points each answer) -105 minutes.
• Oral exam: around 30 minutes to evaluate the student knowledge

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

www.pharmatech.uniurb.it

The examinations can be done both in Italian or English.