Catalogo dei Corsi di studio

The course is the second class on Technology, Law and Socio-economics and its
aim is to provide the basic knowledge on how physicochemical properties of drugs, dosage forms and routes of administration affect the rate and extent of drug absorption. The course gives information on formulation and classification of non-conventional drug delivery systems.
The students will acquire also the fundamentals on National and CEE pharmaceutical laws and in particular the ones governing the pharmacist profession.
General Aims
At the end of theoretical lessons, integrated by highly connotative seminars (always with teacher presence):
- The students will acquire the fundamentals of pharmaceutical technology concerning the non-conventional dosage forms.
- The students will understand the relationships between biopharmaceutics, technology and pharmacokinetic.
- The students will acquire also the fundamentals on pharmaceutical laws and on laws governing the profession of pharmacist, the National Health system, the regional health system, the production and the marketing authorization of medicines and of health product with particular regard to the national and European laws.
- The students will acquire the general fundamentals on socio-economics, pharma-economics, marketing and merchandising.
Knowledge and understanding of:
- fundamentals of drug molecule characterization: preformulation;
- factors affecting drug release and hence biological activity;
- assessment of drug pharmacokinetic properties and their influence on multiple-dosage regimen;
- studies on pharmaceutical technology concerning formulation, compounding and control of the main non-conventional dosage forms;
- national and international pharmaceutical laws concerning production and marketing of drugs and of healthcare products (medical devices, food supplements), and concerning regulatory aspects concerning pharmacy.
Applying knowledge and understanding:
- ability to understand the relationship between physicochemical aspects, dosage forms, drug release, multiple-dosage regimen and drug action;
- ability to understand the law, the economic and the administrative aspects of the pharmacy system and of the regional and national healthcare system.
Making judgements:
Theoretical lessons and seminars will allow the students to understand the pharmacy management, which is a complex system characterized by the coexistence of professional and economical skills, integrated into the public health administration to assure the pharmaceutical support to the community.

Communication skills:
A classroom environment relies heavily on the quality of communication taking place within it. As an instructor, taking steps towards improving the communication skills of our students will contribute positively towards your classroom climate. Furthermore class discussion will be fundamental to develop critical and highest level of competence to be well prepared when entering the professional ranks as a new pharmacist.
Learning skills
The course aims to provide a smooth and easy transition between university and professional pharmacist life and help students to become people with life-long learning abilities and habits. The course aims to help students to become able to dispense medications prescribed by doctors, to explain to their patients how to use these drugs correctly and to help patients in managing illnesses and avoiding drug interactions.

Programme

Due to the high content peculiarity, in order to create optimal learning conditions for students, the use of a differentiated approach to the proposed syllabus is adopted. The framework of the syllabus might be subject to changes, due to the continuous law changes.
Definition of medicines. medicines authorized for introduction on the market (AIC), Masterly and officinal formulas. Medicine classification and requirements for a quality product. Routes of administration of a drug.
Conventional and modified release (prolonged, delayed, repeated) dosage forms.
Development of a pharmaceutical product: discovery, development, preclinical research, marketing. Clinical research.
The concept of preformulation. Preformulation drug characterization: solubility (determination of the solubility of a solid in a liquid, factors affecting the solubility of solids in liquids, pH and solubility, dissociation costants and pKa, Henderson-Hasselbach equation), stability, dissolution mechanisms, dissolution rate (Noyes Whitney equation, film theory, Nernst Brunner), intrinsic dissolution rate, diffusion process. Partition coefficient. Solid state properties, crystallization and crystals, unit cells, crystallin habit, polymorphism (polymorphic transitions), pseudopolimorphism, amorphism. Particle dimensions. Drug and product stability, main degradation processes, stability studies. Drugs-excipients compatibility and incompatibilities that alter physical, chemical, microbiological properties.
Cyclodextrins and drug-cyclodextrin complexes.
The biological membrane, composition and structure. Solute transport across membrane: passive diffusion, diffusion coefficient, partition, concentration gradient; active transport and its characteristics, carrier, Michaelis Menten Law, facilitated transport, convective absorption, by ion coupling, endocytosis.
Plasma protein binding, major drug binding proteins, Drug-protein binding: theoretical description reversible binding kinetics, Determination of Drug-Plasma Protein Binding Kinetics, sites (affinity constants Ka)and Equilibria, strongy bound drugs, factors affecting protein-drug binding, The different approaches used to assess drug–protein binding.
Factors affecting drug absorption .
Definition of biopharmaceutics, pharmacokinetics and pharmacodynamics. LADME system. Distribution and elimination.
Pharmacological parameters: MEC, MTC, onset, duration of action, intensity. Pharmacokinetics. Plasma levels. Pharmacokinetic parameters, pharmacokinetic models (concept and types). Blood levels. The compartment models: one compartment model and two compartment model. One-compartment model: i.v. rapid, elimination constant; one compartment model with I order absorption; Residue method, validity conditions, Batemann bi-exponential equation, ka calculation; Wagner-Nelson method. Clearance. Urinary excretion. Elimination. AUC. Distribution, apparent distribution volume.
Absolute and relative bioavailability, pharmaceutical equivalents, bioequivalence, biosimilar, pharmaceutical alternatives.
Dosage regimens: advantages and disadvantages, time intervals between equal doses: τ, effects of dose size and frequency of administration, concentration time curves and blood levels following oral or i.v administration, calculation of the steady state plasma concentration. I.v. administration, frequency of administration. Intravenous infusion. Administration of repeated oral doses.
Characteristics and used of the most frequently used pharmaceutical excipients.
Definition of modified release dosage forms: conventional and non-conventional according to F.U.; minimum toxic concentration (CMT) and minimum effective concentration (CME), therapeutic index; Controlled or modified release. Release controlling mechanism: diffusion, dissolution, osmotically controlled systems, ion-exchange resins pre-programmed, modular and intelligent systems; diffusion controlled release (reservoir, matrix or monolithic, laminates), chemically controlled (biodegradable, with side chains or grafts), magnetically, activated by solvent (controlled by osmotic pressure and swelling); macroporous, microporous, non-porous systems; examples of commercially available systems (Diffumal-Malesci, Cibalginadue fast, Tissotropic tablets, Madopar DR, Volmax (Oros osmotic pump), Adalat chrono, Floating systems-Madopar HBS, gastroresistant systems-Panacef RM, pH-dependent release- Asacol and Entocort ,etc.). Nanomedicine and drug delivery and targeting (active and passive): microparticles (microcapsules and microspheres) methods of preparation and characterization, applications; nanoparticles, methods of preparation and characterization, applications; liposomes (classification by composition and type and size-MLV, OLV, SUV, LUV, methods of preparation, transition temperature, and characterization, applications, stability and mechanisms of cellular interaction, routes of administration.
Regulatory and Law- General principles of national and Community law.
Community code relating to medicinal products for human use. Definition of medicines. medicines authorized for introduction on the market (AIC), Masterly and officinal formulas.
Evolution of the National Health System and its organization. The system Pharmacy in the territorial structures-Public service of hospital pharmacy-Public service of municipal pharmacy. Administrative classification of pharmacies - Pharmacies of property law and ordinary law – Geographic, Topographic distribution of pharmacies,: opening of pharmaceutical offices and insolvency procedures; Parapharmacies and corner big organized distribution. Activities that can take place in pharmacies (health, cosmetics, diet, food, mc., Medical devices, etc.). Evolution of the pharmacy system. New dimension of the Pharmacy system - Possibility of changes (companies, competition, parallel import, etc.). Pharmacy services. Inspection activities (supervision, inspections and their classification, inspection comission: its composition and attributions, type of inspection activity: types of inspections, inspection report and civil and criminal implications); expired drugs or drugs: disposal procedures, ASSINDE, legal and administrative implications; iter of SSN recipes from Pharmacies to reimbursement. Federation of Provincial Orders - Provincial Order - Ethical Principles - Disciplinary procedures and their applications (disciplinary commission, foreseen penalties, recourse to the provision, penal aspects, etc.). Electronic recipe. Dispensing methods for veterinary drugs. Supplements and medical devices, definition and marketing.
Medicine central, mutual recognition, national and conditioned marketing authorisations. Dossiers.
Activity of Pharmacovigilance.

Adopted texts

Italian Pharmacopeia XII Ed.
European Pharmacopeia
A.T. Florence –D. Atwood: Physicochemical Principles of Pharmacy; Pharmaceutical Pr; 3rd edition (31 may 2004)
M. E. Aulton: Pharmaceutics The Science of Dosage Form Design; Editors: Michael Aulton Kevin Taylor; Imprint: Churchill Livingstone
P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale -Principi di Tecnologia Farmaceutica (II edizione) - Ed. CEA Casa Editrice Ambrosiana
M.Marchetti, P. Minghetti – Legislazione Farmaceutica (edizione corrente) – CEA Casa Editrice Ambrosiana - Milano

Prerequisites

The student must have: a) Good command of specific technical expression. b) mastery of elementary algebra (properties of logarithms, operations with numbers in scientific notation, fractions and percentages) of elementary geometry and trigonometry. c) In order to understand the contents of the lessons and to achieve the learning objectives, it is necessary that the student know the key competences related to General and Inorganic Chemistry, Organic Chemistry, Physics courses (unit of concentration, conversion operations of the main measurement units, definition and measurement units of the main physical quantities, physical state and phase transition processes, thermodynamics, colligative properties, pH effect and ionization, buffer systems, formulas and structures of organic substances, general aspects of organic reactions).

Exam modes

The exam consists of two parts: a written test and an oral test.
Oral exam can only be taken if the written exam has been successfull (minimum mark: 18/30).
During the written exam it is forbidden to use books, notes, reports on practical activities carried out in the laboratory, PC, smartphone and any device that allows access to the internet.
During the oral exam the student have to demonstrate abilities in pharmaceutical technology concerning the non-conventional dosage forms; understand the relationships between biopharmaceutics, technology and pharmacokinetic; acquire also the fundamentals on pharmaceutical laws and on laws governing the profession of pharmacist, the National Health system, the regional health system, the production and the marketing authorization of medicines and of health product with particular regard to the national and European laws and the general fundamentals on socio-economics, pharma-economics, marketing and merchandising.

To obtain a final grade of 18/30 (minimum mark) student must demonstrate to possess basic knowledge and skills related to preformulation, biopharmaceutics and the basic ability to understand the law aspects of the pharmacy system and of the regional and national healthcare system.

To obtain a final grade of 30/30 cum laude, student must demonstrate to possess an excellent knowledge of the overall addressed arguments, with the ability to think critically in a logic and coherent way. The student must also demonstrate to have understood the key and characterizing elements to be able to spend the professional abilities of pharmacist in different working environments.

In case of failure, both the written and the oral test need to be repeated.