OVERVIEW

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

AIMS AND CONTENT

LEARNING OUTCOMES

The course aims to provide the fundamental principles of pharmaceutical pre-formulation and formulation. It focuses on the manufacturing technologies of various dosage forms, alongside the technological assays required to assess their quality, stability, and compliance with the Italian Pharmacopoeia. Fundamentals on Italian law and regulation issues relevant to pharmacist professional practice in the pharmacy are also provided.

AIMS AND LEARNING OUTCOMES

Students will be able to describe the type and function of excipients in pharmaceutical dosage forms, identify their manufacturing processes, and recall the technological tests required by the Italian Pharmacopoeia for quality control. Furthermore, students will be able to propose the composition of a pharmaceutical form, justifying the formulation choices and the preparation technique adopted. Within the field of pharmaceutical legislation, students will be able to apply Italian laws regulating the practice of the pharmacy profession.

The course aims to contribute to the achievement of the following Open Badges: "Advanced Functional Literacy Competence," "Basic Project Creation Competence," and "Advanced Social Competence."
Upon completion of the course, through participation in the planned educational activities, students will be able to:

Upon completion of the course, the student will be able to:

• describe the type and function of the excipients used in pharmaceutical forms;
• identify the production processes for manufacturing these excipients;
• recall the technological tests required by the Pharmacopoeia for their quality control;
• propose the composition of a pharmaceutical form, justifying the formulation choices and the preparation technique adopted;
• apply the Italian laws regulating the profession of pharmacist within pharmaceutical legislation;
• understand the principles underlying the stability of pharmaceutical forms;
• identify the formulary and technological characteristics of pharmaceutical forms;
• analyze the composition of a medicine, recognizing the role of each ingredient, the performance requirements, and the production methods;
• adapt their communication to an international context;
• utilize various sources and tools to process and evaluate information;
• engage with peers from different social and cultural backgrounds in a proactive way;
• develop strategic thinking;
• respect others and their needs;
• overcome social and cultural prejudices;
• communicate effectively in written and oral form in an international setting;
• express and understand diverse points of view;
• connect, collaborate, and organize work with international peers;
• design a pharmaceutical product. 

PREREQUISITES

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

TEACHING METHODS

The course consists of traditional classroom lectures where the program topics are presented and discussed, alongside group work and projects. Within the Ulysseus Alliance, students will participate in an international collaborative project called "Medicine to Market," following the innovative Collaborative Online International Learning (COIL) methodology. Throughout the project, students will interact both synchronously and asynchronously with international peer groups from diverse disciplinary backgrounds at the University of Seville (USE), Spain; Université Côte d'Azur (UniCa), France; Technical University of Košice (TUKE), Slovakia; and Haaga-Helia University of Applied Sciences, Finland.

By virtue of this international collaboration and intercultural exchange, case studies will be approached using knowledge from the various disciplines involved. Communication between students of different nationalities will take place using English as a lingua franca. Specifically, students from Genoa will initiate the first phase of the project by identifying a case study—such as a new formulation not yet on the market for a specific active ingredient, aimed at addressing existing therapeutic gaps—applying the skills acquired during lectures. In the subsequent phases, students will integrate their specific knowledge of pharmaceutical technology with information from related fields through cultural exchange with students from other academic institutions.

At the end of the course, students will present their case analysis and improvement proposals in English, both as a written report and an oral presentation.

Students with Disabilities or SLD:
Students with valid certifications for Specific Learning Disorders (SLD), disabilities, or other educational needs officially submitted to the University are encouraged to contact the instructor and the School/Department disability representative (Prof. Luca Raiteri, Luca.Raiteri@unige.it) at the start of the course. This will allow for the arrangement of teaching methods that respect the learning objectives while accounting for individual learning needs. IMPORTANT: Requests for exam accommodations must be submitted strictly at least 10 working days before the exam date, following the instructions provided at: https://unige.it/disabilita-dsa/comunicazioni.

SYLLABUS/CONTENT

PHARMACEUTICAL TECHNOLOGY
Excipients: general aspects 

• Incompatibilities and interactions between drug and excipients and among excipients 

• Safety and regulatory aspects of excipients 

• Classification of excipients: technological, biopharmaceutical and organoleptic excipients 

• Water for pharmaceutical use and hydrophilic vehicles (ethyl alcohol, glycerol, propylene glycol) 

• Lipophilic excipients (oils, fats, butters and waxes). 

• Organoleptic excipients, antioxidants, preservatives, chelating agents and humectants. 

Solid dosage forms for oral use: excipients for solid dosage forms (diluents, binders, disintegrants, lubricants, glidants, sweeteners, flavouring agents, adsorbents, colourants). 

• Pharmaceutical powders: size, methods for determining powder size, derived properties of powders. 

• Granules as dosage forms: overview of wet and dry granulation, effervescent granules, coated granules, modified-release granules, gastro-resistant granules. 

• Pellets: pellettization excipients, size enlargement techniques. 

• Tablets: uncoated tablets, effervescent tablets, soluble and dispersible tablets, orodispersible tablets, sublingual and buccal tablets, gastro-resistant tablets, modified-release tablets, coated tablets. Overview of compression equipment. Production of tablets from granules and production by direct compression, physics of compression (fragmentation, plastic and elastic deformation of materials). Excipients for film coating and sugar coating. Tablet defects. 

• Capsules: hard capsules and soft capsules. Production, filling and closing. 

Quality control tests: uniformity of mass and content of single-dose dosage forms, resistance to breakage, friability, disintegration test, dissolution test. 

Liquid dosage forms for oral use: 

• Drops 

• Syrups: simple sucrose syrup, flavoured syrup, medicated syrup, syrups for diabetics, mucilage-based syrups. Preparation of syrups. 

Dermal and transdermal dosage forms: overview of skin structure, routes of percutaneous drug absorption and permeation kinetics through the skin. 

Semisolid preparations for cutaneous application: 

• Ointments: hydrophobic ointments, hydrophilic ointments, water-emulsifying ointments. Formulations and excipients. Hot and cold preparation techniques. 

• Creams: hydrophobic creams, hydrophilic creams. Formulations and excipients. 

• Gels: hydrophilic and hydrophobic gels. Formulations and excipients. 

• Pastes: formulations and excipients. 

Dosage forms for rectal and vaginal use: anatomical and physiological aspects of the rectal route. 

• Suppositories: lipophilic and water-soluble excipients, molds, calculation of excipient quantity using displacement factor and double fusion, drug availability after melting or dissolution of excipients. 

• Ovules. 

Quality control tests: uniformity of mass and content of single-dose dosage forms, disintegration test, dissolution test, softening time. 

Ophthalmic dosage forms: overview of eye anatomy and physiology, ocular bioavailability, containers. Otic dosage forms. 

• Eye drops: composition, pH, preservatives, isotonicity calculation. 

• Semisolid ophthalmic preparations and in situ gelling systems. 

• Ophthalmic inserts 

Physical pharmacy of dispersed systems: thermodynamics of dispersed systems, surface and interfacial tension. Stokes' law. 

• Colloidal dispersions: lyophilic, lyophobic and association colloids. 

• Emulsions: emulsifiers, HLB, calculation of required and actual HLB, combination of emulsifiers, preparation techniques, stability, methods for determining emulsion type, multiple emulsions. 

• Suspensions: physical stability of suspensions (flocculated, deflocculated systems, flotation, crystal growth) 

Quality control tests: organoleptic characteristics, rheological analysis, particle size, surface charge, determination of sedimentation degree, resuspendability, accelerated aging tests. 

Parenteral dosage forms: classification according to European Pharmacopoeia, classification based on volume. 

• Formulation aspects of parenteral preparations: solvents and cosolvents, pH and buffers, surfactants, antimicrobials, antioxidants and chelating agents, cryoprotectants 

• Requirements and control of parenteral preparations: sterility, pyrogens and endotoxins, particulate contamination 

Biopharmaceutical classification system: drug solubility, dissolution theory, ability to cross lipid membranes, pH-dependent partition theory for drug absorption, in vitro/in vivo correlation, types of dissolution apparatus.

Herbal drugs: extraction methods; preparation and control of extracts, tinctures, alcoholates, hydrolates, infusions, decoctions, essential oils. 

Rheology: viscosity, Newtonian and non-Newtonian fluids, thixotropy. 

PHARMACEUTICAL LEGISLATION 

National Health Service (SSN): Structure, tasks and organization at central and peripheral levels. 

Types of Pharmacy: Differences between community pharmacies (urban and rural), hospital pharmacies and parapharmacies. 

Definition of Medicinal Product: Legal criteria and distinction between medicinal products for human use, veterinary use and compounded preparations. 

Official Pharmacopoeia (FU): Study of Italian and European Pharmacopoeia as regulatory texts for drug quality. Good Preparation Practice. Pharmacopoeial tables. 

Compounded preparations containing toxic, anorectic or doping substances. 

Classification of medicinal products for supply: Prescription-only medicines (RR), repeatable prescription, non-repeatable prescription (RNR), restricted or special ministerial prescription. 

Medicinal products without prescription: SOP (non-prescription) and OTC (over-the-counter). 

Medical prescription: validity, formal requirements and pharmacist responsibilities in dispensing prescriptions. 

Narcotic and psychotropic substances: Consolidated Law (DPR 309/90), classification into tables, procurement, storage and dispensing, entry and exit register and recording obligations. 

Direct distribution and distribution on behalf. 

Veterinary medicinal products: electronic veterinary prescription, food-producing and non-food-producing animals, cascade use, Regulation (EU) 2019/4. 

Pharmacy inspections. 

Service pharmacy model.

RECOMMENDED READING/BIBLIOGRAPHY

Suggested books:

• Paolo Caliceti " Tecnologia Farmaceutica" - 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 in vigore
• European Pharmacopoeia (EP), United States Pharmacopoeia (USP) edizioni correnti

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

See the calendar published on line

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam consists of two written tests: one on pharmaceutical technology and one on pharmaceutical legislation.

• Pharmaceutical Technology Test:
  • Format: Six open-ended questions.
  • Scoring: Each correct answer is worth 5 points.
  • Duration: Two hours.
• Pharmaceutical Legislation Test:
  • Format: Three open-ended questions.
  • Scoring: Each correct answer is worth 10 points.
  • Duration: One hour.
• Project Work:
  • Before the end of the course, students must present their project orally (15 minutes) and submit a written report.

Final Grade Calculation:
The final score (out of 30) is a weighted average of the three components:

1. 40%: Pharmaceutical Technology Test
2. 35%: Project Work
3. 25%: Pharmaceutical Legislation Test

ASSESSMENT METHODS

The written exam assesses the knowledge acquired during lectures, focusing on medicinal formulation techniques and the regulatory provisions governing their preparation and dispensing in pharmacies.

The evaluation criteria for the exam are:

• Technical terminology: accuracy and command of subject-specific vocabulary;
• Acquired knowledge: the level of mastery of the course content;
• Quality of exposition: clarity and structure in presenting the topics.

Regarding the Medicine to Market project, the following will be assessed:

• Active participation in online meetings on the dedicated platforms;
• The frequency and duration of the meetings;
• The quality of the written report and the oral presentation.