46193 - Pharmaceutical Technology

Learning outcomes

At the end of the course the student: - possesses the knowledge and skills relating to the preparation and formulation of the various conventional pharmaceutical forms and other aspects of pharmaceutical technology  and biopharmaceutics connected to the development of medicinal product, as well as the chemical-technological aspects connected to their industrial production; - possess the knowledge that allows understanding the logic behind the formulation of generic medicinal products and the evaluation of bioequivalence parameters; - possess the knowledge and skills relating to regulatory sciences with emphasis on the quality control of medicinal products.

Course contents

Introduction Definitions of drug, medicinal product, pharmaceutical form, active ingredient, excipient. Classification of pharmaceutical forms according to F.U. XII (conventional release pharmaceutical form, modified release pharmaceutical form, etc.). Pharmacokinetics and Biopharmaceutics: LADME, analysis of plasma curves, factors that influence the shape of a plasma curve. Absolute and relative bioavailability, bioequivalence, therapeutic and pharmaceutical equivalents, pharmaceutical alternatives. Recalls on absorption mechanisms with emphasis in Fick’s law, concepts of concentration gradient, equilibrium and osmosis. Main characteristics of the routes of administration of medicinal products (oral, parenteral, dermal and transdermal, nasal, pulmonary, etc.) with particular reference to the oral route of administration. Advantages and disadvantages in the use of the oral route of administration, physiological and chemical-physical factors that influence the extent and speed of absorption and theory of distribution according to pH.

Solid dosage forms Powders. Definition and general information. Fundamental and derived properties of powders. Basic technological operations on powders (grinding, sieving, mixing, drying): mechanisms and equipment. Granules and pellets. Composition of granules. Granulation techniques and equipment: dry granulation, wet granulation, pelletization by extrusion–spheronization. Tablets. Definitions. Preparation of tablets: single punch and rotary tablet presses, compression phases. Excipients for tablets. Preparation methods: direct compression of a powder and compression of a granules. Properties of tablets and technological controls. Defects of tablets. Coated dosage forms. Excipients for coating. Coating processes. Capsules. Definitions. Hard capsules: gelatin and polymers alternative to gelatin, manufacture of the shell, filling and closing of capsules. Soft gelatin capsules: components of the shell and production. Suppositories and ovules. Formulation and preparation aspects of suppositories and ovules.

Liquid dosage forms Solutions. Properties of solutions, classification and requirements of solutions for pharmaceutical use according to the route of administration. Water for pharmaceutical use. Preparation of solutions. Syrups. Suspensions. Wettability of particles. Sedimentation and Stokes' law. Flocculation and deflocculation. Formulation and preparation of suspensions. Colloidal dispersions. Lyophilic and lyophobic colloids. Electrical properties of interfaces: electric double layer, zeta potential and DLVO theory. Physical stability of colloidal systems. Emulsions. Definitions. Theory of emulsification, considerations for the choice of the emulsifier. Preparation and stability of emulsions. Parenteral preparations. Components of sterile preparations. Requirements of injectable preparations: sterility, apyrogenicity, absence of particulate contamination, extractable volume, isotonic and isohydric.

Semi-solid dosage forms Definitions. Principles of rheology. Lipophilic and hydrophilic excipients. Ointments. Hydrophobic, water-emulsifying and hydrophilic ointments. Creams. Hydrophobic and hydrophilic creams. Gels. Pastes. Preparation of semi-solid dosage forms: production schemes and equipment.

Readings/Bibliography

DIDACTIC MATERIAL

- Book: Tecnologia farmaceutica, by Paolo Caliceti. CEA, 2025;

- Notes of the lessons;

- Slides presented during the lessons.

ADDITIONAL MATERIAL

- Tecnologie farmaceutiche: progettazione e allestimento dei medicinali by M.E. Aulton e K.M.G. Taylor. EDRA, 2015.

- Le basi chimico-fisiche della tecnologia farmaceutica, by A.T. Florence e D. Attwood. Edises, 2002.

Teaching methods

The course consists of classroom lessons delivered by the teacher.

Assessment methods

Oral exam on all the subjects discussed during the course.

Teaching tools

The material discussed and projected during the lessons will be avainabe in the app Virtuale.

Office hours

See the website of Paolo Blasi