46193 - Pharmaceutical Technology

Learning outcomes

At the end of the course, the student:

- acquires the skills to transform a drug into a pharmaceutical form that can be administered to the patient;

- possesses the fundamental knowledge related to the design of solid (powders, granules, capsules and tablets), semi-solid (ointments, creams, gels and pastes) and liquids  (solutions, colloidal dispersions, suspensions and emulsions) pharmaceutical forms and their preparation technologies;

- is able to formulate a  medicine in relation to the chemical-physical properties of the drug, the route of administration and the needs of the patient;

- knows the main technological assays for the quality control of the medicinal product in accordance with current legislation.

Course contents

MODULE 1 (Prof. Nadia Passerini) (36 hours)

Medicinal product and pharmaceutical dosage form

Definitions and classification. Pharmaceutical excipients: definition and general classification based on origin, chemical structure, and function.

General principles of Biopharmaceutics

Routes of drug administration, LADME, with particular reference to factors influencing drug release from the dosage form. Absorption, with particular reference to passive diffusion: Fick’s first law, diffusion coefficient, true and apparent partition coefficient.

Oral route of administration

Drug release from solid oral dosage forms; dissolution rate (Noyes-Whitney equation). Definition of conventional drug release and modified drug release. Biopharmaceutical Classification System (BCS). Other routes of administration.
Pharmaceutical development

Basics of preformulation.

Solid dosage forms

Powders, capsules, granules, tablets, rectal and vaginal preparations.

1. Powders

Fundamental properties: particle size, shape, and specific surface area, and methods for their analysis. Derived properties: density (true, particle, bulk), flowability, and porosity, and methods for their determination.

Solid state properties: crystalline substances (polymorphism, solvates, habitus) and amorphous substances. Methods for solid-state characterization: thermal analysis (TGA, DSC) and X-ray diffraction.

Mechanical methods for powder production: milling process and types of mills.

Mixing of powder: mixing theory and powder-mixing equipment.

Powders as pharmaceutical forms; formulation challenges.

2. Hard and soft capsules

Definitions, types, excipients used, and methods of production and filling, especially in pharmacy. Compendial tests for quality control assessment.

3. Granules and granulation

Reasons for granulation, classification of granulation methods and excipients used, with particular reference to binders (natural, semi-synthetic, and synthetic). Dry and wet granulation: process phases, mechanisms of granule formation, and equipment used. Melt granulation: process phases, mechanisms of granule formation, and equipment used. Advantages and disadvantages of different granulation methods. Granules as dosage forms: definitions. Compendial technological tests for quality control assessment.

4. Tablets and compaction

Characteristics and uses of excipients (diluents-binders, disintegrants, lubricants, etc.); types of tablet press machines, with particular reference to single-punch press and mechanisms of compression of particles. Oral tablets: definitions according to the Italian Official Pharmacopoeia. Compendial and non-compendial tests for quality control assessment. Dissolution tests as quality control tool, and as predictive dissolution testing.

5. Rectal and vaginal dosage forms

Rectal suppositories and vaginal pessaries: definition, preparation, excipients, and drug release mechanisms. Compendial technological tests for quality control of rectal and vaginal dosage forms.

 

MODULE 2 (Prof. Beatrice Albertini) (28 hours)

Liquid preparations: Solutions

Chemical properties of solutions: factors influencing drug solubility. Physical properties of solutions: colligative properties and their technological and clinical importance. Preparation of isotonic solutions.

Solutions as oral pharmaceutical forms: aqueous solutions, medicated syrups, alcoholic, glyceric, and oily solutions. Compendial technological tests for quality control assessment of solutions.

Liquid preparations: Dispersed systems

Classification and definitions.

Interfacial phenomena

Surface and interfacial tension; wettability; interaction forces between dispersed particles (DLVO theory): attractive and repulsive forces, surface electric potentials, reversible and irreversible aggregation; repulsion between hydrated surfaces: protective colloids.

Surfactants and Hydrocolloids

Surfactants and their mechanism of action, hydrophilic-lipophilic balance (HLB), classification of surfactants based on their functions. Hydrocolloids.

Colloidal dispersions

Lyophilic, protective, lyophobic, association colloids, their properties (optical, kinetic, and electrical) and stability (salting out, simple and complex coacervation, coagulation, flocculation). Micelle formation.

Suspensions

Flocculated and deflocculated; flocculating agents; controlled flocculation approach; formulation of suspensions, oral suspensions in pharmacy.

Emulsions

Emulsification theory; physical instability of emulsions; selection of emulsifier or emulsifier mixtures; stabilizing substances. Technological controls on liquid dispersions.

Injectable and infusion preparations

Microbiological (sterility and apyrogenicity) and physicochemical requirements (iso-osmia, isotonicity, isoacidity, clarity, and particulate contamination). Formulation of injectable preparations: vehicles and adjuvants. Technological controls on sterile preparations.

Topical and transdermal drug delivery

Drug absorption through the skin: paracellular, appendageal, and transcellular routes. Diffusion through the membrane and vehicle-membrane interface. Factors influencing percutaneous drug absorption. Liquid (medicated shampoos, foams, aerosols) and semisolid (ointments, creams, gels, pastes) preparations for topical application. Definitions and formulation. Technological controls on semisolid preparations.

Elements of rheology

Viscosity. Newtonian and non-Newtonian fluids (plastic, pseudoplastic, and dilatant). Thixotropy. Viscosity determination: viscometers.

Ophthalmic preparations

Ocular routes of administration. Absorption and elimination of ophthalmic drugs. Eye drops. Microbiological and physicochemical requirements. Semisolid ophthalmic preparations. Ocular inserts.

Ear preparations

Local action.

Nasal preparations

Local and systemic action. Drug absorption through the nasal mucosa. Nasal drops and sprays.

Readings/Bibliography

- P. Caliceti, Tecnologia Farmaceutica (2025) Casa Editrice Ambrosiana.

- Aulton’s Pharmaceutics- The design and manufacture of medicines, Sixth Edition (2022), Elsevier

Teaching methods

Lectures in italian

Assessment methods

Oral exam

Office hours

See the website of Nadia Passerini

See the website of Beatrice Albertini