Pharmaceutical Technology and Legislation I

A.Y. 2021/2022
Overall hours
Learning objectives
The course aims to introduce the principles underlying the design, preparation and control of the main conventional and modified release pharmaceutical dosage forms. The course enables the students to acquire the necessary knowledge to understand the relationships between technological, biopharmaceutical and pharmacokinetic properties of medicinal products. Rationales and strategies to develop different dosage forms are defined, with particular regard to those intended for oral administration.
Expected learning outcomes
At the end of the course the student will have acquired skills in pharmaceutical technology that are fundamental for the industrial development, production and control of oral medicinal products.
Course syllabus and organization

Linea Unica

Lesson period
First semester
More specific information on the delivery modes of training activities for academic year 2021/22 will be provided over the coming months, based on the evolution of the public health situation.
Course syllabus
Biopharmaceutics: classification of dosage forms; conventional and non conventional dosage forms; gastrointestinal transit, drug plasma concentration-time curves; pharmacokinetic parameters; concepts of bioavailability and bioequivalence; absolute and relative bioavailability; L.A.D.M.E.; physiological factors affecting bioavailability; dissolution process (Noyes-Whitney equation); technological factors affecting bioavailability; bioequivalence; biopharmaceutics classification system (BCS)
· Preformulation: wettability, solubility and dissolution rate; Henderson-Hasselbalch equation; approaches to the enhancement of solubility and dissolution rate. Solid state properties (amorphous form, polymorphs, solvates, salts, cocrystals) and techniques for their characterization

· Oral solid dosage forms: general scheme for the preparation of solid dosage forms; properties of powders, analysis of powders; pharmaceutical processing (process and equipment): milling, mixing, granulation, pelletisation, drying, tabletting, coating (sugar coating and film-coating); formulation and manufacture aspects of powders, granules, pellets, tablets, capsules, lozenges; tests for solid oral dosage forms.
· Oral liquid dosage forms: general scheme for the preparation of liquid dosage forms; general pharmaceutical processing; formulation and manufacture aspects of drops, syrups, etc..
· Oral modified drug delivery systems: rationale for modified delivery systems; fast release, prolonged (reservoir, osmotic, inert matrices, hydrophilic matrices), delayed and site-specific delivery systems.
· Stability of raw materials and pharmaceutical dosage forms.
Prerequisites for admission
basic knowledge of anatomy and physiology of the gastrointestinal tract, thermodynamics, chemistry of small molecules and polymers for pharmaceutical use
Teaching methods
Teaching Resources
Slides of the lessons can be downloaded from ARIEL
P. Colombo, P.L. Catellani, A. Gazzaniga et al., Principi e Tecnologie Farmaceutiche, CEA, Milano (2007) A.Martin, Physical Pharmacy, Lippincott Williams & Wilkins, Baltimore (2006); P.Minghetti, M.Marchetti, Legislazione Farmaceutica, CEA, Milano (2013); L.Lachman et al., The Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia (1986)
Assessment methods and Criteria
Learning assessment includes a written test lasting 1 hour, based on 2 open-ended questions and an oral interview. To be admitted to the oral exam the student must gain a minimum mark of 18/30 for both questions. The oral interview, lasting about 40 minutes, entails an in-depth and critical discussion of the topics addressed in the course, divided into 3 or more questions. The final mark results from a weighted evaluation of the answers
Lessons: 72 hours
by appointment
via G. Colombo 71
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71