Chemistry and technology of drugs
Study-unit Code
In all curricula
Stefano Giovagnoli
  • Stefano Giovagnoli
  • 48 ore - Stefano Giovagnoli
Course Regulation
Coorte 2020
Learning activities
Discipline chimiche, farmaceutiche e tecnologiche
Academic discipline
Type of study-unit
Obbligatorio (Required)
Type of learning activities
Attività formativa monodisciplinare
Language of instruction
Concept of industry, pharmaceutical industry, and related legal aspects. Aspects on Research and development in the production of drugs. Concepts of Quality and Quality systems Statistical approaches to the development of industrial processes and QbD
Plant definition and design Industrial plant services and equipment. Pharmaceutical production plants technology transfer activity and scale up. Examples of production plants for pharmaceutical products.
Reference texts
There are no reference books. The slides used for lessons and guidelines bearing regulations and protocols in use as well as information on the industrial installations described in class will be given. The student will be encouraged to investigate autonomously the topics of interest with the support of the teacher.
Educational objectives
The course provides a theoretical knowledge of the basic rules that the installations and industrial processes used for the production of both conventional and non-conventional medicinal forms.
The knowledge-knowledge that will be acquired by the student concerns lalcune basic rules and approaches to deal with the productive problem- from R & D to quality control. In particular, the students will have to prove that they understand the concepts at the basis of the control and design of an industrial process from the point of view of validation. Besides, knowledge is required on the processes and systems for the production of the most common forms of conventional medicines and awareness of regulatory differences and techniques in the production of more advanced medicines such as biosimilars.
Skills- the student will acquire the ability of reasoning and decision-making in investigating the production problems depending on the type of pharmaceutical product considered. In addition, it will have to develop the ability to learn on their own the topic and industrial regulations and to address and solve case studies.
In order to ensure a sufficient level of learning, the student must have acquired knowledge of physical chemistry and Pharmaceutical Technologies. In addition, basic knowledge of formulation processes and some aspects about the methods of characterization of medicinal forms are advised. In particular, it is required a basic knowledge of the conventional pharmaceutical forms such as capsules and tablets and other solid dosage forms for oral use but also topical or parenteral. This knowledge is important for the multidisciplinary nature of the course and to the understanding of technologies applied to industrial production processes. In this regard, a study of the basic concepts and useful approaches to drug delivery is suggested. Some of these aspects will be anyway underlined at the beginning of the course.
Teaching methods
The course consists of classroom lectures on topics with special attention to involve the student to retrieve and evaluate the basic knowledge necessary for learning. For this purpose, it is provided that the slide of the course reference materials and guidelines. This is believed necessary given the lack of a reference text to didactic scope of the student. Both the multi-disciplinary course that the advanced level of the material that the student has available require continuous support from the teacher to verify that the student has the right level of understanding of the topics discussed. In addition, the course includes a period of continuous updating as the rapidly changing regulatory environment in the sector which is also done through the literature. To this end, a second step involves a study that will be done in the hours dedicated to support the course.
Other information
Support activities will be carried out after the course to develop certain aspects of the course to be agreed with the student and help the student in the activity of connection of prior knowledge and necessary learning and new knowledge gained during the course. This activity will be supported by a series of monographic seminars held by industry experts during which students will have to face and try to solve the case studies presented.
This activity will be held at the Department of Pharmaceutical Sciences
Learning verification modality
Oral exams, consisting of questions relating to the theoretical aspects related to the topics covered during the course and, to demonstrate the student knowledge and understanding of the subjects, and the ability to expose the course contents; in particular, the students will have to demonstrate that they understand the philosophy behind standards and processes of industrial production of medicinal forms. in particular, the problems linked to the development and validation of a process that determines the characteristics of the industrial installations designed for this purpose. The reasoning skills of the student in dealing with issues concerning the production processes in the pharmaceutical industry will be evaluated. In addition, the ability of the student to investigate independently the topic will be examined.
Extended program
PART I (GENERAL CONCEPTS) Industry, pharmaceutical industry, current state and related legislative aspects. Structure and organization of a pharmaceutical establishment: Directorate General, Administrative Direction of Personnel and Commerce, Scientific Directorate and Technical Direction. Business culture, business strategies: just in time, benchmarking, time to market, plan-do-check-act. Statistical Approaches to the Development of Industrial Processes - Kaizen, 5S and SixSigma Concept.
Research and development. Role of R & D in the development of a medication, phases of the development of a medicine, process organization. Chemical phase - Laboratory analysis, pilot plant, galenical laboratory. Preclinical Phase - Preclinical Pharmacokinetics, Toxicokinetics, Marked Molecular Testing, Ames Testing, Flint Testing, Scaling Up, Tables. Clinical trials, bioequivalence studies. The protocol. What is a protocol. Clinical Trials of Drugs and Good Clinical Practice (GCP). CTD, e-CTD.
Regulatory Affairs: Marketing Authorization and Production. AIC complete, simplified and hybrid. DLvo 219/2006 Definitions, AP, AIC. National, decentralized and centralized community communal procedure, AlFA, EMA, FDA. Classification of medicines, ATC, medication access. DLvo 219/2006 price of medicines: mechanisms that contribute to its determination, price types, bargaining.
Production, Quality, Quality Control and Validation. Quality in the pharmaceutical industry, company quality system. NBF (ICH). Quality Systems and Certifications ISO, EN, UNI-EN. OS, OC, OA. CGxP standards. Quality Manual and POS. Lot, drug master file. Measure quality, process validation, and operations. Challenge test.
Type and classification of industrial plants. Designing a pharmaceutical plant. Structure and Flowcharts. Separation and isolation strategies.
Classification of workplaces: ventilated, conditioned, dehumidified, sterile. Air conditioning and distribution system. Dehumidification, liquid and solid phase adsorbers, munters. Sterile block (sterile and overpressure sterile blocks) air sterilization. HEPA and UHEPA filters, laminar flow, air classification, laminar flow hoods. Organization of the services facility.
Development of a production plant: technological transfer, scale up methods and pilot plants. Application of Quality by Design.

Centralized Services and Facilities. Water and water systems. Water supply by industry and proper disposal of wastewater (Divo 152/99). Types of water for the pharmaceutical industry. Softening. Deionization with resins (double and mixed) continuous electrodeionization. Distillation: single-effect, multi-effect and thermocouple evaporator (Ponzini). Reverse Osmosis. Ultra-pure water, microfiltration, ultrafiltration. Water for injections.
Thermal plants and steam production. Steam production and distribution plant. Compressed air production plants. Use of compressed air. Compressors. Piston compressor, rotary blade, liquid ring. Compressed air production and distribution plant. Cold production plants. Refrigerator, refrigerator, brine. High cold production. Central air conditioning systems.
Pharmaceutical production facilities.
Plants for parenteral products: special requirements for the structure of the plant and systems for filling and primary packaging. Sterilization systems: Dry heat sterilization: forced ventilation cupboard. Sterilization with wet heat: boiling, flowing steam, saturated steam under pressure. Autoclaves: Steam Autoclave, Vertical, Horizontal. Phases of sterilization in autoclaves, methods for evacuating the air. Sterilization by heat-penetration, in backpressure with overheated water, continuously for bottles. Disinfection with UV. Sterilization with ionizing radiation methods. Chemical sterilization, application fields, used products. Sterilization with gases or vapors: ethylene oxide. Quality control procedures.
Lyophilization and production of depot forms. Lyophilization and production of vials and vials. General concepts. Industrial lyophilizers. Freezing of the solution, primary drying, secondary drying, vacuum rupture and defrosting, vacuum closure of the containers. Freeze-drying tunnel for continuous machining. Wrapping lines for lyophilized.
Solid Forming Systems: Preparation of Pharmaceutical Powders. Crushing, grinding, pulverization, micronization. Cylindrical crushers, with blades. Mills: general characteristics. Micronization. Preparations of solid, liquid, semi-olefinic formulations. Mixing and mixing. (Solid / Solid, Solid / Liquid, Liquid / Liquid) Lines of distribution and packaging for semisolids. Granulation and preparation of granules. Wet granulation: kneading machines, oscillating granulator. Direct granulation. Dry granulation: roller compactor, grinding machine and granulator, continuous cycle system Moist granulation: granulator-dryer in fluid bed, granulator-dryer in continuous fluid bed. Drying. Classification of dryers (static bed, mobile, spray dryer fluid). Air circulation dryer. Continuous air circulation dryer. Mobile bed dryer (fluid bed roller tray, horizontal fluid bed.
Installations for capsules and tablets. Tablet production. Compression, excipients for tablets. Alternative Compressor, Rotary Compressor. Tablet coating. Polishing. Packaging - blistering and packaging line. Capsule production. Hard gelatin capsules: uses, industrial preparation, capsules and closure systems. Automatic capsule filling. Soft gelatin capsules: preparation method. Production suppositories. Preparation and packaging. Organization of production facilities. Packaging lines. Production of advanced biosimilar medicinal forms.
Installations for the production of dry and inhalable powders. Spray or atomization. Spray nozzles with air and no air. Dryer for atomization with cyclone. Spray dryer.
Plant for continuous production. Concepts and examples. RTD models, tracing material and architecture. Dedicated equipment
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