INDUSTRIAL DRUG MANUFACTURING

Course objectives

INDUSTRIAL DRUG MANUFACTURING General expected learning outcomes The Industrial Manufacturing of Medicines course aims to provide the knowledge related to the marketing procedure (AIC), to the industrial plant engineering, to the production processes of drugs, to the Good Manufacturing Practice (GMP) and Standards. At the same time the students will acquire the competences of the pharmaceutical technologies used in the industrial production and packaging of medicines. The course will also allow the students to be informed about the regulations that are needed, and later applied, for an appropriate planning and validation for the industrial production of medicines. During specific moments of discussion and deeper insight the students will have the opportunity to contact people that exert their professional activity in pharmaceutical companies. Industrial Manufacturing of Medicines is an interdisciplinary course that has an applicative approach which will allow, after the final degree (laurea specialistica), to enter the working world because he/she will be able to face, analyze and evaluate the various problems related to the industrial processes that are needed for medicine marketing. Specific expected learning outcomes 1. Knowledge and understanding Regulation, technologies, processes, and plant engineering knowledge required to operate with high qualification in the manufacturing industry of traditional, innovative, and biotechnological medicines will be acquired. 2. Applying knowledge and understanding At the end of the course the student will be able to apply the information given during the lectures that will face the specific topics related to the chemical-pharmaceutical industry, both from a technical point of view as well as in accordance with current regulations. The student will be able to follow the various phases of drug production for the different dosage forms. At the same time, the acquired preparation, will allow him/her to face all the steps and problems related to formulation, regulation, safety, and validation. 3. Making judgements The “classical” lectures will include discussion and assessment method moments, together with programmed interactions with people directly involved in pharmaceutical companies, will allow the students to organize and follow a specific project. Taking into consideration one of the topics that were faced during the course they will be able to write (singularly or as a team) a report that can demonstrate their autonomous ability to evaluate the technological, regulatory and safety issues related to the manufacturing of the various dosage forms. The students will be divided in small groups and then it will be requested to apply, according to a more practical approach, the information acquired during the first part of the lesson. For a deeper insight, experts in the specific fields faced during the lessons will be invited. 4. Communication skills During the course, several moments will be devoted to debates, discussions, and roundtables under the professor’s supervision; in this sense specific selected topics will be assigned to the students. This activity, that will be carried out both individually and as small groups, will allow to evaluate the communication skills of the students with respect to the acquired information. These sessions will be important to develop the ability to critically evaluate technological, regulatory and safety issues related to the manufacturing of the various dosage forms. In these occasions the students will also develop their ability to properly report on the selected topics in front of the professor and their colleagues (peer assessment). 5. Learning skills Both theoretical and practical information that will be given during the course is also intended to develop the personal ability of an autonomous and independent learning (continuous education). This will allow the students to critically evaluate the medicine production and validation processes, and to appropriately understand, and correctly apply, the current regulations. Furthermore, the preparation acquired during the course will allow the students to keep his/her information and skills always updated in the field of industrial pharmaceutical production: a world which is in continuous and rapid evolution. DRUG DELIVERY AND DRUG TARGETING General expected learning outcomes The teaching of Drug Targeting and Delivery provides to the students the main methods to optimize the drug efficiency, starting from the physical-chemical characteristics of the active molecule and the request administration ways. The teaching will present all the most important drug delivery systems, suitable to obtain the therapeutic effect of a specific dug, minimizing its toxicity and increasing the targeting. The teaching tries to increase the interest of the student towards a multidisciplinary research work, employing the knowledge acquired in the previous years of the degree course. Specific expected learning outcomes 1. Knowledge and understanding The student will able to know and understand physical-chemical characteristics of the drugs and the problems related to their delivery such as bioavailability and stability. The student will be able to plain smart drug delivery systems able to target the drug, to the aim of minimizing toxicity and increase the activity. 2. Applying knowledge and understanding The student will be able to value the problems of a drug and to plane innovative pharmaceutical formulations that allow of overcoming these problems. The student will be able to to examine critically the different drug delivery systems in order to choose the most suitable for the specific drug and administration route. 3. Making judgements The lessons will be interactive, with a continue comparison between teacher and students about the arguments, with the aim to stimulate the interest of the students and to increase their critical sense. This discussion will allow calling back arguments already discussed in other teachings, and connected among them. 4. Communication skills The rating of the student will be made through an oral examination that will have as subject one of the arguments treated during the lessons. The student will search in the literature a recent research paper on the argument, and will present critically the results with a Power Point presentation. 5. Learning skills The student will be able to search in the literature and to study critically the scientific papers related to the arguments of the teaching. In this way, he will be able to plan innovative formulations in order to increase the efficacy of old drugs by new technological methodologies, as requested by the industrial world.

Channel 1
FEDERICA RINALDI Lecturers' profile

Program - Frequency - Exams

Course program
Unconventional Routes of Administration Cyclodextrins Liposomes Solid Lipid Nanoparticles Materials Used in Drug Delivery Systems (DDS) Polymeric Micro- and Nanoparticles Self-Assembling Systems Buccal Films Tissue Engineering Composite Systems Topical and Transdermal Formulations Aerosols and Systemic Pulmonary and Nasal Delivery
Prerequisites
To successfully follow the course, students are expected to have already acquired solid knowledge in physical chemistry and Pharmaceutical Technology and Legislation. In addition, a basic understanding of formulation processes and the different types of conventional pharmaceutical dosage forms is particularly useful. These prerequisites are essential to fully grasp the highly multidisciplinary nature of the course, which integrates chemical, physical, and technological aspects. However, key foundational concepts will be reviewed and contextualized during the introductory lessons to ensure a common baseline and facilitate the understanding of more advanced topics.
Books
1. FLORENCE A.T. AND ATTWOOD D.; Le basi chimico-fisiche della Tecnologia Farmaceutica; Edises, Ultima Edizione. 2. Michele Amorosa,principi di tecnica farmaceutica, libreria Universitaria L Tinarelli -Bologna 3 .Caliceti P., Tecnologia farmaceutica , Casa editrice Ambrosiana, Ultima Edizione Teacher's material (slides, scientific articles)
Frequency
Non mandatory attendance
Exam mode
The exam involves the development and presentation of a project, individual or group, developed starting from a practical case. The student must demonstrate the ability of critical analysis and integrated application of the knowledge acquired during the course, starting from the evaluation of a scientific work in the pharmaceutical field. In particular, this work will allow students to apply in a critical and integrated way the knowledge acquired during the course, examining the strategies adopted in the chosen case and proposing, where appropriate, alternative solutions based on innovative approaches. Alternatively, the student may take a written test. To pass the exam, a minimum score of 18 out of 30 is required. Assessment will be based on the following criteria: Knowledge and understanding of the topics covered in the course; Ability to critically analyze and logical coherence in the presentation of the project/critical evaluation of the work that is the subject of the written test; Relevance and precision in the use of technical-specialist language; Expository ability (oral/written), completeness of the discussion and originality in the development of the proposals. Specifically, the evaluation rubric is structured as follows: Failing: Insufficient and fragmented knowledge; poor analytical and synthesis skills; inappropriate generalizations; inadequate or absent use of technical language. 18–20/30: Minimal and not fully consolidated knowledge; weak analytical and synthesis skills; limited ability to use technical terminology. 21–23/30: Sufficient understanding of the topics; coherent but not in-depth argumentation; acceptable use of technical language. 24–26/30: Good level of understanding; well-developed analytical and synthesis skills; clear presentation with appropriate use of technical language. 27–29/30: Solid preparation; rigorous and consistent argumentation; strong command of technical and regulatory terminology. 30–30 with honors: Excellent mastery of content; high-level critical thinking and synthesis; precise, original, and innovative presentation; flawless use of technical language.
Lesson mode
In accordance with the instructions of the University, reported at https://www.uniroma1.it/it/notizia/covid-19-fase-3-lezioni-esami-e-lauree-presenza-e-distanza, the lectures of the courses of all study courses (first degrees, master's degrees, doctoral courses, masters) are in presence, to the extent of 100% of the places originally usable for each classroom , also guaranteeing remote use to allow the participation of those who cannot secure a place in the classroom and / or for health reasons will not be able to participate in face-to-face activities. The students will be divided in small groups and then it will be requested to apply, according to a more practical approach, the information acquired during the first part of the lesson. The lessons, that will be carried out “in presence”, will be supplemented with further explanations and checks following an applicative point of view. For a deeper insight, experts in the specific fields faced during the lessons will be invited.
FEDERICA RINALDI Lecturers' profile

Program - Frequency - Exams

Course program
Unconventional Routes of Administration Cyclodextrins Liposomes Solid Lipid Nanoparticles Materials Used in Drug Delivery Systems (DDS) Polymeric Micro- and Nanoparticles Self-Assembling Systems Buccal Films Tissue Engineering Composite Systems Topical and Transdermal Formulations Aerosols and Systemic Pulmonary and Nasal Delivery
Prerequisites
To successfully follow the course, students are expected to have already acquired solid knowledge in physical chemistry and Pharmaceutical Technology and Legislation. In addition, a basic understanding of formulation processes and the different types of conventional pharmaceutical dosage forms is particularly useful. These prerequisites are essential to fully grasp the highly multidisciplinary nature of the course, which integrates chemical, physical, and technological aspects. However, key foundational concepts will be reviewed and contextualized during the introductory lessons to ensure a common baseline and facilitate the understanding of more advanced topics.
Books
1. FLORENCE A.T. AND ATTWOOD D.; Le basi chimico-fisiche della Tecnologia Farmaceutica; Edises, Ultima Edizione. 2. Michele Amorosa,principi di tecnica farmaceutica, libreria Universitaria L Tinarelli -Bologna 3 .Caliceti P., Tecnologia farmaceutica , Casa editrice Ambrosiana, Ultima Edizione Teacher's material (slides, scientific articles)
Frequency
Non mandatory attendance
Exam mode
The exam involves the development and presentation of a project, individual or group, developed starting from a practical case. The student must demonstrate the ability of critical analysis and integrated application of the knowledge acquired during the course, starting from the evaluation of a scientific work in the pharmaceutical field. In particular, this work will allow students to apply in a critical and integrated way the knowledge acquired during the course, examining the strategies adopted in the chosen case and proposing, where appropriate, alternative solutions based on innovative approaches. Alternatively, the student may take a written test. To pass the exam, a minimum score of 18 out of 30 is required. Assessment will be based on the following criteria: Knowledge and understanding of the topics covered in the course; Ability to critically analyze and logical coherence in the presentation of the project/critical evaluation of the work that is the subject of the written test; Relevance and precision in the use of technical-specialist language; Expository ability (oral/written), completeness of the discussion and originality in the development of the proposals. Specifically, the evaluation rubric is structured as follows: Failing: Insufficient and fragmented knowledge; poor analytical and synthesis skills; inappropriate generalizations; inadequate or absent use of technical language. 18–20/30: Minimal and not fully consolidated knowledge; weak analytical and synthesis skills; limited ability to use technical terminology. 21–23/30: Sufficient understanding of the topics; coherent but not in-depth argumentation; acceptable use of technical language. 24–26/30: Good level of understanding; well-developed analytical and synthesis skills; clear presentation with appropriate use of technical language. 27–29/30: Solid preparation; rigorous and consistent argumentation; strong command of technical and regulatory terminology. 30–30 with honors: Excellent mastery of content; high-level critical thinking and synthesis; precise, original, and innovative presentation; flawless use of technical language.
Lesson mode
In accordance with the instructions of the University, reported at https://www.uniroma1.it/it/notizia/covid-19-fase-3-lezioni-esami-e-lauree-presenza-e-distanza, the lectures of the courses of all study courses (first degrees, master's degrees, doctoral courses, masters) are in presence, to the extent of 100% of the places originally usable for each classroom , also guaranteeing remote use to allow the participation of those who cannot secure a place in the classroom and / or for health reasons will not be able to participate in face-to-face activities. The students will be divided in small groups and then it will be requested to apply, according to a more practical approach, the information acquired during the first part of the lesson. The lessons, that will be carried out “in presence”, will be supplemented with further explanations and checks following an applicative point of view. For a deeper insight, experts in the specific fields faced during the lessons will be invited.
  • Academic year2025/2026
  • CourseIndustrial pharmacy
  • CurriculumSingle curriculum
  • Year4th year
  • Semester2nd semester
  • SSDCHIM/09
  • CFU6