ECTS credits ECTS credits: 3
ECTS Hours Rules/Memories Student's work ECTS: 51 Hours of tutorials: 3 Expository Class: 9 Interactive Classroom: 12 Total: 75
Use languages Spanish, Galician
Type: Ordinary subject Master’s Degree RD 1393/2007 - 822/2021
Departments: Pharmacology, Pharmacy and Pharmaceutical Technology
Areas: Pharmacy and Pharmaceutical Technology
Center Faculty of Pharmacy
Call: First Semester
Teaching: With teaching
Enrolment: Enrollable | 1st year (Yes)
To describe the requirements of bioavailability for different drug models.
To know the main factors influencing the physical, chemical and biopharmaceutical stability of a drug and of a drug product. To define the stability profile of model drugs. To gain knowledge on the current regulatory framework regarding stability test in drugs and drug products.
To define the organoleptic properties of drugs and to know the technological procedures available for their correction.
To acquire an integrative vision of the existing criteria for the design of drug delivery systems.
Block 1. Bioavailability
Definition of optimal bioavailability of a drug through their biopharmaceutical, pharmacokinetic and therapeutic properties.
Block 2. Stability
Studies of drug stability in solution and in solid state: effect of different factors and critical aspects. Current regulatory framework regarding stability test for the registration of drug products.
Block 3. Organoleptic properties.
Characterization of the organoleptic properties of drugs. In vitro models and test panels. Technological procedures for organoleptic correction.
- R. Martínez Pacheco. Tratado de Tecnología Farmacéutica. Volumen III. Madrid. Síntesis, 2017.
- S. Yosioka e Ou.J. Stella, Stability of Drugs and Dosage Forms, Kluwer, New York, 2000
- Avdeef, Absorption and Drug Development, John Wiley & Sons, New Xersei, 2003
- C-J Le, L.H. Le e C-H Lu, Development and Evaluation of Drugs, CRS Press, Boca Raton, 2003
- P. Macheras, C. Reppas e J.B. Dressman, Biopharmaceutics of Orally Administered Drugs, Ellis Horwood, London, 1995
- J. Andre Jackson, Generics & Bioequivalence, CRC Press, Boca Raton, 1994
- Adjei, R. Doyle e T. Reiland, Flavors and Flavors Modifiers, en: Encyclopedia of Pharmaceutical Tecnology, vol 6. J. Swarbrick e J.C. Boylan eds. M. Dekker, New York, 1992, pp 101-141
- J.T. Carstensen, Drug Stability. Principles and Practices, M. Dekker, New York, 1990
Basic skills
CB1. To get understand knowledge that provides a basis or opportunity to be original in the development and/or application of ideas, often in a research context.
CB2. That students know how to apply the acquired knowledge and their ability to solve problems in new or scarcely-known environment within broader (or multidisciplinary) contexts related to their area of study;
CB3. That students are able to integrate knowledge and carry out complex decisions based on information that, being incomplete or limited, include reflections on social and ethical responsibilities linked to the application of their knowledge and judgments;
General competences
CG1. Critical and analytical ability in the field of drug research and development.
CG2. Creativity to propose and carry out new approaches in R&D of drug products.
CG4. Ability to plan, prepare and execute research or development projects in the field of medicines.
CG5. Ability to write, analyze, interpret and present technical reports.
CG7. Ability to evaluate and confront criteria and address decision-making.
CG11. Availability of routine techniques for autonomous learning.
Specific skills
CE1. Acquisition of solid and multidisciplinary research training.
CE3. Ability to define problems and to identify critical points and implement solutions in tasks related to R&D in drug products.
CE4. Ability to design drug R&D experiments.
Theory classes: fundamentals of the requirements for the design of drug delivery systems.
Practice classes: obtaining and analysis of experimental data required for the elaboration of design criteria.
Seminars (case studies): integrative vision
A continuous evaluation will be carried out based on the attendance and participation in theory classes, seminars and practical classes to be carried out by the students (30% of final score)
Evaluation of a case study (70% of final score).
Personal working hours of the student: 51
Mentoring hours: 3
Expositive class hours: 9
Interactive class hours: 12
Total hours: 75
Basic knowledge of scientific English
The fraudulent performance of any exercise or test required in the evaluation of a subject will imply the qualification of failure in the corresponding call, regardless of the disciplinary process that may be followed against the student. It is considered fraudulent, among others, the realization of plagiarized works or obtained from sources accessible to the public without re-elaboration or reinterpretation and without citations to the authors and the sources.
Carlos Alberto Garcia Gonzalez
Coordinador/a- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacy and Pharmaceutical Technology
- Phone
- 881815252
- carlos.garcia [at] usc.es
- Category
- Professor: University Lecturer
Luis Antonio Diaz Gomez
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacy and Pharmaceutical Technology
- Category
- Professor: LOU (Organic Law for Universities) PhD Assistant Professor
| Wednesday | |||
|---|---|---|---|
| 16:30-18:30 | Grupo 1/CLE_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |
| 18:30-19:30 | Grupo /CLIS_01 | Spanish | BROMATOLOGY SEMINAR ROOM 3 |