 SUBJECT: Galenic Pharmacy

 DEPARTMENT: Pharmacy and Food Sciences

 ACADEMIC YEAR: 3

 FOUR-MONTH PERIOD: 2

 TYPE: Compulsory

 ECTS CREDITS: 9



Galenic Pharmacy is a subject in which the basic principles of the design of drug delivery systems are studied. These principles are based on the physico-chemical properties of the active ingredients, the characteristics of the dosage forms, and the physio-pathological conditions of the patients. Therefore, concepts that the students have previously taken in other subjects of the degree (such as Physico-chemistry, Human Anatomy or Human Physiology) are handled. These subjects are scheduled in the 1st or 2nd academic year.



This subject is closely related to the subjects Biopharmacy and Pharmacokinetics, Pharmaceutical Technology I, and Pharmaceutical Technology II, scheduled in the 4th academic year. It is convenient that the students take the subject Galenic Pharmacy before taking the mentioned subjects.

SPECIFIC SKILLS

1.- Evaluate the influence of anatomic and physiological aspects of the site of administration on the disposition of drugs.

2.- Identify and assess the properties of the drugs that condition their disposition in the organism from the dosage forms.

3.- Analyse and evaluate the biopharmaceutical behaviour of drug products that condition the design of the dosage forms.

4.- Select the most suitable route of administration based on the characteristics of the patient, the drug, and the desired therapeutic effect.

5.- Determine the bioavailability, evaluate the bioequivalence, and know the factors that condition them



TRANSVERSAL SKILLS



1. Develop communication and information skills, both oral and written, to deal with patients and users of the work center where the professional activity is performed. Promote working and collaborative capacities in multidisciplinary teams and those capacities related to other healthcare professionals.



2. Recognize the own limitations and the need to maintain and update professional skills, paying special attention to the self-learning of new knowledge based on the available scientific evidence.

THEORETICAL PROGRAMME

MODULE I: RELEASE AND ABSORPTION OF DRUGS

1. Introduction to Galenic Pharmacy.

2. Transit of drugs in the organism: concept of LADME.

3. Drug release.

4. Drug absorption.



MODULE II: ENTERAL ROUTES OF ADMINISTRATION OF DRUGS

5. Drug administration routes.

6. Oral administration.

7. Buccal administration

8. Rectal administration.



MODULE III: PARENTERAL ROUTES OF ADMINISTRATION OF DRUGS

9. Parenteral routes of drug administration.

10. Intravenous and intra-arterial drug administration.

11. Intramuscular administration.

12. Subcutaneous administration.

13. Other routes of parenteral administration.



MODULE IV: ADMINISTRATION OF DRUGS THROUGH MUCOUS

14. Nasal administration

15. Pulmonary administration.

16. Administration of drugs in the skin.

17. Ophthalmic administration.

18. Administration in the ear.

19. Vaginal administration.



MODULE V: ADMINISTRATION OF DRUGS IN THE CENTRAL NERVOUS SYSTEM

20. Administration of drugs in the central nervous system.



MODULE VI: BIOAVAILABILITY AND BIOEQUIVALENCE

21. Bioavailability.

22. Bioequivalence.



MODULE VII: ADMINISTRATION OF BIOLOGICAL DRUGS

23. Administration and delivery of therapeutic peptides and proteins.

24. Administration and delivery of DNA and RNA in gene therapy.



PRACTICAL PROGRAMME

Practice 1. Determination of the partition coefficient of salicylic acid.

Practice 2. Influence of the excipient in the release of active ingredients based on an iodine ointment: release test.

Practice 3. Release study of pantoprazole from gastro-resistant tablets using a continuous flow dissolving equipment.

Practice 4. Determination of the solubility of drugs.

Practice 5. Dissolution kinetics of furantoin from tablets.

Practice 6. Evaluation in of the permeation capacity of various semi-solid formulations by using Franz cell chambers.



COMPUTER PRACTICES:

1. “Biopharmaceutics” program.

2. In vitro equivalence study of citalopram formulations.



CLASSROOM PRACTICES

1. Dissolution kinetics: a practical case

2. Calculation of the permeability constant of a drug: a practical case

3. Preparation of the group work

4. Bioequivalence study: a practical case

5. Self-evaluation tests

METHODOLOGY

1. Lectures. (5.5 ECTS)

2. Classroom practices: solving practical cases. (0.5 ECTS)

3. Practical laboratory classes. (2.6 ECTS)

4. Practical computer class. (0.4 ECTS)

5. Self-evaluation tests through the e-Gela platform.

• Continuous Assessment System
• Final Assessment System
• Tools and qualification percentages:
  • Written test to be taken (%): 60
  • Realization of Practical Work (exercises, cases or problems) (%): 15
  • Individual works (%): 10
  • Team projects (problem solving, project design)) (%): 15

COMBINED EVALUATION SYSTEM

Compulsory written test.

Requirements:

Absence of conceptual errors

Obtain a score higher than 0 in at least 70% of the questions

Obtain a minimum of 5 points

Spelling and syntax errors will be penalised depending on their number (-0.1 points for each one, up to a maximum of -0.5 points).

Practical classes.

Attendance at and benefit from practical classes. Scores from 0 to 5.

Punctuality

Good housekeeping

Attitude

Results and preparation of the practice book

To pass the practical part of the subject, the sum of the scores in sections A and B must be 7 points as a minimum.

Laboratory examination. Students who have not attended all the practical classes. The following will be considered: good housekeeping, laboratory skills and the results and preparation of the final report. The percentage of this test in the final mark is 15% (7% work and 8% oral presentation).

Oral presentation and debate on the group work. 10-15-minute oral presentation of a scientific publication related to the subject, using an audiovisual followed by a 10-minute debate. The professors will decide which part of the work will be presented by each student. An evaluation matrix will be used to evaluate each student. It will be handed over together with the work. The final mark for the work (7%) will be the same for the members of the group (i.e. average for the group).

Withdrawal: The student must submit her/his exam withdrawal request. The deadline will be the day before the official call.

The positive results of the activities of continuous evaluation (laboratory practices and group work) will be maintained in the extraordinary call.

Cuaderno de prácticas de laboratorio y de ordenador. Este cuaderno es elaborado por el profesorado y se hace accesible para los alumnos a través de la plataforma eGELA. Los alumnos deben disponer de él cuando acudan a realizar las prácticas.

Basic bibliography

1. Tratado general de Biofarmacia y Farmacocinética. Volumen I. LADME. Análisis farmacocinético. Biodisponibilidad y Bioequivalencia. J. Domenech, J. Martínez Lanao, J. Plà Delfina. Editorial Síntesis. 2013.

2. Tratado general de Biofarmacia y Farmacocinética. Volumen II. Vías de administración de fármacos: aspectos biofarmacéuticos. Farmacocinética no lineal y clínica. J. Domenech, J. Martínez Lanao, J. Plà Delfina. Editorial Síntesis. 2013.

3. Drug Delivery. Principles and Applications. B. Wang, T. Siahaan, RA Soltero. Wiley Interscienes. 2005

In-depth bibliography

1. Clinical Pharmacokinetics: Concepts and Applications. Malcolm Rowland, Thomas N. Tozer. Lippincott, Williams &Wilkins 4rd edition. 2011.
2. Gene therapy. Tools and potential applications. InTech. 2013 (https://www.intechopen.com/books/gene-therapy-tools-and-potential-applications). Acceso libre.- -3. Drug Bioavailabiliy. Estimation of solubility, permeability, absorption and bioavailability. R. Mannhold, H. Kubinyi, G. Folkes. Wiley-VCH. 2004

Web addresses

1. http://ocw.ehu.es/course/view.php?id=199
2. http://ocw.ehu.es/course/view.php?id=291-
3. www.wits.ac.za/pharmacy/biopharmacy.htm
4. A First Course in Pharmacokinetics and Biopharmaceutics. David Bourne, Ph.D. www.boomer.org/c/p1/
5. www.farm.kuleuven.ac.be/pharbio/aplink.htm
6. Internet Tutorial for Pharmacists: Finding Drug Information on the Web. http://pharmacy.dal.ca/youcanfindit/tutorial.h
7. WILEY. http:///www3.interscience.wiley.com
8. ELSEVIER http:///www. Sciencedirect.com