MEMBERS AND COLLABORATORS

 

Nombre y apellidos	Cargo	E-mail
Juan José García Vieitez (Coord)	CU Farmacología ULE	jjgarv@unileon.es
Matilde Sierra Vega	CU  Farmacología ULE	msiev@unileon.es
Mª José Diez Liébana	TU Farmacología ULE	mjdiel@unileon.es
Mª Nélida Fernández Martínez	TU Farmacología ULE	mnferm@unileon.es
Ana Mª Sahagún Prieto	TU Farmacología ULE	amsahp@unileon.es
Raquel Díez Láiz	PAD Farmacología ULE	rdielz@unileon.es
Vanesa Huerga Mañanes	Becaria de investigación	v.huerga@unileon.es
Angela Pilar Calle Pardo	TU Enfermería ULE	apcalp@unileon.es
Cristina López Cadenas	Veterinario Clínico	clopc@unileon.es
Demetrio Carriedo Ule	Jefe Servicio UCI CAULE	dcarriedo@saludcastillayleon.es
Luís Hernández Echevarría	Facultativo Especialista de Área Servicio Neurología CAULE	lhernandez@ya.com

 

 

OBJECTIVES

 

1. To evaluate the efficacy of drugs (medicines/medicinal products) through pharmacokinetic and pharmacodynamic studies (experimental and clinical), and bioavailability/bioequivalence studies.

2. To investigate drug interactions (PK-PD) and their consequences.

3. To develop new medicinal products of natural origin and new commercial formulations, and to carry out safety experimental studies.

 

 

ACTIVITY

The Unit Safety and Efficacy of Drugs is a multi-disciplinary group which includes pharmacists, veterinarians, physicians, nurses and biologists belonging to the Department of Biomedical Sciences, the Department of Nursing and Physical Therapy, and to different Hospital Services of the Hospital of León. Most members of the Unit belong as well to the Research Group of Excellence GR-42, recognised by the Junta de Castilla y León in 2007. Regarding its learning activity, the Unit takes part in the Doctorate Program Health Sciences (awarded with a quality mention) and the International Doctorate Program Research Applied to Health Sciences, both belonging to the University of León, as well as in the Official Master Degrees in Innovation in Biomedical and Health Sciences, in Research in Medicine, in Ageing and healthy Quality of Life, and in Research in Veterinary and Food Science and Technology, all of them taught by the University of León.

The group has focused its research activity on the development of pharmacokinetic/pharmacodynamic studies as well as drug interaction studies. More recently we have started two new lines of research: the study of new drugs of natural origin, evaluating the antioxidant and antiproliferative activity of Sideritis hyssopifolia and some of its extracts, and the development of new veterinary commercial formulations.

Among the lines of research currently in place we have:

1. Pharmacokinetic/pharmacodynamic studies. Pharmacokinetics is the priority line of research of the Unit. Within this line several studies of Clinical Pharmacokinetics, in which drug bioavailability and other pharmacokinetic processes have been established, whose knowledge contributes to a more efficient and safe use of medicinal products in clinical practice. This area of research has been financially supported by Laboratorios Madaus (currently Rottapharm), the Junta de Castilla y León, the Excma. Diputación de León, or Laboratorios Syva.

2. Drug interaction studies. The largest number of these studies has been developed with the hydrosoluble fibre Plantago ovata husk (the husks of Plantago ovata seeds, also termed as psyllium). This type of fibre regulates intestinal transit, so it has been used in medicine for many years to treat constipation or diarrhea. Moreover, its capacity to reduce glycemia, total cholesterol and LDL-cholesterol has also been shown in recent years. Madaus (company that markets this fibre) became interested in our research and partly supported our research for 10 years, together with CDTI. As summary, we have carried out 2 clinical trials to evaluate the hypoglucemic activity of Plantago ovata husk (one of them with healthy volunteers and the second one with type 2 diabetic patients), and a research project in which we have studied at an experimental level the association of oral hypoglycemic agents (being one of them Plantago ovata husk), more specifically, the effectiveness and pharmacokinetic characteristics of this association.

We have also carried out several experimental studies on levodopa interaction with Plantago ovata husk. Levodopa remains as the pharmacological treatment of choice for Parkinson disease, but its special pharmacokinetic characteristics make considerably complicated its use. After having shown in several experimental studies (developed in rabbits) that this fibre improves levodopa bioavailability, especially with constipation, we carried out a clinical trial, confirming the results obtained our experimental findings. As the association Plantago ovata husk-levodopa was advantageous from a pharmacokinetic point of view, Madaus obtained two patents (national and world patents), whose scientific authors are researchers of this unit. As in the case of oral hypoglycemic agents, this trial was also supported by CDTI/Madaus.

3. Development of new medicinal products of natural origin and new commercial formulations. At present we are carrying out an experimental study on the antioxidant activity of mountain tea (Sideritis hyssopifolia), as well as its protective action against cardiovascular diseases or prostate tumor. On the other hand, we are also working on the development of new veterinary commercial formulations. This line of research has been supported by the Junta of Castilla y León and Laboratorios Syva.

 METHODOLOGY

 

Studies:

• Experimental and clinical studies

• Drug safety and efficacy studies

Methodology:

• Pharmacokinetic and pharmacodynamics studies

•  Drug interactions studies

• Analysis of drugs in biological fluids.

• Drug utilization studies

TECHNOLOGICAL OFFER