Drug development
FAR-GALenia
Currently, there is a significant number of patients lacking therapeutic options adapted to their specific disease and/or condition. At this point, the galenic sections of the Pharmacy Service are responsible for providing a response. The ‘FAR-GALenia’ line has represented a reinvention in the development and optimization of personalized formulations adapted to the patient, with the research group being a national referent in the field. All the results obtained in this research line have had a direct translation to our clinical care practice.
The requirements of the Spanish Agency of Medicines and Medical Devices (AEMPS) for drug manufacturing involve the need for special facilities. In this regard, it is worth noting the excellent provision of infrastructure for the preparation of medications (both sterile and non-sterile). This provides the necessary conditions to prepare medications intended for use either in routine clinical care or in clinical trials.
The methodologies used in this field go from the classical characterization of the prepared formulations (biopharmaceutical characterization, toxicological in vitro-ex vivocharacterization, efficacy in vivo characterization, etc.) to the most novel radiolabeling techniques and molecular imaging.
Research lines in this field are focused on the development and characterization of drugs intended for the treatment of ophthalmic and digestive pathologies.
Precisely, the studies are focused on:
- Increasing the solubility of poorly-soluble drugs
- Developing new controlled release systems
- Performing pharmacokinetic studies
- Performing biodistribution studies through functional imaging: PET and SPECT
- In vivo efficacy and toxicity studies through OCT imaging
These are our active projects
In different pathologies there is an important number of drugs of verified efficacy which have not been commercialized for economic reasons or for galenic or stability issues. This landscape leaves an important number of patients in a precarious situation, forcing the clinicians to resort to alternative options. For all this, and with the purpose of filling these therapeutical gaps, research in this area must be increased. Currently, the following research lines are actively pursued:
OCULAR CYSTINOSIS
Project in which new cysteamine formulations are being developed, to then assess their clinical efficacy in patients with ocular cystinosis. Project funded by the Spanish Society of Hospital Pharmacy (SEFH) and Mutua Madrileña Foundation. Also, the project has received the support of “La Lucha de Iker” association.
Age-related MACULAR DEGENERATION and DIABETIC RETINOPATHY
It is a multidisciplinary project which combines preclinical pharmacokinetic characterization (radiolabeling with Zirconium 89) of monoclonal antibodies, the development of formulations adapted to the administration route and their biopharmaceutical characterization.
Project IN607D 2021/001, funded under the Modality of Researcher with Excellent Trajectory by GAIN-Xunta de Galicia.
VERNAL KERATITIS
In this project, a tacrolimus eye drop formulation is being developed for the treatment of vernal keratitis. The low water solubility of tacrolimus is enhanced by the use of cyclodextrins, avoiding the presence of other ocularly irritating solubilizers, such as ethanol. Project funded by the Spanish Society of Hospital Pharmacy (SEFH).
IMMUNOMODULATION
AND ANTIMICROBIALS
The project involves the development of formulations for the treatment of immunomediated ophthalmological and digestive diseases (radio-labeling and pharmacokinetics of monoclonal antibodies), formulations to enhance the resection of mucosal gastrointestinal polyps, and those aimed at optimizing the ocular treatment of complicated infectious diseases such as fungal and bacterial keratitis. Project funded by the Spanish Society of Hospital Pharmacy (SEFH) and GAIN-Xunta de Galicia.
In vivo characterization of the
developed formulations
The goal of the current project is to characterize the efficacy and toxicity of the intravitreal ophthalmic formulations developed at the Hospital Pharmacy Service in animal models, primarily using a preclinical optical coherence tomography (OCT) imaging system and PET/SPECT.
The imaging methodology is supported by the Experimental Imaging Platform..
Stability of
MEDICINES
This unit has the support and funding of the Galician Innovation Agency of the Xunta de Galicia (GAIN), being consolidated in 2020 a group with growth potential (GPC) in the biosanitary area.
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