Contribution to determining the antioxidant capacity of melatonin in orodispersible tablets - comparison with reference antioxidants.

INTRODUCTION: Melatonin is a hormone used in the treatment of diverse pathologies due to its ability to regulate numerous physiological processes related to biological rhythms and neuroendocrine function. MATERIAL AND METHODS: This study examines whether or not the antioxidant capacities of melatonin are modified during the creation of fast disintegrating oral tablets (FDDTs) through direct compression in which different concentrations of the active substance (3, 5, 10 and 60 mg) and excipients are made. In addition, the antioxidant capacity of melatonin is compared with that of reference antioxidants such as vitamin C, Trolox, resveratrol, glutathione and nicotinamide adenine dinucleotide phosphate (NADPH). RESULTS: Melatonin has a lower antioxidant capacity only 5% of the capacity of resveratrol. Resveratrol is the compound having the greatest antioxidant capacity. As for the influence of the tablets components, it was found that only at higher concentrations of melatonin (60 mg/tablet), with the excipients mannitol, polyvinylpyrrolidone (crospovidone), magnesium stearate and anhydrous colloidal silica, did a decrease occur in the antioxidant capacity value, possibly due to the lower percentage of these excipients in the formulation.

Encapsulation in Cell Therapy: Methodologies, Materials, and Clinical Applications.

BACKGROUND: The clinical application of cells and the development of new delivery systems have allowed significant advances in the field of cell therapy and encapsulation in recent years. The ability to combine cells and biocompatible matrices in the encapsulation of cells providing long-term delivery has provides new therapeutic alternatives in the development of new therapies. METHODS: A structured search of bibliographic databases was carried out to determine the entire methodology related to cell encapsulation with clinical application. RESULTS: Cell encapsulation provides increased retention time in the target tissue improving its therapeutic efficacy. This technology involves the development of a physical barrier (natural or synthetic matrix surrounded by a semipermeable membrane) to isolate and protect cells from the host's immune system maintaining the microenvironment of embedded cells, their viability and their capacity of differentiation, improving their function in vivo, and reducing side effects associated with the use of immunosuppressive therapy. CONCLUSION: The purpose of this review is to discuss the different technologies of cell encapsulation and the different materials utilized from both, natural and synthetic origin, and provide an overview of current therapeutic applications of cell encapsulation, as well as, the perspectives for their clinical application including as a novelty the current application in clinical trials.

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects.

Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs.

Development of a cell-based medicinal product: regulatory structures in the European Union.

INTRODUCTION: New therapies with genes, tissues and cells have taken the emerging field for the treatment of many diseases. Advances on stem cell therapy research have led to international regulatory agencies to harmonize and regulate the development of new medicines with stem cells. SOURCES OF DATA: European Medicines Agency on September 15, 2012. AREAS OF AGREEMENT: Cell therapy medicinal products should be subjected to the same regulatory principles than any other medicine. AREAS OF CONTROVERSY: Their technical requirements for quality, safety and efficacy must be more specific and stringent than other biologic products and medicines. GROWING POINTS: Cell therapy medicinal products are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options. AREAS TIMELY FOR DEVELOPING RESEARCH: The development of cell therapy medicinal products constitutes an alternative therapeutic strategy to conventional clinical therapy, for which no effective cure was previously available.

El futuro de la medicina clínica hacia nuevas terapias: terapia celular, génica y nanomedicina / The future of new therapies in clinical medicine

Las terapias avanzadas aportan un nuevo concepto de medicamento personalizado de origen autólogo, alogénico o xenogénico, basado en células (terapia celular), genes (terapia génica) o tejidos (ingeniería tisular), que, junto a los nanosistemas, ofrecen avances en el diagnóstico, la prevención y el tratamiento de enfermedades. En esta revisión se describirán los fundamentos y campos de actuación de la terapia celular, génica y nanomedicina

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[The future of new therapies in clinical medicine]. / El futuro de la medicina clínica hacia nuevas terapias: terapia celular, génica y nanomedicina.

Advanced therapies provide a new concept of personalized medicament of autologous, allogeneic or xenogeneic origin, based on cells (cell therapy), genes (gene therapy) or tissues (tissue engineering), which, together with nanosystems, provide new advances in the diagnosis, prevention and treatment of diseases. The basis and different fields of action of cell therapy, gene therapy and nanomedicine are described in this review.