ABSTRACT
The aim of the present study was to explore the feasibility of obtaining an IVIVC by combination of data from two bioequivalence (BE) studies of carbamazepine (CBZ) in order to assess if the previously published dissolution media and conditions could be applicable to any other oral immediate release (IR) CBZ products with conventional excipients. Twenty-four healthy male subjects from two BE study received one IR dose of the test (test 1 or 2) or the reference formulation (Tegretol, 400 mg). Dissolution studies of the IR CBZ tablets were performed in two different laboratories. In order to develop IVIVC, individual or average data analysis were considered. A level C, level B and level A correlation have been successfully developed by combining data from different BE studies of CBZ immediate release drug products. A level A IVIVC was developed with all four datasets with a good R2 for all the combinations of in vivo and in vitro data. A dissolution medium containing 1% SLS has demonstrated its suitability as the universal biopredictive dissolution medium, even if different batches and in vivo/in vitro studies were combined.
Subject(s)
Anticonvulsants/administration & dosage , Carbamazepine/administration & dosage , Excipients/chemistry , Anticonvulsants/pharmacokinetics , Carbamazepine/pharmacokinetics , Chemistry, Pharmaceutical/methods , Cross-Over Studies , Drug Liberation , Feasibility Studies , Humans , Male , Single-Blind Method , Solubility , Tablets , Therapeutic EquivalencyABSTRACT
Introducción: La automedicación es, en general, una conducta presente en todas las sociedades, y con frecuencia se autoprescriben antiinflamatorios sin control sanitario y sin que el paciente sea consciente de la intensidad y gravedad de las reacciones adversas que pueden provocar. Desde la oficina de farmacia se debe realizar una correcta atención farmacéutica y mejorar los resultados de la farmacoterapia previniendo, detectando y resolviendo los problemas relacionados con medicamentos antes de que éstos den lugar a morbilidad y mortalidad. Objetivos: 1) Analizar los principios activos más demandados, así como la forma de dispensación más frecuente. 2) Valorar la eficacia y la eficiencia de los medicamentos en las enfermedades para las que se prescriben. 3) Evaluar el grado de conocimiento de los pacientes sobre su farmacoterapia. 4) Realizar un análisis del seguimiento farmacoterapéutico a pacientes crónicos. Material y métodos: Estudio observacional, prospectivo, monocéntrico y concurrente llevado a cabo en pacientes tratados con antiinflamatorios, mediante encuestas y seguimiento farmacoterapéutico de los pacientes crónicos. Resultados: Los pacientes refirieron una disminución en el grado de dolor de 4 puntos según la escala visual analógica (EVA). Se redujo un 23,3% el número de pacientes con presión arterial sistólica (PAS) >=140 mmHg, y un 13,3% los pacientes con presión arterial diastólica (PAD) >=90 mmHg. Más del 90% declararon conocer mejor su enfermedad y su tratamiento, y el 58% mejoraron su adherencia a éste. La calidad de vida del paciente se vio aumentada en casi un 10% según el test EuroQol-5D. Conclusiones: La atención farmacéutica se presenta como una alternativa de calidad muy eficaz para conseguir mejorar el resultado de los tratamientos y la asistencia sanitaria(AU)
Introduction: Self-medication is generally present in all societies. Nonsteroidal anti-infl ammatory medications are one of the most commonly self-administered drugs and many patients without being aware of their side effects that can cause. From the pharmacy must make a proper pharmaceutical care and improve outcomes of drug therapy in preventing, detecting and solving drug therapy problems before they result in morbidity and mortality. Objectives: 1) To analyze the most demanded active principle and the most common form of dispensation. 2) To assess the effectiveness and efficiency of drugs for diseases those are prescribed. 3) To analyze the level of awareness of patients regards their drug thera py. 4) To assess the impact of pharmaceutical care to chronic patients. Methodology: The method used was a single-center prospective observational study in patients receiving anti-infl ammatory by questionnaires drafted and pharmaceutical intervention at pharmaceutical care for chronic patients. Results: The patients reported a reduction of 4 points in degree of pain according to the visual analog scale (VAS). The number of patients with systolic blood pressure (SBP) >=140 mmHg, and the number of patients with diastolic blood pressure (DBP) >=90 mmHg, was reduced 23.3 and 13.3%, respectively. Over 90% reported understand better their disease and treatment, 58% improved adherence. The patients quality of life was increased by almost 10% according to the test EuroQol-5D. Conclusions: Pharmaceutical care is presented as a very effective quality alternative to achieve better treatment outcomes and healthcare(AU)
