RESUMO
Fuse deposition modelling (FDM) has emerged as a novel technology for manufacturing 3D printed medicines. However, it is a two-step process requiring the fabrication of filaments using a hot melt extruder with suitable properties prior to printing taking place, which can be a rate-limiting step in its application into clinical practice. Direct powder extrusion can overcome the difficulties encountered with fabrication of pharmaceutical-quality filaments for FDM, allowing the manufacturing, in a single step, of 3D printed solid dosage forms. In this study, we demonstrate the manufacturing of small-weight (<100 mg) solid dosage forms with high drug loading (25%) that can be easily undertaken by healthcare professionals to treat hypertension. 3D printed nifedipine minitablets containing 20 mg were manufactured by direct powder extrusion combining 15% polyethylene glycol 4000 Da, 40% hydroxypropyl cellulose, 19% hydroxy propyl methyl cellulose acetate succinate, and 1% magnesium stearate. The fabricated 3D printed minitablets of small overall weight did not disintegrate during dissolution and allowed for controlled drug release over 24 h, based on erosion. This release profile of the printed minitablets is more suitable for hypertensive patients than immediate-release tablets that can lead to a marked burst effect, triggering hypotension. The small size of the minitablet allows it to fit inside of a 0-size capsule and be combined with other minitablets, of other API, for the treatment of complex diseases requiring polypharmacy within a single dosage form.
RESUMO
ANTECEDENTES Y OBJETIVOS: Apenas existen estudios que hayan investigado el papel que la inflexibilidad psicológica (IP) pudiera tener en el contexto de la IRC. El objetivo primario de este estudio fue analizar las propiedades psicométricas, la fiabilidad y la validez de la versión española del Acceptance and Action Questionnaire-II adaptada al contexto de pacientes en tratamiento de hemodiálisis. El objetivo secundario fue analizar la relación entre IP y parámetros relacionados con la adhesión al tratamiento y calidad de vida en este tipo de pacientes. MATERIALES Y MÉTODOS: Estudio transversal prospectivo con pacientes en hemodiálisis (n = 186). RESULTADOS: El índice de tejido graso (15,56 ± 5,72 vs. 18,99 ± 8,91; p = 0,033), los niveles de fósforo (3,92 ± 1,24 vs. 4,66 ± 1,38; p = 0,001) y la ganancia de peso interdiálisis (1,56 ± 0,69 vs. 1,89 ± 0,93; p = 0,016) fueron mayores en los pacientes con más puntuación en IP. Los niveles de fósforo (p = 0,013) explicaron de forma significativa la variabilidad de los niveles de IP, la cual también se mostró como un predictor significativo (p = 0,026) de la variabilidad de los niveles de fósforo. CONCLUSIONES: La adaptación del cuestionario Acceptance and Action Questionnaire-II al contexto de hemodiálisis da lugar a una medida válida y fiable de la IP para este tipo de pacientes, y los resultados de este estudio parecen apoyar el papel de la IP con relación a parámetros de salud y calidad de vida en el ámbito de las enfermedades crónicas
BACKGROUND AND OBJECTIVES: Few studies have investigated the role psychological inflexibility (PI) could have in the context of chronic renal failure. The primary objective of this study was to analyse the psychometric features, the reliability and the validity of the Spanish version of the Acceptance and Action Questionnaire-II (AAQ-II) adapted to the context of patients undergoing haemodialysis (HD). The secondary objective was to assess the relationship between PI and parameters related to the adherence to treatment and quality of life in these types of patients. MATERIALS AND METHODS: Prospective cross-sectional study with patients on haemodialysis (n = 186). RESULTS: The fat tissue index (15.56 ± 5.72 vs. 18.99 ± 8.91, P = .033), phosphorus levels (3.92 ± 1.24 vs. 4.66 ± 1.38; P = .001) and interdialytic weight gain (1.56 ± 0.69 vs. 1.89 ± 0.93, P = .016) were higher in patients with a higher PI score. Phosphorus levels (P = .013) significantly explained the variability of PI levels. PI was also shown as a significant predictor (P = .026) of the variability of phosphorus levels. CONCLUSIONS: The adaptation of the AAQ-II questionnaire to the HD context led to a valid and reliable measurement of PI in these types of patients and our results also seem to support the relationship between PI and health and quality of life parameters in patients with chronic conditions
Assuntos
Humanos , Masculino , Feminino , Idoso , Adaptação Psicológica , Insuficiência Renal Crônica/psicologia , Diálise Renal/psicologia , Inquéritos e Questionários , Adiposidade , Estudos Transversais , Insuficiência Renal Crônica/terapia , Cooperação do Paciente , Fósforo , Estudos Prospectivos , Psicometria , Qualidade de Vida , Reprodutibilidade dos Testes , Aumento de PesoRESUMO
BACKGROUND AND OBJECTIVES: Few studies have investigated the role psychological inflexibility (PI) could have in the context of chronic renal failure. The primary objective of this study was to analyse the psychometric features, the reliability and the validity of the Spanish version of the Acceptance and Action Questionnaire-II (AAQ-II) adapted to the context of patients undergoing haemodialysis (HD). The secondary objective was to assess the relationship between PI and parameters related to the adherence to treatment and quality of life in these types of patients. MATERIALS AND METHODS: Prospective cross-sectional study with patients on haemodialysis (n=186). RESULTS: The fat tissue index (15.56±5.72 vs. 18.99±8.91, P=.033), phosphorus levels (3.92±1.24 vs. 4.66±1.38; P=.001) and interdialytic weight gain (1.56±0.69 vs. 1.89±0.93, P=.016) were higher in patients with a higher PI score. Phosphorus levels (P=.013) significantly explained the variability of PI levels. PI was also shown as a significant predictor (P=.026) of the variability of phosphorus levels. CONCLUSIONS: The adaptation of the AAQ-II questionnaire to the HD context led to a valid and reliable measurement of PI in these types of patients and our results also seem to support the relationship between PI and health and quality of life parameters in patients with chronic conditions.
