Video Experimental Relacionado
Updated: Sep 9, 2025
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
10.8K
Estudio multicéntrico de biodisponibilidad de la paliperidona de acción prolongada en pacientes con esquizofrenia o
Thalita Martins da Silva1, Débora Renz Barreto Vianna2, Jessica Meulman1
1Department of Operations, Clinical Research Unit, Adium S.A., São Paulo, São Paulo,Brazil.
Journal of clinical psychopharmacology
|September 3, 2025
Resumen
Una nueva formulación inyectable de paliperidona palmitato de acción prolongada, Vegapali, es bioequivalente al producto de referencia. Esto confirma su eficacia y seguridad para el tratamiento de la esquizofrenia, mejorando el acceso de los pacientes a los antipsicóticos LAI.
Área de la Ciencia:
- Farmacología y Ciencias Farmacéuticas
- Psiquiatría y salud mental
- Investigación clínica
Sus antecedentes:
- Tratamiento de la esquizofrenia La falta de adherencia a los antipsicóticos orales conduce a la recaída y al aumento de los costos de atención médica.
- Los antipsicóticos inyectables de acción prolongada (LAI), como el palmitato de paliperidona, mitigan los riesgos de recaída.
- Las formulaciones bioequivalentes de antipsicóticos ILA mejoran la accesibilidad al tratamiento manteniendo la seguridad y la eficacia.
Objetivo del estudio:
- Para evaluar la bioequivalencia de una suspensión inyectable de liberación prolongada de paliperidona (PP-ERIS), Vegapali.
- Para comparar Vegapali con la formulación de referencia, Invega Sustenna, en pacientes con esquizofrenia o trastorno esquizoaffectivo.
Principales métodos:
- Un estudio farmacocinético de 7 meses, multicéntrico, aleatorizado, abierto y de brazo paralelo.
- Inyecciones intramusculares mensuales de la prueba (Vegapali) o de la formulación de referencia.
- Se determinaron los parámetros de PK en estado estacionario (Cmax,ss y AUCτ,ss). La bioequivalencia se confirmó si las IC del 90% para las relaciones de media geométrica eran del 80,00% al 125,00%.
Principales resultados:
- El análisis farmacocinético confirmó la bioequivalencia, con CI del 90% para Cmax,ss y AUCτ,ss dentro del rango del 80,00% - 125,00%.
- Ambas formulaciones demostraron una exposición sistémica comparable.
- La incidencia de eventos adversos está alineada con el perfil de seguridad conocido de paliperidona palmitato.
Conclusiones:
- La formulación del ensayo, Vegapali, es bioequivalente al ILA de paliperidona de referencia.
- Vegapali es un tratamiento alternativo viable para la esquizofrenia, garantizando la equivalencia terapéutica.
- Este hallazgo amplía el acceso a opciones efectivas y sostenidas de tratamiento de la esquizofrenia.
Videos de Conceptos Relacionados
01:26Psychosis: Goals of Pharmacotherapy
209
Antipsychotic drugs are a crucial treatment method for acute and chronic psychoses, bipolar illness, and behavioral disorders. The selection of these drugs depends on several factors, including the state of the disease, clinical judgment, possible drug interactions, and the patient's sensitivity to adverse effects. In immediate scenarios, such as delirium and dementia, short-term treatment with low doses of high-potency typical or atypical agents can effectively manage symptom exacerbation.
209
01:13Bioavailability: Overview
3.1K
Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
3.1K
01:23Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance
293
The elimination half-life and drug clearance of drugs following nonlinear kinetics can vary with dosage. The Michaelis-Menten parameters and drug concentration influence these factors. As the dose increases, the elimination half-life tends to lengthen, resulting in a reduction in clearance and a disproportionately larger area under the curve. The total clearance can be derived from the Michaelis-Menten equation for drugs following a one-compartment model.
A study on guinea pigs examined the...
A study on guinea pigs examined the...
293
01:28Psychosis and Antipsychotic Drugs: Overview
453
The term "psychosis" refers to a spectrum of mental disorders characterized by abnormal thoughts, perceptions, and behaviors. It can manifest as mood disorders, dementia, delirium with psychotic features, substance-induced psychosis with psychotic features, brief psychotic disorder, delusional disorder, schizoaffective disorder, and schizophrenia. Among all these disorders, schizophrenia is the most common psychotic disorder, affecting 1% of the worldwide population. Psychotic...
453
01:22Nonlinear Pharmacokinetics: Bioavailability and Protein-Drug Binding
273
When a drug follows nonlinear pharmacokinetics, its bioavailability, the amount of the drug that reaches the systemic circulation, can change with different doses. This is due to the presence of a saturable pathway. The pathway becomes saturated as the drug concentration increases, decreasing the absorption rate. Consequently, the drug's bioavailability may be lower than expected at higher doses.
To quantify the extent of bioavailability, pharmacologists often use a parameter called .
To quantify the extent of bioavailability, pharmacologists often use a parameter called .
273
01:12Analysis of Population Pharmacokinetic Data
382
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
382