Design of pediatric oral formulations with a low proportion of methadone or phenobarbital for the treatment of neonatal abstinence syndrome.

CONTEXT: Elaboration of oral liquid formulations is the best alternative when no marketed forms are available for pediatrics. OBJECTIVE: The development, characterization and stability evaluation of methadone (MI, MII, MIII) and phenobarbital (PI, PII) can be used for the treatment of neonatal abstinence syndrome (NAS). MATERIAL AND METHODS: A standard operating procedure was established and parameters such as appearance, pH, rheological behavior and drug content were evaluated at three temperatures for 90 days. RESULTS AND DISCUSSION: Changes in color of phenobarbital made necessary the storage below 25 °C. pH did not change in methadone solutions and was able to maintain phenobarbital solubilized. Degradation data at 4 °C fitted to Plateau equation followed by one phase decay. MI was stable for 60 days at the three temperatures; MII for 90 days at 4 and 25 °C and 60 days at 40 °C; MIII for 60 days at 4 °C, 15 days at 25 °C and 7 days at 4 °C. PI was stable for 60 days at 4 °C and 30 days at 25 °C. PII was stable for 7 days at 4 and 25 °C. All solutions met microbial specifications. CONCLUSION: A correct dosage for the treatment of NAS was guaranteed.

Disbiosis intestinal en enfermos de Crohn pediátricos / Intestinal dysbiosis in pediatric patients with Crohn's disease

Introducción: La enfermedad de Crohn (EC) pediátrica es un desorden caracterizado por presentar inflamación crónica que puede afectar cualquier segmento del tracto gastrointestinal. La disbiosis intestinal es un factor implicado en la patogénesis multifactorial de esta enfermedad. Diferentes suplementos dietarios se han propuesto como terapia alternativa para inducir o mantener la remisión de la EC. Objetivo: Revisar las evidencias científicas publicadas sobre disbiosis intestinal en pacientes de Crohn pediátricos y la eficacia de la terapia con suplementos dietarios (especialmente probióticos). Material y métodos: Se ha realizado una extensa búsqueda de publicaciones científicas en las principales bases de datos electrónicas especializadas: NCBI, Elsevier, Scielo, Scirus y Science Direct. Resultados y Discusión: Se ha observado en la población pediátrica de EC un aumento de Proteobacteria y una reducción de Firmicutes. Los resultados referentes a los phyla Bacteroidetes y Actinobacteria son divergentes. Referente al uso de suplementos dietarios, el uso de probióticos no ha mostrado ningún impacto positivo en la EC pediátrica. Conclusiones: Los resultados publicados hasta la fecha referentes a la disbiosis intestinal en pacientes pediátricos de Crohn, contribuyen al mejor conocimiento y entendimiento de las modificaciones en la flora bacteriana. Sin embargo, no es posible definir una microbiota asociada o causante de la EC. Además, los resultados publicados hasta la fecha no aportan evidencias sólidas de la eficacia de los probióticos como terapia en dichos pacientes (AU)

Introduction: Paediatric Crohn's disease is a disorder characterised by a chronic inflammation that can affect any part of the gastrointestinal tract. Intestinal dysbiosis is a key factor in the multifactorial pathogenesis of this disease. Different dietary supplements have been proposed as alternative therapy both on induction and on maintaining remission of this disease. Objective: To review current scientific evidence of intestinal dysbiosis in paediatric Crohn's disease patients, as well as efficacy of dietary supplement therapy (especially probiotics). Materials and Methods: Extensive search of scientific publications was performed in specialized electronic databases: NBCI, Elsevier, Scielo, Scirus and Science Direct. Results and discussion: An increase of Proteobacteria and a reduction of Firmicutes were observed in Crohn's disease paediatric patients. However the results referring to phyla Bacteroidetes and Actinobacteria are disperse. Referring the use of dietary supplements, the use of probiotics did not show any positive impact in paediatric Crohn's disease patients. Conclusions: A better knowledge and understanding of the bacterial flora modifications in paediatric Crohn's disease patients is possible with the current published results. However, it is not possible to define the precise microbiota associated or causing this disease. In addition, current results do not bring solid evidence of the efficacy of probiotic therapy in those patients (AU)

[Intestinal dysbiosis in pediatric patients with Crohn's disease]. / Disbiosis intestinal en enfermos de Crohn pediátricos.

INTRODUCTION: Paediatric Crohn's disease is a disorder characterised by a chronic inflammation that can affect any part of the gastrointestinal tract. Intestinal dysbiosis is a key factor in the multifactorial pathogenesis of this disease. Different dietary supplements have been proposed as alternative therapy both on induction and on maintaining remission of this disease. OBJECTIVE: To review current scientific evidence of intestinal dysbiosis in paediatric Crohn's disease patients, as well as efficacy of dietary supplement therapy (especially probiotics). MATERIALS AND METHODS: Extensive search of scientific publications was performed in specialized electronic databases: NBCI, Elsevier, Scielo, Scirus and Science Direct. RESULTS AND DISCUSSION: An increase of Proteobacteria and a reduction of Firmicutes were observed in Crohn's disease paediatric patients. However the results referring to phyla Bacteroidetes and Actinobacteria are disperse. Referring the use of dietary supplements, the use of probiotics did not show any positive impact in paediatric Crohn's disease patients. CONCLUSIONS: A better knowledge and understanding of the bacterial flora modifications in paediatric Crohn's disease patients is possible with the current published results. However, it is not possible to define the precise microbiota associated or causing this disease. In addition, current results do not bring solid evidence of the efficacy of probiotic therapy in those patients.

Introducción La enfermedad de Crohn (EC) pediátrica es un desorden caracterizado por presentar inflamación crónica que puede afectar cualquier segmento del tracto gastrointestinal. La disbiosis intestinal es un factor implicado en la patogénesis multifactorial de esta enfermedad. Diferentes suplementos dietarios se han propuesto como terapia alternativa para inducir o mantener la remisión de la EC. Objetivo Revisar las evidencias científicas publicadas sobre disbiosis intestinal en pacientes de Crohn pediátricos y la eficacia de la terapia con suplementos dietarios (especialmente probióticos). Material y métodos Se ha realizado una extensa búsqueda de publicaciones científicas en las principales bases de datos electrónicas especializadas: NCBI, Elsevier, Scielo, Scirus y Science Direct. Resultados y Discusión Se ha observado en la población pediátrica de EC un aumento de Proteobacteria y una reducción de Firmicutes. Los resultados referentes a los phyla Bacteroidetes y Actinobacteria son divergentes. Referente al uso de suplementos dietarios, el uso de probióticos no ha mostrado ningún impacto positivo en la EC pediátrica. Conclusiones Los resultados publicados hasta la fecha referentes a la disbiosis intestinal en pacientes pediátricos de Crohn, contribuyen al mejor conocimiento y entendimiento de las modificaciones en la flora bacteriana. Sin embargo, no es posible definir una microbiota asociada o causante de la EC. Además, los resultados publicados hasta la fecha no aportan evidencias sólidas de la eficacia de los probióticos como terapia en dichos pacientes.