RESUMEN
The objective of this study was to evaluate the feasibility of 10 commonly used active pharmaceutical ingredients (APIs) compounded in oral suspensions using an internationally used suspending vehicle (SyrSpend(®) SF PH4 liquid): (i) amlodipine, (as besylate) 1.0mg/mL; (ii) chloroquine phosphate,15.0 mg/mL; (iii) dapsone, 2.0 mg/mL; (iv) phenytoin, 15.0 mg/mL; (v) pyridoxine hydrochloride, 50.0 mg/mL; (vi) sulfadiazine, 100.0 mg/mL; (vii) sulfasalazine, 100.0 mg/mL; (viii) tetracycline hydrochloride, 25.0 mg/mL; (ix) trimethoprim, 10.0 mg/mL; and (x) zonisamide, 10.0 mg/mL. All suspensions were stored both at controlled refrigeration (2-8 °C) and controlled room temperature (20-25 °C). Feasibility was assessed by measuring the percent recovery at varying time points throughout a 90-day period. API quantification was performed by high-performance liquid chromatography (HPLC-UV), via a stability-indicating method. Given the percentage of recovery of the APIs within the suspensions, the expiration date of the final products (API+vehicle) was at least 90 days for all suspensions with regard to both the controlled temperatures. This suggests that the vehicle is stable for compounding APIs from different pharmacological classes.
Asunto(s)
Estabilidad de Medicamentos , Almacenaje de Medicamentos/métodos , Suspensiones/análisis , Suspensiones/normas , Administración Oral , Amlodipino/análisis , Amlodipino/normas , Cloroquina/análogos & derivados , Cloroquina/análisis , Cloroquina/normas , Cromatografía Líquida de Alta Presión/métodos , Dapsona/análisis , Dapsona/normas , Almacenaje de Medicamentos/normas , Estudios de Factibilidad , Concentración de Iones de Hidrógeno , Isoxazoles/análisis , Isoxazoles/normas , Fenitoína/análisis , Fenitoína/normas , Piridoxina/análisis , Piridoxina/normas , Sulfadiazina/análisis , Sulfadiazina/normas , Sulfasalazina/análisis , Sulfasalazina/normas , Tetraciclina/análisis , Tetraciclina/normas , Trimetoprim/análisis , Trimetoprim/normas , ZonisamidaAsunto(s)
Cromatografía Líquida de Alta Presión/métodos , Cromatografía por Intercambio Iónico/métodos , Ácido Piridóxico/análisis , Piridoxina/análisis , 4-Butirolactona/análogos & derivados , 4-Butirolactona/análisis , Administración Oral , Análisis Químico de la Sangre , Humanos , Ácidos Nicotínicos/análisis , Piridinas/análisis , Piridoxamina/análisis , Ácido Piridóxico/análogos & derivados , Ácido Piridóxico/normas , Piridoxina/análogos & derivados , Piridoxina/metabolismo , Piridoxina/normas , UrinálisisRESUMEN
The purpose of this study was to evaluate the adequacy of dietary intake in 16 female heavyweight rowers during the sprint racing phase of the season. Caloric intake for the rowers was 2,633 kcal/day, lower than expected given the training regimen of these athletes. On average, rowers consumed below-optimal levels of carbohydrate. Protein intake was satisfactory but fat intake was higher than recommended. For the majority of rowers, micronutrient intake met the RDA. However, calcium, zinc, B6, and B12 fell short of meeting two-thirds of the RDA for a significant percentage of rowers. The preevent meal consumed both 15 hr and 2 hr before the event provided less carbohydrate and fluid but more fat than desirable. Female heavyweight rowers would benefit from nutritional counseling that provides strategies for increasing complex carbohydrates, calcium, zinc, B6, and B12 while reducing dietary fat. Adequate fluid intake is also essential.
Asunto(s)
Peso Corporal/fisiología , Dieta/normas , Ingestión de Energía , Deportes , Adulto , Calcio/normas , Registros de Dieta , Carbohidratos de la Dieta/normas , Grasas de la Dieta/normas , Proteínas en la Dieta/normas , Femenino , Humanos , Necesidades Nutricionales , Piridoxina/normas , Factores de Tiempo , Vitamina B 12/normas , Zinc/normasRESUMEN
The raw material of pyridoxine hydrochloride was examined for preparation of the "Pyridoxine Hydrochloride Reference Standard". Analytical data obtained were as follows: loss on drying, 0.00%; pH, 2.87; melting point, 204.6 degrees C (decomposition); infrared spectrum, same as Pyridoxine Hydrochloride Reference Standard (Control 879); thin-layer chromatography, nonimpurities were detected; assay, 100.0% by non-aqueous titration and 100.0% by UV spectrophotometry. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Standard (Control 911).
Asunto(s)
Agencias Gubernamentales , Piridoxina/normas , Cromatografía en Capa Delgada , Higiene , Japón , Farmacopeas como Asunto , Piridoxina/aislamiento & purificación , EspectrofotometríaRESUMEN
The raw material of pyridoxine hydrochloride was examined for the preparation of "Pyridoxine Hydrochloride Reference Standard". Analytical data for the sample were as follows: loss on drying is 0.01%; pH 2.94; melting point 205.2 degrees C (decomposition); IR spectrum same as the Pyridoxine Hydrochloride Reference Standard (Control 801); TLC indicates no impurities; nitrogen is 6.77% (Theoretical value 6.81%); and assay 99.5% by non-aqueous titration, 99.8% by UV spectroscopy, and 100.2% by measuring chloride ion. Based on the above results, this raw material was authorized to be Reference Standard of National Institute of Hygienic Sciences.