Compatibility of Baclofen, Carvedilol, Hydrochlorothiazide, Mercaptopurine, Methadone Hydrochloride, Oseltamivir Phosphate, Phenobarbital, Propranolol Hydrochloride, Pyrazinamide, Sotalol Hydrochloride, Spironolactone, Tacrolimus Monohydrate, Ursodeoxycholic Acid, and Vancomycin Hydrochloride Oral Suspensions Compounded with SyrSpend SF pH4.

Compounded liquid medication is frequently required in children to allow easy dose adjustment and overcome swallowing difficulties. The objective of this study was to evaluate the stability of oral suspensions compounded with SyrSpend SF PH4 and the commonly used active pharmaceutical ingredients baclofen 2.0 mg/mL, carvedilol 5.0 mg/mL, hydrochlorothiazide 2.0 mg/mL, mercaptopurine 10.0 mg/mL, methadone hydrochloride 10.0 mg/mL, oseltamivir phosphate 6.0 mg/mL, phenobarbital 9.0 mg/mL and 15.0 mg/mL, propranolol hydrochloride 0.5 mg/mL and 5.0 mg/mL, pyrazinamide 100.0 mg/mL, spironolactone 2.0 mg/mL and 2.5 mg/mL, sotalol hydrochloride 5.0 mg/mL, tacrolimus monohydrate 0.5 mg/mL, ursodeoxycholic acid 20.0 mg/mL, and vancomycin hydrochloride 25.0 mg/mL. Suspensions were compounded with raw powders, except for mercaptopurine, pyrazinamide, and sotalol hydrochloride, which were made from commercial tablets. Stability was assessed by measuring the percentage recovery at 0 (baseline), 60 days, and 90 days after compounding for suspensions made with raw powders, which were stored at 2ÅãC to 8ÅãC. The stability of tablets, which were stored at 2ÅãC to 8ÅãC and 20ÅãC to 25ÅãC, was assessed by measuring the percentage recovery at 0 (baseline), 7 days, 14 days, 30 days, 60 days, and 90 days. Active pharmaceutical ingredients quantification was performed by ultraviolet high-performance liquid chromatography via a stability-indicating method. Given the percentage of recovery of the active pharmaceutical ingredients within the suspensions, the beyond-use date of the final products (active pharmaceutical ingredients + vehicle) was at least 90 days for all suspensions in the conditions tested. This suggests that SyrSpend SF PH4 is suitable for compounding active pharmaceutical ingredients from different pharmacological classes.

Determinação simplificada de carbamazepina, fenitoína, fenobarbital e lamotrigina em plasma emonitoração terapêutica por HPLC/PDA / Simplified determination of carbamazepine, phenytoin,phenobarbital and lamotrigine in plasma and therapeuticmonitoring by HPLC/PDA

Carbamazepina, fenitoína, fenobarbital e lamotrigina são bem conhecidos como fármacos anticonvulsivantes usados para o tratamento da epilepsia. A utilização destes fármacos é associada a várias reações adversas, tornando necessário o controle terapêutico. Os ensaios foram realizados por meio de cromatografia líquida de alta eficiência e o método de extração utilizado foi o líquido-líquido. Os fármacos e o padrão interno de zolpidem foram separados por uma coluna de fase reversa (ACE5, C18150x 4,6 mm d.i.). A fase móvel constituída de acetonitrila (30%) e ácido cítrico/tampão fosfato pH 5,0 (70%) foi utilizada sob gradiente de fluxo de 0,7 a 1,2 mL/min e o comprimento de onda utilizado para a detecção dos analitos foi fixado em 210 nm. A técnica apresentou linearidade ao longo do intervalo de 0,5 a 20,0μg/mL para carbamazepina/lamotrigina e de 2,0 a 64,0 μg/mL, para fenitoina/fenobarbital com coeficiente de correlação linear maior que 0,98. As amostras de sangue foram obtidas de pacientes adultos com diagnóstico de epilepsia em acompanhamento no Ambulatório Municipal de Psiquiatria de Goiânia. A média de recuperação obtida foi de 96,8% a 108,5% para carbamazepina/lamotrigina e de 93,8% a 108,8% para a fenitoina/fenobarbital. Os limites de quantificação, precisão (CV< 15,0 %)e exatidão (E > 85,0 %) demonstraram estar em conformidade com as exigências da ANVISA. Nove pacientes foram avaliados para confirmar a validade do método.

Carbamazepine, phenytoin, phenobarbital and lamotrigine are well known anticonvulsant drugs used in the treatment of epilepsy. However, these medications are associated with side effects and therefore require therapeutic monitoring. Blood samples of adult outpatients diagnosed with epilepsy at the Goiânia Municipal Psychiatry Clinic (Brazil) were collected and analyzed using high-performance liquid chromatography. The analytes and internal standard (zolpidem) were extracted by liquid-liquid extraction. A reversed phase column (ACE 5, C18, 150 x 4.6 mm i.d.) was used. The mobile phase was composed of acetonitrile (30%) and citric acid/phosphate buffer, pH 5.0 (70%). The gradient flow rate was from 0.7 to 1.2 mL/min and the detection wavelength was set at 210 nm for all analytes. The analysis revealed a linear range from 0.5 to 20.0μg/mL for carbamazepine/lamotrigine and 2.0 to 64.0 μg/mL for phenytoin/phenobarbital. Mean recovery ranged from 96.8% to 108.5% for carbamazepine/lamotrigine and 93.8% to 108.8% for phenytoin/phenobarbital. The quantification limit, precision (CV < 15%) and accuracy (A >85%) proved to be in accordance with the requirements stipulated by the Brazilian National Health Surveillance Agency (ANVISA). Nine outpatients were evaluated to confirm the validity of the method.