Physico-Chemical and Microbiological Study for the Stability of Phenytoin Sodium Extemporaneously Compounded Suspension in Saudi Arabia Hospitals

Syed Ata ur Rahman, Abdullah Alsaedi, Abdulelah Alhusayni, Abdulmalik A Alqurshi, Sameh A. Ahmed, Y. Alahmadi, Alaa Omer M. Abdullaal, Badr Ahmed A. Taher, E. Habib
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Abstract

Epilepsy is a chronic and the fourth most common neurological disorder which affects people of all age groups. Recently research and awareness on epilepsy-related deaths have rapidly grown over the past two decades. Many previous studies are attributed to the guidelines that apprise health care professionals in handling these deaths, but there is a relative scarcity of information accessible for clinicians and pharmacists who are responsible for manufacturing or preparing the extemporaneous anti-epileptic suspensions in the hospitals. Mostly in partial seizures, phenytoin is one of the first-choice drugs. In Saudi Arabian hospitals, the extemporaneous preparation of phenytoin suspension is common, but the hot climatic weather in Saudi Arabia possesses stability problems that should be tackled as the prepared suspension should pass all the stability tests to ensure uniform dosage of the extemporaneous formulation. In the current study, the commercial capsules were used to prepare the oral phenytoin sodium extemporaneous suspension. The physical, chemical and microbiological stability of phenytoin sodium suspension is analyzed at various temperatures.
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沙特阿拉伯医院苯妥英钠临时复合混悬液稳定性的理化和微生物学研究
癫痫是一种慢性和第四大最常见的神经系统疾病,影响所有年龄组的人。最近,对癫痫相关死亡的研究和认识在过去二十年中迅速增长。以前的许多研究都归功于指导卫生保健专业人员处理这些死亡的指导方针,但对于负责在医院制造或准备临时抗癫痫停药的临床医生和药剂师来说,可获得的信息相对缺乏。在大多数部分性癫痫中,苯妥英是首选药物之一。在沙特阿拉伯的医院,临时配制苯妥英混悬液是常见的,但沙特阿拉伯炎热的气候天气存在稳定性问题,配制的混悬液需要通过所有的稳定性试验,以保证临时配方的剂量均匀。本研究采用市售胶囊制备苯妥英钠口服临时混悬液。分析了苯妥英钠悬浮液在不同温度下的物理、化学和微生物稳定性。
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