Khan Hafeez Ullah, Hanif Muhammad, Sarfraz Rai M, Maheen Safirah, Afzal Samina, Sher Muhammad, Afzal Khurram, Mahmood Asif, Shamim Ayesha
Faculty of Pharmacy, University of Sargodha, Sargodha, Pakistan.
Department of Pharmacy, Bahauddin Zakariya University, Multan, Pakistan.
Pak J Pharm Sci. 2017 Sep;30(5):1557-1565.
Objective of present study was to enhance patient compliance in pediatrics and geriatrics patients of Hypertension. To achieve this target, innovative orodispersible tablets of atenolol and atorvastatin was developed to produce instant action by rapidly disintegrating into oral cavity. Three different techniques like direct compression, effervescent and sublimation methods were used to prepare these tablets (Five batches of tablets by each method) by using two superdisintegrants like Sodium starch glycolate and pregelatinized starch alone and in combination. Pre-formulation studies including rheological analysis (Bulk density, tapped density, Angle of repose, Carr's compressibility index, Hausner's ratio), compatibility studies such as Fourier transform infrared spectrophotometry (FTIR) and Differential scanning colorimetry (DSC), Post-compression and stability studies were also performed. Finally, results were statistically evaluated by the applying one way ANOVA test and mean. It was concluded that the formulation F8 containing Sodium starch glycolate 2% and pregelatinized starch 6% found best regarding disintegration time, wetting volume, wetting time, release studies etc. The order in which drug release was quicker is Pregelatinized starch plus Sodium starch glycolate > Pregelatinized starch > Sodium starch glycolate (primojel). It was concluded that sublimation method was the best among three methods used for orodispersible tablets formulations.
本研究的目的是提高儿科和老年高血压患者的服药依从性。为实现这一目标,研发了创新型阿替洛尔和阿托伐他汀口腔崩解片,通过在口腔中迅速崩解产生即时作用。采用直接压片、泡腾和升华三种不同技术制备这些片剂(每种方法制备五批片剂),单独或联合使用两种超级崩解剂,即羟丙基淀粉和预胶化淀粉。还进行了包括流变学分析(堆密度、振实密度、休止角、卡尔压缩指数、豪斯纳比)在内的处方前研究、傅里叶变换红外光谱法(FTIR)和差示扫描量热法(DSC)等相容性研究、压片后和稳定性研究。最后,通过应用单向方差分析测试和均值对结果进行统计学评估。得出结论,含有2%羟丙基淀粉和6%预胶化淀粉的F8制剂在崩解时间、湿润体积、湿润时间、释放研究等方面表现最佳。药物释放更快的顺序是预胶化淀粉加羟丙基淀粉>预胶化淀粉>羟丙基淀粉(Primojel)。得出结论,升华法是用于口腔崩解片制剂的三种方法中最好的。