Nadaf Sameer J, Savekar Pranav L, Bhagwat Durgacharan A, Dagade Komal V, Gurav Shailendra S
Bharati Vidyapeeth College of Pharmacy, Palus 416310, Maharashtra, India.
Shivraj College of Pharmacy, Gadhinglaj 416502, Maharashtra, India.
Heliyon. 2024 Oct 2;10(19):e38793. doi: 10.1016/j.heliyon.2024.e38793. eCollection 2024 Oct 15.
This study investigates the transformation of neat starch (NS) from mung beans into porous starch (PS) for the formulation of fast-disintegrating tablets (FDTs) using the sublimation technique, contrasting their performance with superdisintegrants such as sodium starch glycolate (SSG) and croscarmellose sodium (CS). Camphor was used as a sublimating agent. The interaction between drug and excipients was analyzed using Fourier-transform infrared spectroscopy (FTIR), while preformulation assessments were conducted on powder blends. Model drug Diclofenac sodium (DL)-loaded FDTs were prepared via direct compression technique. Thermal behavior and crystalline properties were evaluated using differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD), respectively. Compressibility of tablets was assessed through Heckel and Kawakita analyses. Post-compression evaluations encompassed hardness, thickness, disintegration, and dissolution studies. FTIR analysis indicated the absence of chemical interactions among constituents, while precompression analyses confirmed favorable flow properties of the blends. Heckel analysis supported the material's notable compressibility. Microscopic examination revealed the formation of pores on the tablet surface due to the sublimation process. Integration of PS significantly accelerated the disintegration time of FDTs, with durations ranging from 50 to 82 s, compared to 76-104 s for NS-FDTs. While PS-FDTs exhibited a longer disintegration time compared to SSG, they demonstrated faster disintegration compared to croscarmellose sodium. A significant disparity () in drug release at 60 min was observed between SSG and PS-FDTs, with DP3 achieving 97.65 % drug release. Most batches followed the Korsmeyer-Peppas model, except for DN2 and DN3, which adhered to Higuchi-matrix drug release kinetics. Stability assessments after 90 days revealed no significant differences (). Conclusively, this study highlights the effectiveness of PS and the sublimation method in creating FDTs with enhanced drug release properties.
本研究利用升华技术,研究了绿豆原淀粉(NS)转变为多孔淀粉(PS)用于制备速崩片(FDT)的过程,并将其性能与淀粉乙醇酸钠(SSG)和交联羧甲基纤维素钠(CS)等超级崩解剂进行对比。樟脑用作升华剂。使用傅里叶变换红外光谱(FTIR)分析药物与辅料之间的相互作用,同时对粉末混合物进行处方前评估。通过直接压片技术制备了载有模型药物双氯芬酸钠(DL)的FDT。分别使用差示扫描量热法(DSC)和粉末X射线衍射(PXRD)评估热行为和结晶性能。通过Heckel和Kawakita分析评估片剂的可压缩性。压片后评估包括硬度、厚度、崩解和溶出度研究。FTIR分析表明各成分之间不存在化学相互作用,而压片前分析证实混合物具有良好的流动性。Heckel分析支持该材料具有显著的可压缩性。显微镜检查显示,由于升华过程,片剂表面形成了孔隙。与NS-FDT的76 - 104秒相比,PS的加入显著加速了FDT的崩解时间,持续时间为50至82秒。虽然PS-FDT的崩解时间比SSG长,但与交联羧甲基纤维素钠相比,其崩解速度更快。在60分钟时,观察到SSG和PS-FDT之间的药物释放存在显著差异(),DP3的药物释放率达到97.65%。除DN2和DN3遵循Higuchi基质药物释放动力学外,大多数批次遵循Korsmeyer-Peppas模型。90天后的稳定性评估显示无显著差异()。总之,本研究强调了PS和升华方法在制备具有增强药物释放特性的FDT方面的有效性。