Pawar Harshal, Varkhade Chhaya, Jadhav Pravin, Mehra Kavita
Department of Quality Assurance, Dr. L.H. Hiranandani College of Pharmacy, Ulhasnagar, Maharashtra, India.
Integr Med Res. 2014 Jun;3(2):91-98. doi: 10.1016/j.imr.2014.03.002. Epub 2014 Mar 18.
Orodispersible tablets or fast dissolving tablets dissolve or disintegrate immediately on the patients' tongue or buccal mucosa. This drug delivery system is suitable for drugs undergoing high first pass metabolism. It improves bioavailability, reduces dosing frequency, and thereby minimizes the side effects and also makes the dosage form more cost-effective. In this study, polysaccharide isolated from the seeds of was investigated as a superdisintegrant in the orodispersible tablets. The model drug chosen was valsartan, an antihypertensive drug.
Valsartan tablets were prepared separately using different concentrations (1%, 2.5%, 5%, and 7.5% w/w) of isolated seed polysaccharide (natural) and sodium starch glycolate (synthetic) as superdisintegrant by the direct compression method. Evaluation of tablets was done for various pre- and postcompression parameters. The stability studies were performed on optimized formulation F4. The disintegration time and drug release of the formulation F4 were compared with marketed formulations (conventional tablets).
The drug excipient interactions were characterized by Fourier transform infrared studies. The formulation F4 containing 7.5% polysaccharide showed good wetting time and disintegration time as compared to a formulation prepared using a synthetic superdisintegrant at the same concentration level. Hence, batch F4 was considered optimized formulation.
The present work revealed that seed polysaccharide has a good potential as a disintegrant in the formulation of orodispersible tablets. Because polysaccharide is inexpensive as compared to synthetic superdisintegrants, nontoxic, compatible, and easy to manufacture, it can be used in place of currently marketed superdisintegrants.
口腔崩解片或速溶片可在患者舌部或颊黏膜上立即溶解或崩解。这种药物递送系统适用于经历高首过代谢的药物。它提高了生物利用度，降低了给药频率，从而将副作用降至最低，并且还使剂型更具成本效益。在本研究中，研究了从[未提及植物名称]种子中分离出的多糖作为口腔崩解片中的超级崩解剂。选择的模型药物是缬沙坦，一种抗高血压药物。
通过直接压片法，分别使用不同浓度（1%、2.5%、5%和7.5% w/w）的分离出的[未提及植物名称]种子多糖（天然的）和羟丙基淀粉（合成的）作为超级崩解剂制备缬沙坦片。对片剂进行了各种压片前和压片后的参数评估。对优化后的制剂F4进行了稳定性研究。将制剂F4的崩解时间和药物释放与市售制剂（普通片剂）进行了比较。
通过傅里叶变换红外光谱研究对药物-辅料相互作用进行了表征。与在相同浓度水平下使用合成超级崩解剂制备的制剂相比，含有7.5%多糖的制剂F4显示出良好的润湿时间和崩解时间。因此，批次F4被认为是优化后的制剂。
目前的工作表明，[未提及植物名称]种子多糖在口腔崩解片的制剂中具有作为崩解剂的良好潜力。由于[未提及植物名称]多糖与合成超级崩解剂相比价格低廉、无毒、相容性好且易于制造，它可用于替代目前市售的超级崩解剂。
