Synthesis and characterisation of starch tartrate and its application as novel disintegrant in telmisartan tablets

• Published in: Die Stärke 2014-03, Vol.66 (3-4), p.409-417
• Main Authors: Assaleh, Fathi H, Katakam, Prakash, Botcha, Ramesh, Chandu, Babu Rao, Adiki, Shanta Kumari
• Format: Article
• Language: English
• Subjects: Characterization; Disintegrant; Fourier transform infrared spectroscopy; gelation; physicochemical properties; potato starch; sodium; starch; Starch tartrate; tartaric acid; Telmisartan
• ISSN: 0038-9056; 1521-379X
• DOI: 10.1002/star.201300136

The aim of the present study was to synthesize potato starch (PS) derivatives of tartaric acid (TA) under semi‐dry conditions and to evaluate the physicochemical properties as per official compendia requirements. Starch tartrate (ST) was synthesized by reacting PS (St–OH) and TA in semi‐dry condition using sodium hypophosphite (SHP) as a catalyst. Further we have applied its use as disintegrant in directly compressed telmisartan tablets. The microscopic, spectroscopic (FTIR), thermal (DSC) and crystallographic (XRD) studies confirmed the formation of ST. No gelling was observed at 100°C but it was converted to a clear solution with a swelling index of 1.666 times. ST was found to have suitable compression properties required for directly compressible tablets. The tablets formulated employing ST (5–15% w/w) as disintegrant gave rapid disintegration and dissolution rates compared to those prepared using commercial superdisintegrants (sodium starch glycolate and crosscarmellose sodium). The optimized formulation showed disintegration time of 31 ± 3 s which is found superior to that of others. It is concluded that the synthesized ST could be employed as a promising disintegrant in dispersible tablet formulations.