Drug-Excipient Compatibility: Preformulation Study with New Grades of Microcrystalline Cellulose from Potential Non-Woody Sources, Sor- ghum and Andropogon

Abstract

Compatibility of Sorghum and Andropogon Microcrystalline Cellulose (MCC) with acetaminophen, ascorbic acid and metronidazole was examined using FTIR. Tablet characteristics of the binary blends were studied. Drug-excipient ratio was 70:30% w/w for acetaminophen and ascorbic acid while metronidazole was 67:33% w/w. Spectra of the polymer, drug and polymer-drug blends were studied within 400-4000 cm-1 wave number. Characteristic peaks were observed for functional group traits. Tablet batches were obtained for each drug using the derived MCC grades as dry binders, at three different pressure units. Tablets made at fixed pressure units were compared with those of Avi- cel PH 101. Disintegration, friability, crushing strength and dissolution profiles served as bases for assessment. Peaks of functional groups remained within reference range for the drugs in the drugpolymer blends; 1660-1590 (C=C), 1660-1590 (C=O) and 3650-3200 (OH) for acetaminophen; 1700-1630 (C=C), 3650-3250 (OH) for ascorbic acid and 1660-1590 (C=N), 1560-1500 (NO2) for metronidazole. Tablets formulated with the excipients exhibited acceptable hardness, crushing strength, friability and dissolution profiles. The t50 and t80 evaluation returned times of 4-11 and 11-29 min after 24 hrs and 6 months of storage respectively. The results are within acceptable range for non-coated tablets. The new MCC grades compared well with Avicel PH 101 as the mean standard variation for the evaluated tablet properties was less than 5%. Sorghum and Andropogon plants are potential none-woody sources of MCC.