Abstract
The major concern with the use of some synthetic excipients is their safety towards biological tissues, hence influencing the reliability of products. With the aim to minimize dependency on highly toxic synthetic excipients, the present study was designed to deliver metronidazole (MNZ) into the colonic region for localized treatment of amoebiasis using natural polysaccharide-based drug delivery. Compression-coated tablets were prepared using water extractable natural polysaccharide from Trigonella foenum-graecum (FG). Physical properties of the tablets were evaluated and dissolution study was performed at pH 1.2, 6.8, and 7.4 with rat cecal material. Results indicate that all batches demonstrated pH-dependent drug release and prevented release into the stomach, allowing traces into the intestine and highest availability into the colon. A significant correlation (r2 = 0.975) was found between the coating levels of extracted polysaccharide and lag time release of drug. Gamma scintigraphy images of in vivo study conducted on human volunteers showed a small intestinal transit time, i.e., 3–5 (4.2 ± 0.4) h and confirmed that the tablets reached the colon within 6–8 h. The present study revealed that the FG polysaccharide-based double compression tablets may be promising colon-specific drug carriers with reduced toxic effects of commonly used synthetic excipients.
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We are highly thankful to the Institute of Nuclear Medicine and Allied Sciences (INMAS), New Delhi, for providing basic technical and instrumental support.
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The protocol was approved by the institutional human ethical committee (vide no: IEC/INM/15-16/1-13) and prior written consent of human volunteers was taken.
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Sharma, N., Sharma, A., Nishad, D.K. et al. Development and Gamma Scintigraphy Study of Trigonella foenum-graecum (Fenugreek) Polysaccharide-Based Colon Tablet. AAPS PharmSciTech 19, 2564–2571 (2018). https://doi.org/10.1208/s12249-018-1066-4
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DOI: https://doi.org/10.1208/s12249-018-1066-4