Health, Toxicology and Mutagenesis, Multidisciplinary, Pharmacology, Toxicology and Pharmaceutics, Molecular Biology
11
Scopus Publications
Scopus Publications
MODULATION OF MESALAMINE RELEASE FROM ENTERIC-COATED MATRIX TABLETS USING NATURAL POLYSACCHARIDES FOR LOCALIZED COLONIC DELIVERY Shilpa Sahu, Prasanta Kumar Choudhury, Gourishyam Pasa, Padala Narasimha Murthy, Poonam Sahu, Renuka Verma Journal of Applied Pharmaceutical Research, 2024 Background: Inflammatory bowel diseases (IBD) require effective colon-targeted drug delivery for improved therapeutic efficacy and minimized systemic side effects. Objectives: The objective of this research was to develop and evaluate novel colon-targeted matrix tablet formulations of mesalamine (5-aminosalicylic acid) for the treatment of IBD. Materials and Methods: Mesalamine matrix tablets were prepared by wet granulation technique using pH-sensitive polymers (HPMC K4M) and biodegradable natural polysaccharides (pectin, chitosan, and guar gum). Tablets were characterized for physicochemical properties, drug content, and in vitro drug release. Compatibility studies using FTIR and DSC confirmed no interaction between mesalamine and polymers. The optimized formulations were enteric-coated with Eudragit S100 and ethyl cellulose. Drug release kinetics and stability studies were conducted. Results and Discussion: The uncoated formulations (M3, M6, M7) showed adequate protection against drug release in simulated gastric (0-2 h) and intestinal (2-5 h) fluids. The enteric-coated formulations (ME3, ME6, ME7) exhibited a lag time of around 2 hours and restricted drug release (<5%) in simulated gastric and intestinal fluids up to 5 hours. However, in simulated colonic fluid (pH 6.8) containing 4% rat cecal contents, these formulations showed enhanced drug release (71-83% in 12 h) due to biodegradation of polymeric matrices by colonic enzymes. Drug release kinetics indicated anomalous transport or super case-II transport mechanisms. Stability studies at 40°C/75% RH for 3 months revealed no significant changes. Conclusion: The developed colon-targeted mesalamine matrix tablets demonstrated the potential to protect the drug from release in the upper GIT while facilitating targeted drug delivery to the colon, which could improve therapeutic efficacy and minimize systemic side effects in the treatment of IBD.
SYSTEMATIC APPROACH TO DEVELOP AND VALIDATE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR EFAVIRENZ AND ITS DEGRADANTS Sudhir Kumar Sahoo, Prasanta Kumar Choudhury, P N Murthy, Uma Shankar Mishra, Saroj Kanta Bisoyi, Lokesh Kumar Journal of Applied Pharmaceutical Research, 2024 Background: The crucial aspect to consider during method development and validation, ensuring accurate, precise, and specific estimation of drug substances and drug products, is stability. Various factors, including environmental, instrumental, reagent, and human factors, can pose challenges in achieving suitable method development and validation. Objective: This work aimed to develop and validate a low flow rate, LCMS compatible, simple, and rapid reverse-phase high-performance liquid chromatographic method for estimating efavirenz and its degradation products at different stress conditions. Materials and Methods: The HPLC system employed a Phenomenex Luna 5μ C18 (2) 100A (250 x 4.6 mm) column and a mobile phase of methanol: 20 millimolar ammonium formate solution (90:10) adjusted to pH 4 with formic acid. All analytes were separated within 15 minutes and detected at 247 nm. Method validation was carried out according to ICH guidelines, including linearity, accuracy, precision, ruggedness, robustness, LOD, and LOQ. Results and Discussion: The method was linear in the 10-90 μg/ml range, with a regression coefficient 0.999. Intra- and inter-day precisions, ruggedness, and robustness were within acceptable limits (≤2% RSD) with LOD and LOQ of 0.35 and 1.16 μg/ml, respectively. Degradation study indicates well resolution of the drug and degradants. Conclusion: Purposeful degradation of efavirenz resulted in different degradation products under various stress conditions, and the method demonstrated satisfactory resolution from its degradants.
Formulation design and development of enteric coated matrix tablets of Ornidazole for colonic delivery Asian Journal of Pharmaceutical and Clinical Research, 2012
Spectrophotometric method development and determination of ornidazole in bulk and tablet dosage form International Journal of Pharmtech Research, 2011
Studies on dissolution behaviour of sustained release solid dispersions of Nimodipine International Journal of Pharmaceutical Sciences Review and Research, 2010
Synthesis of some Mannich base cyclohexanone derivatives and their pharmacological activities Research Journal of Pharmaceutical Biological and Chemical Sciences, 2010
Comparative in vitro antimicrobial activity studies of Sida rhombifolia Linn fruit extracts International Journal of Pharmtech Research, 2010
Nanoparticles as non-viral gene delivery vectors Indian Journal of Pharmaceutical Education and Research, 2010
Formulation design and optimization of an enteric coated sustained release mucoadhesive tablet of metronidazole International Journal of Pharmtech Research, 2010
Antibacterial and analgesic effects of the stem barks of calophyllum inophyllum International Journal of Chemtech Research, 2010
Design, development and evaluation of frusemide loaded micropellets prepared by ionotropic gelation method International Journal of Pharmtech Research, 2010