Formulation Development and Evaluation of Oral Sustained Release Suspension containing Antidiarrheal Drug

Abstract

The research scheme aim at formulation development and evaluation of oral sustained release suspension containing antidiarrheal drug, combination of racecadotril and ofloxacin and the objective to incorporate the fix dose combination of drug in the sustained release to check the suitability of product. To reduce the dosing, frequency and improve the patient compliance particularly in pediatric class to minimize the toxicity due to overdose which often in conventional dosage form. Chewable tablet are not ideal with pediatric and geriatric patient due to need of chewing sustained release suspension will certainly helpful for this patient anti - diarrheal treatment ideally should be effective in combination. The step - by-step studies were performed to develop a stable and acceptable formulation of sustained release oral suspension. Ofloxacin, resin- indion 254, racecadotril, polymer Eudragit EPO were studied for compatibility and interaction study, carried out by FTIR and DSC. Drug, polymer and resin was found to be compatible to each other, therefore selected for further study. Two complexes of each drug were prepared with different objectives and materials. Ofloxacin-Indion complex was prepared for the sustain release action and by batch process in different ratios as 1:1, 1:2, 1:3. Prepared complexes were evaluated for pH and % drug content. Highest drug content of 88.45% was found in 1:3 complex and hence selected for further studies. Rcecadotril-Eudragit EPO polymer complex was prepared for immediate action by kneading method in ratio of 1:1, 1:2, 1:3, were also evaluated for pH and drug content. In case of 1:3 complex 98.45% drug content was found and hence it was chosen for further studies. Sensory in vivo taste was performed to detect the bitterness conc. of drug and complex. The in vivo taste was supported with in vitro drug release study. The result of both studies indicate the satisfactory masking of bitter taste of racecadotril.