Formulation and evaluation of taste masked oral disintegrating tablet of cefixime based on cyclodextrin binary systems

INTRODUCTION: Formulation of orally disintegrating tablets (ODTs) has enormously increased as it is in continuous demand and it has significant impact on the patient compliance. Orally disintegrating tablets offer an advantage for populations who have difficulty in swallowing. ODT s is not only specific with pediatric and geriatric population but also with institutionalized patients and patients with nausea, vomiting and motion sickness complications. ODTs with good taste and flavor increase the acceptability of bitter drugs by various groups of population. Due to several reasons and undesirable taste, most of the pharmaceuticals are administered orally but bitter taste is one of the formulation problem encountered with such oral products 2, . Taste of pharmaceutical product is important parameter in governing the patient compliance. Thus taste masking of oral pharmaceutical formulations has become important tool to improve patient compliance and especially the quality of treatment 4, . β-cyclodextrin is most widely used complexing agent for inclusion type complexes. Cyclodextrins (CD) are cyclic oligosaccharides with a hydrophilic outer surface and a lipophilic central cavity. On account of their relatively hydrophobic interiors, CDs have the ability to form inclusion complexes with a wide range of substrates . This complex-forming ability of CD has been widely exploited in the pharmaceutical field for various applications, including taste-masking of bitter drug . The use of CD as a taste-masking agent has been widely reported 8, . It is sweet, nontoxic, cyclic oligosaccharide obtained from starch. The suppression of bitter taste by cyclodextrin was in increasing order of alpha, gamma and beta cyclodextrin stable complex. The complexing agent is capable of masking the bitter taste of the drug by either decreasing its oral solubility on ingestion or decreasing the amount of drug particles exposed to taste buds thereby reducing the perception of bitter taste . Cefixime Figure 1 is used to treat infections caused by bacteria such as pneumonia, bronchitis, gonorrhoea, and ear, lung, throat, and urinary tract infections. Cefixime has bitter taste so; an attempt has been made to mask the bitter taste of the drug by complexation with β-cyclodextrin . The purpose of the present study was to formulate and evaluate taste masked oral disintegrating tablets of Cefixime to increase the palatability and bioavailability of the drug. In the present work, an attempt was made to mask the taste by complexation technique, Taste improvement of drug by β-Cyclodextrin was done by simple complexation approach using physical and kneading methods with various ratios. Taste perception study was carried and the optimized taste masking ratio 1:3of kneading mixture was selected based on bitterness score and characterized by Fourier transform infrared spectroscopy (FTIR) to identify the physicochemical interaction between drug and carrier and its effect on dissolution. In-vitro drug release studies for the prepared solid dispersions were performed in phosphate buffer pH 7.2 buffer. 1:3 kneading system showed better results when compared to the dispersions prepared by other methods. Tablets were prepared by direct compression technique using super disintegrants like sodium starch glycolate, crospovidone and croscarmellose sodium. Prepared tablets were evaluated for different properties like drug content, hardness, friability, disintegration time and in vitro dissolution study. The different formulations showed disintegration time between 30 to 56s. Among all the formulations, C6 showed 99 % drug release within 20 min. Thus, C6 was considered best among the other formulations.