ABSTRACT
Objective: The objective of this study was to formulate orodispersible tablets containing empagliflozin by direct compression method with sufficient hardness and rapid disintegration time and to study the effect of functionality differences of super-disintegrants on the tablet properties. Methods: A two factor three level factorial design (32) was used for the formulation optimization of orodispersible tablets of Empagliflozin and experimental trials were performed on all possible formulations, in which the amount of β-cyclodextrin, crospovidone and croscarmellose sodium were selected as independent variables (factor) varied at three different levels: low (-1), medium (0), and high (+1) levels. The drug release and disintegration time were used as dependent variables (response). All formulations were characterized for parameters such as diameter, hardness, weight, thickness, friability, disintegration time, drug release. Results: Formulation FD6 having 30 sec disintegration time, 98.84% drug release after 30 min, 2.8 kg/cm2 hardness and 0.292% friability was found best among all formulations and selected as an optimized formulation with rapid onset of action and enhanced bioavailability (more than 98% drug release within 30 min.) as compared to the oral empagliflozin tablet. Conclusion: Empagliflozin orodispersible tablets with different superdisintegrants were successfully prepared and formulation containing highest percentage of crospovidone was found best among all other formulations in terms of bioavailability and rapid onset of action.
ABSTRACT
In the present work, orodispersible tablets of Alfuzosin Hcl were prepared by direct compression and sublimation methods with a view to enhance patient compliance. In these methods, varying concentrations of crospovidone, sodium starch glycolate and croscarmellose sodium of 3.3, 6.6 and 10% w/w were used, along with camphor used as subliming agent in sublimation method. The prepared batches of tablets were evaluated for hardness, friability, drug content, wetting time, dispersion time, disintegration time and dissolution studies. Based on disintegration time (approximately 13-18 seconds) all the promising formulations (from each method) were tested for in-vitro drug release pattern (in pH 6.8 phosphate buffer), drug-excipient interaction (FTIR spectroscopy) and short term stability studies. Among the promising formulations, the formulation F4 and F14 containing 10% w/w Crospovidone emerged as the overall best formulation (t50%1.79 and 1.21 minutes) based on drug release characteristic (in pH 6.8 phosphate buffer) compared to controlled formulation F1 (t50% >10 minutes).
ABSTRACT
Orodispersible tablets are those that dissolve or disintegrate quickly in the oral cavity, resulting in solution or suspension. Allergic rhinitis is a high-prevalence chronic respiratory disease with a negative impact on the subject’s quality of life, work activities, productivity or school performance as well as on healthcare costs. Because of its benign nature, the importance of this condition is often underestimated. In the present study orodispersible tablet of antihistaminic agent was prepared by direct compression method using crosspovidone, Crosscarmellose and Indion 414, as superdisintegrants. FT-IR study shows that there is no significant interactions occur between drug and excipient. The tablets prepared were evaluated for various parameters like various density parameters, thickness, hardness, friability, disintegration time, wetting time and In-vitro dissolution time. All the parameters were found to be within limits. The developed formulation of levocetirizine batch F8 (10% Indion 414) showed good palatability and dispersed within 30 seconds as compare to crosscarmellose sodium and crosspovidone. When the results were compared with that of convectional tablets was found to be better with respect to simple manufacturing and allergic rhinitis.