To Assess the Influence of Hydrophilic Polymers on the Performance of Effervescent Floating Tablets of Tinidazole using 32 Full Factorial Design

Abstract

Aim: The current research was carried out to assess the influencing properties of hydrophilic polymers such as
hydroxypropyl methylcellulose (HPMC) K4M and HPMC K15M on the performance parameters of effervescent
floating tablets (EFT) of tinidazole such as floating lag time (FLT), total floating time (TFT), swelling index
(SI) in HCl, and time taken to release 80% of the drug by applying 32full factorial design to improve the gastric
residence time of the drug in the gastrointestinal tract. Method: The independent variables selected were the
amount of HPMC K4M (X1) and HPMC K15M (X2) and the responses studied were FLT (Y1), TFT (Y2), Swelling
Index (SI) in 0.1N HCl (Y3), and time taken to release 80% of drug (t80%) (Y4) by plotting response surface graphs
and contour plots. Results: The FLT of prepared batches was in the range from 16 ± 0.02 to 45 ± 0.03 sec. and the
minimum FLT was shown by OB-1 (16 sec.) batch. The TFT of all batches showed buoyancy and intactness for
12 h. The swelling in 0.1N HCl at 8 h ranged between 48.20 ± 0.02 and 54.33 ± 0.02. In vitro, drug release studies
demonstrated that more than 95% of the drug was released in 12 h, whereas OB-2 took 10 h to release 80% of the
drug. The response surface graphs and contour plots showed the effect of variables on responses such as FLT (Y1)
which was found to be positively influenced by X2, and analysis of variance (ANOVA) for the response surface
quadratic model for FLT was found to be significant (P < 0.0004). The TFT (Y2) was found to be influenced by X1
and ANOVA for the response surface quadratic model for TFT was found to be significant (P < 0.0001) whereas
SI (Y3) was found to be influenced by X2 and ANOVA for response surface quadratic model for the SI was found
to be significant (P < 0.0001) and time taken for 80% of drug release (t80%) (Y4) was found to be influenced by X2
and ANOVA for response surface quadratic model for the time taken to 80% drug release (t80%) was found to be
significant (P < 0.0006). Conclusion: Both variables influenced the performance parameters, and HPMC K15M
(X2) was more predominant in the overall performance of EFT. From all the batches, the OB-2 batch possesses
ideal performance parameters and hence can be further taken for conducting in vivo studies.