Quality by Design-Based Formulation and Evaluation of Gastroretentive Floating Tablets of Tramadol Hydrochloride

Objectives

The current research is aimed to design and development of a Floating Drug Delivery System (FDDS) for tramadol HCl by enhancing the gastric residence time and by releasing the drug at the targeted site.

Materials and Methods

The formulations were developed by using xanthan gum, HPMC K100M CR, and a combination of both the drug and excipient compatibility study was determined by IR and DSC studies. Quality by Design (QbD) approach was implemented to optimize floating formulations, which were evaluated for the pattern of drug release, floating properties, and dissolution data.

Results

The formulation F8, which consists of HPMC K100M CR and xanthan gum (15% + 10% of tablet weight), was identified as the optimal formulation based on improved sustained release of over 90%, buoyancy lag time of 10 sec and a total buoyancy time of 24 hr. Accelerated stability studies were conducted at 40 ± 2℃ for 30 days on the optimized formulations, and it was observed that there were no significant changes during or after the period.

Conclusion

Optimized floating tablets of tramadol HCl showed a buoyancy time of over 24 hr, and a rapid floating action was observed. The drug release followed non-Fickian diffusion (n = 0.605).