Thermoplastic Granulation Approach to Retard Drug Release from Floating Tablets of Pregabalin

The present work deals with the formulation and evaluation of floating tablets of Pregabalin using Thermoplastic granulation or Melt granulation technology1. Thermoplastic granulation is a process by which granules are obtained through the addition of a meltable binder which melts during the process. This technology is used to modify or control drug release of highly water soluble drugs using hydrophobic meltable binders as done in this present work. Pregabalin is a primary medication for epilepsy, neuropathic pain, and fibromyalgia was selected for this work. The primary objective was to formulate and evaluate floating tablets of the Pregabalin by using different meltable binders like stearic acid, bees wax, carnauba wax along with other excipients such as HPMC K4M (3000cps), ethyl cellulose, sodium bicarbonate in various proportions by employing thermoplastic granulation method Pregabalin has absorption window in the upper region of small intestine hence it is suitable candidate for floating systems. FTIR spectroscopic studies suggested that the drug is compatible with all excipients used in this formulation. The formulations were evaluated for the pre-compressional and post-compressional parameters. The floating tablets were evaluated for the floating ability and also percentage drug release by using 0.1 N HCl as dissolution medium. The formulation F10 with stearic acid as the meltable binder along with ethyl cellulose had floating ability of not less than 12 hours with a good drug release profile. The optimized formulation followed Higuchi mechanism which shows both diffusion and erosion.