Development and Evaluation of Baclofen Orodispersible Tablets by Sublimation Method

Purpose: Baclofen (BCF) is a novel muscle relaxant and antispasmodic drug that belongs to the BCS-III drug class, having low solubility and high permeability used for treating multiple sclerosis symptoms such as spasticity, stiffness, and pain. The aim of the present work is an attempt to develop orodispersible tablets of BCF by using camphor, menthol as sublimating agents and crospovidone, sodium starch glycolate as superdisintegrants. Methods: The tablets were prepared by direct compression technique. The FTIR and DSC were used to investigate the drug excipients compatibility. The prepared tablets were subject to investigating thickness, hardness, weight variation, friability, drug content uniformity, swelling index, disintegration time and In-vitro drug release studies. Results: The FTIR and DSC studies suggest that there is no interaction between the drug and excipients. All the pre-compressed parameters were shown in acceptable limits. The formulated batch (F6) tablets containing crospovidone (12%) and camphor (30%), showing rapid disintegration <18 sec and In-vitro drug release was achieving the highest release of 98.94%w/w at the end of 15 min, followed by Korsmeyer and Peppa’s model, shows diffusion co-efficient n = 0.7606, which indicates the drug release from tablets by the non-Fickian diffusion mechanism. Conclusion: The concentration of sublimating agent in the formulation creates highly porous tablets that significantly increase disintegration and promote faster drug release. Investigation of the research work was concluded that the addition of superdisintegrants and sublimating agents in the formulation of orodispersible tablets by direct compression is a novel technique to speed up drug release and improve patient compliance. Keywords: Baclofen Orodispesiable Tablets, Sublimation Method, Crospovidone, Peppas model, Non- Fickain diffusion.