Abstract
FORMULATION AND EVALUATION OF SUBLINGUAL TABLETS OF LOFEXIDINE HYDROCHLORIDE

Ravi Parmar*, Jaini Patel and Tora Shah

ABSTRACT

In the present research work, sublingual tablets of Lofexidine were developed and evaluated analytically by FTIR Spectra for drug absorption and bioavailability. Lofexidine was chosen as a model drug because its water solubility is good and belongs to BCS class I. The peak plasma concentration occurs after 2-5 hours of oral administration and sublingual formulation has not been developed yet. Pre-formulation studies were carried out to optimize the required quantity for polymers and excipients. Fourier transform Infrared spectroscopy confirmed the absence of any drug/polymers/excipient’s interactions. A total of nine batches of sublingual of Lofexidine were prepared by direct compression technique, using polymers such as SSG, Cross povidone, cross carmellose sodium in different combinations with other standard excipients like Sucralose, Starcap 1500, Aerosil 200 and citric acid. Tablets were evaluated for physical parameters viz. hardness, friability, thickness, weight variation and stability studies. Further, tablets were evaluated in-vitro for drug release. All results were found to be in acceptance criteria; hence it was concluded that sublingual tablet of Lofexidine can be formed as marketed formulation also.

Keywords: Lofexidine, SSG, HPMC, Crospovidone, Croscarmellose sodium, Sucralose, Sublingual tablet.


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