Development and Evaluation of Taste Masked Immediate Release Dosage Forms of Lornoxicam
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Abstract
Lornoxicam (LXM) is a NSAID with better-tolerated alternative for the management of
newlinemoderate to severe pain. It is having half life of 3-5 hours and shows complete absorption
newlinefrom GIT. The conventional formulations of LXM exhibits slow onset of action. This
newlineprovokes a strong need to formulate immediate release dosage forms of LXM which shows
newlinefaster disintegration or dissolution of drug in oral cavity or gastrointestinal tract.
newlineIn present investigation, different immediate release dosage forms of LXM like fast
newlinedisintegrating tablet (FDT), fast dissolving film (FDF), medicated chewing gum (MCG) and
newlineoral soft gel (OSG) were developed in view to improve drug release. Lornoxicam is in bitter
newlinetaste and as this dosage forms are used in mouth cavity, taste masking was found very
newlineessential.
newlineFDT was selected as one of the approach for immediate release of LXM. Eudragit EPO was
newlineselected as taste masking polymer and LXM:Eudragit EPO mixture was prepared by mass
newlineextrusion technique. Preliminary trials indicated LXM:Eudragit EPO in a ratio of 1: 3 as
newlineoptimized and thus, used further for development of FDT. Central composite design was
newlineused to optimize the concentration of Ac-di-sol (Superdisintegrant) and pharmaburst 500
newline(coprocessed excipient). All the prepared tablets were optimized and evaluated for different
newlineparameters and drug release was compared. FDT containing 4% w/w Ac-di-sol and 80% w/w
newlinepharmaburst 500 shown faster disintegration time of 8 seconds and 92% drug release in 20
newlineminutes.
newlineResearch shown high patient compliance for FDF and thus chosen as another approach, As
newlineEudragit EPO masked taste of LXM, it was also used for taste masking of LXM in film.
newlineHowever, film properties were not satisfactory. Thus, ion exchange resin was used, But this
newlinealso shown poor film properties. Thus, inclusion complexation using beta cyclodextrin was
newlineused. Inclusion complexation was done by kneading method using water as solvent for
newlinekneading and kneading time and molar ratio of drug to beta cyclodextrin was optimized. 32
newlinefactori