Formulation and Evaluation of Lornoxicam Fast dissolving tablets

ABSTRACT

Lornoxicam, is a widely prescribed Non-steroidal anti-inflammatory drug belongs to class II under BCS classification and exhibit low and variable oral bioavailability due to its poor aqueous solubility. It needs enhancement in the dissolution rate in its formulation development.  The main objective was to formulate and evaluate Lornoxicam FDT by incorporating the Lornoxicam solid dispersion to enhance dissolution rate and solubility rate with the aid of novel polymers by adopting design of experiment CCD software technology. Nine SD formulations prepared with varying concentrations of PEG 4000, Labrasol, Soluplus, Kolliphor EL, Kolliwax GMS II, HPMC, Colloidal Silicone dioxide (Aerosil 200), and PVPK25 in three different drugs : polymer : surfactant (SLS) ratios of1:1:1,1:2:1 and 1:3:1 by solvent evaporation method and were evaluated for drug content,% practical yield and dissolution rate and solubility studies. The solubility study indicates that formulation (SD9) containing drug: Soluplus (1:3) and SLS has superior solubility of 0.68±0.10µg/ml, which is 75-fold higher than pure drug. The formulations SD9 maximum percentage yield and drug content. The optimized Lornoxicam solid dispersion (SD9) was further used to prepare FDT by direct compression method using 3³ Response surface method (3variables and 3 levels of super disintegrants) by using Design of experiments of tware with super disintegrants like locust bean gum, gum karaya, plantago ovate and diluents such as mannitol, Avicel PH101 and aspartame as sweating agent and aerosol as anti adherent. Total 27 Lornoxicam FDTs formulated using natural super disintegrants locust bean gum, gum karaya, plantago ovate mucilage with varying concentrations by design of experiment tool. All the formulations evaluated for various parameters such as compatibility studies, drug content, weight variation, hardness, thickness, friability, disintegration time, in vitro drug release studies. The formulation LF24 showed highest drug release of 99.21±1.87 % at 10mins. LF24 was found to be optimized formulation which contains different concentrations of locust bean gum, gum karaya, plantago ovate mucilage the results were analysed by ANOVA and FTIR studies which shows no interaction between the ingredients. The % CDR of Lornoxicam FDT (LF24) was much higher than that of Lornoxicam marketed formulation. Thus, Lornoxicam FDTs using natural super disintegrants like locust bean gum, gum karaya, plantago ovate mucilage were suitable combinations for formulating Lornoxicam FDTs.

Keywords: Lornoxicam fast dissolving tablets, central composite design(CCD), Locust bean gum, gum karaya, plantago ovate mucilage super disintegrants, mannitol, AvicelPH101 aspartame, FTIR studies.