Sowjanya Vadrevu

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.

The Developed RP- HPLC method allows rapid and precise determinations of Cefixime  and Paracetamol. The scope of the present work is to expand and optimization of the chromatographic conditions and to develop RP-HPLC method. A series of mobile phases and columns were tried, among the various mobile phases, Buffer: Acetonitrile (65:35A) (PH-3.5) as an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at 1 ml/min. The Linearity and correlation coefficient of Cefixime and Paracetamol was found to be 0.999, and 0.999 respectively. Precision was performed and % RSD for Cefixime and Paracetamol were found to be 1.17% and 1.32% respectively. Three concentrations 50%, 100%, 150%, were injected in a triplicate manner and amount recovered and % Recovery was found to be 100%. Limit of detection was calculated by standard deviation method Cefixime and Paracetamol and LOD for Cefixime and Paracetamol were found to be 0.03and 0.02 respectively. Limit of Quantification was calculated by standard deviation method Cefixime and Paracetamol and LOQ for Cefixime and Paracetamol were found to be 0.08 and 0.06 respectively. Small deliberate changes in method like flow rate, mobile phase ratio, and temperature are made but there were no recognized change in the result and are within range as per ICH Guide lines. The average % Assay was calculated and found to be 100.46% and 99.84% for Cefixime and Paracetamol respectively. Hence, the chromatographic method developed for Cefixime and paracetamol is said to be rapid, simple, specific, sensitive, precise, accurate and reliable that can be effectively applied for routine analysis in research institutions, quality control department in Industries, approved testing laboratories, Bio-pharmaceutics and Bio-equivalence studies and in clinical pharmacokinetic studies.