45 μ filter (Millipore, India). After appropriate
dilution the samples were analysed and cumulative percentages of the drug released was calculated. The mean values GDC-0199 nmr of six tablets from three different batches were used in the data analysis. The FT-IR spectra acquired were taken from dried samples. An FT-IR (Thermo Nicolet 670 spectrometer, UK) was used for the analysis in the frequency range between 4000 and 400 cm−1 with a 4 cm−1 resolution. The results were the means of six determinations. A quantity equivalent to 2 mg of pure drug from matrix tablets was selected for the study. Differential scanning calorimetry (DSC) of matrix tablets was performed using a Diamond DSC (Mettler Star SW 8.10, Switzerland) to determine the drug excipient compatibility studies. Selleck ALK inhibitor The analysis was performed at a rate 5 °C min−1 from 50 to 200 °C range under nitrogen flow of 25 ml min−1. Selected formulations (F-3 and F-5) from prepared matrix
tablets were filled in high density polyethylene (HDPE) containers, capped and stored at 40 ± 2 °C and 75 ± 5% RH for three months as per ICH guidelines. The samples were characterized for percentage of drug content, FTIR and DSC studies for the possible degradation of LAMI. In vivo study of LAMI XR matrix tablets was performed in healthy rabbits (New Zealand, white) of either sex weighing 2.8–3.2 kg were divided into two groups each consisting of six animals. The first group received conventional tablets of LAMI (100 mg) by oral administration. 26 and 27 The second group received the F-3 matrix tablets (half tablet equivalent to 100 mg Calpain of LAMI). The conventional tablets and formulation F-3 were labelled as R and T respectively. The tablets were put behind the tongue to avoid their destruction due to biting. All rabbits had free access to water throughout the study. The Institutional
Animal Ethical Committee approved the protocol for this study (protocol number, NCOP/IAEC/2008-09/02). The estimation of LAMI from plasma samples was performed using the analytical method developed by Kano et al. 28 Analyses were performed on a liquid chromatographic system (Shimadzu Scientific Instruments, Kyoto, Japan) composed of an LC-10AT pump, an SPD-10A UV detector and an ODS C-18 column (94.6 mm ID × 25 cm length) with oven using 25 μl Hamilton injection syringe. Stavudine was used as an internal standard in the HPLC analysis. Matrix tablets of LAMI were successfully compressed with 9 mm flat faced round punch. The tablets were examined for various physical properties. No sticking was observed during the compression process which indicated the uniform lubrication of the blends. Significant flow of powder was observed during the compression by the use of the directly compressible excipients. The thickness and hardness were found in the range of 3.53 ± 0.04 to 3.60 ± 0.05 mm and 6.0 ± 0.4 to 7.0 ± 0.1 kg/cm2 respectively.