Assessment of possible incompatibilities between an active drug substance and different excipients forms an important part of the pre-formulation stage during the development of solid dosage form. Therefore FTIR spectra of the drug and the polymer-drug mixture were recorded on Thermo Nicolet FTIR 330, spectrometer using a thin film supported on KBr pellets in order to find out the physico–chemical interactions

between the polymer and drug-polymer mixture.9 Before compressing into the tablets the tablet blend was evaluated for its rheological properties like angle of repose (Ѳ), bulk density (B.D), tapped density (T.D), Carr’s index (C.I) and Hausner’s ratio (H.R).10 The tablet ingredients were weighed accurately as mentioned in Table 1. The above ingredients were then passed Obeticholic Acid datasheet through a 20-mesh sieve and properly mixed. Finally the blends were mixed for 5 min after the addition of magnesium-stearate

and talc. The blends were compressed using a 16 station rotary punch tablet machine (Cadmach, Germany) having caplet shaped concave punches. Hydrogel tablets were evaluated for drug content uniformity, weight variation, friability, thickness and hardness according to the specifications of British pharmacopoeia. Drug content was analyzed using Shimadzu UV–Visible spectrophotometer (1700) at 271 nm and the % of the drug content was estimated.11 The swelling index for the formulation 5 was calculated by placing the weighed tablets in the medium (900 mL of 0.1 N HCl) at 37 ± 0.5 °C. Periodically MDV3100 concentration the tablets were removed from the medium and were re-weighed. Percentage swelling of the tablet was stated as percentage water uptake.12 WaterUptake%=Weightofswollentablet−InitialweightofthetabletInitialweightofthetablet×100 The release of CP from hydrogel matrix tablets was carried out using a USP apparatus II (Electrolab Disso 8000) in 900 mL of 0.1N HCl at 75 rpm maintained at 37 °C ± 0.5°. Samples of 5 ml were taken

at regular 1 h time intervals and the absorbance was measured at 271 nm with UV–Visible Calpain spectrophotometer of JASCO V 670. The sink condition was maintained by replacing with fresh buffer medium. The dissolution study was carried out for 24 h. For all the pharmaceutical dosage forms it is important to determine the stability of the dosage form. The stability studies were carried out for the most satisfactory formulation as per the ICH guidelines to estimate the stability of the prepared drug dosage formulation. The formulation sealed in aluminum package and kept in humidity chamber maintained at 40 ± 2 °C, 75 ± 5% RH and at 30 ± 2 °C, 65 ± 5% for 3 months. At the end of studies in-vitro drug release and post compression parameters were evaluated to the samples. 13 Drug-polymer interaction study was carried out for pure drug, sodium alginate, Carbopol, NaHCO3 and physical mixture of pure drug and polymers.