Stabilization of low glass transition temperature indomethacin formulations: impact of polymer-type and its concentration.

The objectives of this study were to formulate and stabilize amorphous formulation of low T(g) drug (Indomethacin, INM) with selected polymers and compare these formulations based on solubility and dissolution rate studies. Eudragit EPO (EPO), Polyvinylpyrrolidone-vinyl acetate copolymer (PVP-VA), and Polyvinylpyrrolidone K30 (PVPK30) were selected as hydrophilic polymers. The melt extrudates were characterized using differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), intrinsic dissolution rate and solubility studies.

Improving the dissolution rate of poorly water soluble drug by solid dispersion and solid solution: pros and cons.

The solid dispersions with poloxamer 188 (P188) and solid solutions with polyvinylpyrrolidone K30 (PVPK30) were evaluated and compared in an effort to improve aqueous solubility and bioavailability of a model hydrophobic drug. All preparations were characterized by differential scanning calorimetry, powder X-ray diffraction, intrinsic dissolution rates, and contact angle measurements. Accelerated stability studies also were conducted to determine the effects of aging on the stability of various formulations.

Characterization of physico-mechanical properties of indomethacin and polymers to assess their suitability for hot-melt extrusion processs as a means to manufacture solid dispersion/solution.

The objective of the study was to characterize the physical and viscoelastic properties of binary mixtures of drug and selected polymers to assess their suitability for use in the hot-melt extrusion (HME) process as a means to improve solubility by manufacturing either solid dispersion or solid solution. Indomethacin (INM) was selected as a model drug. Based on comparable solubility parameters, the selected polymers were Eudragit EPO (EPO), polyvinylpyrrolidone/vinyl acetate copolymer (PVP-VA), polyvinylpyrrolidone K30 (PVPK30), and poloxamer 188 (P188).