Molecular properties of propranolol hydrochloride prepared as drug-resin complexes.

Drug-resin complexes, as well as physical dispersions, containing varying contents of propranolol were prepared. The molecular properties of samples were investigated by differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), and infrared (IR) spectroscopy. In addition, the USP paddle method was used to determine the release behavior of drug from various formulations prepared from the samples. The data from DSC and XRPD indicated that the molecular state of drug in the complexes was amorphous, whereas that in the physical dispersions exhibited the crystalline state of pure drug. These results suggested that the molecule of drug prepared as drug-resin complexes was monomolecularly dispersed in the resin bead. The IR study provided evidence that demonstrated the interaction between the drug and resin in the complexes. The release behavior of drug from the complexes was governed by the cross-linkage structure and equilibrium treatment of drug exchange of resin.