MECHANISTIC MODELS IN THE ASSESSMENT OF DROTAVERINE HYDROCHLORIDE SOLUBILITY AFTER TABLET DISINTEGRATION IN THE PRESENCE OF SELECTED EXCIPIENTS IN PHARMACOPOEIAL ACCEPTOR FLUID

Research studies have been carried out on the possibility of producing a solid dosage form with drotaverine hydrochloride by direct compression technique with the use of individual excipients such as: Vivapur, Prosolv 90 HD, Emdex, Emcompress, lactose and Pearlitol 200 SD. Granulometric parameters of tablet mass, model dosage forms as well as a reference form were analyzed. The determined pharmaceutical availability in the form of a Q% coefficient was in the time function (t, mitt) an inspiration for estimating the rate of dissolution of the therapeutic agent in the presence of an excipient and for assessing the impact of the grain structure and surface in the environment of 0.1 M of HCl on the process of its sorption. Kinetic equations of "0" and "I" order and Higuchi, Korsmeyer-Peppas and Hixson-Crowell models, based on the thesis that the process of dissolution (release) is consistent with Fick's law, were used to describe the process of dissolution of drotaverine hydrochloride in 0.1 M HCl. It results from the analysis of approximation equations, both in the kinetic and mechanistic model (Higuchi, Korsmeyer-Peppas. Hixson-Crowell models). that symmetrically to the dissolution process there conies to adsorption of the therapeutic agent by granulometric grains which points to its deficit in the acceptor fluid (Freundlich adsorption isotherm).Formulation with Prosolv 90HD is characterized by a profile of the rate of dissolution of drotaverine hydrochloride that is compatible with a reference form. Granulometric combination of lactose with Vivapur 101 is also worthy of note front the application point of view.