Abstract
The influence of excipients on the disintegration times of tablets and the release of papaverine hydrochloride (PAP) from tablets were studied. Ten different formulations of tablets with PAP were prepared by direct powder compression. Different binders, disintegrants, fillers, and lubricants were used as excipients. The release of PAP was carried out in the paddle apparatus using 0.1 N HCl as a dissolution medium. The results of the disintegration times of tablets showed that six formulations can be classified as fast dissolving tablets (FDT). FDT formulations contained Avicel PH 101, Avicel PH 102, mannitol, (3-lactose, PVP K 10, gelatinized starch (CPharmGel), Prosolv Easy Tab, Prosolv SMCC 90, magnesium stearate, and the addition of disintegrants such as AcDiSol and Kollidon CL. Drug release kinetics were estimated by the zero- and first-order, Higuchi release rate, and Korsmeyer-Peppas models. Two formulations of the tablets containing PVP (K10) (10%), CPharmGel (10% and 25%), and Prosolv Easy Tab (44% and 60%) without the addition of a disintegrant were well-fitted to the kinetics models such as the Higuchi and zero-order, which are suitable for controlled- or sustained-release.
Highlights
The successful formulation of a stable, effective dosage form and bioavailability of the active substances depend on the selection of the excipients
Available blends of Microcrystalline cellulose (MCC) with colloidal silicon dioxide ensure better flowability and compressibility compared with Emcocel and Avicel PH 101 or a physical mixture of MCC with colloidal silicon dioxide [5]
The two formulations T7 and T10 had excessively long disintegration times which amounted to 34.4 min and 25.43 min, respectively
Summary
The successful formulation of a stable, effective dosage form and bioavailability of the active substances depend on the selection of the excipients. The Higuchi model describes drug release through the diffusion mechanism and it is used to describe drug dissolution from systems such as matrix tablets containing water-soluble drugs. Different formulations of tablets were employed and dissolution tests of papaverine hydrochloride were carried out to investigate the kinetics of the active substance release.
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