[Applications of synthetic and semisynthetic polymers (Kollidon K25, Kollidon K90 and Hydroksyethylocellulose) as carriers of ketoprofen in solid oral prolonged release dosage forms. The impact of selected non-ionic surfactants (Tween 80 and Rofam 70) on the release kinetics].

Abstract

BACKGROUND Hydrophilic matrices used as oral forms of sustained release drugs are a suitable application medium for short-acting nonsteroidal anti-inflammatory drugs (NSAID) - ketoprofen. A properly selected hydrophilic matrix in oral preparations may significantly increase efficacy and application safety of ketoprofen. OBJECTIVES The aim of the research was to analyze the usefulness of polymers (synthetic Kollidon K25 and K90, semi-synthetic hydroxyethylcellulose) and calcium hydrogen phosphate dihydrate (as an inorganic filler) in manufacturing solid oral matrix forms of ketoprofen and to study of the effect of non-ionic surfactants (Tween 80, Rofam 70) on release kinetics. MATERIAL AND METHODS Ketoprofen, HEC, Kollidon K25, and K90, calcium hydrogen phosphate, magnesium stearate. Incorporation. Studies on the tablet mass. Direct tableting. Studies on the pharmacopoeial parameters and pharmaceutical availability. Approximation of the results. RESULTS The results of the granulometric studies on tablet mass were in accordance with pharmacopoeial standards. The results of morphological and biopharmaceutical studies of the obtained matrices (tablets) were consistent with the pharmacopoeial standards for formulations with HEC, K25 and K90. The release results most closely related to row 0 kinetics were obtained for the matrix containing HEC and K25. Tween 80 added to 0.1N HCl accelerated the release of ketoprofen, while Rofam 70 decelerated it. Tween 80 and Rofam 70 added to the pH 7.4 buffer accelerated the release of ketoprofen. CONCLUSIONS The presented model system of preformulation studies showed the usefulness of HEC and Kolidon K25 in the technology of hydrophilic matrices with ketoprofen. Surfactants added to the medium do not affect the release rate of ketoprofen.