STUDYING OF THE TECHNOLOGICAL AND BIOPHARMACEUTICAL CHARACTERISTICS OF EXPERIMENTAL SAMPLES OF IBUPROFEN ORAL GEL WITH PROLONGED RELEASE

Issue: 
1
Year: 
2017

E.O. Bakhrushina
Post-graduate Student, Department of Pharmaceutical Technology, I.M. Sechenov First Moscow State Medical University
E-mail: bachrauschenh@mail.ru
M.N. Anurova
Ph.D.(Pharm.), Associate Professor, Department of Pharmaceutical Technology,
I.M. Sechenov First Moscow State Medical University
N.B. Diomina
Dr.Sc. (Pharm.), Professor, Department of Pharmaceutical Technology, I.M. Sechenov First Moscow State Medical University
I.I. Krasnuk
Dr.Sc. (Pharm.), Professor, Head of Department of Pharmaceutical Technology,
I.M. Sechenov First Moscow State Medical University

This article consecrates experiment to study the technological and biopharmaceutical characteristics of the experimental samples of oral sustained-release ibuprofen gel. The Russian pharmaceutical market drugs ibuprofen are presented in the form of solid, liquid and viscous-plastic formulations. As of the 2016 range of drugs ibuprofen has 86 titles in 12 dosage forms. Development of a new dosage form of ibuprofen - oral sustained release gel, combining advantages of solid and liquid dosage forms, will reduce the dosing frequency of the drug, reduce the incidence of side effects, improve treatment compliance. The aim of this work was the development of composition and technology of oral sustained-release ibuprofen gel having optimal biopharmaceutical characteristics. In the used substance ibuprofen (BASF, Germany), previously micronized to a particle size of 90-120 microns. Developed oral prolonged gels were combined matrix, in which as matritseobrazovateley to achieve prolonged effect used acrylic acid derivatives at various concentrations (interpolymer complex polymethacrylic acid and polyethylene glycol CPV, a copolymer of methacrylic acid and ethyl acrylate Kollicoat ® MAE 100 P, redkosshitye acrylic polymers Carbopol 974P , Carbopol 971 P), as well as thickening agents - cellulose derivatives (Blanose®, Benecel®) at a concentration of 2%. Due to the low stability aggregate samples based on a CPV and Kollicoat® composition administered as gels Soluplus® stabilizer concentration of 4%, which is a graft copolymer of polyvinylpolyvinylacetate polivinilglikol. For the experimental samples studied aggregative stability during storage for 6 months, and evaluated ibuprofen release from the dosage form by the test "Dissolution" using the "rotating basket". During the scientific research had been chosen the optimal in technological and biopharmaceutical characteristics of the sample of oral sustained-release ibuprofen gel: composition of CPV 5,0% / Blanose® 2,0% / Soluplus® 4,0%. The buffer medium of pH 6.8 2 hours solution passes experiment 28.35 ± 6.8% ibuprofen for 4 hours - 53,15 ± 8,5%, for 6 hours of dissolution of - 63.34 ± 3.6 %. Therefore, the selected sample based on CPV has a sustained release dosage form of ibuprofen.

Keywords: 
Key words: ibuprofen
oral gel with prolonged release
derivatives of acrylic acid
Soluplus®.