Romanian Society of Pharmaceutical Sciences
 

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NEW MODIFIED RELEASE TABLETS WITH PENTOXIFYLLINE BASED ON LIPOPHILIC MATRIX. NOTE 1. FORMULATION, PHYSICAL STUDY AND DETERMINATION OF DISSOLUTION PROFILES OF THE ACTIVE SUBSTANCE FROM THE PROPOSED FORMULATIONS

ELEONORA MIRCIA1*, EMESE SIPOS2, SILVIA IMRE3, VERONICA AVRIGEANU1, GABRIEL HANCU4, BARNA IANTOVICS5, TEODORA BALACI6

University of Medicine and Pharmacy Târgu-Mureş, Faculty of Pharmacy, Gh. Marinescu 38, 540139, Târgu-Mureş, Romania
1 Organic Chemistry Department
2 Pharmaceutical Technology Department
3 Drug Analysis Department
4 Pharmaceutical Chemistry Department
5 “Petru Maior” University, Faculty of Science and Letters, Department of Mathematics and Informatics, Târgu-Mureş, Romania
6 University of Medicine and Pharmacy “Carol Davila”, Faculty of Pharmacy, Pharmaceutical Technology Department, Bucharest, Romania

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The objective of this study is to test new formulations, regarding modified release tablets containing pentoxifylline, obtained by technological modulation of the drug release from tablets. Precirol AT 05 in different ratios was used as a lipophilic matrix agent; pentoxifylline incorporation in the matrix has been carried out by granulation followed by compression of granulates in tablets. The weight uniformity, friability, hardness, thickness and the disintegration of the tablets were determined according to the stipulations of the 2001 Supplement of the Romanian Pharmacopoeia Xth edition, the United States Pharmacopeia (USP) 27 and the European Pharmacopoeia (EPh) 5. The dissolution studies were performed using the official method in USP 24, using the paddle apparatus, and water as medium of dissolution at 37±0.5ºC, at a rotation speed of 50 rpm. The determination was performed by spectrophotometric assay in UV at 274 nm. The study of experimental formulations with 400 mg pentoxifylline/tablet was performed in comparison with an industrial reference product, Trental SR® 400 mg. The prepared tablets were found to comply with the stipulations of the 2001 Supplement of the Romanian Pharmacopoeia Xth edition, USP 27 and EPh 5 regarding the weight uniformity, friability, hardness, thickness and disintegration time. The study results show that the proposed formulations present the specific characteristics of controlled release tablets. The studied tablets presented dissolution profiles close to that of the reference product (Trental SR® 400 mg), over a period of eight hours, with the exception of the formulation without Precirol AT 05.