Abstract

QUALITY VERIFICATION OF SIX MEDICINES IN WHOLES AND HALVES TABLETS, RE-PACKAGED IN INDIVIDUAL PLASTIC COMPARTMENTS DURING SIXTY DAYS

Dr. Olga Baudrit* Eleaneth Baltodano, Luis Jimenez, Jeimy Blanco, Maria-Fernanda Jimenez

Abstract

Plastic boxes with individual compartments are often used to improve medication compliance and only a few studies have been done on the stability of the tablet halves after placing them on these devices. In this investigation, wholes and halves tablets of furosemide, hydrochlorothiazide, spironolactone, warfarin sodium and atenolol and levothyroxine sodium were re-packaged and storing for sixty days under normal environmental conditions. The physical characteristics were observed and the quality attributes were verified. There were no changes in physical characteristics of all products. All products, except halves tablets of atenolol, showed accuracy according the test of uniformity of mass. The comparisons of dissolution profiles between whole tablets and tablets halves were adequate for hydrochlorothiazide and atenolol, but not for formulations of furosemide, spironolactone and warfarin sodium. Levothyroxine sodium showed a different dissolution behavior than expected. Whole tablets of atenolol do not meet specifications for uniformity of contents, neither the halves tablets of atenolol and spironolactone. According to the results, it is possible to re-package wholes tablets of furosemide, hydrochlorothiazide, spironolactone and warfarin sodium; but it is not advisable to maintain this practice for whole tablets of atenolol and levothyroxine sodium, neither for the halves of the rest of the products, except hydrochlorothiazide. These findings may become opportunities for improvement for pharmaceutical laboratories, as well as become a study topic for practitioners to advise the use of multi-compartment compliance aids, finally, these results should not be extrapolated to drugs, manufacturers, lots and conditions other than those used in this study.

Keywords: Repackaging, drug stability, quality assurance, multicompartment compliance aids.