تحضير مضغوطات طافية مطولة التأثير من كبريتات الحديدي وتقييمها في الزجاج

Abstract

Oral tablets are one of the most acceptable pharmaceutical forms for patients. Floating tablets are one of the forms of formulation of tablets that ensure a prolongation of the time that drug remains in stomach and thus increase the bioavailability of many pharmaceutical compounds, including oral iron supplements. Ferrous sulfate supplements are used to treat iron deficiency cases, but the side effects associated with the use of these supplements limit patients’ compliance with treatment, in addition to the effect of gastrointestinal emptying time and pH on the bioavailability of these supplements. This study aims to formulate extended-release ferrous sulfate floating tablets using a combination of Carbopol 934 as an excipient to control drug release, HPMC K100M as a binder, sodium alginate for gel formation, and sodium bicarbonate to extend the floating time. The evaluation of the powder parameters before compression proved that all the prepared powder blends had a suitable flowability based on results of the compressibility index values ​​falling below 10% and the Hausner ratio value falling below 1.2%. The friability value of all prepared tablets did not exceed 1%, which confirms that the tablets can withstand shocks during transportation and handling. The hardness values ​​of the prepared tablets ranged between 60.28±3.18 N and 73.92±2.26 N, which are all higher than 40 N, the number that is considered the optimal minimum for the hardness of tablets. In-vitro dissolution study of the prepared floating tablets confirmed that the polymeric excipients used sprouted when in contact with water and retained water within their polymeric network, which raised the viscosity and led to delayed release of the drug substance from within its matrix. Formula F2 was characterized by the longest floating time of the prepared tablets and the longest duration of release of the drug substance. As a result, the prepared floating tablets allow a slow release of iron, which leads to an increase in its bioavailability and a reduction in its undesirable side effects.