Comparative studies on the dissolution profiles of oral ibuprofen suspension and commercial tablets using biopharmaceutical classification system criteria

Abstract

In vitro dissolution studies for solid oral dosage forms have recently widened the scope to a variety of special dosage forms such as suspensions. For class II drugs, like Ibuprofen, it is very important to have discriminative methods for different formulations in physiological conditions of the gastrointestinal tract, which will identify different problems that compromise the drug bioavailability. In the present work, two agitation speeds have been performed in order to study ibuprofen suspension dissolution. The suspensions have been characterised relatively to particle size, density and solubility. The dissolution study was conducted using the following media: buffer pH 7.2, pH 6.8, 4.5 and 0.1 M HCl. For quantitative analysis, the UV/Vis spectrophotometry was used because this methodology had been adequately validated. The results show that 50 rpm was the adequate condition to discriminate the dissolution profile. The suspension kinetic release was found to be dependent on pH and was different compared to tablet release profile at the same experimental conditions. The ibuprofen release at pH 1.0 was the slowest.

Comparison of the Usp Apparatus 2 and 4 for Testing the in Vitro Release Performance of Ibuprofen Generic Suspensions

“…This compound is manufactured as solid oral dosage forms and suspensions. Ibuprofen suspension is widely used as antipyretic in children [1] and it is accessible for the elderly who cannot swallow easily [2]. Some ibuprofen formulations are available as generic drug products.…”

“…The establishment of a significant IVIVC provides the basis for estimating the in vivo performance of the drug and waives the costly bioequivalence studies [5]. Previously, some researchers have reported the dissolution profiles of ibuprofen suspension using the BCS criteria [2]. Experiments were carried out with the United State Pharmacopeia (USP) paddle apparatus (USP Apparatus 2) with 900 ml of buffer pH 7.2, pH 6.8, pH 4.5, and 0.1 M HCl as dissolution medium.…”

Experimental and chemoinformatics evaluation of some physicochemical properties of excipients influencing release kinetics of the acidic drug ibuprofen

“…Powder equivalent to a dose of 200 mg IBU was weighed accurately and dissolved in sufficient amount of 50 mM MPPB pH 6.8 and the volume was adjusted to 100 mL. Aliquot of filtrate was suitably diluted and analyzed by UV-Visible spectrophotometer at 221 nm against buffer pH 6.8 as a blank (Rivera-Leyva et al, 2012). From calibration curve the drug content of the tablet was determined in triplicate for each batch (n = 3).…”

“…Prepared compacts (600 ± 5 mg) from each batch were evaluated to test the dissolution pattern in triplicate using USP Type-II (paddle method) dissolution test apparatus (Electrolab, TDT 08L, Mumbai, Maharashtra, India). Dissolution medium used was 900 mL of 100 mM HAB pH 1.2 for initial 2 h, followed by 50 mM MPPB pH 6.8, both maintained at 37.5 ± 0.5°C (Rivera-Leyva et al, 2012;USPNF, 1995c). Paddle speed was kept constant at 50 rpm (USPNF, 1995d).…”

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“…Therefore, in order to ensure the required quality, drug manufacturers are required to test their product during and after manufacturing and at various intervals during the shelf life of the product. As such they require to ensure that the generic and branded drugs products are pharmaceutically equivalent cannot be overemphasized and the requirement to select one product from several generic drug products of the same active ingredients during the course of therapy is always a cause for concern to health practitioners 11,12 .…”