Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

Abstract

The aim of this study was to investigate the influence of dissolution medium on the in vitro release of lamivudine (100 mg) from four commercially available lamivudine tablets (one reference and three generic). Three different buffer solutions (pH 1.2, 4.5, 6.8) and deaerated water were used as the dissolution media (900 mL), and the paddle rotation speed was kept at 50 rpm with twelve replicates. An RP-HPLC method was developed for analysis of lamivudine in samples obtained from dissolution studies. The mobile phase consisted of acetonitrile/water (10:90) pH adjusted to pH 2.5 with o-phosphoric acid, a C 18 column (Ace 250 × 4.60 mm, 5 µm) was used, and the flow rate was set at 1 mL/min. All the drugs tested were very rapidly dissolving (more than 85% of the labeled amount in 15 min), and the dissolution profiles of the generic tablets were thus considered similar to that of the reference tablet in each of the buffers at pH 1.2, 4.5, and 6.8, and deaerated water. Because of the dissolution results and the high solubility and borderline permeability, a biowaiver can be proposed for lamivudine immediate-release solid oral dosage forms provided that the excipient composition of the test product is the same as or similar to that of the reference product and the excipients that have an effect on bioavailability are qualitatively and quantitatively the same as that of the reference product.

Development and validation of ultraviolet spectrophotometric methods for lamivudine and zidovudine quantification in dissolution test

“…4, both drugs complied with the requirement for products exhibiting very rapid dissolution, namely, more than 85% of the drugs were dissolved within 15 minutes in all three buffers (WHO, 2017). Similar results were reported by (Ozturk et al, 2015;Reddy et al, 2014;Strauch et al, 2011). The intermediate precision analysis at all sampling times, showed RSD values below 7% for both drugs, demonstrating the intermediate precision of the method.…”

“…In the British Pharmacopoeia, the methods provided use ultraviolet spectrophotometry at 280 nm and 266 nm, for lamivudine and zidovudine, respectively (BP, 2018a;2018b). Some published works have reported methods of quantification of lamivudine and zidovudine tablets in dissolution studies through UV spectrophotometric and HPLC (Fernandes et al, 2003;Hwisa et al, 2013;Mandloi et al, 2009;Ozturk et al, 2015;Stuart et al, 2014).…”

Comparison of Dissolution Profiles and Apparent Permeabilities of Commercially Available Metformin Hydrochloride Tablets in Turkey

“…The dissolution test is an important tool in drug development and quality control studies for tablet formulations. It is also used to design new formulations, develop in vitro-in vivo correlations, control in-process and finished product specifications, show the similarity of pharmaceutical dosage forms, and evaluate the bioequivalence of reference and generic products (11,12). Permeability is the rate-limiting step in the oral absorption of BCS Class 3 compounds such as MH (13).…”

Evaluación comparativa de perfiles de disolución del medicamento genérico lamivudina tableta 150 mg comercializado en Perú frente al innovador Epivir

“…Regarding the dissolution profiles, our results agree with the study conducted in Turkey by Otzurk et al . which obtained more than 85% of the labeled amount dissolved in 15 min in the three-dissolution media: pH 1.2 (97.5%, 100.0% and 99.9%); pH 4.5 (96.4%, 101.0% and 99.8%); and pH 6.8 (103.0%, 98.8% and 100.0%); therefore, the mathematical comparison of similarity (f2) was not necessary either 17 . On the contrary, a study carried out in Argentina showed that the results obtained for LMV and abacavir presented an f2 greater than 50 for the three generic lots for both LMV and abacavir at pH 1.2 and 6.8; however, for pH 4.5, lot 1 did not meet f2 for either of the two actives 18 .…”