Abstract
Objective: To study the in vitro dissolution performance of four generic formulations of the poorly soluble drug meloxicam and the reference under hydrodynamic environments generated by flow-through cell method and USP paddle apparatus (pharmacopeial test).
 Methods: Dissolution method was validated according to ICH guidelines. Dissolution profiles were carried out with an automated flow-through cell apparatus (laminar flow at 16 ml/min with 22.6 mm cells) and USP paddle apparatus at 75 rpm. Phosphate buffer pH 7.5 at 37.0±0.5 °C was used as dissolution medium. Spectrophotometric determination of drug at 362 nm was carried out during 30 min. Dissolution profiles were compared with model-dependent and-independent methods.
 Results: Practically, all generic formulations showed significant differences with the percentage of drug dissolved at 30 min, mean dissolution time and dissolution efficiency, when USP paddle apparatus was used (*P<0.05), while only two generic formulations were different to reference using flow-through cell method. After adjustment to different mathematical equations, Weibull function was the best model to describe meloxicam dissolution performance and significant differences were found with all drug products when USP paddle apparatus was used, while only one formulation was different with flow-through cell method.
 Conclusion: The study reveals the need to look for better dissolution schemes for meloxicam tablets since USP paddle apparatus may not reflect properly the in vitro dissolution performance of meloxicam generic formulations and reference.
Highlights
Meloxicam is a member of enolic acid group of non-steroidal antiinflammatory drugs (NSAIDs) used to treat rheumatoid arthritis, osteoarthritis and other joint pains
In vitro dissolution studies are used to assess batch-tobatch consistency of drug release from solid dosage forms, but they are essential in several stages of formulation development, for screening and proper assessment of different formulations [3]
Results of content uniformity and assay test made to meloxicam formulations are shown in table 2
Summary
Meloxicam is a member of enolic acid group of non-steroidal antiinflammatory drugs (NSAIDs) used to treat rheumatoid arthritis, osteoarthritis and other joint pains. Meloxicam has pKa values of 1.1 and 4.2 and is considered a class II drug [2]. Class II drugs are expected to have a dissolution-limited absorption and significant in vitro/in vivo correlation should be projected using a well-designed in vitro dissolution test. 1. In vitro dissolution studies are used to assess batch-tobatch consistency of drug release from solid dosage forms, but they are essential in several stages of formulation development, for screening and proper assessment of different formulations [3]. Some methods have been proposed to compare dissolution profiles of reference and test formulations. FDA use f2 similarity factor [4] while model-dependent,-independent and ANOVA-base comparisons are the most commonly approaches used for a complete evaluation [5, 6]
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