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Formulation of nimesulide-loaded polylactide/poly(lactic-co-glycolic acid) nanoparticles and the evaluation of release kinetics

Pobudkowska A., Nosol K., Gierycz P., Domańska U.

Polimery

2018

T. 63, nr 9

586--593

Polymeric nanoparticles containing nimesulide (NIM) were prepared by the emulsion solvent evaporation method. Biodegradable polymers were used as materials for nanoparticle formulations with the application of studies for the drug delivery sector in mind. Two analytical methods, scanning electron microscopy (SEM) and particle size analysis, were applied to investigate the obtained nanoparticles. Characteristic parameters were calculated to describe the amount of active pharmaceutical ingredient trapped in nanoparticles. The biological active substance release process was investigated under different conditions. The impact of various parameters [kind of polymer (PLA or PLGA), speed of mixing and especially of pH] is presented across our research.

Polimerowe nanocząstki zawierające nimesulid (NIM) otrzymano metodą emulsyjną z odparowaniem rozpuszczalnika. Do ich wytworzenia wykorzystano biodegradowalne polimery. Wytworzone nanocząstki zbadano za pomocą skaningowej mikroskopii elektronowej (SEM) oraz analizatora wielkości cząstek. Obliczono charakterystyczne parametry opisujące ilość substancji farmaceutycznie aktywnej uwięzionej wewnątrz nanocząstek. Oceniono wpływ rodzaju polimeru stosowanego do kapsułkowania, szybkości mieszania suspensji, w szczególności pH środowiska na proces uwalniania substancji biologicznie czynnej.

Development and validation of a high-performance liquid chromatographic method for analysis of nimesulide residues on manufacturing equipment surfaces

Milenović D. M., Todorović Z. B.

Acta Chromatographica

2009

Vol. 21, no. 4

603--618

In the pharmaceutical industry it is important to remove drug residues from the equipment and areas used. Cleaning procedures must be validated, so special attention must be devoted to the methods used for analysis of trace amounts of drugs. To monitor a cleaning procedure, a high-performance liquid chromatographic method for analysis of nimesulide residues in swab samples has been developed and validated. The swabbing procedure was optimized to achieve suitable recovery of nimesulide from stainless steel. Mean recovery was >80% when two swabs were used. The precision of the results, reported as the relative standard deviation (RSD), was <2.00%. The method was validated over the concentration range 0.30–50.00 μg mL -1. Small amounts of the drug residues were analysed by HPLC with an ODS column (250 mm × 4.6 mm, 5-μm particles), at 20°C, with 65:35:3:0.13 ( v/v/v/w ) methanol-water-phosphate buffer (pH 3; 0.05 M )-sodium heptane sulfonate as mobile phase at a flow rate of 0.8 mL min -1. Nimesulide was detected at 235 nm. This procedure enabled simple, sensitive, and convenient HPLC analysis of nimesulide residues on stainless steel.