Suárez PY, García PO, Placert ÁM

Language: Spanish
References: 17
Page: 225-238
PDF size: 248.55 Kb.

ABSTRACT

Introduction: Naproxen suppository for children and adults is one of the developing research lines of "Roberto Escudero Diaz" drug production enterprise. The stability studies are indispensable for the registration of a new formulation.
Objective: to determine the stability of Naproxen suppositories for children and adults, taking the physical and chemical stability of the analyte into account in the new formulations.
Methods: pursuant to the methodology of the Center for the State Quality Control of Drugs (CECMED), the stability study for developing formulations was conducted in Naproxen suppositories for children and adults. These products packaged in heat-seal aluminum blister packs from three pilot batches were used for each evaluated dose. They were stored at 2 to 8 °C refrigeration and at air temperature of 30 ± 2 °C during one year, and sampled at 0, 1, 3, 6 and 12 months after preparation. For the analysis of the chemical stability, the Naproxen content determined by the neutralizing volumetry and high performance liquid chromatography tests and the possible degradation products identified in the thin layer chromatography test were taken into account.
Results: this study proved the adequate physical stability of suppositories at both doses regardless of the storage temperatures during 12 months because their organoleptic characteristics and weight remained unchanged. Although the liquefaction time decreased under the storage conditions, it was lower than the set limit. The high performance liquid chromatography detected slight changes in the analyte concentration, so this method was better for the chemical stability analysis than the neutralization volumetry method. The chromatographic techniques did not detect any degradation product in the suppositories.
Conclusions: the suppositories were physically and chemically stable at a refrigerating temperature of 2 to 8 °C and at air temperature of 30 ±: 2 °C during 12 months.

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