Development of a New Dosage Form of Naproxen
The aim of the study was to create a new dosage form of naproxen — granules for rapid dissolution in the oral cavity, also to develop their optimum composition and drug formulation.
Materials and Methods. The active ingredient: naproxen substance; excipients: lactose monohydrate, mannitol 100 SD (fillers), polyvinylpyrrolidone Kollidon CL (a disintegrant), sodium hydrogen carbonate and citric acid (gas-forming agent).
Moisture-activated dry granulation with subsequent addition of citric acid was used to produce granules. Alcohol in different concentrations (5, 10, 20, and 30%) served as granulating liquid.
Results. There has been developed the composition and drug manufacturing technology of the new dosage form of naproxen — granules for rapid dissolution in the oral cavity. It has been established experimentally that granules obtained with the use of 20% alcohol have the most favorable technological characteristics. Quality assessment was carried out in accordance with the State Pharmacopoeia XIII (SP XIII).
Conclusion. There has been obtained a new easy-to-use dosage form of naproxen with a high safety profile.
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