Formulation and Development of Sustained Release Oral Drug Delivery System Comprising Naproxen Sodium Microspheres

Author: Pagar Madhumanjiri K., Gangurde Avinash B., Pagar Rahul Y. and Bairagi Vinod A.

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Abstract

Designing a sustained release formulation can be complex, as it requires a deep understanding of the drug's physicochemical properties, release kinetics, and compatibility with various excipients. Finding the right combination of polymers, fillers, and other excipients to achieve the desired release profile can be challenging. In the present study, naproxen-loaded polymeric microspheres were compressed into naproxen sustained-release tablets. To prevent the GI side effects of the drugs, research aimed to create simple, affordable sustained-release tablets containing microspheres loaded with naproxen. To formulate the microspheres, an O/W emulsification method was used. An analytical method was developed using a UV- spectrophotometer for about 200-400nm of wavelengths. Later for formulation development, qualitative determination of Naproxen and ethyl cellulose was done in different solvents. Evaluation of microspheres prepared was done in 6.8 phosphate buffer by determining drug loading, percentage of yield, drug release study, X-ray diffraction (XRD), scanning electron microscopic (SEM) analysis, Fourier transform infrared (FT-IR), and In vitro dissolution study and the formulation batches F1, F2, F3, F4, F5, and F6, had DR 100 % at 4 h, 8h, 10h, 12h, 14h, and 24h respectively. The tablets were created using the optimized microsphere formulation naproxen. For the characterization of granules, certain parameters like tapped density, bulk density, a range for angle of repose, Hausner ratio, and Compressibility index were determined for all 5 batches B1, B2, B3, B4, and B5. For the characterization of the tablet, certain parameters like weight, thickness, hardness, friability, and DT were determined.

Keywords

Ethyl cellulose, Microsphere, Naproxen sodium, Oral drug delivery system, Sustained release

Conclusion

An alternate medication strategy is introduced by not only using the pure drug but by formulating naproxen-loaded ethyl cellulose microspheres. This will lead to sustained release and later can be encapsulated in a tablet dosage form. Such tablet dosage form will give drug release up to 24h and ultimately it will reduce the dosing frequency. There might be no need for multiple administration of doses. By O/W emulsification technique, fast disintegrating tablets were made by conversion of microspheres. Later we can successfully make formulations that show reduced dosing frequency which will help to avoid the GI complications associated with the pure drug. The tablets might enhance patient compliance by improving the taste and swallowing ability of pediatric and geriatric patients. There may be less chance of missing the dose.

References

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How to cite this article

Pagar Madhumanjiri K., Gangurde Avinash B., Pagar Rahul Y. and Bairagi Vinod A. (2023). Formulation and Development of Sustained Release Oral Drug Delivery System Comprising Naproxen Sodium Microspheres. Biological Forum – An International Journal, 15(5a): 510-520.