Copyright (c) 2024 Manikandan G, Mohammed Omar
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Formulation and Evaluation of Naproxen Sodium 220 Mg Modified Release Tablet Using Novel Technology
Corresponding Author(s) : Manikandan G
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 12 No. 4 (2024): 2024 Volume -12 - Issue 4
Abstract
Development of an experimental design (DOE) aimed at enhancing the modified release formulation of Naproxen Sodium 220 mg through innovative technology. This experimental approach focuses on improving the assay of Naproxen Sodium release tablets by incorporating DisintegrantsValidation of this method will encompass the processes of raw material dispensing, sifting, dry mixing, binder preparation, wet mixing, drying, milling, lubrication, compression. This study illustrates that the solid dispersion technique can significantly enhance the dissolution rate of Naproxen. The results are consistent with numerous other investigations into solid dispersion methods, indicating that this strategy serves as a viable option for pharmaceutical companies seeking to prolong the life cycle of products that exhibit poor solubility. A comparative analysis of the dissolution profiles was performed across various media, both with and without surfactants.
The findings clearly demonstrate that an increase in the concentration of Disintegrants does not lead to interactions with the drug when combined with other excipients, thereby facilitating sustained drug delivery over prolonged periods. The improved formulation, developed through factorial design, can be administered as a single daily dose. The experimental design lays the groundwork for further optimization. In this investigation, Trial #3 emerged as the formulation that most effectively satisfies all criteria for an optimal formulation
Keywords
- Chang R, Guo X, Burnside B, Couch R. An evaluation of fast dissolving tablets. Pharm Tech North Am 2000; 12:52-8.
- Bi Y, Sunada H, Yonezawa Y, Danjo K, Iida K. Training and evaluation of compressed tablets rapidly disintegrating in the oral cavity. Chem Pharm Bull (Tokyo) 1996; 44:2121-7.
- Mishra DN, Bindal M, Singh SK, Kumar SG. Spray dried excipient base: a original technique for the formulation of orally collapsing tablets. Chem Pharm Bull 2006;54:99-102.
- Fu Y, Jeong SH, Park K. Fast-melting tablets based on highly plastic granules. J Control Release 2005; 109:203-10.
- Sammour OA, Hammad MA, Megrab NA, Zidan AS. Formulation and optimization of mouth dissolve tablets encompassing rofecoxib solid dispersion. AAPS PharmSciTech 2006;7:E55.
- Gohel M, Patel M, Amin A, Agrawal R, Dave R, Bariya N. Formulation design and optimization of mouth dissolve tablets of nimesulide using space drying technique. AAPS PharmSciTech 2004;5:e
- Suresh S, Pandit V, Joshi HP. Preparation and evaluation of mouth dissolving tablets of salbutamol sulphate. Indian J Pharm Sci. 2007;69:467-9.
- Heinemann H, Rothe W. Preparation of porous tablets. US patent 3 885 026. May 20, 1975.
- Knistch A, Hagen E, Munz HD. Production of porous tablets. US patent 4 134 843. January 16, 1979.
- Roser BJ, Blair J. Rapidly soluble oral dosage forms, methods of making the same and composition thereof. US patent 5 762 961, June 9, 1998.
- Ahmed IS, Fatahalla FA. Pilot study of relative bioavailability of two oral formulations of ketoprofen in healthy subjects, a fastdissolving lyophilized tablet as compared to immediate release tablet. Drug Develop In Pharm 2007; 33:505-11.
- Ahmed IS, Nafud MM, Fatahalla FA. Formulation of fast dissolving ketoprofen tablet using freeze drying in blister technique. Drug Develop In Pharm 2006; 32:437-42.
- Corveleyn S, Remon JP. Formulation and production of rapidly disintegrating tablets by lyophilisation using hydrochlorothiazide as a model drug. Into J Pharm 1997; 152:215-25.
- Remon JP, Corveleyn S. Freeze-dried rapidly disintegrating tablets. US patent 6 010 719, January 4, 2000.
- Marshall K, Lachman N, Lieberman HA. The theory and practice of industrial pharmacy. 3rd ed. Mumbai: Varghese Publishing House; 1987. p. 66-9.
- Kimura S, Imai T, Onagri M, Pharmaceutical evaluation of Ibuprofen syrup containing low molecular weight gelatine. J Pharm Sic 1992; 81:141-4.
- Wuxia B, Yorinobu Y, Kazumi D, Akinobu O. Preparation and evaluation of oral tablet rapidly dissolving in oral cavity. Chem Pharm Bull 1996; 44:2121-7
References
Chang R, Guo X, Burnside B, Couch R. An evaluation of fast dissolving tablets. Pharm Tech North Am 2000; 12:52-8.
Bi Y, Sunada H, Yonezawa Y, Danjo K, Iida K. Training and evaluation of compressed tablets rapidly disintegrating in the oral cavity. Chem Pharm Bull (Tokyo) 1996; 44:2121-7.
Mishra DN, Bindal M, Singh SK, Kumar SG. Spray dried excipient base: a original technique for the formulation of orally collapsing tablets. Chem Pharm Bull 2006;54:99-102.
Fu Y, Jeong SH, Park K. Fast-melting tablets based on highly plastic granules. J Control Release 2005; 109:203-10.
Sammour OA, Hammad MA, Megrab NA, Zidan AS. Formulation and optimization of mouth dissolve tablets encompassing rofecoxib solid dispersion. AAPS PharmSciTech 2006;7:E55.
Gohel M, Patel M, Amin A, Agrawal R, Dave R, Bariya N. Formulation design and optimization of mouth dissolve tablets of nimesulide using space drying technique. AAPS PharmSciTech 2004;5:e
Suresh S, Pandit V, Joshi HP. Preparation and evaluation of mouth dissolving tablets of salbutamol sulphate. Indian J Pharm Sci. 2007;69:467-9.
Heinemann H, Rothe W. Preparation of porous tablets. US patent 3 885 026. May 20, 1975.
Knistch A, Hagen E, Munz HD. Production of porous tablets. US patent 4 134 843. January 16, 1979.
Roser BJ, Blair J. Rapidly soluble oral dosage forms, methods of making the same and composition thereof. US patent 5 762 961, June 9, 1998.
Ahmed IS, Fatahalla FA. Pilot study of relative bioavailability of two oral formulations of ketoprofen in healthy subjects, a fastdissolving lyophilized tablet as compared to immediate release tablet. Drug Develop In Pharm 2007; 33:505-11.
Ahmed IS, Nafud MM, Fatahalla FA. Formulation of fast dissolving ketoprofen tablet using freeze drying in blister technique. Drug Develop In Pharm 2006; 32:437-42.
Corveleyn S, Remon JP. Formulation and production of rapidly disintegrating tablets by lyophilisation using hydrochlorothiazide as a model drug. Into J Pharm 1997; 152:215-25.
Remon JP, Corveleyn S. Freeze-dried rapidly disintegrating tablets. US patent 6 010 719, January 4, 2000.
Marshall K, Lachman N, Lieberman HA. The theory and practice of industrial pharmacy. 3rd ed. Mumbai: Varghese Publishing House; 1987. p. 66-9.
Kimura S, Imai T, Onagri M, Pharmaceutical evaluation of Ibuprofen syrup containing low molecular weight gelatine. J Pharm Sic 1992; 81:141-4.
Wuxia B, Yorinobu Y, Kazumi D, Akinobu O. Preparation and evaluation of oral tablet rapidly dissolving in oral cavity. Chem Pharm Bull 1996; 44:2121-7