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Abstract
In the study, antiepileptic drug was selected for designing extended release matrix tablets. Pre-Formulation studies were done with Acetazolamide. Compatibility was done before choosing the excipients for the study with physical observation and FTIR studies. The samples were charged in stability chambers at conditions 30°C/65%RH and 40°C/75%RH for 30 days. All the pre-formulation studies and compatibility studies were found to be satisfactory. So formulation trials were followed with the selected excipients. Blend for ER formulation was prepared by wet granulation method. Hypromellose K4M and Hypromellose K15M were used as release retarding polymers for optimizing the formula.Six trials were taken to optimize the release of Acetazolamide in ER form to be within specifications. F5 is the optimized formula with 11.66% concentration of HPMC K15M polymer which optimized the drug release profile as per predetermined specificatons. A reproducibility trial F6 was performed to check the reproducibility of process of drug release as per F5.For the ER form, Other excipients include povidone as binder, Lactose monohydrate as diluent, colloidal silicon dioxide as glidant and Magnesium stearate as Lubricant. Instacoatyellow was used as ready mix. Post-Compression analysis of all formulations like Hardness, Weight variation, Friability and Assay were within the limits for all the formulations. In- vitro dissolution studies were performed by HPLC method revealed that the formulation F5 released the drug as per the specifications. Kinetic Model fitting was done by plotting graphs for Zero-Order kinetics, First-Order kinetics, Higuchi’s Kinetic model and Korsemeyer - Peppas kinetic model. The formulation selected was F5 which has shown the release rate of the drug by First order kinetics and follows matrix diffusion controlled mechanism. Accelerated stability studies are being performed
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References
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- 10. Madhavi N, Sudhakar B, Ravikanth PV, Mohon K, Ramana Murthy K. Formulation and evaluation of Phenytoin sodium sustained release matrix tablet. J Bioequiv Availab. 2012;4:128-33. Doi: 10.4172/jbb.1000125
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References
1. Bhavani A, Hemalatha B, Padmalatha K. Formulation development and in vitro Evaluation of sustained release matrix tablets of Cefpodoxime proxetil. Asian Journal of Pharmacy and Technology. 2021;11(4):273-8. https://www.indianjournals.com/ijor.aspx?target=ijor:ajpt&volume=11&issue=4&article=003
2. Patel KB, Vyas JR, Upadhyay UM. Formulation and evaluation of sustained release matrix tablets of nateglinide. Journal of Drug Delivery and Therapeutics. 2015 Sep 21;5(5):19-25. http://www.jddtonline.info/index.php/jddt/article/view/1130
3. Chen W, Desai D, Good D, Crison J, Timmins P, Paruchuri S, Wang J, Ha K. Mathematical model-based accelerated development of extended-release metformin hydrochloride tablet formulation. AAPS PharmSciTech. 2016 Aug;17:1007-13. https://link.springer.com/article/10.1208/s12249-015-0423-9
4. Rheims S, Ryvlin P. Once-daily lamotrigine extended release for epilepsy management. Expert Review of neurotherapeutics. 2009 Feb 1;9(2):167-73. https://www.tandfonline.com/doi/abs/10.1586/14737175.9.2.167
5. Chaudhary A, Pacharane S, Jadhav KR, Kadam VJ. Formulation and development of extended release tablet of Lamotrigine. Int. J. Pharm. Sci. 2011;2:975-6299.
6. Huang Y, Khanvilkar KH, Moore AD, Hilliard-Lott M. Effects of manufacturing process variables on in vitro dissolution characteristics of extended-release tablets formulated with hydroxypropyl methylcellulose. Drug development and industrial pharmacy. 2003 Jan 1;29(1):79-88. https://www.tandfonline.com/doi/abs/10.1081/DDC-120016686
7. Furlanetto S, Cirri M, Maestrelli F, Corti G, Mura P. Study of formulation variables influencing the drug release rate from matrix tablets by experimental design. European journal of pharmaceutics and biopharmaceutics. 2006 Jan 1;62(1):77-84. https://www.sciencedirect.com/science/article/pii/S0939641105001980
8. Bialer M. Extended-release formulations for the treatment of epilepsy. CNS drugs. 2007 Sep;21:765-74. https://link.springer.com/article/10.2165/00023210-200721090-00005
9. Atef E, Belmonte AA. Formulation and in vitro and in vivo characterization of a phenytoin self-emulsifying drug delivery system (SEDDS). European journal of pharmaceutical sciences. 2008 Nov 15;35(4):257-63. https://www.sciencedirect.com/science/article/pii/S0928098708003369
10. Madhavi N, Sudhakar B, Ravikanth PV, Mohon K, Ramana Murthy K. Formulation and evaluation of Phenytoin sodium sustained release matrix tablet. J Bioequiv Availab. 2012;4:128-33. Doi: 10.4172/jbb.1000125
11. Rompicharla Bhargavi et al.(2013) Formulation, Development and Evaluation of Acetazolamide matrix tablets. American.J.Pharmtech Research. ISSN: 249-33