Volume : 09, Issue : 12, December – 2022
Title:
03.FORMULATION DEVELOPMENT AND INVITRO CHARACTERIZATION OF BILAYERED MATRIX TABLETS OF METOPROLOL TARTRATE AND METFORMIN HYDROCHLORIDE
Authors :
Shilpa Lakinapally*, Ramakrishna Raparla
Abstract :
Diabetes Mellitus (T2DM) is one of the complex metabolic disorders with multiple effects. Hypertension is one of the major and common conditions that is associated with it. In the present study, attempts were made to formulate a dosage form which is a combination of both anti-diabetic and anti-hypertensive agents. Metoprolol tartrate was formulated in IR Layer using disintegrants and Metformin was formulated in CR layer using natural gums and Eudragit RLPO. The evaluation tests of both formulations were conducted and dissolution study of optimized bilayered formulation has revealed that the formulations can offer a bimodal release, i.e., Metoprolol was found to be 97.42% within 2 hrs and Metformin from CR layer was 98.45% at the end of 24 hrs. Kinetic studies showed good linearity with Zero order Kinetics (Regression coefficient-0.982) and Korsemeyer Peppas model for release mechanism (Regression coefficient-0.996, n-0.758) indicating super case II transport. Hence these bilayer formulations may be considered suitable for the treatment of Diabetes associated Hypertension.
Key Words: Bilayer tablets, Metformin Hydrochloride, Metoprolol tartrate, Combination therapy.
Cite This Article:
Please cite this article in press Shilpa Lakinapally et al, Formulation Development And Invitro Characterization Of Bilayered Matrix Tablets Of Metoprolol Tartrate And Metformin Hydrochloride.., Indo Am. J. P. Sci, 2022; 09(12).
Number of Downloads : 10
References:
1. Bhagwat RR and Vaidhya IS. Novel Drug Delivery Systems: An Overview. International Journal of Pharmaceutical Sciences and Research 2013, 4(3):970-982.
2. Alqahtani MS, Kazi M, Alsenaidy MA and Ahmad MZ. Advances in Oral Drug Delivery. Front. Pharmacol, 2021.12:618411.
3. Zaman M. Oral controlled release drug delivery system and characterization of oral tablets; A review. Pakistan journal of Pharmaceutical Research 2016. 2(1):67-76.
4. Manisha G and Jain S: Oral controlled release drug delivery system, a review. Pharma tutor, Volume 2(8), 2014:170-178.
5. Zheng Y., Ley S. H., Hu F. B. Global Aetiology and Epidemiology of Type 2 Diabetes Mellitus and its Complications. Nat. Rev. Endocrinol 2018. 14 (2), 88–98. 10.1038/nrendo.2017.151.
6. Mathew RC. Standards of Medical Care in Diabetes. Diabetes Care, The Journal of Clinical and Applied Research and Education, Volume 42, Supplement 1, 2019.
7. IDF DIABETES ATLAS, Ninth edition 2019.
8. Li S., Vandvik P. O., Lytvyn L., Guyatt G. H., Palmer S. C., Rodriguez-Gutierrez R. et al. SGLT-2 Inhibitors or GLP-1 Receptor Agonists for Adults with Type 2 Diabetes: A Clinical Practice Guideline, 2021. BMJ 373, n1091.
9. Jia W., Weng J., Zhu D., Ji L., Lu J., Zhou Z., et al. Standards of Medical Care for Type 2 Diabetes in China 2019. Diabetes Metab. Res. Rev. 35 (6), e3158. 10.1002/dmrr.3158.
10. Li C, Luo J, Jiang M, Wang K. The Efficacy and Safety of the Combination Therapy with GLP-1 Receptor Agonists and SGLT-2 Inhibitors in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. Front Pharmacol. 2022 Feb 4.13:838277.
11. Srihari R, Patan A, Reddy PS, Sasikanth K, Brahmaiah B and Nama S. An emerging trend on bilayer tablets. International Journal of Innovative Drug Discovery, 2013. 3(21):45-50.
12. Divya A, Kavitha K, Kumar MR, Dakshayani S, Jagadeesh and Singh SD. Bilayer tablet technology: An overview. Journal of Applied Pharmaceutical Science 2011; 01(08): 43-47.
13. Gavate NT, Gondkar SB and Saudagar RB: Multilayer Tablet: A New Trend in Solid Dosage Forms. World Journal of Pharmacy and Pharmaceutical Sciences, 2013; 3(1): 271-284.
14. Gautam CS and Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. Br Journal of Clinical Pharmacology, 2008; 65: 795-796.
15. More S, Ghodekar S, Rane B, Bavaskar K, Patil M and Jain A. Multilayered tablet: a novel approach for oral drug delivery. Int J Pharm Sci & Res 2018. 9(3): 872-82.
16. M. Epstein and J. R. Sowers. Diabetes mellitus and hypertension. Hypertension, 1992, vol. 19, no. 5, pp. 403–418.
17. G. F. H. Ehud, E. Z. Messerlib, and A. Tenenbaum. Hypertension and diabetes. Cardiovascular Diabetologyclinical, Metabolic and Inflammatory Facets, 2008. Advances in Cardiology, vol.45, pp. 82–106.
18. Sweetman, S.C.: Martindale, The complete drug reference, Pharmaceutical Press, 2002:33, 931.
19. Luna B and Mark NF. American Family physician, Volume 63, Number 9, May 2001.
20. Firas TA, Ali KA, Ibrahim SA, Salih AH, Ghadah JJ, Alsallami and Ikbal HA. Evaluation of the activity of gluco herb DM2 as natural Drug against diabetes mellitus (type 2) as comparison study with metformin drug. World Journal of Pharmaceutical Research 2018, 7(19):74-81.
21. Palei NN, Mamidi SK and Rajangam J. Formulation and evaluation of Lamivudine sustained release tablet using okra mucilage. J App Pharm Sci, 2016. 6 (09): 069-075.
22. Newton AMJ, Swathi P, Narinder Kumar and Manoj Kumar K. A comparative study of Okra gum on controlled release kinetics and other formulation characteristics of Tramadol HCl extended release matrix tablets Vs Synthetic hydrophilic polymers. International Journal of Drug Delivery 2014. 6:339-350.
23. Reddy MS, Sowmya G and Shruthi B: Formulation and Evaluation of Nevirapine sustained release matrix tablets using mucilage of Abelmoschus esculentus as release modifier. Int J Pharm Pharm Sci 2014. 6 (4): 661-668.
24. M.Sunitha Reddy, T. Jyothirmaye. Formulation and Evaluation of ibuprofen sustained release matrix tablets using manlikara zapota gum as a release retarding polymer. International journal of Innovative pharmaceutical sciences and research. Vol 3(9), 2015. ISSN: 2347-2154, Pg No. 1350-1361.
25. Singh, S., & Bothara, S. B. Development of Oral Mucoadhesive Tablets of Losartan Potassium using Natural Gum from Manilkara Zapota Seeds. International Journal of Pharmaceutical Sciences and Nanotechnology (IJPSN), 2013. 6(4), 2245-2254.
26. Tarade Vijay D., Chemate Satyam Z, Tushar Joshi V. and Kalyani Jadhav A. A research on formulation and evaluation chewing gum of simvastatin. World Journal of Pharmaceutical Research, 2016. Volume 5, Issue 4, 1465-1481.
27. Satish K, Anchal P, Dhruv D, Prasad DN and Monika: Formulation and evaluation of sustained release matrix tablet of Metoprolol succinate by using xanthan gum and carbopol. Journal of Drug Delivery & Therapeutics 2019; 9(3-s):309-316.
28. Harika Ryakala, S. Dineshmohan, Alluri Ramesh, V. R. M. Gupta. Formulation and In Vitro Evaluation of Bilayer Tablets of Nebivolol Hydrochloride and Nateglinide for the Treatment of Diabetes and Hypertension. Journal of Drug Delivery, 2015, Article ID 827859, 14 pages.
29. Deore PD, Katti SA and Sonawane SS. Formulation and evaluation of sustain release matrix tablet of fluvoxamine maleate using Moringa oleifera gum. Int J Pharm Sci & Res 2021.12(7): 3879-86.
30. Rajeswari A, Rao BS, Bangaruthalli J and Sravya K. Formulation and Evaluation of Metformin hydrochloride and Gliclazide sustained release bilayer tablets: A combination therapy in management of Diabetes. International Journal of Applied Pharmaceutics 2021; 13 (5).
31. Kalpesh W, Sachin K, Mali KD, Satish KP and Dheeraj TB. Design and evaluation of bilayer tablets of glimepiride and metformin hydrochloride with the combination of hydrophilic and hydrophobic polymers by hot-melt extrusion of bilayer tablets of Glimepiride and metformin. Asian J Pharm Clin Res 2014. 7:300-304.
32. D. Rohini, S. Alexandar, and M. J. N. Chandrasekar, “Preparation and in vitro evaluation of sustained release tablet formulations of metformin HCL,” Asian Journal of Pharmaceutical and Clinical Research, vol. 5, no. 1, pp. 45–48, 2012.
33. G. H. Kumar, K. Jaganathan, R. S. Kumar, and P. Peruma, “Formulation and in-vitro evaluation of bilayer floating tablets of Metformin hydrochloride and Sitagliptin phosphate,” International Journal of Advanced Pharmaceutics, vol. 2, no. 2, pp. 64–81, 2012.
34. Indian Pharmacopoeia, Indian Pharmacopoeia, vol. 3, Worldwide Book Service, 2014.
35. United States Pharmacopoeia 34, vol. 3, pp. 3611–3614, 2011.
2. Alqahtani MS, Kazi M, Alsenaidy MA and Ahmad MZ. Advances in Oral Drug Delivery. Front. Pharmacol, 2021.12:618411.
3. Zaman M. Oral controlled release drug delivery system and characterization of oral tablets; A review. Pakistan journal of Pharmaceutical Research 2016. 2(1):67-76.
4. Manisha G and Jain S: Oral controlled release drug delivery system, a review. Pharma tutor, Volume 2(8), 2014:170-178.
5. Zheng Y., Ley S. H., Hu F. B. Global Aetiology and Epidemiology of Type 2 Diabetes Mellitus and its Complications. Nat. Rev. Endocrinol 2018. 14 (2), 88–98. 10.1038/nrendo.2017.151.
6. Mathew RC. Standards of Medical Care in Diabetes. Diabetes Care, The Journal of Clinical and Applied Research and Education, Volume 42, Supplement 1, 2019.
7. IDF DIABETES ATLAS, Ninth edition 2019.
8. Li S., Vandvik P. O., Lytvyn L., Guyatt G. H., Palmer S. C., Rodriguez-Gutierrez R. et al. SGLT-2 Inhibitors or GLP-1 Receptor Agonists for Adults with Type 2 Diabetes: A Clinical Practice Guideline, 2021. BMJ 373, n1091.
9. Jia W., Weng J., Zhu D., Ji L., Lu J., Zhou Z., et al. Standards of Medical Care for Type 2 Diabetes in China 2019. Diabetes Metab. Res. Rev. 35 (6), e3158. 10.1002/dmrr.3158.
10. Li C, Luo J, Jiang M, Wang K. The Efficacy and Safety of the Combination Therapy with GLP-1 Receptor Agonists and SGLT-2 Inhibitors in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. Front Pharmacol. 2022 Feb 4.13:838277.
11. Srihari R, Patan A, Reddy PS, Sasikanth K, Brahmaiah B and Nama S. An emerging trend on bilayer tablets. International Journal of Innovative Drug Discovery, 2013. 3(21):45-50.
12. Divya A, Kavitha K, Kumar MR, Dakshayani S, Jagadeesh and Singh SD. Bilayer tablet technology: An overview. Journal of Applied Pharmaceutical Science 2011; 01(08): 43-47.
13. Gavate NT, Gondkar SB and Saudagar RB: Multilayer Tablet: A New Trend in Solid Dosage Forms. World Journal of Pharmacy and Pharmaceutical Sciences, 2013; 3(1): 271-284.
14. Gautam CS and Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. Br Journal of Clinical Pharmacology, 2008; 65: 795-796.
15. More S, Ghodekar S, Rane B, Bavaskar K, Patil M and Jain A. Multilayered tablet: a novel approach for oral drug delivery. Int J Pharm Sci & Res 2018. 9(3): 872-82.
16. M. Epstein and J. R. Sowers. Diabetes mellitus and hypertension. Hypertension, 1992, vol. 19, no. 5, pp. 403–418.
17. G. F. H. Ehud, E. Z. Messerlib, and A. Tenenbaum. Hypertension and diabetes. Cardiovascular Diabetologyclinical, Metabolic and Inflammatory Facets, 2008. Advances in Cardiology, vol.45, pp. 82–106.
18. Sweetman, S.C.: Martindale, The complete drug reference, Pharmaceutical Press, 2002:33, 931.
19. Luna B and Mark NF. American Family physician, Volume 63, Number 9, May 2001.
20. Firas TA, Ali KA, Ibrahim SA, Salih AH, Ghadah JJ, Alsallami and Ikbal HA. Evaluation of the activity of gluco herb DM2 as natural Drug against diabetes mellitus (type 2) as comparison study with metformin drug. World Journal of Pharmaceutical Research 2018, 7(19):74-81.
21. Palei NN, Mamidi SK and Rajangam J. Formulation and evaluation of Lamivudine sustained release tablet using okra mucilage. J App Pharm Sci, 2016. 6 (09): 069-075.
22. Newton AMJ, Swathi P, Narinder Kumar and Manoj Kumar K. A comparative study of Okra gum on controlled release kinetics and other formulation characteristics of Tramadol HCl extended release matrix tablets Vs Synthetic hydrophilic polymers. International Journal of Drug Delivery 2014. 6:339-350.
23. Reddy MS, Sowmya G and Shruthi B: Formulation and Evaluation of Nevirapine sustained release matrix tablets using mucilage of Abelmoschus esculentus as release modifier. Int J Pharm Pharm Sci 2014. 6 (4): 661-668.
24. M.Sunitha Reddy, T. Jyothirmaye. Formulation and Evaluation of ibuprofen sustained release matrix tablets using manlikara zapota gum as a release retarding polymer. International journal of Innovative pharmaceutical sciences and research. Vol 3(9), 2015. ISSN: 2347-2154, Pg No. 1350-1361.
25. Singh, S., & Bothara, S. B. Development of Oral Mucoadhesive Tablets of Losartan Potassium using Natural Gum from Manilkara Zapota Seeds. International Journal of Pharmaceutical Sciences and Nanotechnology (IJPSN), 2013. 6(4), 2245-2254.
26. Tarade Vijay D., Chemate Satyam Z, Tushar Joshi V. and Kalyani Jadhav A. A research on formulation and evaluation chewing gum of simvastatin. World Journal of Pharmaceutical Research, 2016. Volume 5, Issue 4, 1465-1481.
27. Satish K, Anchal P, Dhruv D, Prasad DN and Monika: Formulation and evaluation of sustained release matrix tablet of Metoprolol succinate by using xanthan gum and carbopol. Journal of Drug Delivery & Therapeutics 2019; 9(3-s):309-316.
28. Harika Ryakala, S. Dineshmohan, Alluri Ramesh, V. R. M. Gupta. Formulation and In Vitro Evaluation of Bilayer Tablets of Nebivolol Hydrochloride and Nateglinide for the Treatment of Diabetes and Hypertension. Journal of Drug Delivery, 2015, Article ID 827859, 14 pages.
29. Deore PD, Katti SA and Sonawane SS. Formulation and evaluation of sustain release matrix tablet of fluvoxamine maleate using Moringa oleifera gum. Int J Pharm Sci & Res 2021.12(7): 3879-86.
30. Rajeswari A, Rao BS, Bangaruthalli J and Sravya K. Formulation and Evaluation of Metformin hydrochloride and Gliclazide sustained release bilayer tablets: A combination therapy in management of Diabetes. International Journal of Applied Pharmaceutics 2021; 13 (5).
31. Kalpesh W, Sachin K, Mali KD, Satish KP and Dheeraj TB. Design and evaluation of bilayer tablets of glimepiride and metformin hydrochloride with the combination of hydrophilic and hydrophobic polymers by hot-melt extrusion of bilayer tablets of Glimepiride and metformin. Asian J Pharm Clin Res 2014. 7:300-304.
32. D. Rohini, S. Alexandar, and M. J. N. Chandrasekar, “Preparation and in vitro evaluation of sustained release tablet formulations of metformin HCL,” Asian Journal of Pharmaceutical and Clinical Research, vol. 5, no. 1, pp. 45–48, 2012.
33. G. H. Kumar, K. Jaganathan, R. S. Kumar, and P. Peruma, “Formulation and in-vitro evaluation of bilayer floating tablets of Metformin hydrochloride and Sitagliptin phosphate,” International Journal of Advanced Pharmaceutics, vol. 2, no. 2, pp. 64–81, 2012.
34. Indian Pharmacopoeia, Indian Pharmacopoeia, vol. 3, Worldwide Book Service, 2014.
35. United States Pharmacopoeia 34, vol. 3, pp. 3611–3614, 2011.