Saravanakumar K., Durga Srinivasa Rao M., Kothapalli Bannoth Chandrasekhar
Saravanakumar K.1*, Durga Srinivasa Rao M.2, Kothapalli Bannoth Chandrasekhar3
1Professor and Head, Dept. of Pharmaceutics, Sree Vidyanikethan College of Pharmacy, A. Rangampet, Sree Sainath Nagar, Tirupati-517102, Chittoor (Dist.), A.P., India.
2Research Scholar, Dept. of Pharmaceutical Sciences, JNTU Anantapur, Anantapur- 515002, A.P., India.
3Professor, Dept. of Chemistry and Director, Foreign Affairs and Alumni Matters, JNTU Anantapur, Anantapur- 515002, A.P., India.
Volume - 14,
Issue - 1,
Year - 2021
Aim and Objectives: The aim of the current study is to study the effect of combination of synthetic and natural polymers in extending the release of Tolperisone HCl (TH) from its effervescent Floating Tablets (FT), which can extend its release up to 12 h. Methods: The drug- excipient compatibility studies of TH and the polymers used in the study were carried by FTIR studies. THFT were prepared by direct compression method. All batches were evaluated for pre-compression, post-compression and in vitro buoyancy studies. Accelerated stability studies were performed for the optimized formulation THFT11 as per ICH guidelines. Results and Discussion: The drug-excipient compatibility studies reveal that TH and the polymers used for the study are compatible. Pre- and post-compression parameters were within the acceptable limits for all formulations. In vitro dissolution studies showed the formulation THFT11 (6.25% w/w sodium alginate and 18.75% w/w HPMC K100M) had extended the release of TH up to 12 h, with a floating lag time (FLT) of 58 ± 0.71 sec, total floating time (TFT) and matrix integrity (MI) maintained up to 12 h, hence it is selected as an optimized one. In vitro drug release kinetics of optimized THFT11; suggests the drug release follows zero order profile (r2=0.988), drug release is predominantly by diffusion and the release mechanism is by super case-II transport. DSC and FT-IR studies of TH and accelerated stability samples of F11 further confirmed the drug is in the same state as pure TH. Accelerated stability studies of optimized THFT11; indicates it passes the test for stability as per ICH guidelines. Conclusion: Finally, it was concluded that an optimized effervescent THFT was formulated and evaluated with the combination of synthetic and natural polymers.
Cite this article:
Saravanakumar K., Durga Srinivasa Rao M., Kothapalli Bannoth Chandrasekhar. Combination Effect of Natural and Synthetic Polymers in Extending the Release of Tolperisone HCl from its Effervescent Floating Tablets. Research J. Pharm. and Tech. 2021; 14(1):171-178. doi: 10.5958/0974-360X.2021.00030.5
Saravanakumar K., Durga Srinivasa Rao M., Kothapalli Bannoth Chandrasekhar. Combination Effect of Natural and Synthetic Polymers in Extending the Release of Tolperisone HCl from its Effervescent Floating Tablets. Research J. Pharm. and Tech. 2021; 14(1):171-178. doi: 10.5958/0974-360X.2021.00030.5 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-1-30
1. S Vijaya Kumar, Manoj Kumar Deka, Manish Bagga, M Sasi Kala, Guru Sharan. A Systematic Review on Floating Drug Delivery System. Res. J. Pharm. and Tech. 2011; 4 (1): 19-25.
2. Nirav Patel, Nagesh C., Chandrashekhar S., Patel Jinal, Jani Devdatt. Floating drug delivery system: An innovative acceptable approach in Gastro retentive drug delivery. Asian J. Pharm. Res. 2012; 2(1): 07-18.
3. Rajesh Mujoriya , Ramesh Babu Bodla. A Overview on Study of Floating Drug Delivery Systems. Res. J. Pharm. Dosage Forms and Tech. 2012; 4(1): 01-13.
4. Nirav Patel, Nagesh C., Chandrashekhar S., Patel Jinal, Jani Devdatt. Floating drug delivery system: An innovative acceptable approach in gastroretentive drug delivery. Res. J. Pharma. Dosage Forms and Tech. 2012; 4(2): 93-103.
5. Swapnil T. Deshpande, P. S. Vishwe, Rohit D. Shah, Swati S. Korabu, Bhakti R. Chorghe, DG Baheti. Floating Drug Delivery Systems: A Novel Approach towards Gastroretentive Drug Delivery Systems. Res. J. Pharma. Dosage Forms and Tech. 2013; 5(4): 191-201.
6. Zope Janhavi S., Sonawane Pradnya L., Darekar A. B., Saudagar R.B. A Comprehensive Review on Gastro-Retentive Floating Drug Delivery Systems. Asian J. Pharm. Res. 2015; 5(4): 211-20.
7. Gunjan L. Zope, A. B. Darekar, R. B. Saudagar. Glimpse of Floating Drug Delivery in Pharmaceutical Formulations: A Review. Asian J. Pharm. Res. 2016; 6(1): 31-38.
8. Sarika S. Lokhande. Recent Trends in Development of Gastro-Retentive Floating Drug Delivery System: A Review. Asian J. Res. Pharm. Sci. 2019; 9(2): 91-96.
9. Agam Vora. Tolperisone-Drug review. J. Assoc. Physicians of India. 2010; 58(2):127-28.
10. Ashok Thulluru, M. Mohan Varma, C. M. Setty. Formulation and in vitro Evaluation of Tolperisone HCl Gastro retentive floating tablets. J pharm chem. 2016; 10(2): 31-38.
11. Cooper J, Gunn C, Powder flow and compaction, In: Carter SJ, eds. Tutorial Pharmacy. New Delhi, India: CBS Publishers and Distributors; 1986; 211-233.
12. Aulton M.E., Wells T.I., Pharmaceutics: The Science of Dosage Form Design, London, England: Churchill Livingstone; 1988.
13. Leon Lachman, Herbert A. lieberman, Joseph L. kanic, The Theory and Practice of Industrial pharmacy, Varghese publishing house,3rd Ed., p: 293-345.
14. Remington, The Science and Practice of Pharmacy, 19th Ed., Vol. I, P: 1669-70.
15. United States Pharmacopoeia 30, National Formulary 25, USP Convention, Rockville 2007, p. 2648.
16. Rosa M., Zia H., Rhodes T. Dosing and in vitro testing of a bioadhesive and floating drug delivery system for oral application. Int J. Pharm. 1994; 105: 65-70.
17. Suvakanta Dash, Padala Narasimha Murthy, Lilakanta Nath and Prasanta Chowdhury. Kinetic modeling on drug release from controlled drug delivery systems. Acta Poloniae Pharmaceutica - Drug Research, 2010; 67(3): 217-23.
18. Higuchi T. Mechanism of sustained action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J. Pharm. Sci.1963; 52: 1145-1149.
19. Korsmeyer RW, Gurny R, Doelker E, Buri P and Peppas NA. Mechanisms of solute release from porous hydrophilic polymers. Int. J. Pharm.1983; 15: 25-35.
20. Ashok Thulluru, M. Mohan Varma, C. Mallikarjuna Setty, Ch. Pavan Kumar, S. Sri Harsha Vardhan. Effect of Sodium Alginate in Combination with HPMC K 100 M in Extending the Release of Metoprolol Succinate from its Gastro-Retentive Floating Tablets. Indian J Pharm Edu Res. 2015; 49 (3): 250-59.
21. Ashok Thulluru, M. Mohan Varma, C. M. Setty, Ch. Pavan Kumar and S. Sriharsha Vardhan. Formulation and Evaluation of Gastro-Retentive Floating Extended Release Metoprolol Tablets using Sodium Alginate and HPMC K-100M. Int J Pharm Sci Nanotech. 2015; 8(3): 2947-54.
23. Ankita U. Patel, Dipti V. Caudhari, Pranav J. Shah and Shailesh A. Shah. Hot melt granulation method for the preparation of floating matrix tablets of Tolperisone Hydrochloride. Future Journal of Pharmaceutical Sciences. 2018; 4(2): 139-49.
24. Manisha Kumari, Prasanjit Paul and Nitin Kumar. A research on formulation and evaluation of floating microspheres of tolperisone hydrochloride. World Journal of Pharmaceutical Research. 2018; 7(19): 1165-98.
25. Ashok Thulluru, Janga Mary Sushma. Optimization of HPMC K100M and HPMC K4M Ratio in Extending the Release of Valacyclovir HCl from its Gastro Retentive Floating Tablet. Inventi Rapid: Novel Excipients. 2016 (1): 1-8, 2015.
26. Ashok Thulluru, S. Shakir Basha, C. Bhuvaneswara Rao, Ch. S. Phani Kumar, Nawaz Mahammed, K. Saravanakumar. Optimization of HPMC K100M and sodium alginate ratio in Metronidazole Floating Tablets for the Effective Eradication of Helicobacter pylori. Asian J Pharm. Tech. 2019; 9(3): 195-203.
27. K. Sarvanakumar, Ashok Thulluru, Ramu Samineni, M. Ishwarya, Pommala Nagaveni and Nawaz Mahammed. Effect of Sodium Alginate in Combination with Natural and Synthetic Polymers on the Release of Verapamil HCl from its Floating Microspheres. J Pharm Sci Res. 2019; 11(5): 2028-35.
28. Ashok Thulluru, M. Mohan Varma, C. M. Setty, A. Anusha, P. Chamundeeswari, Sk. Sanufar. Formulation, in vitro and in vivo Evaluation of Pioglitazone Hydrochloride - Effervescent Gastro Retentive Floating Hydrophilic Matrix Tablets. Int J Pharm Tech Res. 2016; 9(7): 388-98.