Formulation development and evaluation of controlled release matrix tablets of glibenclamide

Year 2023, Volume: 6 Issue: 1, 34 - 55, 01.07.2023

Biji Palatty Praveen Raj Daiay Pa Boby Johns .g

https://doi.org/10.54994/emujpharmsci.1215120

Abstract

The present study aimed to formulate and evaluate the controlled-release matrix tablets of Glibenclamide which is an antidiabetic drug that belongs to the second-generation oral hypoglycemics. Matrix tablets were prepared by three different polymers as sustained-release agents, using Glibenclamide as a model drug. Three polymers were selected for this study- HPMC K 15, HPMC K 100, and EC in different drug: polymer ratios. The drug was identified by FTIR spectroscopic method. The pre-compression and post-compression parameters of all formulations were found to be within acceptable limits. The release rate of Glibenclamide from matrix tablets was studied using the USP Dissolution Testing Apparatus type-I (Basket method). The formulation F6 which contained EC 50mg showed a maximum release of 99.28% in 24 hrs and revealed that EC was more effective in sustaining the drug release therefore formulation F6 was selected as the optimized formulation. The in-vitro release data of optimized formulation was fit into various kinetic models, among the different model's data of in-vitro release of best fit into Zero order kinetic model. The formulation best fit the Higuchi model and showed that drug release from the prepared matrix tablets occurs via a diffusion process.

Keywords

Glibenclamide, HPMC, Controlled release, Matrix Tablet

References

• Adepu S, Ramakrishna S (2021). Controlled Drug Delivery Systems: Current Status and Future Directions. Molecules (Basel, Switzerland) 26(19): 5905.
• Adriana IS (2019). Preformulation: The use of FTIR in compatibility studies- review. Journal of Innovations in Applied Pharmaceutical Science 4(3): 01-06.
• Ajit K, Trushali M, Nagesh A (2017). Application of novel natural polymer for controlling the release of fenoverine from controlled release matrix tablets. Int J Appl Pharm 9(2):1-9.
• Ashok KN, Hadida H, Mohamed IN, Wan AWI (2001). Development of a High-Performance Liquid Chromatographic Method for Analysis of Glibenclamide from Dissolution Studies: Malaysian Journal of Pharmacy (MJP): 29-34.
• Bhavani B, Kamala PV, Chowdary KPR (2012). Formulation and evaluation of glipizide sustained release tablets. International Journal of Pharmaceutical and biomedical Research 3(1): 44-48.
• Brian LF (2007). Glibenclamide. xPharm: The Comprehensive Pharmacology Reference, 1-5.
• Girish KT, Satyawan S, Baljee VP (2013). U.V. spectroscopy technique for analysis to clarithromycin for gastric pH sensitive formulation. Journal of Chemical and Pharmaceutical Research 5(12):1258-1262.
• Harnish P, Dhrupesh R, Panchal UP, Tushar B, Mayur S (2011). Matrix Type Drug Delivery System: A Review. Journal of Pharmaceutical Science and Bioscientific Research 1(3): 143-151.
• Hindustan A, Harinath R, Sreenivasulu R, Kishore KRB, Chandrasekhar A, Krishna MCH, Sushma K, Sairam T (2016). Formulation and evaluation of glipizide prosophiscumanensis fruit mucilage and povidone sustained release matrix tablets. International Journal of Pharmaceutical Research and Innovation 2: 17-21.
• Indian Pharmacopoeia. 2014, Volume 2. The Indian Pharmacopoeia Commission, Ghaziabad. 1860- 1863. Lisik A, Musiał W (2019). Conductomeric Evaluation of the release kinetics of active substances from pharmaceutical preparations containing iron ions. Materials (Basel) 12(5):730. Mahajan PSC, Mahajan,.Mishra DK (2011). Valsartan release from sustained release matrix tablet and effect of cellulose derivatives. Int J of Pharm & Life Sci 2(1): 521-530.
• Malan SF, Chetty DJ, Plessis J (2002). Physicochemical properties of drugs and membrane permeability. South African Journal of Science 98: 385- 391.
• Morin G, Briens L (2013). The effect of lubricants on powder flowability for pharmaceutical application. AAPS PharmSciTech. 14(3):1158-1168.
• Nish S, Mathew G, Lincy J (2012). Matrix Tablets: An Effective Way for Oral Controlled Release Drug Delivery. Iranian Journal of Pharmaceutical Sciences 8(3): 165-170.
• Nokhodchi A, Raja S, Patel P, Asare-Addo K (2012). The role of oral controlled release matrix tablets in drug delivery systems. Bioimpacts. 2012; 2(4):175-87.
• Ouhaddouch HA, Cheikh MOB, Idrissi M, Draoui M (2019). "FT-IR Spectroscopy Applied for Identification of a Mineral Drug Substance in Drug Products: Application to Bentonite", Journal of Spectroscopy.
• Rajeshwar V, Sarada PS, Purnachander K, Ram-Naresh CH, Venkateswara CH (2013). Formulation and in vitro evaluation of sustained release Tablets of carvedilol. International Journal of Research in Pharmaceutical and Nano Sciences 2(2): 221 - 233.
• Sajid KS, Kamran AC, Rooh U, Zahid H, Majid KS, Shafiq R, Farhad U (2013). Formulation development and evaluation of domperidone sustained release matrix tablets by two different methods using guar gum as a sustaining agent. World Appl Sci Journal 25(12): 1704-1712.
• Sarika P, Ashutosh B, Deepak S (2013). Sustained release matrix technology and recent advance in matrix drug delivery system: a review. International Journal of Drug Research and Technology 3(1):12-20.
• Shantveer V, Salger L, Shivanandhiremath A (2010). Preparation and evaluation of sustained release matrix tablets of propranolol hydrochloride. International Journal of Pharma and Bio Sciences 1(4): 227- 241.
• Sirisolla J, Ramanamurthy KV (2015). Formulation and Evaluation of Cefixime Trihydrate Matrix Tablets Using HPMC, Sodium CMC, Ethyl Cellulose. Indian J Pharm Sci 77(3):321-7.
• Tanbir A, Moynul H, Ishtiaq A, & Muhammad RS (2011). Effect of granulation technique and drug-polymer ratio on release kinetics of gliclazide from methocel k15M CR matrix tablet. International Journal of Pharmaceutical Sciences and Research 2(4): 1063-1068.
• The International Pharmacopoeia - Sixth Edition, 2016.
• Trevor MJ (2018). Preformulation Studies (Chapter 1) in Pharmaceutical Formulation. The Science and Technology of Dosage Forms, 1-41.