DEVELOPMENT AND CHARACTERIZATION OF ORO-DISPERSIBLE TABLETS OF METFORMIN HYDROCHLORIDE USING CAJANUS CAJAN STARCH AS A NATURAL SUPERDISINTEGRANT

Authors

  • SONIA DHIMAN Chitkara College of Pharmacy, Chitkara University, Punjab, 140401, India https://orcid.org/0000-0002-0385-4808
  • RITCHU BABBAR Chitkara College of Pharmacy, Chitkara University, Punjab, 140401, India https://orcid.org/0000-0002-5418-7646
  • THAKUR GURJEET SINGH Chitkara College of Pharmacy, Chitkara University, Punjab, 140401, India
  • SHIVANGI ANAND Chitkara College of Pharmacy, Chitkara University, Punjab, 140401, India
  • ASHI MANNAN Chitkara College of Pharmacy, Chitkara University, Punjab, 140401, India https://orcid.org/0000-0003-0040-0103
  • SANDEEP ARORA Chitkara College of Pharmacy, Chitkara University, Punjab, 140401, India

DOI:

https://doi.org/10.22159/ijap.2022v14i1.42904

Keywords:

Metformin hydrochloride, Cajanus cajan starch, Oro-dispersible Tablets, Sodium starch glycolate, superdisintegrant.

Abstract

Objective: The aim of the research work was to explore the use of Cajanus cajan (Pigeon pea) polysaccharide as a superdisintegrant. The novel superdisintegrant has been evaluated for its action by incorporating it into oro-dispersible tablets of Metformin Hydrochloride.

Methods: Cajanus cajan starch was extracted from its seeds and superdisintegrant was developed by microwave modification of the extract. Various characterization tests such as gelatinization temperature, water absorption index, pH, and viscosity were used to identify the microwave-modified polysaccharide. The orodispersible tablets were made using a direct compression process employing varying concentrations of modified Cajanus cajan starch. Prepared tablets were tested for several pre and post compression parameters and compared with a well-established synthetic superdisintegrant, sodium starch glycolate. The stability studies were conducted on an optimized formulation.

Results: Fourier transform infrared spectroscopy study showed that the drug had no interactions with the microwave-modified Cajanus cajan starch. SEM confirmed that Cajanus cajan starch granules exhibited intact granular structure in oval shapes and smooth surfaces. After microwave modification, the Cajanus cajan starch component lost its granular structure, which further led to the generation of surface pores and internal channels causing overall swelling responsible for superdisintegrant activity. The optimized formulation (ODF5) containing 15 % modified Cajanus cajan starch performed better in terms of wetting time (22.21 s), disintegration time (53.3 s), and in vitro drug release (92%), as compared to formulation prepared by synthetic superdisintegrant (ODF1).

Conclusion: The present investigation concluded that modified Cajanus cajan starch has good potential as a superdisintegrant for formulating oro-dispersible tablets. Furthermore, modified Cajanus cajan starch is inexpensive, non-toxic and compatible incomparison with available synthetic superdisintegrants.

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References

Dhiman S, Singh TG, Dharmila PP. Mouth dissolving tablets: as a potential drug delivery system-a review. Int J Pharm Sci Rev Res 2011;11:85-94.

Midha K, Nagpal M, Aggarwal G, Singh TG. Development of dispersible self-microemulsifying tablet of atorvastatin. Pharm Methods 2015;6:09-25.

Mahesparan VA, Bin Abd Razak FS, Ming LC, Uddin AH, Sarker MZ, Bin LK. Comparison of Disintegrant-addition Methods on the Compounding of Orodispersible Tablets. Int J Pharm Compd 2020;24:148-155.

Mushtaq M, Fazal N, Niaz A. Formulation and Evaluation of Fast-disintegrating Tablets of Flurbiprofen and Metoclopramide. J Pharm Innov 2020;1-20.

Ghosh D, Singh SK, Khursheed R, Pandey NK, Kumar B, Kumar R, et al. Impact of solidification on micromeritic properties and dissolution rate of self-nanoemulsifying delivery system loaded with docosahexaenoic acid. Drug Dev Ind Pharm 2020;46:597-605.

Wasilewska K, Ciosek-Skibińska P, Lenik J, Srčič S, Basa A, Winnicka K. Utilization of Ethylcellulose Microparticles with Rupatadine Fumarate in Designing Orodispersible Minitablets with Taste Masking Effect. Materials 2020;13:2715.

Swarnalatha N, Maravajhala V. Formulation, In Vitro, And In Vivo Evaluation of Taste-Masked Oral Disintegrating Tablets Of Fexofenadine Hydrochloride Using Semisynthetic And Natural Super disintegrants. Int J Appl Pharm 2021;99-108.

Iurian S, Dinte E, Iuga C, Bogdan C, Spiridon I, Barbu-Tudoran L, et al. The pharmaceutical applications of a biopolymer isolated from Trigonella foenum-graecum seeds: Focus on the freeze-dried matrix forming capacity. SPJ 2017;25:1217-1225.

Sankhyan A, Pawar PK. Metformin loaded non-ionic surfactant vesicles: optimization of formulation, effect of process variables and characterization. DARU J Pharm Sci 2013;21:1-8.

Wu N, Fu K, Fu YJ, Zu YG, Chang FR, Chen YH, et al. Antioxidant activities of extracts and main components of pigeonpea [Cajanus cajan (L.) Millsp.] leaves. Molecules 2009;14:1032-1043.

Kumar H, Bajpai VK, Dubey RC, Maheshwari DK, Kang SC. Wilt disease management and enhancement of growth and yield of Cajanus cajan (L) var. Manak by bacterial combinations amended with chemical fertilizer. Crop Prot. 2010;9:591-598.

Zu YG, Liu XL, Fu YJ, Wu N, Kong Y, Wink M. Chemical composition of the SFE-CO2 extracts from Cajanus cajan (L.) Huth and their antimicrobial activity in vitro and in vivo. Phytomedicine 2010;17:1095-101.

Gulsun T, Akdag Y, Izat N, Cetin M, Oner L, Sahin S. Development and Characterization of Metformin Hydrochloride-and Glyburide-Containing Orally Disintegrating Tablets. Pharm Dev Technol 2020;25:999-1009.

Thakur G, Singh A, Singh I. Chitosan-montmorillonite polymer composites: formulation and evaluation of sustained release tablets of aceclofenac. Sci Pharm 2016;84:603-617.

Vanbillemont B, Everaert H, De Beer T. New advances in the characterization of lyophilised orally disintegrating tablets. Int J Pharm 2020;579.

Dhaliwal SK, Talukdar A, Gautam A, Sharma P, Sharma V, Kaushik P. Developments and Prospects in Imperative Underexploited Vegetable Legumes Breeding: A Review. Int J Mol Sci 2020;21.

Sun X, Ohanenye IC, Ahmed T, Udenigwe CC. Microwave treatment increased protein digestibility of pigeon pea (Cajanus cajan) flour: Elucidation of underlying mechanisms. Food Chem 2020;329.

Ogoda Onah J, Akubue PI, Okide GB. The kinetics of reversal of pre‐sickled erythrocytes by the aqueous extract of Cajanus cajan seeds. Phytother Res 2002;16:748-750.

Maninder K, Sandhu KS, Singh N. Comparative study of the functional, thermal and pasting properties of flours from different field pea (Pisum sativum L.) and pigeon pea (Cajanus cajan L.) cultivars. Food Chem 2007;104:261-267.

Hoover R, Swamidas G, Vasanthan T. Studies on the physicochemical properties of native, defatted, and heat-moisture treated pigeon pea (Cajanus cajan L) starch. Carbohydr Res 1993;246:185.

Pawar H, Varkhade C, Jadhav P, Mehra K. Development and evaluation of orodispersible tablets using a natural polysaccharide isolated from Cassia tora seeds. Integr Med Res 2014;3:91-98.

Sivadasan D, Sultan MH, Madkhali O, Javed S, Jabeen, A. Formulation and in vitro evaluation of orodispersible tablets of fexofenadine hydrochloride. Trop J Pharm Res 2020;19:919-925.

Rao AHOP, Kumar RS, Kandukuri S, Ramya, M. 2021. Optimization Of Starch Glycolate as Novel Super disintegrant In The Formulation Of Glipizide Fast Dissolving Tablets Through 23factorial Design. Int J Appl Pharm 2021; 244-251.

Gajera KG, Raval AG. Formulation and evaluation of orodispersible tablets of paliperidone. Int J Pharm Biol Sci Arch 2019;7:175-178.

Subhranshu P. Formulation and Evaluation of Metoprolol Succinate Orodispersible Tablets Using Directly Compressible Coprocessed Excipient of Moringa Gum. AJP 2020;14.

Vijayanand P, Patil JS, Reddy MV. Formulation and comparative pharmacokinetic evaluation of orodispersible tablets and films of nebivolol hydrochloride.

Int J Pharm Investig 2015;45:237-47.

Dhiman S, Singh TG. Design and optimization of floating matrix tablets of famotidine by central composite design. Asian J Pharm Clin Res 2012;5:45-9.

Kumari N, Sharma R. An Immediate Release tablet of Carvedilol with Natural Superdisintegrants Fenugreek seed Mucilage and synthetic Superdisintegrants. AJPTech 2020;10:156-164.

Bala R, Sharma S. Formulation and Evaluation of Fast Dissolving Tablet of Aprepitant by using natural and synthetic superdisintegrants. Int J App Pharm 2020;64-71

Huanbutta K, Yunsir A, Sriamornsak P, Sangnim T. Development and in vitro/in vivo evaluation of tamarind seed gum-based oral disintegrating tablets after fabrication by freeze drying. J Drug Deliv Sci Technol 2019;54.

Kumari N, Sharma R. An Immediate Release tablet of Carvedilol with Natural Superdisintegrants Fenugreek seed Mucilage and synthetic Superdisintegrants. Asian J Pharm Tech 2020;10:156-164.

Tashan E, Karakucuk A, Celebi N. Development of Nanocrystal Ziprasidone Orally Disintegrating Tablets: Optimization by Using Design of Experiment and In Vitro Evaluation. AAPS PharmSciTech 2020;21:1-2.

Mazzo DJ. The ICH stability guideline. In International Stability Testing. CRC Press;2020:1-13.

Singh K, Sharma S. Development And Characterization Of Orodispersible Tablets Of Propranolol Hydrochloride Using Calcium Cross-Linked Cassia Fistula Gum And Cross Carmellose Sodium. International Journal of Applied Pharmaceutics 2020;160-169.

Pawar H, Varkhade C, Jadhav P, Mehra K. Development and evaluation of orodispersible tablets using a natural polysaccharide isolated from Cassia tora seeds. Integr Med Res 2014;3(2):91-98. doi: 10.1016/j.imr.2014.03.002.

Panda SA, Hemalatha N, Shankar PU, Baratam SR. Formulation and evaluation of orodispersible tablets (ODTS) of diclofenac sodium by using superdisintegrant from natural origin. Int J App Pharm 2019;11(6):190-7.

Oliveira LJ, Veiga A, Stofella NCF, Cunha AC, da Graça T Toledo M, Andreazza IF, Murakami FS. Development and Evaluation of Orodispersible Tablets Containing Ketoprofen. Curr Drug Deliv. 2020;17(4):348-360. doi: 10.2174/1567201817666200317122807. PMID: 32183668.

Manda P, Popescu C, Juluri A, Janga K, Kakulamarri PR, Narishetty S, Narasimha Murthy S, Repka MA. Micronized Zaleplon Delivery via Orodispersible Film and Orodispersible Tablets. AAPS PharmSciTech. 2018;19(3):1358-1366. doi: 10.1208/s12249-017-0924-9. Epub 2018 Jan 19. PMID: 29352403.

Published

22-11-2021

How to Cite

DHIMAN, S., BABBAR, R., SINGH, T. G., ANAND, S., MANNAN, A., & ARORA, S. (2021). DEVELOPMENT AND CHARACTERIZATION OF ORO-DISPERSIBLE TABLETS OF METFORMIN HYDROCHLORIDE USING CAJANUS CAJAN STARCH AS A NATURAL SUPERDISINTEGRANT. International Journal of Applied Pharmaceutics, 14(1). https://doi.org/10.22159/ijap.2022v14i1.42904

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