FORMULATION AND INVITRO EVALUATION OF VENLAFAXINE MATRIX TABLETS USINGGUM KONDAGOGU AS EXCIPIENT

Authors

  • ANIL KUMAR DINDIGALA Raghavendra Institute of Pharmaceutical Education and Research, Anantapur-515721, Andhra Pradesh, India https://orcid.org/0000-0001-6485-8493
  • SURYAPRAKASH REDDY CHAPPIDI Department of Pharmaceutics, Annamacharya College of Pharmacy, New Boyanapalli, Rajampet, Annamayya Dt-516126, Andhra Pradesh, India https://orcid.org/0000-0001-6485-8493
  • ANANTHA MAKINENI Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chandramoulipuram, Chowdavaram, Guntur-522019, India https://orcid.org/0009-0002-2063-445X

DOI:

https://doi.org/10.22159/ijap.2025v17i1.52292

Keywords:

Gum Kondagogu, Venlafaxine HCl, Sodium Alginate, Zinc Acetate, Matrix Tablets, Controlled release

Abstract

Objective: A naturally obtained Gum Kondagogu (GK) investigated as a novel matrix-forming material for sustained drug delivery using Venlafaxine HCl (VH) as a model drug.

Methods: The VH tablets were prepared with different concentrations of GK along with other excipients such as sodium alginate and zinc acetate. The compressed tablets were then evaluated for pre-compression parameters, including flow properties, and post-compression parameters, such as hardness, friability, and drug content uniformity. Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC) studies were conducted to assess potential interactions between the excipients and the drug. Additionally, the lead formulation underwent accelerated stability studies at 40 ± 2°C / 75 ± 5% RH for 3 months to evaluate the stability and consistency of drug release.

Results: The compressed tablets of VH with GK were found to have acceptable pre- and post-compression parameters. Among the various formulations tested, the one containing 0.25%w/v of GK, 0.3% of sodium alginate, and 0.3% of zinc acetate demonstrated a release profile closely matching that of a commercial tablet dosage form. FTIR and DSC studies confirmed that there were no interactions between the excipients and the drug. The lead formulation-maintained stability over 3 months of accelerated stability studies, with no significant changes in drug release observed during this period.

Conclusion: GK has shown potential as a controlled release agent for oral dosage forms, particularly for drugs like VH. The formulation containing 0.25%w/v of GK, 0.3% of sodium alginate, and 0.3% of zinc acetate exhibited a release profile similar to that of a commercial product and maintained stability under accelerated conditions. These findings suggest that GK could be a viable option for developing control release oral formulations.

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References

Silva NDC, Silva CJT, Gonçalves MP,BorsagliFGLM. Carboxymethyl-cellulose-based hydrogels incorporated with cellulose nanocrystals loaded with vitamin D for controlled drug delivery. Processes 2024, 12, 1437. https://doi.org/10.3390/pr12071437.

Ijaz F, Tahir HM, Ali S, Ali A, Khan HA, Muzamil A, Manzoor HH, Qayyum KA. Biomolecules based hydrogels and their potential biomedical applications: A comprehensive review. Int J Biol Macromol. 2023;253:127362. DOI: 10.1016/j.ijbiomac.2023.127362.

Cai Y, Xin L, Li H, Sun P, Liu C, Fang L. Mussel-inspired controllable drug release hydrogel for transdermal drug delivery: Hydrogen bond and ion-dipole interactions. J. Control. Release 2024, 365, 161–175.https://doi.org/10.1016/j.jconrel.2023.11.016

Kamalakkannan V, Sivaprakash R, Venkatraman P, Sambath KR, Arul Kumaran KSG. Design and development of sustained release matrix tablets of tramadol hydrochloride using gum kondagogu as a natural polymer. Scholars Acad. J. Pharm. 2015, 4(3), 199-207.

Lee TWY, Robinson JR. Controlled-release drug-delivery systems. In: The Science and Practice of Pharmacy; 2001; 1:903.

Harris R, Paños I, Acosta N, Heras A. Preparation and characterization of chitosan microspheres for controlled release of tramadol. J. Control. Release 2008, 132(3), e76-e77.

Venlafaxine extended-release tablets (venlafaxine hydrochloride) extended-release tablets for oral use initial U.S. approval: 1993 package insert. U.S. Food and Drug Administration. 2023. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022104s023lbl.pdf.

Ganesh KY, Sreekanth J, Satyavati D, Chaitanya P, Swetha B. Formulation design and in vitro evaluation of sustained release matrix tablets of losartan potassium using HPMC polymers. Int. J. PharmTech Res. 2013, 5(3), 1332-1344.

ChandanaCH, Ganesh KY, Vamshi VY, Minnu MM. Metoprolol succinate sustained release matrix tablets - Formulation development and in-vitro evaluation. Int. J. Pharm. Pharm. Sci. 2014, 6(7), 481-486.

Vikas SG, Ganesh KY, Chandana CH, Kashyap JASK. Formulation design, development and evaluation of gastroretentive floating matrix tablets of cefpodoxime proxetil using different polymers. J. Pharma Res. 2014, 3(7), 137-141.

Gondikar SV, Ganesh KY, ChandanaCH,BhajanlalB. Effect of polymers and their combinations on gastroretentive and floating property of cefpodoxime proxetil matrix tablets. J. Sci. Res. Pharm. 2014, 3(3), 81-85.

Ganesh GNK, SureshKR, Jawahar N, Senthil V, Venkatesh DN, Srinivas MS. Preparation and evaluation of sustained release matrix tablet of diclofenac sodium using natural polymer. J. Pharm. Sci. Res. 2010, 2(6), 360-368.

Malviya R, Srivastava P, Bansal V, Sharma PK. Formulation, evaluation and comparison of sustained release matrix tablets of diclofenac sodium using natural polymers as release modifier. Int. J. Pharma Bio Sci. 2010, 1(1), 1-8.

Prakash D, Arora V, Dewangan HK. A Systematic Review Of The Application Of Natural Polymers In The Formulation Of Oro-Dispersible Tablet. International Journal of Applied Pharmaceutics, 2023, 15(5), 27–36. https://doi.org/10.22159/ijap.2023v15i5.48183.

VinodVPT, Sashidhar R. Surface morphology, chemical and structural assignment of gum kondagogu (Cochlospermumgossypium D.C): An exudates tree gum of India. Indian J. Nat. Prod. Resour. 2010, 1, 181-192.

Janaki B, Sashidhar RB. Physico-chemical analysis of gum kondagogu (Cochlospermumgossypium): A potential food additive. Carbohydr. Polym. 2009, 76, 464-471.

Rathore HS,Sarubala M, Ramanathan G, SingaraveluS, Raja MD, Gupta S, et al. Fabrication of biomimetic porous novel sponge from gum kondagogu for wound dressing. Mater. Lett. 2016, 177, 108-111.

Butani SB. Development and optimization of venlafaxine hydrochloride sustained release triple-layer tablets adopting quality by design approach. Pharmacol. Pharm. 2013, 4, 9–16. https://doi.org/10.4236/pp.2013.43A002.

Bamba M,Puisievx F, Marty JP, Carstensen JT. Release mechanism in gel forming sustained release formulations. Int. J. Pharm. 1979, 2(5-6), 307-311. doi:10.1016/0378-5173(79)90037-1.

Prasannaraju Y,Asnutha G,Satyanandam S, Ramana Murthy KV. A study on physical characterization of Hupu gum, a natural polysaccharide for pharmaceutical use. J. Innov. Pharm. Sci. 2011, 2(6), 174-183.

Emami J, Tajeddin M, Ahmadi F. Preparation and in vitro evaluation of sustained-release matrix tablets of flutamide using synthetic and naturally occurring polymers. Iran. J. Pharm. Res. 2008, 7(4), 247-257.

Ford JL, Mann TE. Fast-scan DSC and its role in pharmaceutical physical form characterization and selection. Adv. Drug Deliv. Rev. 2012, 64, 422-430.

Ilett KF,Haccett LP,Dusci LJ, Roberts MJ, Kristensen JH, Paech M, Groves A.Distribution and excretion of venlafaxine and o-desmethyl venlafaxine in human milk. Br. J. Clin. Pharmacol. 1998, 45(5), 459-462.

Qin XY, Meng J, Li XY, Zhou J, Sun XL, Wen AD. Determination of venlafaxine in human plasma by high-performance liquid chromatography using cloud-point extraction and spectrofluorimetric detection. J. Chromatogr. 2008, 872(1, Suppl 2), 38-42.

He J, Zhou Z, Li H. Simultaneous determination of fluoxetine, citalopram, paroxetine, and venlafaxine in plasma by high performance liquid chromatography-electrospray ionization mass spectrometry. J. Chromatogr. 2005, 820(1), 33-39.

Baldania SL, Bhatt KK, Mehta RS, Shah DA, Gandhi TR. RP-HPLC estimation of venlafaxine HCl in tablet dosage forms. Indian J. Pharm. Sci. 2008, 70(1), 124-128.

Samanidou VF, Kourti PV. Rapid HPLC method for the simultaneous monitoring of duloxetine, venlafaxine, fluoxetine, and paroxetine in bio fluids. Bioanalysis 2009, 1(5), 905-917.

British Pharmacopoeia. Volume II; 2008; p. 2242.

European Pharmacopoeia. Volume II; 2008; 6th ed.; p. 3184.

Ganesh KY, Sreekanth J, Satyavati D. Formulation design and development of sustained release matrix tablets of vildagliptin by using different grades of carbopol and eudragit. J. Chem. Pharm. Res. 2015, 7(5), 1213-1224.

Ganesh KY, Sreekanth J, Satyavati D. Formulation and evaluation parameters of sustained release matrix tablets of vildagliptin using different grades of carbopol and eudragit. Int. J. Chem. Pharm. Res. 2014, 6(1), 201-209.

Hall A, Reiss R, Stumpf RA, Wong Y, Park SS, Meyer EA, Johnson DE. Controlled release of venlafaxine from matrix tablets. Pharmaceutics 2019, 11, 123.

HerreroVR, MedinaM, MartinezR, Alvarez J, Martinez F. Controlled release of venlafaxine from polyelectrolyte multilayer microspheres. Investig. Ophthalmol. Vis. Sci. 2006, 47, 3895-3901.

Alam S, Amlan B, Bratati B. Formulation And Evaluation Of Metformin Hydrochloride Sustained Release Matrix Tablets. International Journal of Current Pharmaceutical Research, vol. 13, no. 5, Sept. 2021, pp. 82-88, doi:10.22159/ijcpr.2021v13i5.1899.

Dash TK,Konkimalla VB. Polymeric controlled drug delivery systems: Applications, issues, and challenges. J. Control. Release 2012, 164(2), 235-250.

Ashwin K, Ram MRT. In Vivo Evaluation Of Quinapril Trilayered Matrix Tablets. Asian Journal of Pharmaceutical and Clinical Research, vol. 14, no. 7, July 2021, pp. 117-25, doi:10.22159/ajpcr.2021.v14i7.42002.

Ram D, Himanshu P. Formulation, Evaluation And Optimization Of Sustained-Release Drug Delivery System Of Cisapride Tablet. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 13, no. 9, Sept. 2021, pp. 56-62, doi:10.22159/ijpps.2021v13i9.41799.

Machado MC, Meurer RH, Figueiredo AC, De Oliveira EA, Santos EM. Structural, mechanical and biological evaluations of chitosan-based hydrogels for drug delivery. Colloids Surf. B Biointerfaces 2013, 111, 334-342.

Matricardi P,Alhaique F, Laurienzo P. Polymeric systems for controlled release of drugs: A review. J. Control. Release 2020, 321, 165-177.

Tushar DF, Vijay RP, Tushar AD.Evaluation of vateria indica modified gum as a release retardant matrix in the tablet dosage form. Int J Pharm Pharm Sci, Vol 15, Issue 4, 28-32. DOI: https://doi.org/10.22159/ijpps.2023v15i4.47329.

McCarron PA, Weller CD, Armstrong RW, Grice JE, Roberts MS. Design and evaluation of hydrogel-based sustained release systems for drugs in topical and transdermal delivery. Carbohydr. Polym. 2010, 82(2), 391-397.

Published

26-10-2024

How to Cite

DINDIGALA, A. K., CHAPPIDI, S. R., & MAKINENI, A. (2024). FORMULATION AND INVITRO EVALUATION OF VENLAFAXINE MATRIX TABLETS USINGGUM KONDAGOGU AS EXCIPIENT. International Journal of Applied Pharmaceutics, 17(1). https://doi.org/10.22159/ijap.2025v17i1.52292

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