DESIGNING, DEVLOPMENT AND EVALUATION OF GASTRORETENTIVE FLOATING HBS SYSTEM OF METFORMIN: IN VITRO IN VIVO STUDIES
DOI:
https://doi.org/10.22159/ijap.2024v16i5.51674Keywords:
Gastroretentive, Chitosan, Floating, HBS, FTIRAbstract
Objective: The main objective of this study is to formulate, characterized and evaluate the Medium Molecular Mass Chitosan (MMMCH) – Xanthan Gum (XG) based polymeric carrier mediate of non effervescent floating Hydrodynamically Balanced System (HBS) capsule of metformin for developed stomach specific sustain drug delivery over a prolong periods of time.
Methods: Different capsules of metformin were formulated by physical blending of metformin with polymeric mixture to encapsulate in 000 size single unit hard gelatine capsule than evaluate the different parameters like micromeritics properties, weight uniformity, drug content uniformity, in vitro drug release with their kinetics model, DSC and FTIR study, in vitro in vivo floating characteristic.
Results: After evaluating the characteristic properties it was clearly indicated that excellent value ranges, coefficient of weight variation in between 1.39-2.06%, content uniformity of drug in between 98.23-100.05%, in vitro drug release in between 60–80 % after 12h that can follow Korsmeyer-Peppas model to release the drug no-fickian diffusion method. FTIR and DSC study exhibit no much more incompatibility between drug and polymer and formation of electrolyte complex help to sustaining release over a prolong periods of time. In vitro and in vivo floatation study, it was clearly indicated that all formulation (especially MC4) floated in gastric content more than 12h without any floating lag time and excellent in vivo buoyancy by the help of x ray images of animal model by replacing the drug with barium sulphate.
Conclusion: So this type of formulation showing great gastroretentive floating drug delivery system in future with another drugs for a prolong periods of time.
Downloads
References
J. Lou, H. Duan, Q. Qin, Z. Teng, F. Gan, X. Zhou, X. Zhou, Advances in oral drug delivery systems: challenges and opportunities, Pharmaceutics 15 (2023) 484, https://doi.org/10.3390/pharmaceutics15020484.
M.S. Alqahtani, M. Kazi, M.A. Alsenaidy, M.Z. Ahmad, Advances in oral drug delivery, Front. Pharmacol. 12 (2021), 618411, https://doi.org/10.3389/fphar.2021.618411.
He S., Liu Z., Xu D. Advance in oral delivery systems for therapeutic protein. J. Drug Target. 2019; 27:283–291, doi: 10.1080/1061186X.2018.1486406.
S. Dhiman, N. Philip, T. Gurjeet Singh, R. Babbar, N. Garg, V. Diwan, P. Singh, An insight on novel approaches & perspectives for gastro-retentive drug delivery systems, Curr. Drug Deliv. 20 (2023) 708–729, https://doi.org/10.2174/ 1567201819666 220819200236.
M. J. Bhandwdwalkar, P. S. Dubal, A. K.Tupe, S. N. Mandrupkar, Review on Gastroretentive Drug Delivery system, Asian J Pharm Clin Res, 13, 12, 2020, 38-45, DOI: http://dx.doi.org/10.22159/ajpcr.2020.v13i12.37264.
P. K. Mohapatra, C. H. Satyavani, S. Sahoo, Design and Devlopment of Carvedilol Gastroretentive Floating Drug Delivery System using Hydrophillic Polymers and In vitro characterization, Int J Pharm Pharm Sci, 12, 7, 2020 66-73, DOI: http://dx.doi.org/10.22159/ijpps.2020v12i7.38024.
N. Desai, R. Purohit, Development of novel high density gastroretentive multiparticulate pulsatile tablet of clopidogrel bisulfate using quality by design approach, AAPS PharmSciTech 18 (2017) 3208–3218, https://doi.org/10.1208/ s12249-017-0805-2.
J. Malakar, A.K. Nayak, Floating bioadhesive matrix tablets of ondansetron HCl: Optimization of hydrophilic polymer-blends. Asian J. Pharm., 2013, 7, 174-183.
A.K. Nayak, D. Pal, Trigonella foenum-graecum L. seed mucilage-gellan mucoadhesive beads for controlled release of metformin HCl, Carbohydr. Polym. 107 (2014) 31–40, https://doi.org/10.1016/j.carbpol.2014.02.031.
A.Z. Juthi, F. Li, B. Wang, M.M. Alam, M.E. Talukder, B. Qiu, pH-responsive super-porous hybrid hydrogels for gastroretentive controlled-release drug delivery, Pharmaceutics 15 (2023) 816, https://doi.org/10.3390/pharmaceutics15030816.
R. A. A. Muzzarelli, Genipin-cross-linked chitosan hydrogels as biomedical and pharmaceutical aids. Carbohydr. Polym., 2009, 77,1-9, https://doi.org/10.1016/j.carbpol.2009.01.016.
Y. Zhou, N. Gu, F. Yang, In situ microbubble-assisted, ultrasound-controlled release of superparamagnetic iron oxide nanoparticles from gastro-retentive tablets, Int. J. Pharm. 586 (2020), 119615, https://doi.org/10.1016/j.ijpharm.2020.119615.
J. Siepmann, H. Kranz, R. Bodmeier, N. A. Peppas, HPMC matrices for controlled drug delivery: A new model combining diffusion, swelling and dissolution mechanisms and predicting the release kinetics. Pharm. Res., 1999, 16, 1748-1756, https://doi.org/10.1023/a:1018914301328.
L, Srinivas, S. Sagar, design, optimization and evluation of raft forming gastroretentive drug delivery system of lafutidine usingbox-behnken design, Int J App Pharm, 14, 1, 2022, 266-274, DOI: https://dx.doi.org/10.22159/ijap.2022v14i1.43358.
J. Malakar, A. K. Nayak, S. Goswami, Use of response surface methodology in the formulation and optimization of bisoprolol fumarate matrix tablets for sustained drug release. ISRN Pharm., 2012, doi: 10.5402/2012/730624.
J. Ali, S. Arora, A. Ahuja, A. K. Babbar, R. K. Sharma, R. K. Khar, S. Baboota. Formulation and development of hydrodynamically balanced system for metformin: In vitro and in vivo evaluation.Eur J Pharm Biopharm, 2007 Aug; 67(1):196-201.doi: 10.1016/j.ejpb.2006.12.01
A. Rajora, K. Nagpal, A critical review on floating tablets as a tool for achieving better gastric retention, Crit. Rev. Ther. Drug Carr. Syst. 39 (2022) 65–103, https://doi.org/10.1615/CritRevTherDrugCarrierSyst.2021038568.
J. Dubey, A. Verma, N. Verma, Evaluation of chitosan based polymeric matrices for sustained stomach specific delivery of propranolol hydrochloride. Indian J. Mater. Sci., 2015, DOI:10.1155/2015/312934.
A.K. Nayak, B. Das, R. Maji, Gastroretentive hydrodynamically balanced system of ofloxacin: formulation and in vitro evaluation, Saudi Pharm. J. 21 (2013) 113–117, https://doi.org/10.1016/j.jsps.2011.11.002.
D. B. Raju, R. Sreenivas and M. M. Varma. Formulation and evaluation of floating drug delivery system of Metformin Hydrochloride, J. Chem. Res., 2(2), 2010, 274-278.
A. Verma , A. K. Bansal, A. Ghosh, J. K. Pandit, Low molecular mass chitosan as carrier for a hydrodynamically balanced system for sustained delivery of ciprofloxacin hydrochloride. Acta Pharm., 2012, 62, 237-250, doi: 10.2478/v10007-012-0013-2.
N. Bhattarai, J. Gunn, M.Zhang, Chitosan-based hydrogels for controlled, localized drug delivery. Adv. Drug Deliv. Rev., 2010, 62, 83-99, doi: 10.1016/j.addr.2009.07.019.
A. Verma, J. Dubey, N. Verma, A.K. Nayak, Chitosan-hydroxypropyl methylcellulose matrices as carriers for hydrodynamically balanced capsules of moxifloxacin HCl, Curr. Drug Deliv. 14 (2017) 83–90, https://doi.org/10.2174/ 156720181 3666160504100842.
A.K. Azad, T. Bhattacharya, M.S. Hasnain, G. Tripathi, A.K. Nayak, Chitin- and chitosan-based nanomaterials for therapeutic applications, in: M.S. Hasnain, A. K. Nayak, T.M. Aminabhavi (Eds.), Polymeric Nanosystems, Theranostic Nanosystems, Academic Press, vol. 1, Elsevier Inc., United States, 2023, pp. 173–205.
D. Gugulothu, S. K. Choudhary, Design and In vitro Evaluation of floating drug delivery system of Glipizide using Combination of Natural Mucilages and Synthetic Polymers, Int J Pharm Pharm Sci,13,7, 2021 40-48, DOI: https://dx.doi.org/10.22159/ijpps.2021v13i7.41644.
S. Peers, A. Montembault, C. Ladavi`ere, Chitosan hydrogels for sustained drug delivery, J. Control. Release 326 (2020) 150–163, https://doi.org/10.1016/j. jconrel.2020.06. 012.
J. Patel, B. Maji, N.S.H.N. Moorthy, and S. Maiti, Xanthan gum derivatives: Review of synthesis, properties and diverse applications. RSC Adv. 2020; 10:27103–27136, doi: 10.1039/D0RA04366D.
S. Ray, S. Banerjee, S. Maiti, B. Laha, S. Barik, B. Sa, U. K. Bhattacharyya, Novel interpenetrating network microspheres of xanthan gum–poly(vinyl alcohol) for the delivery of diclofenac sodium to the intestine—In vitro and in vivo evaluation. Drug Deliv. 2010; 17: 508–519, doi: 10.3109/10717544.2010.483256.
M. S. Reddy, Z. Begum, Formulation and In vitro Evaluation of Gastroretentive In situ Floating Gels of Telmisarten Cubosomes, Int J Curr Pharm Res, Vol 14, Issue 1, 44-53, DOI: https://dx.doi.org/10.22159/ijcpr.2022v14i1.44111
J. Malakar, P. Dutta, S.D. Purokayastha, S. Dey, A.K. Nayak, Floating capsules containing alginate-based beads of salbutamol sulfate: in vitro-in vivo evaluations, Int. J. Biol. Macromol. 64 (2014) 181–189, https://doi.org/10.1016/j.ijbiomac. 2013.11.014.
Published
How to Cite
Issue
Section
Copyright (c) 2024 RADHESHYAM SAMANTA, GAURAV TIWARI, NAVEEN GUPTA, DHARMENDRA SINGH RAJPUT
![Creative Commons License](http://i.creativecommons.org/l/by/4.0/88x31.png)
This work is licensed under a Creative Commons Attribution 4.0 International License.