Hostname: page-component-78c5997874-s2hrs Total loading time: 0 Render date: 2024-11-17T18:24:42.409Z Has data issue: false hasContentIssue false

Formulation and release kinetics of ibuprofen–bentonite tablets

Published online by Cambridge University Press:  29 November 2022

Jamal Alyoussef Alkrad*
Affiliation:
Faculty of Pharmacy, Department of Applied Pharmaceutical Sciences and Clinical Pharmacy, Isra University, PO Boxes 22 and 23, Amman, Jordan
Sind Al-Sammarraie
Affiliation:
Faculty of Pharmacy, Department of Applied Pharmaceutical Sciences and Clinical Pharmacy, Isra University, PO Boxes 22 and 23, Amman, Jordan
Eman Zmaily Dahmash
Affiliation:
School of Life Sciences, Pharmacy and Chemistry, Department of Chemical and Pharmaceutical Sciences, Kingston University, Surrey KT1 2EE, UK
Nidal A. Qinna
Affiliation:
University of Petra Pharmaceutical Center (UPPC), Faculty of Pharmacy and Medical Sciences, University of Petra, PO Box 961344, Amman 11196, Jordan
Abdallah Y. Naser
Affiliation:
Faculty of Pharmacy, Department of Applied Pharmaceutical Sciences and Clinical Pharmacy, Isra University, PO Boxes 22 and 23, Amman, Jordan

Abstract

Bentonite-based tablets offer multiple advantages over other types of formulated tablets, including being biocompatible and cost-effective, and they can be used to develop gel-like matrices that have potential for use in sustained-release formulations. Developing a high-load sustained-release formulation has been reported to be challenging; therefore, the aim of this study was to develop systematically bentonite-based sustained-release tablets for a high-load active agent (ibuprofen) and investigate their release kinetics. Ibuprofen-loaded tablets (800 mg) were prepared using wet and dry granulation followed by enteric coating of the tablets. Fourier-transform infrared spectroscopy, differential scanning calorimetry and X-ray powder diffraction were used to evaluate the compatibility of ibuprofen with bentonite. The results show that these tablets comply with compendial requirements. In addition, the release profile of the formulations reveals that the drug follows a non-Fickian release model. The present formulation demonstrates a new use of bentonite as a safe and cost-effective excipient with adequate binding and compaction for preparing sustained-release tablets.

Type
Article
Copyright
Copyright © The Author(s), 2022. Published by Cambridge University Press on behalf of The Mineralogical Society of Great Britain and Ireland

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

Accepted Manuscript online: 29 November 2022; Associate editor: Zhou Chun-Hui

References

Agarwal, G., Agarwal, S., Karar, P. & Goyal, S. (2017) Oral sustained release tablets: an overview with a special emphasis on matrix tablet. American Journal of Advanced Drug Delivery, 5, 6477.Google Scholar
Alkrad, J.A., Abu Shmeis, R., Alshwabkeh, I., Abazid, H. & Mohammad, M.A. (2017) Investigation of the potential application of sodium bentonite as an excipient in formulation of sustained release tablets. Asian Journal of Pharmaceutical Sciences, 12, 259265.CrossRefGoogle ScholarPubMed
Aulton, M.E. & Taylor, K. (2013) Aulton's Pharmaceutics: The Design and Manufacture of Medicines. Elsevier Health Sciences, Amsterdam, The Netherlands, 908 pp.Google Scholar
Bechgaard, H. & Nielsen, G.H. (1978) Controlled-release multiple-units and single-unit doses a literature review. Drug Development and Industrial Pharmacy, 4, 5367.CrossRefGoogle Scholar
Bendou, S. & Amrani, M. (2014) Effect of hydrochloric acid on the structural of sodic–bentonite clay. Journal of Minerals and Materials Characterization and Engineering, 2, 404413.CrossRefGoogle Scholar
Boek, E.S., Coveney, P.V. & Skipper, N.T. (1995) Monte Carlo molecular modeling studies of hydrated Li-, Na-, and K-smectites: understanding the role of potassium as a clay swelling inhibitor. Journal of the American Chemical Society, 117, 1260812617.CrossRefGoogle Scholar
Bruschi, M.L., editor (2015a) Mathematical models of drug release. Pp. 6386 in: Strategies to Modify the Drug Release from Pharmaceutical Systems. Woodhead Publishing, Sawston, UK.Google Scholar
Bruschi, M.L., editor (2015b) Strategies to Modify the Drug Release from Pharmaceutical Systems. Woodhead Publishing, Sawston, UK, 199 pp.Google Scholar
Cao, Q.-R., Choi, J.-S., Liu, Y., Xu, W.-J., Yang, M., Lee, B.-J. & Cui, J.-H. (2013) A formulation approach for development of HPMC-based sustained release tablets for tolterodine tartrate with a low release variation. Drug Development and Industrial Pharmacy, 39, 17201730.Google ScholarPubMed
Chakraborty, S., Pandit, J.K. & Srinatha, A. (2009) Development of extended release divalproex sodium tablets containing hypdrophobic and hydrophilic matrix. Current Drug Delivery, 6, 291296.CrossRefGoogle ScholarPubMed
Chaw, C.S., Yazaki, E. & Evans, D.F. (2001). The effect of pH change on the gastric emptying of liquids measured by electrical impedance tomography and pH-sensitive radiotelemetry capsule. International Journal of Pharmaceutics, 227, 167175.CrossRefGoogle ScholarPubMed
Chen, X., Wen, H. & Park, K. (2010). Challenges and new technologies of oral controlled release. Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice, 16, 257277.CrossRefGoogle Scholar
Council of Europe, editor (2003) European Pharmacopoeia: Monograph Chromatographic Separation Techniques (4th edition). European Directorate for the Quality of Medicine & Health Care of the Council of Europe, Strasbourg, France.Google Scholar
Dash, S., Murthy, P.N., Nath, L. & Chowdhury, P. (2010) Kinetic modeling on drug release from controlled drug delivery systems. Acta Poloniae Pharmaceutica, 67, 217223.Google ScholarPubMed
Dziadkowiec, J., Mansa, R., Quintela, A., Rocha, F. & Detellier, C. (2017) Preparation, characterization and application in controlled release of ibuprofen-loaded guar gum/montmorillonite bionanocomposites. Applied Clay Science, 135, 5263.CrossRefGoogle Scholar
Evonik (2021) EUDRAGIT® L 30 D-55 specification and test methods. Retrieved from https://www.stobec.com/DATA/PRODUIT/1598~v~data_8595.pdfGoogle Scholar
FDA (2021) Code of Federal Regulations Title 21 – Sec. 184.1155 Bentonite. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=184.1155Google Scholar
Franc, A. Vetchý D., Vodáčková, P., Kubal’ák, R., Jendryková, L. & Goněc, R. (2018) Co-processed excipients for direct compression of tablets: společně zpracované pomocné látky pro přímé lisování tablet. Česká a Slovenská Farmacie, 67, 175181.Google Scholar
Gao, P., Nixon, P.R. & Skoug, J.W. (1995) Diffusion in HPMC gels. II. Prediction of drug release rates from hydrophilic matrix extended-release dosage forms. Pharmaceutical Research, 12, 965971.Google ScholarPubMed
García-Guzmán, P., Medina-Torres, L., Calderas, F., Bernad-Bernad, M. J., Gracia-Mora, J., Mena, B. & Manero, O. (2018) Characterization of hybrid microparticles/montmorillonite composite with raspberry-like morphology for atorvastatin controlled release. Colloids and Surfaces B: Biointerfaces, 167, 397406.Google ScholarPubMed
Gattermann, J., Wittke, W. & Erichsen, C. (2001) Modelling water uptake in highly compacted bentonite in environmental sealing barriers. Clay Minerals, 36, 435446.CrossRefGoogle Scholar
Ghosal, K., Chakrabarty, S. & Nanda, A. (2011) Hydroxypropyl methylcellulose in drug delivery. Der Pharmacia Sinica, 2, 152168.Google Scholar
Gökalp, Z., Başcsaran, M. & Uzun, O. (2011) Compaction and swelling characteristics of sand–bentonite and pumice–bentonite mixtures. Clay Minerals, 46, 449459.CrossRefGoogle Scholar
González-Santamaría, D.E., Fernández, R., Ruiz, A.I., Ortega, A. & Cuevas, J. (2020) High-pH/low pH ordinary Portland cement mortars impacts on compacted bentonite surfaces: application to clay barriers performance. Applied Clay Science, 193, 105672.Google Scholar
Haoue, S., Derdar, H., Belbachir, M. & Harrane, A. (2020) Polymerization of ethylene glycol dimethacrylate (EGDM), using an Algerian clay as eco-catalyst (maghnite-H+ and Maghnite-Na+). Bulletin of Chemical Reaction Engineering & Catalysis, 15, 221230.CrossRefGoogle Scholar
Hun Kim, M., Choi, G., Elzatahry, A., Vinu, A., Bin Choy, Y. & Choy, J.-H. (2016) Review of clay–drug hybrid materials for biomedical applications: administration routes. Clays and Clay Minerals, 64, 115130.Google Scholar
ICH (2005) Validation of analytical procedures: text and methodology Q2(R1). Presented at: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdfGoogle Scholar
Ikhtiyarova, G.A., Özcan, A.S., Gök, Ö. & Özcan, A. (2012) Characterization of natural- and organobentonite by XRD, SEM, FT-IR and thermal analysis techniques and its adsorption behaviour in aqueous solutions. Clay Minerals, 47, 3144.Google Scholar
Joshi, G.V, Kevadiya, B.D. & Bajaj, H.C. (2010) Controlled release formulation of ranitidine-containing montmorillonite and Eudragit® E-100. Drug Development and Industrial Pharmacy, 36, 10461053.CrossRefGoogle ScholarPubMed
Kalaleh, H.-A., Tally, M. & Atassi, Y. (2013) Preparation of a clay based superabsorbent polymer composite of copolymer poly (acrylate-co-acrylamide) with bentonite via microwave radiation. Research & Reviews on Polymer, 4, 145150.Google Scholar
Karaborni, S., Smit, B., Heidug, W., Urai, J. & Van Oort, E. (1996) The swelling of clays: molecular simulations of the hydration of montmorillonite. Science, 271, 11021104.CrossRefGoogle Scholar
Klech, C.M. & Simonelli, A. P. (1989) Examination of the moving boundaries associated with non-Fickian water swelling of glassy gelatin beads: effect of solution pH. Journal of Membrane Science, 43, 87101.CrossRefGoogle Scholar
Koros, W. & Punsalan, D. (2001) Glasses: Diffusion in. Pp. 73057315 in: Encyclopedia of Materials: Science and Technology, 2nd edition (Buschow, K.H.J., Cahn, R.W., Flemings, M.C., Ilschner, B., Kramer, E.J., Mahajan, S. & Veyssière, P., editors). Elsevier Science Ltd, Amsterdam, The Netherlands.CrossRefGoogle Scholar
Laity, P.R., Asare-Addo, K., Sweeney, F., Šupuk, E. & Conway, B.R. (2015) Using small-angle X-ray scattering to investigate the compaction behaviour of a granulated clay. Applied Clay Science, 108, 149164.CrossRefGoogle Scholar
Li, C., Wang, M., Liu, Z., Xu, Y., Zhou, C. & Wang, L. (2021) Kaolinite-armoured polyurea microcapsules fabricated on Pickering emulsion: controllable encapsulation and release performance of a lipophilic compound. Clay Minerals, 56, 4654.CrossRefGoogle Scholar
Macías-Quiroga, I.F., Giraldo-Gómez, G.I. & Sanabria-González, N.R. (2018) Characterization of Colombian clay and its potential use as adsorbent. The Scientific World Journal, 2018, 5969178.Google ScholarPubMed
Mallick, S., Pattnaik, S., Swain, K., De, P. K., Saha, A., Mazumdar, P. & Ghoshal, G. (2008) Physicochemical characterization of interaction of ibuprofen by solid-state milling with aluminum hydroxide. Drug Development and Industrial Pharmacy, 34, 726734.CrossRefGoogle ScholarPubMed
Matusewicz, M., Pirkkalainen, K., Liljeström, V., Suuronen, J.-P., Root, A., Muurinen, A. et al. (2013) Microstructural investigation of calcium montmorillonite. Clay Minerals, 48, 267276.CrossRefGoogle Scholar
Mouzon, J., Bhuiyan, I.U. & Hedlund, J. (2016) The structure of montmorillonite gels revealed by sequential cryo-XHR-SEM imaging. Journal of Colloid and Interface Science, 465, 5866.Google ScholarPubMed
Narashimhan, B., Mallapragada, S.K. & Peppas, N.A. (1999) Release kinetics, data interpretation. Pp. 921934 in: Encyclopedia of Controlled Drug Delivery (1st edition) (Mathiowitz, E., editor). Wiley-Interscience, Hoboken, NJ, USA.Google Scholar
Nutting, P.G. (1943) The Action of Some Aqueous Solutions on Clays of the Montmorillonite Group. US Government Printing Office, Washinton, DC, USA, 25 pp.Google Scholar
Olsson, H. & Nyström, C. (2001) Assessing tablet bond types from structural features that affect tablet tensile strength. Pharmaceutical Research, 18, 203210.CrossRefGoogle ScholarPubMed
Pergher, S.B.C., Oliveira, A.S. & Alcântara, A. (2017) Bionanocomposite systems based on montmorillonite and biopolymers for the controlled release of olanzapine. Materials Science and Engineering: C: Materials for Biological Applications, 75, 12501258.Google Scholar
Ramukutty, S. & Ramachandran, E. (2012) Growth, spectral and thermal studies of ibuprofen crystals. Crystal Research and Technology, 47, 3138.CrossRefGoogle Scholar
Saravanan, M., Nataraj, K.S. & Ganesh, K.S. (2002) The effect of tablet formulation and hardness on in vitro release of cephalexin from Eudragit L100 based extended release tablets. Biological and Pharmaceutical Bulletin, 25, 541545.CrossRefGoogle ScholarPubMed
Senturk, H.B., Ozdes, D., Gundogdu, A., Duran, C. & Soylak, M. (2009) Removal of phenol from aqueous solutions by adsorption onto organomodified Tirebolu bentonite: equilibrium, kinetic and thermodynamic study. Journal of Hazardous Materials, 172, 353362.Google ScholarPubMed
Sharma, A.K., Mortensen, A., Schmidt, B., Frandsen, H., Hadrup, N., Larsen, E.H. & Binderup, M.-L. (2014) In-vivo study of genotoxic and inflammatory effects of the organo-modified montmorillonite Cloisite® 30B. Mutation Research/Genetic Toxicology and Environmental Mutagenesis, 770, 6671.Google ScholarPubMed
Tabak, A. (2009) Structural analysis of reactive dye species retained by the basic alumina surface. Journal of Thermal Analysis and Calorimetry, 95, 3136.Google Scholar
Tantishaiyakul, V. (2004) Prediction of aqueous solubility of organic salts of diclofenac using PLS and molecular modeling. International Journal of Pharmaceutics, 275, 133139.CrossRefGoogle ScholarPubMed
Timmins, P., Delargy, A.M., Howard, J.R. & Rowlands, E.A. (1991) Evaluation of the granulation of a hydrophilic matrix sustained release tablet. Drug Development and Industrial Pharmacy, 17, 531550.Google Scholar
Tudja, P., Khan, M.Z.I., Meštrovic, E., Horvat, M. & Golja, P. (2001) Thermal behaviour of diclofenac sodium: decomposition and melting characteristics. Chemical and Pharmaceutical Bulletin, 49, 12451250.CrossRefGoogle ScholarPubMed
USP-35 (2011) The United States Pharmacopeia: The National Formulary: USP 35 NF (30th edition). United States Pharmacopeia, Rockville, MD, USA, 5089 pp.Google Scholar
Van Olphen, H. (1953). Interlayer forces in bentonite. Clays and Clay Minerals, 2, 418438.CrossRefGoogle Scholar
Wahab, A., Khan, G.M., Akhlaq, M., Khan, N.R., Hussain, A., Zeb, A. & Shah, K.U. (2011) Pre-formulation investigation and in vitro evaluation of directly compressed ibuprofen–ethocel oral controlled release matrix tablets: a kinetic approach. African Journal of Pharmacy and Pharmacology, 5, 21182127.Google Scholar
Wen, H. & Park, K. (2011) Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice. John Wiley & Sons, Hoboken, NJ, USA, 376 pp.Google Scholar
Willhite, C.C., Ball, G.L. & McLellan, C.J. (2012) Total allowable concentrations of monomeric inorganic aluminum and hydrated aluminum silicates in drinking water. Critical Reviews in Toxicology, 42, 358442.CrossRefGoogle ScholarPubMed
Youssef, A.M., Al-Awadhi, M.M. & Akl, M.A. (2014) Solid phase extraction and spectrophotometric determination of methylene blue in environmental samples using bentonite and acid activated bentonite from Egypt. Journal of Analytical & Bioanalytical Techniques, 5, 18.Google Scholar