DEVELOPMENT OF SUSTAINED RELEASE ALOGLIPTIN TABLETS USING A MULTIPARTICULATES SYSTEM MADE OF BENTONITE

RASHAD M. KAOUD; ALHAMZA HOSHI  KHALAF; JAMAL ALYOUSSEF ALKRAD

doi:10.22159/ijap.2021v13i3.40664

Authors

RASHAD M. KAOUD Pharmacy Department, Ashur University College, Bagdad, Iraq
ALHAMZA HOSHI KHALAF Faculty of Pharmacy, Isra University, PO Box 22 and 23, Amman, Jordan
JAMAL ALYOUSSEF ALKRAD Faculty of Pharmacy, Isra University, PO Box 22 and 23, Amman, Jordan

DOI:

https://doi.org/10.22159/ijap.2021v13i3.40664

Keywords:

Bentonite, Alogliptin, Sustained-release, Montmorillonite

Abstract

Objective: This study was designed to evaluate the use of bentonite in the formulation of sustained-release tablets containing alogliptin benzoate after granulation.

Methods: Bentonite was used for preparing tablets after granulation. The prepared tablets were tested for their pharmacopeial requirements. Further, a high-performance liquid chromatography (HPLC) method was developed to assess the release pattern of alogliptin from the tablets. Besides, differential scanning calorimetry (DSC), fourier transform infrared spectroscopy (FTIR), and powder X-ray diffraction (XRD) were used for evaluating the compatibility the drugs and bentonite. Finally, the release from the tablets was tested using the paddle apparatus.

Results: The FTIR and DSC did not show any interaction between the drug and the excipient in contrast to the powder-XRD pattern, which showed a shift for montmorillonite crystal peak. This shift was interpreted by increasing in the spacing of the crystalline structure of montmorillonite. However, the results of pharmacopeial tests showed that the prepared tablets comply with the compendial requirements, In addition, the release profiles of these tablets with aid of hydroxypropyl methylcellulose (HPMC) as a binder revealed a sustained release of alogliptin. Furthermore, the fitting of release data showed that the release from these tablets followed Fickian diffusion that alogliptin released by diffusion from bentonite gel matrix.

Conclusion: Bentonite was successfully used for producing sustained-release tablets of alogliptin. However, maintaining the crystal structure of montmorillonite was essential for building the gel structure of bentonite and releasing the drug in a controlled manner.

Downloads

Download data is not yet available.

References

Teramachi H, Ohta H, Tachi T, Toyoshima M, Mizui T, Goto C, et al. Pharmacoeconomic analysis of DPP-4 inhibitors. Die Pharmazie 2013;68:909–15.

Christopher R, Covington P, Davenport M, Fleck P, Mekki QA, Wann ER, et al. Pharmacokinetics, pharmacodynamics, and tolerability of single increasing doses of the dipeptidyl peptidase-4 inhibitor alogliptin in healthy male subjects. Clin Ther 2008;30:513–27.

Chen X, Wen H, Park K. Challenges and new technologies of oral controlled release. In: Wen H, Park K. editors. Oral controlled release formulation design and drug delivery: Theory to Practice. New Jersey: Wily; 2010. p. 257-77.‏

Qiu Y, Zhang G, Wise DL. Research and development aspects of oral controlled-release dosage forms. In: L Wise DL. Editor. Handbook of pharmaceutical controlled release technology. New York: Marcel Dekker; 2000. p. 527-30.

Agarwal G, Agarwal S, Karar PK, Goyal S. Oral sustained-release tablets: an overview with a special emphasis on matrix tablet. Am J Adv Drug Delivery 2017;5:64-76.

Bhowmik D, Bhanot R, Kumar KP. Extended-release drug delivery-an effective way of novel drug delivery system. Res J Pharma Dosage Forms Tech 2018;10:233-44.‏

Zalte HD, Saudagar RB. Review on sustained release matrix tablet. Int J Pharm Biol Sci 2013;3:17-29.

Dash TR, Verma P. Matrix tablets: an approach towards oral extended-release drug delivery. Int J Pharm Sci Rev Res 2013;2:12-24.

Jaimini M, Kothari AH. Sustained-release matrix-type drug delivery system: a review. Drug Delivery Ther 2012;2:142-8.

Patel H, Panchal DR, Patel U, Brahmbhatt T, Suthar M. Matrix type drug delivery system: a review. J Pharm Sci Biosci Res 2011;1:143-51.

European council. European Pharmacopoeia. 4th ed. Strasbourg; 2002.

CFR-Code of Federal Regulations Title 21, Part 184. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1155. [Last accessed on 26 Dec 2020]

Ozcan AS, Ozcan A. Adsorption of acid dyes from aqueous solutions onto acid-activated bentonite. J Colloid Interface Sci 2004;276:39-46.

Lagaly G. Bentonites: adsorbents of toxic substances. In: Schwuger MJ, Haegel FH. editors. Surfactants and Colloids in the Environment. Darmstadt: Dr. Dietrich Steinkopff Verlag GmbH; 1994. p. 61–72.

Bai H, Jiang Y, Xu J. Preparation of ibuprofen dispersible tablets using purified bentonite as the disintegrants. Chinese J Hosp Pharm 2010;5:394–6.

Lin FH, Lee YH, Jian CH, Wong JM, Shieh MJ, Wang CY. A study of purified montmorillonite intercalated with 5-fluorouracil as drug carrier. Biomaterials 2002;23:1981-7.

Joshi GV, Kevadiya BD, Bajaj HC. Controlled release formulation of ranitidine-containing montmorillonite and Eudragit® E-100. Drug Dev Ind Pharm 2010;36:1046-53.

Bounabi L, Mokhnachi NB, Haddadine N, Ouazib F, Barille R. Development of poly(2-hydroxyethyl methacrylate)/clay composites as drug delivery systems of paracetamol. J Drug Delivery Sci Tech 2016;33:58–65.

Oliveira AS, Alcântara AC, Pergher SB. Bionanocomposite systems based on montmorillonite and biopolymers for the controlled release of olanzapine. Mater Sci Eng C 2017;75:1250-8.

Alkrad JA, Shmeis RA, Alshwabkeh I, Abazid H, Mohammad MA. Investigation of the potential application of sodium bentonite as an excipient in formulation of sustained-release tablets. Asian J Pharm Sci 2017;12:259-65.

Chen H, Aburub A, Sun CC. Direct compression tablet containing 99% active ingredient—a tale of spherical crystallization. J Pharm Sci 2019;108:1396-400.

Aulton ME. Pharmaceutics: the science of dosage form design. New York: Churchill Livingstone; 2002.

United States Pharmacopeia Convention. United States Pharmacopeia and National Formulary (USP 34-NF29). United States Pharmacopeia Convention; 2011.

Kothiya OM, Patel BA, Patel KN, Patel MM. Formulation and characterization of sustained release matrix tablets of ivabradine using 32 full factorial design. Int J Appl Pharm 2018;10:59-66.

Adedokun M, Onah BE, Attama AN. Physico-mechanical and release properties of sustained-release artesunate tablets in hydroxypropyl methylcellulose matrix. Int J Appl Pharm 2018;10:103-8.

Mishra B, Mohanty B. Once-daily immediate and extended-release bilayer tablets of etoricoxib: a study on the release kinetics. Int J Appl Pharm 2019;1:230-5.

Caglar B, Afsin B, Koksal E, Tabak A, Eren E. Characterization of unye bentonite after treatment with sulfuric acid. Quimica Nova 2013;36:955-9.

Caglar B, Afsin B, Tabak A, Eren E. Characterization of the cation-exchanged bentonites by XRPD, ATR, DTA/TG analyses and BET measurement. Chem Eng J 2009;149:242-8.

Senturk HB, Ozdes D, Gundogdu A, Duran C, Soylak M. Removal of phenol from aqueous solutions by adsorption onto organomodified tirebolu bentonite: Equilibrium, kinetic and thermodynamic study. J Hazard Mater 2009;172:353-62.

Carter JR, Hatcher MT, Di Carlo L. Quantitative analysis of quartz and cristobalite in bentonite clay-based products by X-ray diffraction. Anal Chem 1987;59:513-9.

Ravindra Reddy T, Kaneko S, Endo T, Lakshmi Reddy S. Spectroscopic characterization of bentonite. Laser Photonics Rev 2017;4:1-4.

Arita S. Characterization of bentonite by XRD and SEM-EDS and use to increase pH and color removal, Fe and organic substances in peat water. J Clean Energy Technol 2013;1:313-7.

Schiano S, Chen L, Wu CY. The effect of dry granulation on flow behaviour of pharmaceutical powders during die filling. Powder Technol 2018;337:78-83.

Cantor SL, Augsburger LL, Hoag SW, Gerhardt A. Pharmaceutical granulation processes, mechanism and the use of binders. In: Augsburger LL, Hoag SW. editors. Pharmaceutical dosage forms: tablets 3rd ed. London: CRC Press; 2008. p. 261-302.

Rojek B, Wesolowski M. DSC supported by factor analysis as a reliable tool for compatibility study in pharmaceutical mixtures. J Therm Anal Calorim 2019;138:4531-9.

Pani NR, Nath LK, Acharya S, Bhuniya B. Application of DSC, IST, and FTIR study in the compatibility testing of nateglinide with different pharmaceutical excipients. J Therm Anal Calorim 2012;108:219-26.

Bendou S, Amrani M. Effect of hydrochloric acid on the structural of sodic-bentonite clay. J Miner Mater Charact Eng 2014;2:404-13.

Siepmann J, Peppas NAA. Modeling of drug release from delivery systems based on hydroxypropyl methylcellulose (HPMC). Adv Drug Delivery Rev 2012;64:163-74.‏

Gharti KP, Budhathoki U, Thapa P, Bhargava A. Formulation in vitro evaluation of floating tablets of hydroxypropyl methylcellulose and polyethylene oxide using ranitidine hydrochloride as a model drug. J Young Pharm 2012;4:201-8.

Gurny R, Doelker E, Peppas NA. Modelling of sustained release of water-soluble drugs from porous, hydrophobic polymers. Biomaterials 1982;3:27-32.‏

Paudel P, Noori MH, Poudel BK, Shakya S, Bhatta P, Lamichhane S. Influence of different grades and concentrations of hydroxypropyl methylcellulose on the release of metformin hydrochloride. World J Pharm Sci 2014;2:966-80.

Saravanan M, Nataraj KS, Ganesh KS. The effect of tablet formulation and hardness on in vitro release of cephalexin from Eudragit L100 based extended-release tablets. Biol Pharm Bull 2002;25:541-5.‏

Korosa W, Punsalanb D. Polymer glasses: diffusion in. In: Buschow KHJ, Flemings EJ, Kramer EJ, Veyssière P, Cahn RW, Ilschner B, et al. editors. Encyclopedia of materials: science and technology. 2nd ed. Chatillon: Pergamon; 2001. p. 7305-315.