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Original Research

Physicochemical properties and drug-release mechanisms of dual-release bilayer tablet containing mirabegron and fesoterodine fumarate

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Pages 2459-2474 | Published online: 23 Jul 2019

References

  • Chapple, CR, Nazir J, Hakimi Z. et al. Persistence and adherence with mirabegron versus antimuscarinic agents in patients with overactive bladder: a retrospective observational study in UK clinical practice. Eur Urol. 2017;72(3):389–399. doi:10.1016/j.eururo.2017.01.03728196724
  • Abrams, P., Kelleher C, Staskin D. et al. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015;67(3):577–588. doi:10.1016/j.eururo.2014.02.01224612659
  • Kadekawa, K., Sugaya K, Nishijima S. et al. Effects of combination treatment with fesoterodine and mirabegron on urinary bladder functions of pelvic congestion model in rats. in neurourology and urodynamics. 111 River St, Hoboken 07030-5774, NJ, USA: Wiley-Blackwell; 2016.
  • Michel MC. Fesoterodine: a novel muscarinic receptor antagonist for the treatment of overactive bladder syndrome. Expert Opin Pharmacother. 2008;9(10):1787–1796. doi:10.1517/14656566.9.10.178718570610
  • Matsuzaki N, Yamamoto Y, Murayama D, et al. Evaluation of maltose-induced chemical degradation at the interface of bilayer tablets. Chem Pharm Bulletin. 2017;65(5):478–486. doi:10.1248/cpb.c16-00929
  • Abebe A, Akseli I, Sprockel O, Kottala N, Cuitiño AM. Review of bilayer tablet technology. Int J Pharm. 2014;461(1–2):549–558. doi:10.1016/j.ijpharm.2013.12.02824370841
  • Panchal HA, Tiwari AK. A novel approach of bilayer tablet technology: a review. Int Res J Pharm. 2012;3(5):44–49.
  • Chapple C, Van Kerrebroeck P, Tubaro A, et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007;52(4):1204–1212. doi:10.1016/j.eururo.2007.07.00917651893
  • Chapple CR, Kaplan SA, Mitcheson D, et al. Mirabegron 50 mg once‐daily for the treatment of symptoms of overactive bladder: an overview of efficacy and tolerability over 12 weeks and 1 year. Int J Urol. 2014;21(10):960–967. doi:10.1111/iju.1256825092441
  • Göpferich A. Polymer bulk erosion. Macromolecules. 1997;30(9):2598–2604. doi:10.1021/ma961627y
  • Bose A, Wong TW, Singh N. Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics. Saudi Pharm J. 2013;21(2):201–213. doi:10.1016/j.jsps.2012.03.00623960836
  • Bagde, SB, Bakde BV, Channawar MA, Chandewar AV. Formulation and evaluation of bi layer tablet of metoprolol succinate and Ramipril. Int J Pharm Pharm Res. 2011;6:1416–1428.
  • Van Nguyen H, Nguyen VH, Lee B-J. Dual release and molecular mechanism of bilayered aceclofenac tablet using polymer mixture. Int J Pharm. 2016;515(1–2):233–244. doi:10.1016/j.ijpharm.2016.10.02127744034
  • Jun, H, Lee HJ, Shin BS, Park CW. Preparation and in vivo characterization of dual release tablet containing sarpogrelate hydrochloride. J Pharm Invest. 2018;48(3):363–372. doi:10.1007/s40005-017-0330-z
  • Coffel J, Gandhi S, Nuxoll E. Unified polymer erosion model for pulsatile drug delivery. J Memb Sci. 2016;512:61–72. doi:10.1016/j.memsci.2016.03.055
  • Kazarian SG, Chan KA. “Chemical photography” of drug release. Macromolecules. 2003;36(26):9866–9872. doi:10.1021/ma035210l
  • Ribar T, Bhargava R, Koenig JL. FT-IR imaging of polymer dissolution by solvent mixtures. 1. Solvents. Macromolecules. 2000;33(23):8842–8849. doi:10.1021/ma000851r
  • Coutts-Lendon C, Wright NA, Mieso EV, Koenig JL. The use of FT-IR imaging as an analytical tool for the characterization of drug delivery systems. J Control Release. 2003;93(3):223–248.14644574
  • van der Weerd J, Chan KA, Kazarian SG. An innovative design of compaction cell for in situ FT-IR imaging of tablet dissolution. Vib Spectrosc. 2004;35(1–2):9–13. doi:10.1016/j.vibspec.2003.11.004
  • Hashem FM, Nasr M, Fathy G, Ismail A. Formulation and in vitro and in vivo evaluation of lipid-based terbutaline sulphate bi-layer tablets for once-daily administration. AAPS PharmSciTech. 2016;17(3):727–734. doi:10.1208/s12249-015-0404-z26335420
  • Tambe ST,, Padekar HB, Dhobale SM, Jadhav SL. Design and characterisation of bi-layer tablets containing simvastatin as sustained release and labetalol HCl as immediate release. J Drug Deliv Ther. 2019;9(2 Suppl):263–270.
  • Aryal S, Škalko-Basnet N. Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types. Acta Pharmaceutica. 2008;58(3):299–308. doi:10.2478/v10007-008-0012-519103566
  • Vaithiyalingam SR, Sayeed VA. Critical factors in manufacturing multi-layer tablets—assessing material attributes, in-process controls, manufacturing process and product performance. Int J Pharm. 2010;398(1–2):9–13. doi:10.1016/j.ijpharm.2010.07.02520656000
  • Gurny R, Doelker E, Peppas N. Modelling of sustained release of water-soluble drugs from porous, hydrophobic polymers. Biomaterials. 1982;3(1):27–32.7066463
  • Higuchi T. Mechanism of sustained‐action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci. 1963;52(12):1145–1149.14088963
  • Hixson A, Crowell J. Dependence of reaction velocity upon surface and agitation. Ind Eng Chem. 1931;23(8):923–931. doi:10.1021/ie50260a018
  • Uhrich KE, Cannizzaro SM, Langer RS, Shakesheff KM. Polymeric systems for controlled drug release. Chem Rev. 1999;99(11):3181–3198.11749514
  • Lamoudi L, Chaumeil JC, Daoud K. Swelling, erosion and drug release characteristics of sodium diclofenac from heterogeneous matrix tablets. J Drug Delivery Sci Technol. 2016;31:93–100. doi:10.1016/j.jddst.2015.12.005
  • Nep E, Asare-Addo K, Ghori MU, Conway BR, Smith AM. Starch-free grewia gum matrices: compaction, swelling, erosion and drug release behaviour. Int J Pharm. 2015;496(2):689–698. doi:10.1016/j.ijpharm.2015.10.07126536530
  • Chaibva FA, Khamanga SM, Walker RB. Swelling, erosion and drug release characteristics of salbutamol sulfate from hydroxypropyl methylcellulose-based matrix tablets. Drug Dev Ind Pharm. 2010;36(12):1497–1510. doi:10.3109/03639045.2010.48864820528615
  • Sriamornsak P, Thirawong N, Weerapol Y, Nunthanid J, Sungthongjeen S. Swelling and erosion of pectin matrix tablets and their impact on drug release behavior. Eur J Pharm Biopharm. 2007;67(1):211–219. doi:10.1016/j.ejpb.2006.12.01417267193
  • Yadav D, Survase S, Kumar N. Dual coating of swellable and rupturable polymers on Glipizide loaded MCC pellets for pulsatile delivery: formulation design and in vitro evaluation. Int J Pharm. 2011;419(1–2):121–130. doi:10.1016/j.ijpharm.2011.07.02621807081
  • Punčochová K, Ewing AV, Gajdošová M, et al. Identifying the mechanisms of drug release from amorphous solid dispersions using MRI and ATR-FTIR spectroscopic imaging. Int J Pharm. 2015;483(1–2):256–267. doi:10.1016/j.ijpharm.2015.02.03525686660
  • Hifumi H, Ewing AV, Kazarian SG. ATR-FTIR spectroscopic imaging to study the drying and dissolution of pharmaceutical polymer-based films. Int J Pharm. 2016;515(1–2):57–68. doi:10.1016/j.ijpharm.2016.09.08527720876
  • Grassi M, Grassi G. Mathematical modelling and controlled drug delivery: matrix systems. Curr Drug Deliv. 2005;2(1):97–116.16305412
  • Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic modeling on drug release from controlled drug delivery systems. Acta Pol Pharm. 2010;67(3):217–223.20524422
  • Chen S, Zhu J, Cheng J. Preparation and in vitro evaluation of a novel combined multiparticulate delayed-onset sustained-release formulation of diltiazem hydrochloride. Die Pharmazie-An Int J Pharm Sci. 2007;62(12):907–913.