Development and evaluation of orally disintegrating tablets containing the mosapride resin complex

Open access

Abstract

The purpose of this study was to prepare a mosapride citrate-resin (Amberlite® IRP 88) complex and orally fast-disintegrating tablets of the resin complex. The resinate complex of mosapride-Amberlite® IRP 88, mass ratio 2:1, was prepared in an ethanol-water solution. The effects of alcohol concentration, temperature, and pH of the solution on complex formation were evaluated. The complex physicochemical properties were characterized by differential scanning calorimetry, X-ray diffraction and scanning electron microscopy. Orally disintegrating tablets were prepared by direct compression and were optimized using the response surface method. Optimized orally fast-disintegrating tablets disintegrated within 18 s. The pH dependence of mosapride release from the tablet decreased drug dissolution in simulated saliva, whereas it promptly released in the pH 1.0 solution. The data reported herein clearly demonstrate that tablets containing the mosapride-Amberlite® IRP 88 complex for oral disintegration could be particularly useful for patients with swallowing difficulties.

1. M. Ruth, B. Hamelin, K. Röhss and L. Lundell, The effect of mosapride, a novel prokinetic, on acid reflux variables in patients with gastro-oesophageal reflux disease, Aliment. Pharm. Ther. 12 (1998) 35–40; https://doi.org/10.1046/j.1365-2036.1998.00268.x

2. Y. Takayuki, T. Hiroaki, M. Atsushi, K. Masataka, S. Kazuhiro and U. Takahiro, Mechanism of controlled drug release from a salting-out taste-masking system, J. Control. Release 131 (2008) 47–53; https://doi.org/10.1016/j.jconrel.2008.07.009

3. A. Siddiqui, R. B. Shah and M. A. Khan, Oseltamivir phosphate-amberlite(TM) IRP 64 ioniccomplexfor taste masking: preparation and chemometric evaluation, J. Pharm. Sci. 102 (2013) 1800–1812; https://doi.org/10.1002/jps.23518

4. R. B. Shah, M. A. Tawakkul, V. A. Sayeed and M. A. Khan, Complexation between risperidone and amberlite resin by various methods of preparation and binding study, Drug Dev. Ind. Pharm. 35 (2009) 1409–1418; https://doi.org/10.3109/03639040902939247

5. Z. Z. Ge, M. Y. Yang, Y. L. Wang, L. Shan and C. S. Gao, Preparation and evaluation of orally disintegrating tablets of taste masked phencynonate HCl using ion-exchange resin, Drug Dev. Ind. Pharm. 41 (2015) 934–941; https://doi.org/10.3109/03639045.2014.914529

6. W. Samprasit, P. Opanasopit, P. Akkaramongkolporn, T. Ngawhirunpat, K. Wongsermsina and S. Panomsuka, Preparation and evaluation of taste-masked dextromethorphan oral disintegrating tablet, Pharm. Dev. Technol. 17 (2012) 315–320; https://doi.org/10.3109/10837450.2010.535828

7. E. Roblegg, P. Dittrich, K. Haltmeyer and A. Zimmer, Reformulation of a codeine phosphate liquid controlled-release product, Drug Dev. Ind. Pharm. 36 (2010) 1454–1462; https://doi.org/10.3109/03639045.2010.487870

8. M. Preis, L. Grother, P. Axe and J. Breitkreutz, In-vitro and in-vivo evaluation of taste-masked cetirizine hydrochloride formulated in oral lyophilisates, Int. J. Pharm. 491 (2015) 8–16; https://doi.org/10.1016/j.ijpharm.2015.06.002

9. C. P. Yewale, M. N. Rathib, G. G. Koreb, G. V. Jadhava and M. P. Wagha, Formulation and development of taste masked fast-disintegrating tablets (FDTs) of chlorpheniramine maleate using ion-exchange resins, Pharm. Dev. Technol. 18 (2013) 367–376; https://doi.org/10.3109/10837450.2011.627870

10. P. Akkaramongkolporn, T. Ngawhirunpat and P. Opanasopit, Preparation and evaluation of differently sulfonated styrene-divinylbenzene cross-linked copolymer cationic exchange resins as novel carriers for drug delivery, AAPS PharmSciTech. 10 (2009) 641–648; https://doi.org/10.1208/s12249-009-9259-5

11. A. Siddiqui, R. B. Shah and M. A. Khan, Oseltamivir phosphate-amberlite (TM) IRP 64 ionic complex for taste masking: Preparation and chemometric evaluation, J. Pharm. Sci. 102 (2013) 1800–1812; https://doi.org/10.10.1002/jps.23518

12. D. Shukla, S. Chakraborty, S. Singh and B. Mishra, Fabrication and evaluation of taste masked resinate of risperidone and its orally disintegrating tablets, Chem. Pharm. Bull. 57 (2009) 337–345; https://doi.org/10.1248/cpb.57.337

13. M. A. Tawakkul, R. B. Shah, A. Zidan, V. A. Sayeed and M. A. Khan, Complexation of risperidone with a taste-masking resin: Novel application of near infra-red and chemical imaging to evaluate complexes, Pharm. Dev. Technol. 14 (2009) 409–421; https://doi.org/10.1080/10837450802712666

14. V. K. Suhagiya, A. N. Goyani and R. N. Gupta, Taste masking by ion exchange resin and its new applications: A review, Int. J. Pharm. Sci. Res. 1 (2010) 22–37; https://doi.org/10.13040/IJPSR.0975-8232.1(4).22-37

15. S. Patra, R. Samantaray, S. Pattnaik and B. Barik, Taste masking of Etoricoxib by using ion-exchange resin, Pharm. Dev. Technol. 15 (2010) 511–517; https://doi.org/10.3109/10837450903322787

16. A. Solaiman, A. S. Suliman, S. Shinde, S. Naz and A. A. Elkordy, Application of general multilevel factorial design with formulation of fast disintegrating tablets containing croscarmellose sodium and Disintequick MCC-25, Int. J. Pharm. 501 (2016) 87–95; https://doi.org/10.1016/j.ijpharm.2016.01.065

17. M. Sugimoto, K. Matsubara, Y. Koida and M. Kobayashi, The preparation of rapidly disintegrating tablets in the mouth, Pharm. Dev. Technol. 6 (2001) 487–493; https://doi.org/10.1081/PDT-120000287

18. Y. Kuno, K. Masazumi, S. Ando and H. Nakagami, Evaluation of rapidly disintegrating tablets manufactured by phase transition of sugar alcohols, J. Control. Release 105 (2005) 16–22; https://doi.org/10.1016/j.jconrel.005.01.018

19. B. Daihom, A. Alayoubi, D. J. Ma, L. J. Wang, S. Mishra, R. Helms and H. Almoazen, Development and physicochemical characterization of clindamycin resinate for taste masking in pediatrics, Drug Dev. Ind. Pharm. 42 (2016) 1600–1608; https://doi.org/10.3109/03639045.2016.1160104

20. H. Sohi, Y. Sultana and R. K. Khar, Taste masking technologies in oral pharmaceuticals: recent developments and approaches, Drug Dev. Ind. Pharm. 30 (2004) 429–448; https://doi.org/10.1081/DDC-120037477

21. C. de C Bergamaschi, L. A. Berto, P. C. Venâncio, K. Cogo, M. Franz-Montan, R. H. L. Motta, M. P. Santamaria and F. C. Groppo, Concentrations of metronidazole in human plasma and saliva after tablet or gel administration, J. Pharm. Pharmacol. 66 (2014) 40–47; https://doi.org/10.1111/jphp.12161

22. F. Gut, W. Schiek, W. E. Haefeli, I. Walter-Sack and J. Burhenne, Cation exchange resins as pharmaceutical carriers for methylene blue: binding and release, Eur. J. Pharm. Biopharm. 69 (2008) 582–587; https://doi.org/10.1016/j.ejpb.2007.12.016

Acta Pharmaceutica

The Journal of Croatian Pharmaceutical Society

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