Development of Rapid Dispersible Tablet Preparations Using Synthetic and Natural Superdisintegrant Disintegrants: Comparative Performance Analysis

Authors

  • putri tri hartini Universitas Muhammadiyah Riau, Indonesia
  • pertiwi awilda universitas nahdlatul ulama kalimantan selatan, Indonesia
  • Ratna mildawati Stikes Ganesha Husada Kediri, Indonesia
  • Khazanah Nurain Nurdin Universitas Muhammadiyah Riau, Indonesia
  • Dara Sukma Ratmelya Universitas Syiah Kuala, Indonesia

Keywords:

Rapid dispersible tablet, superdisintegrant, croscarmellose sodium, crospovidone, Plantago ovata, Ispaghula husk, metformin HCl, direct compression, comparative study

Abstract

Rapid dispersible tablets (RDTs) are patient-friendly oral dosage forms designed to disintegrate rapidly in the oral cavity or in the presence of a small amount of water, thereby improving patient compliance, particularly among pediatric, geriatric, and dysphagic populations. The performance of RDTs is highly dependent on the type and concentration of superdisintegrants used, as these excipients play a critical role in governing tablet disintegration behavior, wetting characteristics, mechanical strength, and drug release kinetics. Synthetic superdisintegrants such as croscarmellose sodium (CCS) and crospovidone (CPVP) are widely utilized due to their high swelling capacity and capillary action, whereas natural superdisintegrants like Plantago ovata husk (ispaghula husk) have gained increasing interest as eco-friendly and biocompatible alternatives. However, comparative information regarding the efficiency of synthetic and natural superdisintegrants in high-dose drug formulations remains limited. In this study, metformin hydrochloride (500 mg), a high-dose and highly water-soluble antidiabetic drug, was formulated into RDTs using different superdisintegrants via direct compression. The results demonstrated that the optimized formulation containing crospovidone exhibited the fastest disintegration time of 29.1 seconds, along with rapid tablet breakup and efficient drug release, compared to formulations containing croscarmellose sodium and Plantago ovata husk.

References

American Diabetes Association. (2024). Standards of medical care in diabetes—2024. Diabetes Care, 47(Suppl. 1), S1–S321.

Bhatt, D. C., Bhatt, S., Shrikhande, S., & Ghule, M. (2011). Recent advancements in fast dissolving drug delivery systems: A review. Pharma Science Monitor, 2, 37–53.

Bhowmik, D., Chiranjib, B., Krishnakanth, P., Pankaj, & Chandira, R. M. (2009). Fast dissolving tablet: An overview. Journal of Chemical and Pharmaceutical Research, 1(1), 163–177.

Bi, Y. X., Sunada, H., Yonezawa, Y., & Dayo, K. (1999). Evaluation of rapidly disintegrating tablets prepared by a direct compression method. Drug Development and Industrial Pharmacy, 25(5), 571–581. https://doi.org/10.1081/DDC-100102246

Corveleyn, S., & Remon, J. P. (1997). Formulation and production of rapidly disintegrating tablets by lyophilization using hydrochlorothiazide as a model drug. International Journal of Pharmaceutics, 152(2), 215–225. https://doi.org/10.1016/S0378-5173(97)04925-8

Deveswaran, R., Bharath, S., Basavaraj, B. V., Abraham, S., Furtado, S., & Madhavan, V. (2009). Isolation and evaluation of Plantago ovata seed mucilage as a natural suspending agent. Pakistan Journal of Pharmaceutical Sciences, 22(4), 403–408.

European Pharmacopoeia Commission. (2014). Orodispersible tablets (Ph. Eur. monograph 0478). In European Pharmacopoeia (8th ed.). Council of Europe.

Gohel, M., Patel, M., Amin, A., Agrawal, R., Dave, R., & Bariya, N. (2004). Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique. AAPS PharmSciTech, 5(3), Article e36. https://doi.org/10.1208/pt050336

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). ICH Q1A(R2): Stability testing of new drug substances and drug products.

BASF Pharma Solutions. (2020). Kollidon CL: Technical information.

Korsmeyer, R. W., Gurny, R., Doelker, E., Buri, P., & Peppas, N. A. (1983). Mechanisms of solute release from porous hydrophilic polymers. International Journal of Pharmaceutics, 15(1), 25–35. https://doi.org/10.1016/0378-5173(83)90064-9

Mohanachandran, P. S., Sindhu, R., & Panayappan, L. (2010). Superdisintegrants: An overview. International Journal of Pharmaceutical Sciences Review and Research, 1(1), 33–40.

Puttewar, T. Y., Kshirsagar, M. D., Chandewar, A. V., & Chikhale, R. V. (2010). Formulation and evaluation of orodispersible tablet of taste masked doxylamine succinate using ion exchange resin. Journal of King Saud University - Science, 22(4), 229–240. https://doi.org/10.1016/j.jksus.2010.04.004

Rowe, R. C., Sheskey, P. J., & Quinn, M. E. (Eds.). (2009). Handbook of pharmaceutical excipients (6th ed.). Pharmaceutical Press.

Sakr, W., Alanazi, F., & Sakr, A. (2011). Evaluation of croscarmellose sodium as a tablet disintegrant. Saudi Pharmaceutical Journal, 19(4), 213–221. https://doi.org/10.1016/j.jsps.2011.04.002

Shah, U., Patel, M., Dalwadi, C., et al. (2018). Ispaghula husk as a natural superdisintegrant for formulation of orally disintegrating tablets. Journal of Pharmaceutical Investigation, 48(4), 419–430. https://doi.org/10.1007/s40005-017-0356-0

Singhvi, G., & Singh, M. (2011). Review: In-vitro drug release characterization models. International Journal of Pharmaceutical Studies and Research, 2(1), 77–84.

United States Pharmacopeial Convention. (2023). The United States Pharmacopeia and National Formulary (USP 46–NF 41). USP.

U.S. Food and Drug Administration. (2008). Guidance for industry: Orally disintegrating tablets. FDA.

Yadav, A. K., Mohite, S. K., & Magdum, C. S. (2020). Formulation and evaluation of fast dissolving tablet of metformin HCl using natural and synthetic superdisintegrants. Pharmatutor, 8(5), 12–19.

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Published

2026-05-04

How to Cite

putri tri hartini, pertiwi awilda, Ratna mildawati, Khazanah Nurain Nurdin, & Dara Sukma Ratmelya. (2026). Development of Rapid Dispersible Tablet Preparations Using Synthetic and Natural Superdisintegrant Disintegrants: Comparative Performance Analysis. Fundamental and Applied Research in Medicine and Allied Sciences Indonesia, 2(1), 30–44. Retrieved from https://gpijournal.com/index.php/farmasi/article/view/525

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