Formulation, Manufacturing Techniques, and Evaluation of Orally Disintegrating Tablets
Keywords:
Orally Disintegrating Tablets, Fast Dissolving Tablets, Oral Drug Delivery, Excipients, APIAbstract
The oral route of drug administration is widely considered the most preferred method due to its safety, ease of administration, cost-effectiveness, and high level of patient acceptance. Despite these advantages, conventional oral dosage forms may pose swallowing difficulties, particularly in pediatric, geriatric, and dysphagic patients, leading to poor compliance. To address these challenges, orally disintegrating tablets (ODTs) have emerged as a novel and patient-friendly dosage form. ODTs are designed to disintegrate rapidly in the oral cavity and dissolve in saliva without the need for water, thereby facilitating ease of administration. This feature makes them particularly suitable for patients experiencing conditions such as motion sickness, frequent vomiting, and neurological disorders. Additionally, ODTs can enhance the onset of action for drugs that are readily absorbed through the oral mucosa. The increasing demand for such advanced drug delivery systems has led to the development of various formulation strategies and manufacturing techniques. This review provides an overview of the ideal properties, benefits and limitations, formulation components, preparation methods, and evaluation parameters of ODTs. Furthermore, it highlights commercially available products and recent advancements in this field, along with future perspectives in oral drug delivery technology.
Downloads
References
1. Uchegbu IF, Vyas SP. Niosomes as drug delivery systems. Int J Pharm. 1998;172:33–70.
2. Chang RK, Guo X, Burnside BA, Couch RA. Fast-dissolving tablets. Pharm Technol. 2000;24(6):52–58.
3. Kuchekar BS, Badhan AC, Mahajan HS. Mouth dissolving tablets: A novel drug delivery system. Pharma Times. 2003;35:7–10.
4. Seager H. Drug-delivery products and the Zydis fast-dissolving dosage form. J Pharm Pharmacol. 1998;50:375–382.
5. Dobetti L. Fast-melting tablets: Developments and technologies. Pharm Technol Eur. 2001;13:44–50.
6. Habib W, Khankari R, Hontz J. Fast-dissolve drug delivery systems. Crit Rev Ther Drug Carrier Syst. 2000;17:61–72.
7. Fu Y, Yang S, Jeong SH, Kimura S, Park K. Orally fast disintegrating tablets. Crit Rev Ther Drug Carrier Syst. 2004;21:433–475.
8. Shukla D, Chakraborty S, Singh S, Mishra B. Mouth dissolving tablets: An overview. Indian J Pharm Sci. 2009;71:335–341.
9. Bi Y, Sunada H, Yonezawa Y, Danjo K, Otsuka A, Iida K. Preparation and evaluation of compressed tablets rapidly disintegrating in oral cavity. Chem Pharm Bull. 1996;44:2121–2127.
10. Gohel M, Patel M, Amin A, Agrawal R, Dave R, Bariya N. Formulation design of mouth dissolving tablets. J Pharm Sci. 2004;7:1–6.
11. Kuno Y, Kojima M, Ando S, Nakagami H. Evaluation of rapidly disintegrating tablets. Int J Pharm. 2005;298:147–155.
12. Hirani JJ, Rathod DA, Vadalia KR. Orally disintegrating tablets: A review. Trop J Pharm Res. 2009;8:161–172.
13. Reddy LH, Ghosh B, Rajneesh. Fast dissolving drug delivery systems. Indian J Pharm Sci. 2002;64:331–336.
14. Sastry SV, Nyshadham JR, Fix JA. Recent technological advances in oral drug delivery. Pharm Sci Technol Today. 2000;3:138–145.
15. Allen LV. Pharmaceutical dosage forms and drug delivery systems. 8th ed. Lippincott Williams & Wilkins; 2005.
16. Banker GS, Anderson NR. Tablets. In: Lachman L, Lieberman HA, Kanig JL, editors. The Theory and Practice of Industrial Pharmacy. 3rd ed. 1987. p. 293–345.
17. Aulton ME. Pharmaceutics: The Science of Dosage Form Design. 2nd ed. Churchill Livingstone; 2002.
18. Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Ghaziabad; 2018.
19. United States Pharmacopeia (USP). USP-NF. Rockville; 2020.
20. European Pharmacopoeia. Council of Europe; 2019.
21. Bhise SB, Rajkumar M. Effect of superdisintegrants in formulation of fast dissolving tablets. Int J Pharm Sci. 2010;2:66–72.
22. Desai PM, Er PXH, Liew CV, Heng PW. Review of disintegrants and superdisintegrants. J Pharm Sci. 2016;105:2545–2555.
23. Bandari S, Mittapalli RK, Gannu R, Rao YM. Orodispersible tablets: An overview. Asian J Pharm. 2008;2:2–11.
24. Sohi H, Sultana Y, Khar RK. Taste masking technologies in oral pharmaceuticals. Drug Dev Ind Pharm. 2004;30:429–448.
25. Jivraj M, Martini LG, Thomson CM. An overview of different excipients useful for direct compression. PSTT. 2000;3:58–63.
26. Shangraw RF. Direct compression tableting. J Pharm Sci. 1989;78:2–7.
27. Mizumoto T, Masuda Y, Yamamoto T, Yonemochi E, Terada K. Formulation design of fast disintegrating tablets. Int J Pharm. 2005;306:83–90.
28. Patil BS, Tate PM, Kulkarni U. Formulation and evaluation of mouth dissolving tablets. Int J Pharm Sci Rev Res. 2011;7:47–54.
29. Panigrahi R, Behera SP. Review on fast dissolving tablets. WebmedCentral Pharm Sci. 2010;1:WMC001146.
30. Nagar P, Singh K, Chauhan I, Verma M, Yasir M, Khan A. Orally disintegrating tablets: Formulation, preparation techniques. J Appl Pharm Sci. 2011;1:35–45.
31. Ghosh T, Ghosh A, Prasad D. A review on new generation orodispersible tablets. Int J Pharm Pharm Sci. 2011;3:1–7.
32. Abdelbary G, Eouani C, Prinderre P, Joachim J, Reynier JP, Piccerelle P. Determination of disintegration profile. Int J Pharm. 2005;292:29–41.
33. Suresh S, Pandit V, Joshi HP. Preparation and evaluation of mouth dissolving tablets. Indian Drugs. 2007;44:467–471.
34. Sharma D, Chopra R, Bedi N. Development and evaluation of paracetamol fast dissolving tablets. J Chem Pharm Res. 2012;4:435–441.
35. Yadav G, Kapoor A, Bhargava S. Fast dissolving tablets: A review. Int J Pharm Res Dev. 2012;4:1–8.
36. Kaur T, Gill B, Kumar S, Gupta GD. Mouth dissolving tablets: A novel approach. Int J Curr Pharm Res. 2011;3:1–7.
37. Mohanachandran PS, Sindhumol PG, Kiran TS. Superdisintegrants: An overview. Int J Pharm Sci Rev Res. 2011;6:105–109.
38. Gupta A, Mishra AK, Gupta V, Bansal P, Singh R. Recent trends of fast dissolving tablet. Int J Pharm Sci Res. 2010;1:1–10.
39. Mahajan HS, Kuchekar BS. Mouth dissolving tablets: A novel drug delivery system. Drug Dev Ind Pharm. 2009;35:114–122.
40. Patel DM, Patel NM, Patel MM. Fast dissolving tablets: An overview. J Pharm Sci. 2006;5:1–10.
Downloads
Published
How to Cite
Issue
Section
License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

.