Development of the composition and manufacturing technology of orodispersible tablets (ODT) is becoming increasingly promising due to their applicability in pediatric and geriatric practice, including for patients with dysphagia or in the absence of water. Furthermore, the ability to ensure the absorption of the active pharmaceutical ingredient (API) through the oral mucosa, bypassing the gastrointestinal tract, opens up new opportunities for preventing the adverse effects of the acidic gastric environment and first-pass metabolism on the API. This article provides an overview of the principal methods and technologies for the production of ODT, featuring examples of the most advanced technologies, as well as the excipients employed.
1. Алексеев К.В., Блынская Е.В., Сизяков С.А. и др. Вспомогательные вещества в технологии таблеток с модифицированным высвобождением. Фармация. 2009;(6):49-56.
2. Блынская Е.В., Тишков С.В., Алексеев К.В. Технологии трёхмерной печати для производства лекарственных форм. Разработка и регистрация лекарственных средств. 2018;(3):10-19.
3. Тишков С.В., Гаврилов Д.И., Алексеев К.В. и др. Инновационные технологии производства таблеток-лиофилизатов и таблеток, диспергируемых в полости рта. Известия ГГТУ. Медицина, фармация. 2024;4(20);113-119.
4. Шевченко А.М., Ковалевская Е.Г. Технологические особенности разработки состава и способов производства ородисперсных лекарственных форм. Разработка и регистрация лекарственных средств. 2014;1(6):26-30.
5. Brown D. Orally disintegrating tablets-taste over speed. Drug Del Technol. 2003;3:58-61.
6. Deepak K. Orally disintegrating tablets. Tablets and Capsules. 2004;7:30-35.
7. Chandrasekhar R, Hassan Z, Alhusban F, et al. The role of formulation excipients in the development of lyophilised fast-disintegrating tablets. Eur J Pharm Biopharm. 2009 May;72(1):119-29. doi: 10.1016/j.ejpb.2008.11.011.
8. Fukami J, Yonemochi E, Yoshihashi Y, Terada K. Evaluation of rapidly disintegrating tablets containing glycine and carboxymethylcellulose. Int J Pharm. 2006 Mar 9;310(1-2):101-9. doi: 10.1016/j.ijpharm.2005.11.041.
9. Goel H, Rai P, Rana V, Tiwary AK. Orally disintegrating systems: innovations in formulation and technology. Recent Pat Drug Deliv Formul. 2008;2(3):258-74. doi: 10.2174/187221108786241660.
10. Parakh SR, Gothoskar AV. A review of mouth dissolving tablet technologies. Pharmaceutical Technology. 2003;27(11):92-100.
11. Koizumi K, Watanabe Y, Morita K, et al. New method of preparing high-porosity rapidly saliva soluble compressed tablets using mannitol with camphor, a subliming material. Int J Pharm. 1997;152(1):127-131. doi: 10.1016/S0378-5173(97)04924-7.
12. Ghosh TK, Pfister WR. Quick-Dissolving Oral Dosage Forms: Scientific and Regulatory Considerations from a Clinical Pharmacology and Biopharmaceutics Perspective. In: Ghosh TK, Pfister WR, eds. Drug Delivery to the Oral Cavity: Molecules to Market. New York, NY: Marcel Dekker; 2005:337-356.
13. Kuno Y, Kojima M, Ando S, Nakagami H. Evaluation of rapidly disintegrating tablets manufactured by phase transition of sugar alcohols. J Control Release. 2005 Jun 20;105(1-2):16-22. doi: 10.1016/j.jconrel.2005.01.018.
14. Schiermeier S, Schmidt PC. Fast dispersible ibuprofen tablets. Eur J Pharm Sci. 2002 Apr;15(3):295-305. doi: 10.1016/s0928-0987(02)00011-8.
15. Seager H. Drug-delivery products and the Zydis fast-dissolving dosage form. J Pharm Pharmacol. 1998 Apr;50(4):375-82. doi: 10.1111/j.2042-7158.1998.tb06876.x.
16. Corveleyn S, Remon JP. Formulation of a lyophilized dry emulsion tablet for the delivery of poorly soluble drugs. Int J Pharm. 1998;166(1):65-74. doi: 10.1016/S0378-5173(98)00024-6.
17. Dobetti L. Fast-melting tablets: Developments and technologies. Pharmaceutical Technology. 2001;(Suppl):44-50.
18. Bogner RH, Wilkosz MF. Fast-dissolving tablets: New dosage convenience for patients. US Pharmacist. 2002;27(3):34-43.
19. Ayenew Z, Puri V, Kumar L, Bansal AK. Trends in pharmaceutical taste masking technologies: a patent review. Recent Pat Drug Deliv Formul. 2009 Jan;3(1):26-39. doi: 10.2174/187221109787158364.
20. Sasidhar RLC, Vidyadhara S, Maheswari GV, et al. Solubility and dissolution rate enhancement of olmesartan medoxomil by complexation and development of mouth dissolving tablets. Advan. Biol. Res. 2013;7(2):32-41. doi: 10.5829/idosi.abr.2013.7.2.7244.
21. Parkash V, Maan S, Deepika, Yadav SK, Hemlata, Jogpal V. Fast disintegrating tablets: Opportunity in drug delivery system. J Adv Pharm Technol Res. 2011 Oct;2(4):223-35. doi: 10.4103/2231-4040.90877.
22. Gohel M, Patel M, Amin A, et al. Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique. AAPS PharmSciTech. 2004 Apr 26;5(3):e36. doi: 10.1208/pt050336.
23. Lee KJ, Kang A, Delfino JJ, et al. Evaluation of critical formulation factors in the development of a rapidly dispersing captopril oral dosage form. Drug Dev Ind Pharm. 2003 Oct;29(9):967-79. doi: 10.1081/ddc-120025454.