Evaluation of Orally Disintegrating Tablet Formulations in The Treatment of Oral Mucositis

Abstract

Aim: Orally disintegrating tablets (ODT) are widely used dosage forms with high patient compliance, which preferred in the treatment of many diseases currently. In this study we aimed to develop an orally disintegrating tablet formulation can be preferred in the treatment of oral mucositis, which often occurs after chemotherapy during cancer treatment. Methods: Lidocaine hydrochloride, which is a local anesthetic substance, was used as active pharmaceutical ingredient to obtain ODT formulation for the treatment of oral mucositis. ODTs were prepared by direct compression technique and crospovidone was used as super-dispersant Results: The method developed for lidocaine determination was validated. Characterization of powder mixtures conducted; angle repose was found to be as 25.78°±0.810, flow time was 4.18±0.772 s, compressibility index was 9.591±0.774% and Hausner’s ratio was calculated as 1.106±0.014. The uniformity of weight and content for the ODT formulation was 493.705±3.583 g, 78.89+2.546 mg, respectively. The tablets had a diameter of 12.031 ±0.015 mm while thickness was 4.420 ±0.021 mm. The hardness was calulated as 28.7±1.123 N, while percent friability value was 0.76%. Disintegration time of the tablets were 31.55±0.354 sec., and approximately 90% of the prepared formulation dissolved in around 20 minutes according to dissolution testing. Conclusions: The prepared formulation was evaluated through powder and tablet controls, it was found to comply with the limits specified in the European Pharmacopoeia. The developed ODT formulation for the treatment of oral mucositis, is planned to be evaluated through in vivo tests to complete the assessment of the formulation.

Keywords

• Orally disintegrating tablets
• Evaluation methods
• Lidocaine hydrochloride

Kaynakça

1. 1. Arora P, Sethi VA. Orodispersible tablets: A comprehensive review. Int J Res Dev Pharm Life Sci. 2013;2(2):270-284.
2. 2. Dey P, Maiti S. Orodispersible tablets: A new trend in drug delivery. J Nat Sci Biol Med. 2010;1(1):2-5. doi: 10.4103/0976-9668.71663 3. Velmurugan S, Vinushitha S. Oral disintegrating tablets: An overview. Int J Chem Pharm Sci. 2010;1(2):1-12. 4. Chaudhary SA, Chaudhary AB, Metha, TA. Excipients updates for orally disintegrating dosage forms. Int J Res Pharm Sci. 2010;1(2):103-107.
3. 5. Shirsand SB, Suresh S, Swamy PV et. al. Formulation Design of Fast Disintegrating Tablets Using Disintegrant Blends. Indian J Pharm Sci. 2010;72(1):130–133. doi: 10.4103/0250-474X.62244.
4. 6. Goel H, RaiP, Ranal V et al. Orally Disintegrating Systems: Innovations in Formulation and Technology. Recent Pat Drug Deliv Formul. 2008;2(3):258-274. doi: 10.2174/187221108786241660.
5. 7. Panchal DM, Tiwari A, Srivastava P. A review on orodispersible tablets – A novel formulation for oral drug delivery system and its future prospective. Indo Am J Pharm Res. 2013;3(2):4149-4168.
6. 8. Pahwa R, Piplani M, Sharma PC et al. Orally disintegrating tablets-friendly to pediadrics and geriatrics. Arch. Apll. Sci. Res. 2010;2(2):35-48.
7. 9. Covino BG, Wildsmith JAW. Clinical pharmacology of local anesthtetic agents. Neural Blockade in Clinical Anesthesia and Management of Pain, 3rd ed, Cousins MJ, Bridenbaugh PO (Eds). Lippincott-Raven Publishers, Philadelphia, 1998.
8. 10. Kayaalp O, Tıbbi Farmakoloji, 10. baskı, Hacettepe Taş Kitapçılık, Ankara, 2002.

9. 11. Çıtlak K, Kapucu S. Kemoterapi alan hastalarda görülen oral mukozitin önlenmesi ve tedavisinde güncel yaklaşımlar: Kanıta dayalı uygulamalar. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi. 2015;70-77.
10. 12. Peterson D, Lalla R. Oral mucositis: the new paradigms. Curr Opin Oncol. 2010;22(4):318-322. doi: 10.1097/CCO.0b013e32833a9fab.
11. 13. European Directorate for the Quality of Medicines (EDQM). Powder flow. European Pharmacopoeia, 8th ed, 2013.
12. 14. Takka S, Acartürk F, Ağabeyoğlu İ, Çelebı̇ N, Değı̇m T, Değı̇m Z. Önformülasyon. Modern Farmasötik Teknoloji, 2. baskı, Türk Eczacılar Birliği Eczacılık Akademisi Yayını, Ankara, 2009.
13. 15. Govender T, Stolnik S, Garnett MC, Illum L, Davis SS. PLGA nanoparticles prepared by nanoprecipitation: Drug loading and release studies of a water soluble drug. J Control Release. 1999;57(2):171-185.
14. 16. Deshmukh VN, Zade NH, Sakarkar DM. Development and evaluation of orally disintegrating tablet by direct compression method. Int J PharmTech Res. 2012;4(4):1351-1357.
15. 17. European Directorate for the Quality of Medicines (EDQM). Uniformity of mass of single dose preparations. European Pharmacopoeia, 8th ed, 2013.
16. 18. European Directorate for the Quality of Medicines (EDQM). Uniformity of content of single dose preparations. European Pharmacopoeia, 8th ed, 2013.
17. 19. Gul S, Sajid S. Formulation of improved norfloxacin HCl tablets: quality control assessment and comparison study of acidic and basic form of norfloxacin in tablet formulation. J Dev Drugs. 2015;5(1):ID716736. doi:10.4172/2329-6631.1000145.
18. 20. European Directorate for the Quality of Medicines (EDQM). Friability of uncoated tablets. European Pharmacopoeia, 8th ed, 2013. 21. European Directorate for the Quality of Medicines (EDQM). Orodispersible Tablet. European Pharmacopoeia, 8th ed, 2013. 22. Klancke J. Dissolution testing of orally disintegrating tablets. Dissolution Technol. 2003;10(2):6-8. doi: 10.14227/DT100203P6 23. Dressman JB, Reppas C. In vitro–in vivo correlations for lipophilic, poorly water-soluble drugs. Eur J Pharm Sci. 2000;11(2):73-80. doi: 10.1016/s0928-0987(00)00181-0.