Author(s): Suhail H. Alghanem, Dimah N. Ibraheem, Basem M. Mansour, Aktham N. Shraiba


DOI: 10.52711/0974-360X.2023.00268   

Address: Suhail H. Alghanem*, Dimah N. Ibraheem, Basem M. Mansour, Aktham N. Shraiba
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Al-Andalus University, Tartous, Syria.
*Corresponding Author

Published In:   Volume - 16,      Issue - 4,     Year - 2023

The aim of this study was to prepare Nystatin lozenges (suitable for many age categories, easy to administrate and preferable in many medical cases) using a variety of excipients, then evaluate these formulations In vitro to select the best one for later use to treat Candida Albicans ( the cause of oral candidiasis). Two formulations were prepared, in F1 (only Arabic gum was used) while in F2 (Arabic gum with propylene glycol were used). A comparison was performed to evaluate the two formulations. The results of our comparison indicated that the F2 formula was the best (disintegrating time: 21.37±0.88 min, Td = 40.59 min is the time required to release 63.2% of the Nystatin content). Nystatin is released from the F2 formulation according to zero order kinetics (linearity between the amount of drug released with time).

Cite this article:
Suhail H. Alghanem, Dimah N. Ibraheem, Basem M. Mansour, Aktham N. Shraiba. Formulation and Characterization of Two Nystatin Lozenge Formulations as a New Pharmaceutical Dosage form in The Syrian Market. Research Journal of Pharmacy and Technology 2023; 16(4):1639-3. doi: 10.52711/0974-360X.2023.00268

Suhail H. Alghanem, Dimah N. Ibraheem, Basem M. Mansour, Aktham N. Shraiba. Formulation and Characterization of Two Nystatin Lozenge Formulations as a New Pharmaceutical Dosage form in The Syrian Market. Research Journal of Pharmacy and Technology 2023; 16(4):1639-3. doi: 10.52711/0974-360X.2023.00268   Available on:

1.    Singh A, Verma R, Murari A, Agrawal A. Oral candidiasis: An overview. J Oral Maxillofac Pathol. 2014;18(5):81-85. doi:10.4103/0973-029X.141325
2.    Epstein JB, Frcd C, Silverman S. 18 Oral Fungal Infections. 2016;(C):170-179.
3.    Armenta-Rojas E, Cornejo-Bravo JM, Serrano-Medina A, et al. Nystatin-loaded polyelectrolyte complex films as a mucoadhesive drug delivery system for potential buccal application. Biointerface Res Appl Chem. 2022;12(4):4384-4398. doi:10.33263/BRIAC124.43844398
4.    Alfahdawi IH, Alsewuidi WM. Effect of Oleuropein on Fungal Infection for Denture Wearers. Published online 2022:1-9.
5.    Vila T, Sultan AS, Montelongo-Jauregui D, Jabra-Rizk MA. Oral candidiasis: A disease of opportunity. J Fungi. 2020;6(1):1-28. doi:10.3390/jof6010015
6.    Lyu X, Zhao C, Yan ZM, Hua H. Efficacy of nystatin for the treatment of oral candidiasis: A systematic review and meta-analysis. Drug Des Devel Ther. 2016;10:1161-1171. doi:10.2147/DDDT.S100795
7.    Narayana Charyulu R, Parvathy Devi P, Jose J, Veena Shetty A. Formulation and evaluation of mucoadhesive oral gel containing Miconazole nitrate for oral candidiasis. Res J Pharm Technol. 2013;6(11):1251-1257.
8.    Yuvaraj S, Gheena S, Gopinath P. Comparison of oral candidal flora of diabetics and non diabetics. Res J Pharm Technol. 2016;9(10):1645-1646. doi:10.5958/0974-360X.2016.00330.9
9.    Noël de Tilly A, Tharmalingam S. Review of Treatments for Oropharyngeal Fungal Infections in HIV/AIDS Patients. Microbiol Res (Pavia). 2022;13(2):219-234. doi:10.3390/microbiolres13020019
10.    Garcia-Cuesta C, Sarrion-Pérez MG, Bagán J V. Current treatment of oral candidiasis: A literature review. J Clin Exp Dent. 2014;6(5):e576-e582. doi:10.4317/jced.51798
11.    De Aguiar MMGB, De Albuquerque RP, Marinho DS, et al. Oral sustained release nystatin tablets for the treatment of oral candidiasis: Formulation development and validation of UV spectrophotometric analytical methodology for content determination. Drug Dev Ind Pharm. 2010;36(5):594-600. doi:10.3109/03639040903384729
12.    Chamorro-Petronacci C, García-García A, Lorenzo-Pouso AI, et al. Management options for low-dose methotrexate-induced oral ulcers: A systematic review. Med Oral Patol Oral y Cir Bucal. 2019;24(2):e172-e180. doi:10.4317/medoral.22978
13.    Samein LH. Preparation and evaluation of Nystatin loaded-solid-lipid nanoparticles for topical delivery. Int J Pharm Pharm Sci. 2014;6(SUPPL. 2):592-597.
14.    Marzban A, Aghdam MK, Ahadi S. Effectiveness of Oral Nystatin Prophylaxis in the Prevention of Candida Colonization in Very Low Birth Weight Preterm Neonates ; a Randomized Controlled Trial. 2022;13(2). doi:10.22038/IJN.2022.57803.2084
15.    Enache A-C, Cojocaru C, Samoila P, et al. Evaluation of Physically and/or Chemically Modified Chitosan Hydrogels for Proficient Release of Insoluble Nystatin in Simulated Fluids. Gels. 2022;8(8):495. doi:10.3390/gels8080495
16.    Towers M. British Pharmacopoeia. Vol 12.; 2000. doi:10.1093/ajhp/18.1.88
17.    Sklenář Z, Ščigel V, Horáčkova K, Slanař O. Compounded preparations with nystatin for oral and oromucosal administration. Acta Pol Pharm - Drug Res. 2013;70(4):759-762.
18.    Katzung B, Masters S, Trevor A. Farmacologia Básica e Clínica. Lange. Published online 2012:790-841.
19.    Aljaffary M, Jang H, Alomeir N, Zeng Y, Alkhars N, ... Effects of nystatin oral rinse on oral Candida species and Streptococcus mutans among healthy adults. Published online 2022:1-25.
20.    Youn Y-S, Lee J-H, Jeong S-H, Shin B-S, Park E-S. Pharmaceutical Usefulness of Biopharmaceutics Classification System: Overview and New Trend. J Pharm Investig. 2010;40(spc):1-7. doi:10.4333/kps.2010.40.s.001
21.    British Medical Assosiation and Royal Pharmaceutical Society of Great Britain. BNF 78 (Biritsh National Formularly).; 2019.
22.    Nenoff P, Krüger C, Neumeister C, Schwantes U, Koch D. In vitro susceptibility testing of yeasts to nystatin – low minimum inhibitory concentrations suggest no indication of In vitro resistance of Candida albicans, Candida species or non-Candida yeast species to nystatin. Clin Med Investig. 2016;1(3):71-76. doi:10.15761/cmi.1000116
23.    Gopale O, Jethawa S, Shelke S. Medicated Lozenges: A Review. Asian J Pharm Res Dev. 2022;10(2):129-134.
24.    Allen L V., Ansel HC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems: Tenth Edition.; 2014.
25.    Rathod M, Poharkar S, Pandhre Y, Muneshwar M, Sul S. MEDICATED LOZENGES AS AN EASY TO USE DOSAGE FORM. World J Pharm Res. 2018;7(16):305-322. doi:10.20959/wjpr201816-13148
26.    Aulton ME, Taylor KM. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. Fourth Edi. Churchill Livingstone, Elsevier; 2013.
27.    Choursiya S, Indurkhya A. Development and evaluation of hard candy lozenges containing roxithromycin for treatment of oral infection. Asian J Pharm Anal. 2020;10(3):150. doi:10.5958/2231-5675.2020.00027.7
28.    Ahmad S. Ambroxol Lozenges: Introduction and Recent Advances. Res J Pharm Dos Forms Technol. 2016;8(4):296. doi:10.5958/0975-4377.2016.00041.0
29.    Babasaheb Kolap M, Kisan Omase P, Dashwant AV, Namde RS. Review on Lozenges. Res J Pharmacol Pharmacodyn. 2021;13(02):75-78. doi:10.52711/2321-5836.2021.00016
30.    Pravalika L, Shravan Kumar Y. Formulation and evaluation of theophylline lozenges. Res J Pharm Technol. 2021;14(3):1601-1606. doi:10.5958/0974-360X.2021.00284.5
31.    Malkawi WA, Alrafayah E, Alhazabreh M, Abulaila S, Al-Ghananeem AM. Formulation Challenges and Strategies to Develop Pediatric Dosage Forms. Children. 2022;9(4). doi:10.3390/children9040488
32.    Rao T V., Suma K, Sahitya K, et al. Design and Development of Tramadol Hydrochloride Lozenges for Pediatrics. Res J Pharm Dos Forms Technol. 2018;10(3):157. doi:10.5958/0975-4377.2018.00024.1
33.    Ali MY, Qureshi S, Das B, Rao KP. Design and Evaluation of Nimesulide Lozenges for Pediatrics. 2010;3(3):818-820.
34.    Dibbern H., Müller R., Wirbitzki E. UV and IR Spectra: Pharmaceutical Substances (UV and IR) and Pharmaceutical and Cosmatic Exciepients (IR). Vol 7. (Verlag CA, ed.).; 2002.
35.    Costa P, Manuel J, Lobo S. Modeling and comparison of dissolution profiles of diltiazem modified-release formulations. Dissolution Technol. 2009;16(2):41-46. doi:10.14227/DT160209P41
36.    Zhang Y, Huo M, Zhou J, et al. DDSolver : An Add-In Program for Modeling and Comparison of Drug Dissolution Profiles. 2010;12(3). doi:10.1208/s12248-010-9185-1
37.    Reddy YK, Tasleem J. Formulation and Evaluation of Bioadhesive Buccal Drug Delivery of Sumatriptan Succinate Tablets. Asian J Pharm Res. 2020;10(2):105. doi:10.5958/2231-5691.2020.00020.9
38.    Gómez AVDLC, Iglesias RMR, Afanador TSR, Bolívar IBP, Moré GPD. Comparison between the dissolution profiles of prolonged-release ciprofloxacin tablets available in the Colombian market. J Appl Pharm Sci. 2022;12(3):209-217. doi:10.7324/JAPS.2022.120322
39.    Trucillo P. Drug Carriers : A Review on the Most Used Mathematical Models for Drug Release. Published online 2022.
40.    Shah H, Jain A, Laghate G, Prabhudesai D. Pharmaceutical excipients. In: Remington: The Science and Practice of Pharmacy. ; 2020:633-643. doi:10.1016/B978-0-12-820007-0.00032-5

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