Stability studies of compression coated ornidazole tablets for colon specific drug delivery

Year 2019, Volume: 23 Issue: 1, 34 - 43, 27.06.2025

Seda Rençber Zeynep Senyiğit , Mine Özyazıcı

Abstract

In our previous study, colon targeted tablets of ornidazole were prepared with compression coating technique. Pectin was used as the coating layer and different ethyl cellulose (EC) types (EC N7, N 10 and N 100) were added to Pectin to enhance mechanical and release properties. The object of the present study was performed stability testing of these coated tablets of ornidazole in a high density polyethylene plastic bottle with/without silica gel as per ICH guidelines. For this aim, several quality-control parameters such as uniformity of weight, diameter and thickness of tablets, tablet hardness, friability, content uniformity and tablet dissolution rate are determined in stability conditions (25±2°C / 60±5% relative humidity and 40±2°C / 75±5% relative humidity). These parameters were evaluated at 0 month, 3 month, 6 month and 12 month intervals. It was concluded that the coated ornidazole tablets should be stored in a high density polyethylene plastic bottle with silica gel at controlled room temperature (25°C) or below their relative humidities and the presence of desiccant in the market package was essential.

Keywords

Stability studies , compression coated ornidazole tablet , ethylcellulose , characterization of tablet , dissolution study

References

• [1] Punam T, Shubhangi W, Rahul S, Sargar A, Bhujbal A, Shinde A. Stability study of dosage form: An inovative step. World J Pharm Pharm Sci. 2014; 3(2): 1031-1050.
• [2]Bozkır A, Coşkun Cetintas H, Saka O M. Investigation of the stability with bracketing design in tablet form. Pharm Anal Acta. 2013; S1-005. [CrossRef]
• [3] Acartürk F, Agabeyoglu I, Celebi N, Degim T, Degim Z, Doğanay T, Takka S, Tırnaksız F. Reaksiyon kinetiği ve stabilite. In: Modern Farmasötik Teknoloji. Türk Eczacıları Birliği Eczacılık Akademisi Yayını, Ankara, 2007, No:1, pp. 141-182. ISBN:978-975-01139-1-8.
• [4]Bajaj S, Singla D, Sakhuja N. Stability testing of pharmaceutical products. J Appl Pharm Sci. 2012; 2(3): 129-138. [CrossRef]
• [5] Al-Gohary OMN, Al-Kassas RS. Stability studies of aspirin-magaldrate double layer tablets. Pharm Acta Helv. 2000; 74(4): 351–360. [CrossRef]
• [6] Note for guidance on stability testing: Stability testing of new drug substances and products. In: ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products. European Medicines Agency. 2003; CPMP/ICH/2736/99. SADC Guideline For Stability Testing, 2004.
• [7] SADC Guideline For Stability Testing, 2004.
• [8]Krishnaiah YSR, Muzib YI, Rao GS, Bhaskar P, Satyanarayana V. Studies on the development of colon targeted oral drug delivery systems for ornidazole in the treatment of amoebiasis. Drug Deliv. 2003; 10: 111-117. [CrossRef]
• [9] World Health Organization, Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. WHO Technical Report Series, 2009; No. 953.
• [10] Özyazıcı M, Ay Şenyiğit Z, Aksu B. Compression coated ornidazole tablets for colon spesific drug delivery: Development, in vitro evaluation and optimisation by artificial neural network. Lat Am J Pharm. 2015; 34 (4): 681-93.
• [11] Krishnaiah YSR, Satyanarayana S, Rama Prasad YV, Narasimha Rao S. Evaluation of guar gum as a compression coat for drug targeting to colon. Int J Pharm. 1998; 171: 137-146. [CrossRef]
• [12] Türkoğlu M, Uğurlu T. In vitro evaluation of Pectin-HPMC compression coated 5-aminosalicylic acid tablets for colonic delivery. Eur J Pharm Biopharm. 2002; 53: 65-73. [CrossRef]
• [13] Stability testing of active pharmaceutical ingredients and finished pharmaceutical products, World Health Organization, Technical Report Series, No. 953, 2009.
• [14] Ren Y, Jiang L, Yang S, Gao S, Yu H, Hu J, Hu D, Mao W, Peng H, Zhou Y. Design and preparation of a novel colon targeted tablet of hydrocortisone. Braz J Pharm Sci. 2016; 52(2): e15009. [CrossRef]
• [15] Baloğlu E, Hızarcıoğlu SY. Quality control studies on enalapril maleate tablets available on the Turkish drug market. Ankara Ecz Fak Derg. 2001; 30(1): 1-16. [CrossRef]
• [16] Güven KC. İlaç Endüstrisi Teknolojisi. Cilt II, Hüsnütabiat Matbaası, İstanbul, 1979.
• [17] Aslani A, Jahangiri H. Formulation, Characterization and physicochemical evaluation of ranitidine effervescent tablets. Adv Pharm Bull. 2013; 3(2): 315-322. [CrossRef]
• [18] Potu A, Pasunooti S, Veerareddy P, Burra S. Formulation and evaluation of fenoprofen calcium compressed coated tablets for colon specific drug delivery. Asian J Pharm Clin Res. 2011; 4(2): 88-95.
• [19] Carstensen JT. Drug stability principles and practices. Marcel Dekker Inc., New York, 1990, pp. 209-261.
• [20] Parrot EL. Solid pharmaceuticals, In: Pharmaceutical Technology, 3rd ed., Burgess Publishing Company, USA, 1971, pp. 58-106.
• [21] Geçgil Ş. Katı İlaç Şekilleri, In: Farmasötik Teknolojiye Başlangıç, Cihan Matbaacılık, İstanbul, 1991, pp. 365.
• [22] Özyazıcı M, Sevgi F. Formulation and evaluation of salbutamol sulphate tablets prepared by direct compression using various excipients: Statistical comparison of dissolution methods and tablet properties. FABAD J Pharm Sci. 2003; 28: 1-11.
• [23] Shafer E, Wollish EG, Engel CE. The Roche Friabilator. J Am Pharm Assoc Sci. 1956; 45: 116-144.
• [24] Novozymes product sheet, fruit & Vegetable/2002-15554-02.pdf, (2008) Available at .
• [25] Faisal U, Ibrahim J, Rasheed S, Ranjha NM, Hussain L, Massud A. Accelerated stability studies of flurbiprofen film coated tablets of five different national brands in Pakistan. J Drug Deliv Ther. 2013; 3 (2): 9-11. [CrossRef]