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

Seda Rençber; Zeynep Senyiğit; Mine Özyazıcı

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

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

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]

Details

Primary Language

English

Subjects

Pharmaceutical Biotechnology

Journal Section

Research Article

Authors

Seda Rençber This is me
Türkiye

Zeynep Senyiğit
Türkiye

Mine Özyazıcı ^*
Türkiye

Publication Date

June 27, 2025

Submission Date

May 22, 2018

Acceptance Date

August 14, 2018

Published in Issue

Year 2019 Volume: 23 Number: 1

IZ

https://izlik.org/JA86KK89PP

Cite

RIS / Bibtex

APA

Rençber, S., Senyiğit, Z., & Özyazıcı, M. (2025). Stability studies of compression coated ornidazole tablets for colon specific drug delivery. Journal of Research in Pharmacy, 23(1), 34-43. https://izlik.org/JA86KK89PP

AMA

1.Rençber S, Senyiğit Z, Özyazıcı M. Stability studies of compression coated ornidazole tablets for colon specific drug delivery. J. Res. Pharm. 2025;23(1):34-43. https://izlik.org/JA86KK89PP

Chicago

Rençber, Seda, Zeynep Senyiğit, and Mine Özyazıcı. 2025. “Stability Studies of Compression Coated Ornidazole Tablets for Colon Specific Drug Delivery”. Journal of Research in Pharmacy 23 (1): 34-43. https://izlik.org/JA86KK89PP.

EndNote

Rençber S, Senyiğit Z, Özyazıcı M (June 1, 2025) Stability studies of compression coated ornidazole tablets for colon specific drug delivery. Journal of Research in Pharmacy 23 1 34–43.

IEEE

[1]S. Rençber, Z. Senyiğit, and M. Özyazıcı, “Stability studies of compression coated ornidazole tablets for colon specific drug delivery”, J. Res. Pharm., vol. 23, no. 1, pp. 34–43, June 2025, [Online]. Available: https://izlik.org/JA86KK89PP

ISNAD

Rençber, Seda - Senyiğit, Zeynep - Özyazıcı, Mine. “Stability Studies of Compression Coated Ornidazole Tablets for Colon Specific Drug Delivery”. Journal of Research in Pharmacy 23/1 (June 1, 2025): 34-43. https://izlik.org/JA86KK89PP.

JAMA

1.Rençber S, Senyiğit Z, Özyazıcı M. Stability studies of compression coated ornidazole tablets for colon specific drug delivery. J. Res. Pharm. 2025;23:34–43.

MLA

Rençber, Seda, et al. “Stability Studies of Compression Coated Ornidazole Tablets for Colon Specific Drug Delivery”. Journal of Research in Pharmacy, vol. 23, no. 1, June 2025, pp. 34-43, https://izlik.org/JA86KK89PP.

Vancouver

1.Seda Rençber, Zeynep Senyiğit, Mine Özyazıcı. Stability studies of compression coated ornidazole tablets for colon specific drug delivery. J. Res. Pharm. [Internet]. 2025 Jun. 1;23(1):34-43. Available from: https://izlik.org/JA86KK89PP