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Influence of Physical Factors on Tablet ‎Splitting, Weight and Content Uniformity ‎of Atenolol Tablets

Sun, 2014-06-29 09:32 — Abdel Naser Zaid
Journal Title, Volume, Page: 
Journal of Pharmaceutical Investigation, Volume 42, Issue 5, pp 229-234
Year of Publication: 
2012
Link: 
http://link.springer.com/article/10.1007/s40005-012-0030-7
Authors: 
Abdel Naser Zaid
Division of Pharmaceutics and Pharmacokinetics, Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, P.O. Box 7, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
[email protected]
Rowa’ Al-Ramahi
Division of Pharmacology and Toxicology, Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Abeer Abu Ghoush
Division of Pharmaceutics and Pharmacokinetics, Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, P.O. Box 7, Nablus, Palestine
Numan Malkieh
Jerusalem Pharmaceuticals Company, Al Bireh-Ramallah, Palestine
Maher Kharoaf
Jerusalem Pharmaceuticals Company, Al Bireh-Ramallah, Palestine
Preferred Abstract (Original): 

Tablet splitting is widely practiced worldwide. Several studies have considered weight variation of split tablets as a mean of estimating drug content uniformity but the analysis of their drug content and physical factors that may affect splitting are limited. The aim of this study is to evaluate the impact of manufacturing parameters and splitting on content and weight uniformity of atenolol tablets. Atenolol tablets (100 and 50 mg) were prepared under the same manufacturing conditions and using the same excipients. The obtained tablets were checked for hardness, weight, and disintegration. The weight and the content of the two strength atenolol tablets after splitting into two halves were evaluated. Atenolol tablets (100 mg) showed higher values of hardness, disintegration time and diameter than atenolol tablets (50 mg). Atenolol tablets (100 mg) passed both weight and content uniformity while atenolol tablets (50 mg) failed these tests. Half tablet weight appears to be directly correlated with its drug content. Manufacturers should investigate physical factors such as tablet hardness, diameter, and disintegration time that may play an important role in achieving both weight and content uniformity in the resultant tablet halves.

Rowa Al Ramahi's picture

Influence of Physical Factors on Tablet Splitting, Weight and Content Uniformity of Atenolol Tablets

Fri, 2013-02-15 17:10 — Rowa' Jamal Al-Ramahi
Journal Title, Volume, Page: 
Journal of Pharmaceutical Investigations. 2012; 42(5): 229-234
Year of Publication: 
2012
Link: 
http://link.springer.com/article/10.1007/s40005-012-0030-7/fulltext.html
Authors: 
Zaid AN
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Al-Ramahi R
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
[email protected]
Abu Ghoush A
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Malkieh N
Jerusalem Pharmaceuticals Company, Al Bireh-Ramallah, Palestine
Kharoaf M
Jerusalem Pharmaceuticals Company, Al Bireh-Ramallah, Palestine
Preferred Abstract (Original): 
Tablet splitting is widely practiced worldwide. Several studies have considered weight variation of split tablets as a mean of estimating drug content uniformity but the analysis of their drug content and physical factors that may affect splitting are limited. The aim of this study is to evaluate the impact of manufacturing parameters and splitting on content and weight uniformity of atenolol tablets. Atenolol tablets (100 and 50 mg) were prepared under the same manufacturing conditions and using the same excipients. The obtained tablets were checked for hardness, weight, and disintegration. The weight and the content of the two strength atenolol tablets after splitting into two halves were evaluated. Atenolol tablets (100 mg) showed higher values of hardness, disintegration time and diameter than atenolol tablets (50 mg). Atenolol tablets (100 mg) passed both weight and content uniformity while atenolol tablets (50 mg) failed these tests. Half tablet weight appears to be directly correlated with its drug content. Manufacturers should investigate physical factors such as tablet hardness, diameter, and disintegration time that may play an important role in achieving both weight and content uniformity in the resultant tablet halves.
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