Splitting

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Compliance of Scored Tablet Halves Produced by Palestinian ‎Pharmaceutical Companies with the New European ‎Pharmacopoeia Requirements

Journal Title, Volume, Page: 
Arch Pharm Res.;34(7):1183-9
Year of Publication: 
2011
Authors: 
Zaid AN
Department of Pharmaceutics and Biopharmaceutics, College of Pharmacy, An-Najah National University, Nablus, P.O. Box 7, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Ghosh AA
Department of Pharmaceutics and Biopharmaceutics, College of Pharmacy, An-Najah National University, Nablus, P.O. Box 7, Palestine
Preferred Abstract (Original): 

The aim of this study was to evaluate the weight uniformity of commonly divided tablets produced by Palestinian Pharmaceutical Companies and to evaluate the importance of both patient- and formulation-related variables on the splitting results. Eighty-four volunteers were enrolled in this study; their age, gender and occupation were documented in order, and the effect of these variables on the tablet splitting results was evaluated. Each volunteer was asked to divide six scored tablets of each product tested and was given clear instructions on how to conduct the splitting process. The split units were individually weighed and the RSD for each product was calculated as instructed in the European Pharmacopoeia (Ph. Eur. 5.5). Only one scored tablet product passed the Ph. Eur. test of mass uniformity, while the remaining 13 products failed; this indicates that the splitting of these tablet products is not a reliable means for the provision of accurate doses to patients. Age, gender and occupation of volunteers were not found to be predictive of any variability noted in the splitting results. The only factors that were suspected to be linked to passing the splitting test, as per the European Pharmacopoeia, were the shape, friability and hardness of the tablets. As a result of this study, we believe that the practice of dividing tablets, which should provide therapeutic and economic benefits for the patient, may potentially cause significant problems, especially in drugs with low therapeutic indices. Tablets produced by Palestinian Pharmaceutical Companies should comply with the new Ph. Eur. splitting regulations to reduce this potential for complications.

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

Journal Title, Volume, Page: 
Journal of Pharmaceutical Investigation, Volume 42, Issue 5, pp 229-234
Year of Publication: 
2012
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
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.

shawahna's picture

Prescribing Errors involved Splitting of Tablets: A Two-Hospital Case Analysis

Journal Title, Volume, Page: 
Pak J Med Health Sci Jun 2008;2(2):54-58
Year of Publication: 
2008
Authors: 
Shawahna R
Department of Pharmacy, Faculty of Pharmacy & Alternative Medicine, The Islamia University of Bahawalpur, Pakistan
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Nisar Ur Rahman
Department of Pharmacy, Faculty of Pharmacy & Alternative Medicine, The Islamia University of Bahawalpur, Pakistan
Preferred Abstract (Original): 

Objectives: To decide on whether tablet splitting scenarios represent prescribing error situations or not by a panel of expert judges composed of thirty members and to analyze splitting of tablets orders in two teaching hospitals.
Methods: A questionnaire containing scenarios was submitted to each member of the panel of expert judges, and a two round Delphi technique was followed to obtain consensus. Based on the Delphi rounds results, 902 and 316 medication orders were screened from Services hospital and Punjab Institute of Cardiology, respectively.

Results: Two scenarios were considered prescribing error situations, one was excluded and one was partially agreed upon. In Services Hospital 42 errors were detected, out of which 20 errors involved splitting of modified release tablets while 22 errors involved splitting of coated tablets. In Punjab Institute of Cardiology 41 errors were detected, out of which 23 errors involved splitting of modified release tablets while 18 errors involved splitting of coated tablets.
Conclusion: It was concluded that programs are needed to increase the current awareness regarding unsuitability of splitting all tablet types.

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Weight and Content Uniformity of Lorazepam Half-Tablets: a Study of Correlation of a Low Drug Content Product

Journal Title, Volume, Page: 
Saudi Pharmaceutical Journal Volume 21, Issue 1, January 2013, Pages 71–75
Year of Publication: 
2013
Authors: 
Abdel Naser Zaid
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
Rowa’ J. Al-Ramahi
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Abeer Abu Ghoush
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Aiman Qaddumi
Pharmacare Ltd., Beitunia, P.O. Box 677, Ramallah, Palestine
Yara Abu Zaaror
Pharmacare Ltd., Beitunia, P.O. Box 677, Ramallah, Palestine
Preferred Abstract (Original): 

The aim of this study was to investigate the degree of correlation between the weight and the content of spilt-halves of lorazepam 2.5 mg tablets. Weight variation and drug content of lorazepam half-tablets were evaluated according to the European Pharmacopoeia tests. Only one individual mass of the 30 half tablets was outside the limits of 85–115% of the average mass, but since it was within 75–125% of the average mass, the product passed the test. Each individual content was between 85% and 115% of the average content (99.8% expressed as a percent to label claim) and within the limits of 75–125%, so the product passed the uniformity of content test. The correlation coefficient (r) between the weight and the content of split halves was found to be 0.994. The weights of split tablet halves appear to be directly correlated with their drug content even for a medication with a low drug content, thus it is recommended that pharmacists who split tablets into two halves, assure the weight uniformity of the resultant halves. Manufacturers should develop formulation and manufacturing procedures that ensure high degree of correlation between weight and content not only among the whole tablet but also among the obtained tablet halves.

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

Journal Title, Volume, Page: 
Journal of Pharmaceutical Investigations. 2012; 42(5): 229-234
Year of Publication: 
2012
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
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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