Session
Medical, Chemical and Pharmaceutical Sciences
Description
Tablet division is a widespread phenomenon nowadays in Albania, because of different factors such as the absence of small dosages in the pharmaceutical market, financial reasons etc. The purpose of this study is to identify the positive and negative aspects of tablets division by patients. It aims to show experimentally if the division affects or not, in a significant way the percentage of the active substance. It was selected Amlodipine as a drug for analysis, because of two reasons. First it is used in chronic therapy and second it is part of the List of Reimbursement of Medicines in the Republic of Albania.It was used besylate amlodipine as RS, three different productions of Amlodipine tablets bought directly in a community pharmacy, methanol HPLC grade and ammonium acetate. It was selected the method based on the HPLC analysis of the solutions obtained by dissolution of amlodipine in methanol as described in the European Pharmacopoeia 2011. This was an ongoing analysis for four weeks. The divided tablets have been kept in similar conditions as a patient can do.The organoleptic control after division showed no changes for all three productions. Only halves of sample A fulfill the pharmacopoeia criteria for RD ± 7.5%. From the results obtained, it was noted that there was a decrease in the percentage of the active substance, on halves taken randomly for analysis. The concentration of the active substance in sample A at the end of the analysis resulted to be 83.6%, in sample B 84.37% and sample C 83.75%. The level of impurities remain ≤ 2% conform limits in Eur. Ph. Based on these results, it is concluded that tablet division is a process that significantly affects the percentage of the tablet's active substance. Reducing the concentration of the active substance implies that the patient does not receive the required dose for treatment and the success of therapy is in doubt. The division of amlodipine tablets is economically convenient, but is a practice that should be avoided and not advised by the healthcare providers.
Keywords:
amlodipine, tablet division, efficacy, stability
Session Chair
Arianit Jakupi
Session Co-Chair
Valon Ejupi
Proceedings Editor
Edmond Hajrizi
ISBN
978-9951-437-67-7
First Page
21
Last Page
26
Location
Durres, Albania
Start Date
28-10-2017 9:00 AM
End Date
28-10-2017 10:30 AM
DOI
10.33107/ubt-ic.2017.286
Recommended Citation
Myftari, Brunilda; Andrea, Enxhi; Myftari, Elton; and Malaj, Ledjan, "The Influence of Division of Amlodipine Tablets on their Efficacy and Stability" (2017). UBT International Conference. 286.
https://knowledgecenter.ubt-uni.net/conference/2017/all-events/286
Included in
The Influence of Division of Amlodipine Tablets on their Efficacy and Stability
Durres, Albania
Tablet division is a widespread phenomenon nowadays in Albania, because of different factors such as the absence of small dosages in the pharmaceutical market, financial reasons etc. The purpose of this study is to identify the positive and negative aspects of tablets division by patients. It aims to show experimentally if the division affects or not, in a significant way the percentage of the active substance. It was selected Amlodipine as a drug for analysis, because of two reasons. First it is used in chronic therapy and second it is part of the List of Reimbursement of Medicines in the Republic of Albania.It was used besylate amlodipine as RS, three different productions of Amlodipine tablets bought directly in a community pharmacy, methanol HPLC grade and ammonium acetate. It was selected the method based on the HPLC analysis of the solutions obtained by dissolution of amlodipine in methanol as described in the European Pharmacopoeia 2011. This was an ongoing analysis for four weeks. The divided tablets have been kept in similar conditions as a patient can do.The organoleptic control after division showed no changes for all three productions. Only halves of sample A fulfill the pharmacopoeia criteria for RD ± 7.5%. From the results obtained, it was noted that there was a decrease in the percentage of the active substance, on halves taken randomly for analysis. The concentration of the active substance in sample A at the end of the analysis resulted to be 83.6%, in sample B 84.37% and sample C 83.75%. The level of impurities remain ≤ 2% conform limits in Eur. Ph. Based on these results, it is concluded that tablet division is a process that significantly affects the percentage of the tablet's active substance. Reducing the concentration of the active substance implies that the patient does not receive the required dose for treatment and the success of therapy is in doubt. The division of amlodipine tablets is economically convenient, but is a practice that should be avoided and not advised by the healthcare providers.