Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteers
Background: In the wake of economic challenges, the role of generic medicines has become crucial in meeting the healthcare needs of people. Their use, however, can only be guaranteed if established to be bioequivalent to their corresponding innovator products. Aim: In this study, we assess the suita...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-01-01
|
| Series: | Heliyon |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405844022039536 |
| _version_ | 1828043805625942016 |
|---|---|
| author | Gideon Onuh Joseph K. Adu Samuel O. Bekoe Raphael Johnson Reimmel K. Adosraku Samuel Asare-Nkansah |
| author_facet | Gideon Onuh Joseph K. Adu Samuel O. Bekoe Raphael Johnson Reimmel K. Adosraku Samuel Asare-Nkansah |
| author_sort | Gideon Onuh |
| collection | DOAJ |
| description | Background: In the wake of economic challenges, the role of generic medicines has become crucial in meeting the healthcare needs of people. Their use, however, can only be guaranteed if established to be bioequivalent to their corresponding innovator products. Aim: In this study, we assess the suitability of a generic brand of cetirizine hydrochloride tablet to be used in place of the innovator brand on the Ghanaian market through bioequivalence assessment. Method: An HPLC bioanalytical method was developed and validated for the detection and quantitation of cetirizine in a urine matrix. This was then used to quantify the amount of cetirizine excreted unchanged in urine samples of 12 healthy male volunteers collected over a 24-h period using a two-way crossover design approach. Results: Chromatographic separation was successfully achieved with an isocratic elution on a reverse-phase column. The mean retention time for cetirizine was 2.890 ± 0.243 min. The mean cumulative amounts of cetirizine in the reference and test drugs excreted were 5.69 ± 0.98 mg and 5.82 ± 1.96 mg respectively. Other pharmacokinetic parameters including mean relative Areas Under Curve (AUC0-24) of 13.32 and 13.05 μg/mL, and peak Concentration (Cmax) of 3.378 and 3.043 μg/mL at the times at which Cmax was observed (Tmax) being 7.25 and 7.42 min were established respectively for the reference and test drugs. The relative bioavailability was determined to be 102.28, making the locally manufactured brand bioequivalent to the innovator brand. Conclusion: The locally manufactured test Cetirizine drug was found to be bioequivalent with the innovator brand and could serve as a suitable alternative to the latter. Additionally, relevant pharmacokinetic parameters for cetirizine has been established using urinary excretion data. |
| first_indexed | 2024-04-10T17:46:32Z |
| format | Article |
| id | doaj.art-8060643d5cc9443da03033a41d8b2da5 |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-04-10T17:46:32Z |
| publishDate | 2023-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-8060643d5cc9443da03033a41d8b2da52023-02-03T04:58:29ZengElsevierHeliyon2405-84402023-01-0191e12665Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteersGideon Onuh0Joseph K. Adu1Samuel O. Bekoe2Raphael Johnson3Reimmel K. Adosraku4Samuel Asare-Nkansah5Department of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Corresponding author.Department of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, GhanaDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, GhanaDepartment of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, GhanaDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, GhanaDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Corresponding author.Background: In the wake of economic challenges, the role of generic medicines has become crucial in meeting the healthcare needs of people. Their use, however, can only be guaranteed if established to be bioequivalent to their corresponding innovator products. Aim: In this study, we assess the suitability of a generic brand of cetirizine hydrochloride tablet to be used in place of the innovator brand on the Ghanaian market through bioequivalence assessment. Method: An HPLC bioanalytical method was developed and validated for the detection and quantitation of cetirizine in a urine matrix. This was then used to quantify the amount of cetirizine excreted unchanged in urine samples of 12 healthy male volunteers collected over a 24-h period using a two-way crossover design approach. Results: Chromatographic separation was successfully achieved with an isocratic elution on a reverse-phase column. The mean retention time for cetirizine was 2.890 ± 0.243 min. The mean cumulative amounts of cetirizine in the reference and test drugs excreted were 5.69 ± 0.98 mg and 5.82 ± 1.96 mg respectively. Other pharmacokinetic parameters including mean relative Areas Under Curve (AUC0-24) of 13.32 and 13.05 μg/mL, and peak Concentration (Cmax) of 3.378 and 3.043 μg/mL at the times at which Cmax was observed (Tmax) being 7.25 and 7.42 min were established respectively for the reference and test drugs. The relative bioavailability was determined to be 102.28, making the locally manufactured brand bioequivalent to the innovator brand. Conclusion: The locally manufactured test Cetirizine drug was found to be bioequivalent with the innovator brand and could serve as a suitable alternative to the latter. Additionally, relevant pharmacokinetic parameters for cetirizine has been established using urinary excretion data.http://www.sciencedirect.com/science/article/pii/S2405844022039536BioequivalenceUrine excretion dataCetirizineHPLC-UVPharmacopeia assessment |
| spellingShingle | Gideon Onuh Joseph K. Adu Samuel O. Bekoe Raphael Johnson Reimmel K. Adosraku Samuel Asare-Nkansah Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteers Heliyon Bioequivalence Urine excretion data Cetirizine HPLC-UV Pharmacopeia assessment |
| title | Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteers |
| title_full | Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteers |
| title_fullStr | Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteers |
| title_full_unstemmed | Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteers |
| title_short | Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteers |
| title_sort | bioequivalence studies of cetirizine tablets using the urine excretion data of healthy ghanaian male volunteers |
| topic | Bioequivalence Urine excretion data Cetirizine HPLC-UV Pharmacopeia assessment |
| url | http://www.sciencedirect.com/science/article/pii/S2405844022039536 |
| work_keys_str_mv | AT gideononuh bioequivalencestudiesofcetirizinetabletsusingtheurineexcretiondataofhealthyghanaianmalevolunteers AT josephkadu bioequivalencestudiesofcetirizinetabletsusingtheurineexcretiondataofhealthyghanaianmalevolunteers AT samuelobekoe bioequivalencestudiesofcetirizinetabletsusingtheurineexcretiondataofhealthyghanaianmalevolunteers AT raphaeljohnson bioequivalencestudiesofcetirizinetabletsusingtheurineexcretiondataofhealthyghanaianmalevolunteers AT reimmelkadosraku bioequivalencestudiesofcetirizinetabletsusingtheurineexcretiondataofhealthyghanaianmalevolunteers AT samuelasarenkansah bioequivalencestudiesofcetirizinetabletsusingtheurineexcretiondataofhealthyghanaianmalevolunteers |