Pharmacokinetics and bioequivalence assessment of optimized directly compressible Aceclofenac (100 mg) tablet formulation in healthy human subjects
The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smo...
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| Published in | PloS one Vol. 15; no. 9; p. e0238951 |
|---|---|
| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
San Francisco
Public Library of Science
08.09.2020
Public Library of Science (PLoS) |
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| Online Access | Get full text |
| ISSN | 1932-6203 1932-6203 |
| DOI | 10.1371/journal.pone.0238951 |
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| Abstract | The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smokers male subjects with overnight fasting of >10hr. The study was a randomized, single-dose, open-label, two sequence, and two treatment crossover design, with a washout period of 2 weeks. Blood samples (5 mL) from the human subjects were collected before (0 hr) and after drug administration at 13different time points (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 18 hrs). The drug plasma concentration was analyzed by a validated RP-HPLC method using a solvent system containing acetonitrile and deionized water (60:40% v/v). Linearity was found to be 0.999 over the drug concentration range of 50[mu]g/mL to 0.05[mu]g/mL with LLOQ and LOD of 0.05[mu]g/mL and 0.025[mu]g/mL respectively. Non-compartmental pharmacokinetic analysis was performed using Kinetica.sup.® (ver. 5.1) software. Using the log-transformed data C.sub.max, AUC.sub.0-t, AUC.sub.0-[infinity], AUMC.sub.tot, and MRT were calculated. The C.sub.max of the test and brand was found to be 8.629±1.251[mu]g/mL and 8.478±0.913[mu]g/mL. The AUC.sub.0-t and AUC.sub.0-[infinity] of the test and the reference were computed to be 20.890 ±2.2021[mu]g/mL.h, 23.272 ±1.914 [mu]g/mL.h and 19.850 ±2.911 [mu]g/mL.h, 22.890 ± 2.110 [mu]g/mL.h correspondingly. Two-way analysis of variance (ANOVA) test and two one-sided t-test (p>0.05; non-significant) were applied to assess the variation in the period, sequence, subjects, and treatment. Geometric mean ratios for above mentioned pharmacokinetic parameters of reference/test were found within the acceptable FDA limits of 80-125% using 90% CI. There was no inter and intrasubject variation (p> 0.05) that was observed. Therefore, the directly compressible aceclofenac (100 mg) test formulation and the commercial reference tablets were declared to be biosimilar. |
|---|---|
| AbstractList | The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smokers male subjects with overnight fasting of >10hr. The study was a randomized, single-dose, open-label, two sequence, and two treatment crossover design, with a washout period of 2 weeks. Blood samples (5 mL) from the human subjects were collected before (0 hr) and after drug administration at 13different time points (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 18 hrs). The drug plasma concentration was analyzed by a validated RP-HPLC method using a solvent system containing acetonitrile and deionized water (60:40% v/v). Linearity was found to be 0.999 over the drug concentration range of 50μg/mL to 0.05μg/mL with LLOQ and LOD of 0.05μg/mL and 0.025μg/mL respectively. Non-compartmental pharmacokinetic analysis was performed using Kinetica® (ver. 5.1) software. Using the log-transformed data Cmax, AUC0-t, AUC0-∞, AUMCtot, and MRT were calculated. The Cmax of the test and brand was found to be 8.629±1.251μg/mL and 8.478±0.913μg/mL. The AUC0-t and AUC0-∞ of the test and the reference were computed to be 20.890 ±2.2021μg/mL.h, 23.272 ±1.914 μg/mL.h and 19.850 ±2.911 μg/mL.h, 22.890 ± 2.110 μg/mL.h correspondingly. Two-way analysis of variance (ANOVA) test and two one-sided t-test (p>0.05; non-significant) were applied to assess the variation in the period, sequence, subjects, and treatment. Geometric mean ratios for above mentioned pharmacokinetic parameters of reference/test were found within the acceptable FDA limits of 80-125% using 90% CI. There was no inter and intrasubject variation (p> 0.05) that was observed. Therefore, the directly compressible aceclofenac (100 mg) test formulation and the commercial reference tablets were declared to be biosimilar.The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smokers male subjects with overnight fasting of >10hr. The study was a randomized, single-dose, open-label, two sequence, and two treatment crossover design, with a washout period of 2 weeks. Blood samples (5 mL) from the human subjects were collected before (0 hr) and after drug administration at 13different time points (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 18 hrs). The drug plasma concentration was analyzed by a validated RP-HPLC method using a solvent system containing acetonitrile and deionized water (60:40% v/v). Linearity was found to be 0.999 over the drug concentration range of 50μg/mL to 0.05μg/mL with LLOQ and LOD of 0.05μg/mL and 0.025μg/mL respectively. Non-compartmental pharmacokinetic analysis was performed using Kinetica® (ver. 5.1) software. Using the log-transformed data Cmax, AUC0-t, AUC0-∞, AUMCtot, and MRT were calculated. The Cmax of the test and brand was found to be 8.629±1.251μg/mL and 8.478±0.913μg/mL. The AUC0-t and AUC0-∞ of the test and the reference were computed to be 20.890 ±2.2021μg/mL.h, 23.272 ±1.914 μg/mL.h and 19.850 ±2.911 μg/mL.h, 22.890 ± 2.110 μg/mL.h correspondingly. Two-way analysis of variance (ANOVA) test and two one-sided t-test (p>0.05; non-significant) were applied to assess the variation in the period, sequence, subjects, and treatment. Geometric mean ratios for above mentioned pharmacokinetic parameters of reference/test were found within the acceptable FDA limits of 80-125% using 90% CI. There was no inter and intrasubject variation (p> 0.05) that was observed. Therefore, the directly compressible aceclofenac (100 mg) test formulation and the commercial reference tablets were declared to be biosimilar. The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smokers male subjects with overnight fasting of >10hr. The study was a randomized, single-dose, open-label, two sequence, and two treatment crossover design, with a washout period of 2 weeks. Blood samples (5 mL) from the human subjects were collected before (0 hr) and after drug administration at 13different time points (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 18 hrs). The drug plasma concentration was analyzed by a validated RP-HPLC method using a solvent system containing acetonitrile and deionized water (60:40% v/v). Linearity was found to be 0.999 over the drug concentration range of 50μg/mL to 0.05μg/mL with LLOQ and LOD of 0.05μg/mL and 0.025μg/mL respectively. Non-compartmental pharmacokinetic analysis was performed using Kinetica® (ver. 5.1) software. Using the log-transformed data Cmax, AUC0-t, AUC0-∞, AUMCtot, and MRT were calculated. The Cmax of the test and brand was found to be 8.629±1.251μg/mL and 8.478±0.913μg/mL. The AUC0-t and AUC0-∞ of the test and the reference were computed to be 20.890 ±2.2021μg/mL.h, 23.272 ±1.914 μg/mL.h and 19.850 ±2.911 μg/mL.h, 22.890 ± 2.110 μg/mL.h correspondingly. Two-way analysis of variance (ANOVA) test and two one-sided t-test (p>0.05; non-significant) were applied to assess the variation in the period, sequence, subjects, and treatment. Geometric mean ratios for above mentioned pharmacokinetic parameters of reference/test were found within the acceptable FDA limits of 80–125% using 90% CI. There was no inter and intrasubject variation (p> 0.05) that was observed. Therefore, the directly compressible aceclofenac (100 mg) test formulation and the commercial reference tablets were declared to be biosimilar. The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smokers male subjects with overnight fasting of >10hr. The study was a randomized, single-dose, open-label, two sequence, and two treatment crossover design, with a washout period of 2 weeks. Blood samples (5 mL) from the human subjects were collected before (0 hr) and after drug administration at 13different time points (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 18 hrs). The drug plasma concentration was analyzed by a validated RP-HPLC method using a solvent system containing acetonitrile and deionized water (60:40% v/v). Linearity was found to be 0.999 over the drug concentration range of 50μg/mL to 0.05μg/mL with LLOQ and LOD of 0.05μg/mL and 0.025μg/mL respectively. Non-compartmental pharmacokinetic analysis was performed using Kinetica ® (ver. 5.1) software. Using the log-transformed data C max , AUC 0-t , AUC 0-∞ , AUMC tot , and MRT were calculated. The C max of the test and brand was found to be 8.629±1.251μg/mL and 8.478±0.913μg/mL. The AUC 0-t and AUC 0-∞ of the test and the reference were computed to be 20.890 ±2.2021μg/mL.h, 23.272 ±1.914 μg/mL.h and 19.850 ±2.911 μg/mL.h, 22.890 ± 2.110 μg/mL.h correspondingly. Two-way analysis of variance (ANOVA) test and two one-sided t -test ( p >0.05; non-significant) were applied to assess the variation in the period, sequence, subjects, and treatment. Geometric mean ratios for above mentioned pharmacokinetic parameters of reference/test were found within the acceptable FDA limits of 80–125% using 90% CI. There was no inter and intrasubject variation ( p > 0.05) that was observed. Therefore, the directly compressible aceclofenac (100 mg) test formulation and the commercial reference tablets were declared to be biosimilar. The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smokers male subjects with overnight fasting of >10hr. The study was a randomized, single-dose, open-label, two sequence, and two treatment crossover design, with a washout period of 2 weeks. Blood samples (5 mL) from the human subjects were collected before (0 hr) and after drug administration at 13different time points (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 18 hrs). The drug plasma concentration was analyzed by a validated RP-HPLC method using a solvent system containing acetonitrile and deionized water (60:40% v/v). Linearity was found to be 0.999 over the drug concentration range of 50[mu]g/mL to 0.05[mu]g/mL with LLOQ and LOD of 0.05[mu]g/mL and 0.025[mu]g/mL respectively. Non-compartmental pharmacokinetic analysis was performed using Kinetica.sup.® (ver. 5.1) software. Using the log-transformed data C.sub.max, AUC.sub.0-t, AUC.sub.0-[infinity], AUMC.sub.tot, and MRT were calculated. The C.sub.max of the test and brand was found to be 8.629±1.251[mu]g/mL and 8.478±0.913[mu]g/mL. The AUC.sub.0-t and AUC.sub.0-[infinity] of the test and the reference were computed to be 20.890 ±2.2021[mu]g/mL.h, 23.272 ±1.914 [mu]g/mL.h and 19.850 ±2.911 [mu]g/mL.h, 22.890 ± 2.110 [mu]g/mL.h correspondingly. Two-way analysis of variance (ANOVA) test and two one-sided t-test (p>0.05; non-significant) were applied to assess the variation in the period, sequence, subjects, and treatment. Geometric mean ratios for above mentioned pharmacokinetic parameters of reference/test were found within the acceptable FDA limits of 80-125% using 90% CI. There was no inter and intrasubject variation (p> 0.05) that was observed. Therefore, the directly compressible aceclofenac (100 mg) test formulation and the commercial reference tablets were declared to be biosimilar. |
| Audience | Academic |
| Author | Ali, Huma Bushra, Rabia Shoaib, Muhammad Harris Ghayas, Sana |
| AuthorAffiliation | 1 Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan 2 Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan Bhagwan Mahvir College of Pharmacy, INDIA |
| AuthorAffiliation_xml | – name: 1 Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan – name: 2 Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan – name: Bhagwan Mahvir College of Pharmacy, INDIA |
| Author_xml | – sequence: 1 givenname: Rabia surname: Bushra fullname: Bushra, Rabia – sequence: 2 givenname: Muhammad Harris orcidid: 0000-0002-3639-0026 surname: Shoaib fullname: Shoaib, Muhammad Harris – sequence: 3 givenname: Huma surname: Ali fullname: Ali, Huma – sequence: 4 givenname: Sana surname: Ghayas fullname: Ghayas, Sana |
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| CitedBy_id | crossref_primary_10_12677_hjmce_2024_123023 crossref_primary_10_1134_S1061934823030103 crossref_primary_10_1080_10826076_2023_2202231 crossref_primary_10_3389_fphar_2021_660541 crossref_primary_10_18027_2224_5057_2024_14_1_56_66 |
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| Copyright | COPYRIGHT 2020 Public Library of Science 2020 Bushra et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2020 Bushra et al 2020 Bushra et al |
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| DOI | 10.1371/journal.pone.0238951 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Current address: Faculty of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan Current address: Faculty of Pharmacy, Jinnah Sindh Medical University, Karachi, Pakistan Competing Interests: The authors have declared that no competing interests exist. Current address: Department of Pharmaceutics, Faculty of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan |
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| Title | Pharmacokinetics and bioequivalence assessment of optimized directly compressible Aceclofenac (100 mg) tablet formulation in healthy human subjects |
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