The Bioequivalence Study of Two Cefdinir 250 mg/5 mL Oral Suspension Formulations in Healthy Males Under Fasting Conditions
Abstract
A new liquid oral formulation of cefdinir has been developed and a bioequivalence study was conducted. This single-center study was designed as an open-label, randomized, two-period, cross-over trial, and was performed with healthy males under fasting conditions in compliance with Good Clinical Practice (GCP) principles. Two 250 mg/5mL suspension formulation of cefdinir was compared in terms of their pharmacokinetic properties and the bioequivalence of the new formulation was assessed according to the requirement of the authorities. The blood samples of the volunteers were taken at certain points specified to cefdinir, to evaluate the plasma concentrations and pharmacokinetic properties of two cefdinir formulations by using a validated LC-MS/MS analytical method. The bioequivalence of the new formulation has been shown and the tolerability of both products was acceptable.
Keywords
References
- 1. Richer M, Allard S, Manseau L, Vallée F, Pak R, LeBel M: Suction-induced blister fluid penetration of cefdinir in healthy volunteers following ascending oral doses. Antimicrobial Agents and Chemotherapy 1995, 39(5):1082–1086.
- 2. Cabri W, Ghetti P, Alpegiani M, Pozzi G, Justoerbez A, Perezmartinez J, Munozruiz A. Cefdinir: A comparative study of anhydrous vs. monohydrate form. Microstructure and tabletting behaviour. European Journal of Pharmaceutics and Biopharmaceutics 2006, 64(2):212–221.
- 3. Powers JL, Gooch WM 3rd, Oddo LP. Comparison of the palatability of the oral suspension of cefdinir vs. amoxicillin/clavulanate potassium, cefprozil and azithromycin in pediatric patients. Pediatric Infectious Diseases Journal 2000, 19(12 Suppl):S174-80.
- 4. Block SL, Schmier JK, Notario GF, Akinlade BK, Busman TA, Mackinnon GE 3rd, Halpern MT, Nilius AM. Efficacy, tolerability, and parent reported outcomes for cefdinir vs. high-dose amoxicillin/clavulanate oral suspension for acute otitis media in young children. Current Medical Research and Opinion 2006, 22(9):1839-1847.
- 5. Perry CM, Scott LJ. Cefdinir. Drugs 2004, 64(13):1433–1464.
- 6. Republic of Turkey Ministry of Health, (2015), The Guidance for GCP. https://titck.gov.tr/storage/Archive/2020/legislation/KADKLVZ01IKU13.11.2015Rev08_13ac0133-274b-44dc-98cd-33998758cc72.pdf, Access Date: 14.04.2022.
- 7. EMA, (2011), Guideline on Bioanalytical Method Validation, EMEA/CHMP/EWP/192217/2009 Rev.1 Corr.2, London, 21 July 2011. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf, Access Date: 14.04.2022
The Bioequivalence Study of Two Cefdinir 250 mg/5 mL Oral Suspension Formulations in Healthy Males Under Fasting Conditions
Abstract
A new liquid oral formulation of cefdinir has been developed and a bioequivalence study was conducted. This single-center study was designed as an open-label, randomized, two-period, cross-over trial, and was performed with healthy males under fasting conditions in compliance with Good Clinical Practice (GCP) principles. Two 250 mg/5mL suspension formulation of cefdinir was compared in terms of their pharmacokinetic properties and the bioequivalence of the new formulation was assessed according to the requirement of the authorities. The blood samples of the volunteers were taken at certain points specified to cefdinir, to evaluate the plasma concentrations and pharmacokinetic properties of two cefdinir formulations by using a validated LC-MS/MS analytical method. The bioequivalence of the new formulation has been shown and the tolerability of both products was acceptable.
Keywords
References
- 1. Richer M, Allard S, Manseau L, Vallée F, Pak R, LeBel M: Suction-induced blister fluid penetration of cefdinir in healthy volunteers following ascending oral doses. Antimicrobial Agents and Chemotherapy 1995, 39(5):1082–1086.
- 2. Cabri W, Ghetti P, Alpegiani M, Pozzi G, Justoerbez A, Perezmartinez J, Munozruiz A. Cefdinir: A comparative study of anhydrous vs. monohydrate form. Microstructure and tabletting behaviour. European Journal of Pharmaceutics and Biopharmaceutics 2006, 64(2):212–221.
- 3. Powers JL, Gooch WM 3rd, Oddo LP. Comparison of the palatability of the oral suspension of cefdinir vs. amoxicillin/clavulanate potassium, cefprozil and azithromycin in pediatric patients. Pediatric Infectious Diseases Journal 2000, 19(12 Suppl):S174-80.
- 4. Block SL, Schmier JK, Notario GF, Akinlade BK, Busman TA, Mackinnon GE 3rd, Halpern MT, Nilius AM. Efficacy, tolerability, and parent reported outcomes for cefdinir vs. high-dose amoxicillin/clavulanate oral suspension for acute otitis media in young children. Current Medical Research and Opinion 2006, 22(9):1839-1847.
- 5. Perry CM, Scott LJ. Cefdinir. Drugs 2004, 64(13):1433–1464.
- 6. Republic of Turkey Ministry of Health, (2015), The Guidance for GCP. https://titck.gov.tr/storage/Archive/2020/legislation/KADKLVZ01IKU13.11.2015Rev08_13ac0133-274b-44dc-98cd-33998758cc72.pdf, Access Date: 14.04.2022.
- 7. EMA, (2011), Guideline on Bioanalytical Method Validation, EMEA/CHMP/EWP/192217/2009 Rev.1 Corr.2, London, 21 July 2011. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf, Access Date: 14.04.2022
Details
| Primary Language | English |
|---|---|
| Subjects | Pharmacology and Pharmaceutical Sciences |
| Journal Section | Research Articles |
| Authors | |
| Publication Date | March 1, 2023 |
| Acceptance Date | September 10, 2022 |
| Published in Issue | Year 2023 Volume: 43 Issue: 1 |