Abstract
600 mg sefdinir içeren yeni bir oral tablet formülasyonu geliştirilmiş ve bu çalışmada bu formülasyonun bağıl biyoyararlanımı halihazırda piyasada bulunan başka bir oral katı dozaj formu olan Sefdinir 300 mg Kapsül ile karşılaştırılmıştır. Sağlıklı erkeklerde, açlık koşulları altında açık etiketli, randomize, iki periyotlu, çapraz geçişli bir bağıl biyoyararlanım çalışması İyi Klinik Uygulamaları (İKU) ilkelerine uygun olarak yürütülmüştür. Tek doz uygulanan 600 mg Sefdinir Tablet formülasyonunun farmakokinetik özellikleri, iki doz (tek seferde iki kapsül) olarak uygulanan Sefdinir 300 mg Kapsül ile karşılaştırılmıştır. Bu karşılaştırma çalışması, tek merkezli bir klinik çalışma olarak gerçekleştirilmiştir ve katılımcıların kan örnekleri, dozlamadan önce ve sonra belirtilen zaman noktalarında alınmıştır. Sefdinir formülasyonlarının plazma konsantrasyonları ve farmakokinetik özellikleri, valide edilmiş bir LC-MS/MS analitik yöntemi ile toplanan örnekler kullanılarak değerlendirilmiştir. Çalışmada yeni formülasyonun bağıl biyoyararlanımı gösterilmiş ve her iki ürünün de güvenli olduğu bildirilmiştir.
Keywords
References
- Cabri, W., Ghetti, P., Alpegiani, M., Pozzi, G., Justoerbez, A., Perezmartinez, J., Munozruiz, A. (2006). Cefdinir: A comparative study of anhydrous vs. monohydrate formMicrostructure and tabletting behaviour. European Journal of Pharmaceutics and Biopharmaceutics, 64(2), 212–221.
- 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: 12.04.2022
- FDA, (2020), Cefdinir 300 mg Capsules Label, https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=38f6adf7-e26c-4764-8ec9-360813874dd4&type=display, Access Date: 12.04.2022
- Perry, C. M., & Scott, L. J. (2004). Cefdinir. Drugs, 64(13), 1433–1464.
- 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: 12.04.2022.
- Richer, M., Allard, S., Manseau, L., Vallée, F., Pak, R., & LeBel, M. (1995). Suction-induced blister fluid penetration of cefdinir in healthy volunteers following ascending oral doses. Antimicrobial Agents and Chemotherapy, 39(5), 1082–1086. https://doi.org/10.1128/AAC.39.5.1082
The Relative Bioavailability Study of Two Cefdinir Formulations in Healthy Males Under Fasting Conditions
Abstract
A new oral formulation of cefdinir, Cefdinir 600 mg Tablets has been developed and in this study, its relative bioavailability has been compared with another oral solid dosage form, Cefdinir 300 mg Capsules, which is already on the market. An open-label, randomized, two-period, cross-over relative bioavailability study has been conducted with healthy males under fasting conditions in compliance with Good Clinical Practice (GCP) principles. A single dose of the novel tablet formulation of 600 mg cefdinir has been compared to two doses of Cefdinir 300 mg Capsules (two capsules at once) in terms of their pharmacokinetic properties. The comparison study was performed as a single-center clinical study, and blood samples of the participants were withdrawn at specified time points, before and after dosing. The plasma concentrations and pharmacokinetic properties of two cefdinir formulations were assessed from the collected samples by using a validated LC-MS/MS analytical method. The relative bioavailability of the new formulation has been shown and both products were introduced as safe.
Keywords
References
- Cabri, W., Ghetti, P., Alpegiani, M., Pozzi, G., Justoerbez, A., Perezmartinez, J., Munozruiz, A. (2006). Cefdinir: A comparative study of anhydrous vs. monohydrate formMicrostructure and tabletting behaviour. European Journal of Pharmaceutics and Biopharmaceutics, 64(2), 212–221.
- 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: 12.04.2022
- FDA, (2020), Cefdinir 300 mg Capsules Label, https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=38f6adf7-e26c-4764-8ec9-360813874dd4&type=display, Access Date: 12.04.2022
- Perry, C. M., & Scott, L. J. (2004). Cefdinir. Drugs, 64(13), 1433–1464.
- 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: 12.04.2022.
- Richer, M., Allard, S., Manseau, L., Vallée, F., Pak, R., & LeBel, M. (1995). Suction-induced blister fluid penetration of cefdinir in healthy volunteers following ascending oral doses. Antimicrobial Agents and Chemotherapy, 39(5), 1082–1086. https://doi.org/10.1128/AAC.39.5.1082
Details
| Primary Language | English |
|---|---|
| Subjects | Pharmacology and Pharmaceutical Sciences |
| Journal Section | Research Article |
| Authors | |
| Publication Date | March 1, 2023 |
| Submission Date | April 19, 2022 |
| Published in Issue | Year 2023 |