Research Article
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Year 2023, Volume: 48 Issue: 1, 25 - 36, 01.03.2023
https://doi.org/10.55262/fabadeczacilik.1103532

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.

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

Year 2023, Volume: 48 Issue: 1, 25 - 36, 01.03.2023
https://doi.org/10.55262/fabadeczacilik.1103532

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.

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
There are 6 citations in total.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences
Journal Section Research Article
Authors

Fırat Yerlikaya 0000-0003-4648-3258

Aslihan Arslan 0000-0002-3520-608X

Özlem Atik 0000-0001-7867-6316

Seda Kozan This is me 0000-0003-3925-0317

Ahmet Parlak 0000-0002-4921-0004

Meltem Özel Karataş 0000-0001-9226-2603

Onursal Sağlam This is me 0000-0002-1421-6633

Sevim Peri Aytaç 0000-0002-9985-3382

Publication Date March 1, 2023
Submission Date April 19, 2022
Published in Issue Year 2023 Volume: 48 Issue: 1

Cite

APA Yerlikaya, F., Arslan, A., Atik, Ö., Kozan, S., et al. (2023). The Relative Bioavailability Study of Two Cefdinir Formulations in Healthy Males Under Fasting Conditions. Fabad Journal of Pharmaceutical Sciences, 48(1), 25-36. https://doi.org/10.55262/fabadeczacilik.1103532