Single dose bioequivalence study of sultamicillin tablets marketed in Turkey on healthy volunteers

B. Guvener, A. Canberk, Serife Eti, H. Sabuncu, S. Sak, H. Kirkoyun, E. Buget

Research output: Contribution to journalArticle

Abstract

Sultamicillin is a pro-drug hydrolysed in human body to release ampicillin and sulbactam which is a β-lactamase inhibitor. In this study was tested two sultamicillin tablets products, namely Alfasid (Bio-Sen, Fako) and Duocid (Pfizer) marketed in Turkey, their in vitro dissolution properties and the bioequivalence in two ways, crossover, double blind design. The tests were carried out on 19 healthy male adults volunteers who were given orally single dose (2 x 375 = 750 mg). The serum levels of ampicillin and sulbactam were determined by HPLC and microbiological assay methods. The statistical analysis of pharmacokinetic parameters (AUC, C(max), t(max)) for bioequivalence of the two formulations was performed by two-one sided Student's t test (80%-120%, p < 0.05). Area under concentration-time curve (AUC), maximum concentration (C(max)) and time to achieve maximum concentration (t(max)) of ampicillin were found as for Alfasid 23.01 ± 3.4 mcg/ml.h., 9.3 ± 1.5 mcg/ml, 1.2 ± 0.1 h. and for Duocid 24.4 ± 4 mcg/ml.h., 10.5 ± 1.9 mcg/ml, 0.9 ± 0.2 h. by microbiological assay and for Alfasid 19.9 ± 3.1 mcg/ml.h., 9.2 ± 1.4 mcg/ml, 0.82 ± 0.1 h. and for Duocid 22.1 ± 4.2 mcg/ml.h., 10.5 ± 1.8 mcg/ml, 0.83 ± 0.2 h. by HPLC method. The AUC, C(max) and t(max) of serum sulbactam were found as for Alfasid 11.74 ± 2.1 mcg/ml.h., 6.7 ± 1.03 mcg/ml, 0.82 ± 0.1 h. and for Duocid 12.16 ± 2.4 mcg/ml.h., 7.4 ± 1.37 mcg/ml, 0.83 ± 0.1 h. The in vitro dissolution tests have similar results for both drugs (Alfasid and Duocid tablets contained 375 mg sultamicillin) tested. In conclusion, two sultamicillin tablet formulations (Alfasid, Bio-Sen, Fako and Duocid, Pfizer) were found to be bioequivalent since they were pharmaceutically equivalent, the in vitro dissolution characteristics were similar and there were not any statistically significant differences between the pharmacokinetic parameters (AUC, C(max) and t(max)).

Original languageEnglish (US)
Pages (from-to)73-88
Number of pages16
JournalActa Pharmaceutica Turcica
Volume35
Issue number3
StatePublished - 1993
Externally publishedYes

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Therapeutic Equivalency
Turkey
Tablets
Healthy Volunteers
Pharmacokinetics
High Pressure Liquid Chromatography
Sulbactam
Prodrugs
Ampicillin
Serum
Human Body
sultamicillin
Volunteers
Students
Pharmaceutical Preparations
In Vitro Techniques

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Guvener, B., Canberk, A., Eti, S., Sabuncu, H., Sak, S., Kirkoyun, H., & Buget, E. (1993). Single dose bioequivalence study of sultamicillin tablets marketed in Turkey on healthy volunteers. Acta Pharmaceutica Turcica, 35(3), 73-88.

Single dose bioequivalence study of sultamicillin tablets marketed in Turkey on healthy volunteers. / Guvener, B.; Canberk, A.; Eti, Serife; Sabuncu, H.; Sak, S.; Kirkoyun, H.; Buget, E.

In: Acta Pharmaceutica Turcica, Vol. 35, No. 3, 1993, p. 73-88.

Research output: Contribution to journalArticle

Guvener, B, Canberk, A, Eti, S, Sabuncu, H, Sak, S, Kirkoyun, H & Buget, E 1993, 'Single dose bioequivalence study of sultamicillin tablets marketed in Turkey on healthy volunteers', Acta Pharmaceutica Turcica, vol. 35, no. 3, pp. 73-88.
Guvener, B. ; Canberk, A. ; Eti, Serife ; Sabuncu, H. ; Sak, S. ; Kirkoyun, H. ; Buget, E. / Single dose bioequivalence study of sultamicillin tablets marketed in Turkey on healthy volunteers. In: Acta Pharmaceutica Turcica. 1993 ; Vol. 35, No. 3. pp. 73-88.
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abstract = "Sultamicillin is a pro-drug hydrolysed in human body to release ampicillin and sulbactam which is a β-lactamase inhibitor. In this study was tested two sultamicillin tablets products, namely Alfasid (Bio-Sen, Fako) and Duocid (Pfizer) marketed in Turkey, their in vitro dissolution properties and the bioequivalence in two ways, crossover, double blind design. The tests were carried out on 19 healthy male adults volunteers who were given orally single dose (2 x 375 = 750 mg). The serum levels of ampicillin and sulbactam were determined by HPLC and microbiological assay methods. The statistical analysis of pharmacokinetic parameters (AUC, C(max), t(max)) for bioequivalence of the two formulations was performed by two-one sided Student's t test (80{\%}-120{\%}, p < 0.05). Area under concentration-time curve (AUC), maximum concentration (C(max)) and time to achieve maximum concentration (t(max)) of ampicillin were found as for Alfasid 23.01 ± 3.4 mcg/ml.h., 9.3 ± 1.5 mcg/ml, 1.2 ± 0.1 h. and for Duocid 24.4 ± 4 mcg/ml.h., 10.5 ± 1.9 mcg/ml, 0.9 ± 0.2 h. by microbiological assay and for Alfasid 19.9 ± 3.1 mcg/ml.h., 9.2 ± 1.4 mcg/ml, 0.82 ± 0.1 h. and for Duocid 22.1 ± 4.2 mcg/ml.h., 10.5 ± 1.8 mcg/ml, 0.83 ± 0.2 h. by HPLC method. The AUC, C(max) and t(max) of serum sulbactam were found as for Alfasid 11.74 ± 2.1 mcg/ml.h., 6.7 ± 1.03 mcg/ml, 0.82 ± 0.1 h. and for Duocid 12.16 ± 2.4 mcg/ml.h., 7.4 ± 1.37 mcg/ml, 0.83 ± 0.1 h. The in vitro dissolution tests have similar results for both drugs (Alfasid and Duocid tablets contained 375 mg sultamicillin) tested. In conclusion, two sultamicillin tablet formulations (Alfasid, Bio-Sen, Fako and Duocid, Pfizer) were found to be bioequivalent since they were pharmaceutically equivalent, the in vitro dissolution characteristics were similar and there were not any statistically significant differences between the pharmacokinetic parameters (AUC, C(max) and t(max)).",
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AU - Sak, S.

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AU - Buget, E.

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N2 - Sultamicillin is a pro-drug hydrolysed in human body to release ampicillin and sulbactam which is a β-lactamase inhibitor. In this study was tested two sultamicillin tablets products, namely Alfasid (Bio-Sen, Fako) and Duocid (Pfizer) marketed in Turkey, their in vitro dissolution properties and the bioequivalence in two ways, crossover, double blind design. The tests were carried out on 19 healthy male adults volunteers who were given orally single dose (2 x 375 = 750 mg). The serum levels of ampicillin and sulbactam were determined by HPLC and microbiological assay methods. The statistical analysis of pharmacokinetic parameters (AUC, C(max), t(max)) for bioequivalence of the two formulations was performed by two-one sided Student's t test (80%-120%, p < 0.05). Area under concentration-time curve (AUC), maximum concentration (C(max)) and time to achieve maximum concentration (t(max)) of ampicillin were found as for Alfasid 23.01 ± 3.4 mcg/ml.h., 9.3 ± 1.5 mcg/ml, 1.2 ± 0.1 h. and for Duocid 24.4 ± 4 mcg/ml.h., 10.5 ± 1.9 mcg/ml, 0.9 ± 0.2 h. by microbiological assay and for Alfasid 19.9 ± 3.1 mcg/ml.h., 9.2 ± 1.4 mcg/ml, 0.82 ± 0.1 h. and for Duocid 22.1 ± 4.2 mcg/ml.h., 10.5 ± 1.8 mcg/ml, 0.83 ± 0.2 h. by HPLC method. The AUC, C(max) and t(max) of serum sulbactam were found as for Alfasid 11.74 ± 2.1 mcg/ml.h., 6.7 ± 1.03 mcg/ml, 0.82 ± 0.1 h. and for Duocid 12.16 ± 2.4 mcg/ml.h., 7.4 ± 1.37 mcg/ml, 0.83 ± 0.1 h. The in vitro dissolution tests have similar results for both drugs (Alfasid and Duocid tablets contained 375 mg sultamicillin) tested. In conclusion, two sultamicillin tablet formulations (Alfasid, Bio-Sen, Fako and Duocid, Pfizer) were found to be bioequivalent since they were pharmaceutically equivalent, the in vitro dissolution characteristics were similar and there were not any statistically significant differences between the pharmacokinetic parameters (AUC, C(max) and t(max)).

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