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A comparative bioavailability study of a generic capsule formulation containing carbocysteine
D Jovanović1, S Cusić, Z Segrt
1National Poison Control Centre, Military Medical Academy, Belgrade, Serbia & Montenegro. NCKTVMA@Eunet.yu
Die Pharmazie
|May 27, 2006
Summary
Two carbocysteine capsule formulations were found to be bioequivalent in healthy volunteers. This study confirms that Bronchobos capsules are therapeutically similar to Mucopront capsules.
Area of Science:
- Pharmacokinetics
- Analytical Chemistry
- Clinical Pharmacology
Background:
- Carbocysteine is a mucolytic agent used in respiratory diseases.
- Assessing the bioequivalence of different formulations is crucial for therapeutic interchangeability.
- A sensitive analytical method is required for accurate pharmacokinetic studies.
Purpose of the Study:
- To evaluate the bioequivalence of two carbocysteine capsule formulations (Bronchobos vs. Mucopront).
- To develop and validate a sensitive method for carbocysteine quantification in human plasma.
- To compare pharmacokinetic parameters between the two carbocysteine preparations.
Main Methods:
- A randomized, two-period crossover study in 18 healthy volunteers.
- Single 750 mg dose administration of each carbocysteine formulation.
- Plasma carbocysteine levels analyzed using high-performance liquid chromatography-electrospray ionization-mass spectrometry (HPLC-ESI-MS).
Main Results:
- The 90% confidence intervals for Cmax (0.898-1.112) and AUC(0-infinity) (0.923-1.210) were within the accepted bioequivalence range (0.80-1.25).
- The point estimates for Cmax and AUC(0-infinity) were 0.999 and 1.057, respectively.
- No significant difference was observed in the time to reach Cmax (p=0.4497).
Conclusions:
- Bronchobos capsules are bioequivalent to Mucopront capsules.
- The developed HPLC-ESI-MS method is suitable for quantifying carbocysteine in plasma.
- The findings support the therapeutic interchangeability of the two carbocysteine formulations.