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Bioavailability of rifampicin capsules
International Journal of Clinical Pharmacology, Therapy, and Toxicology
|August 1, 1983
Summary
Bioavailability of rifampicin (RMP) capsules varies significantly based on manufacturing and food intake. Poor absorption can lead to ineffective therapy, impacting patient treatment outcomes.
Area of Science:
- Pharmacology
- Pharmaceutical Sciences
- Drug Development
Background:
- Rifampicin (RMP) is a crucial antibiotic, but its bioavailability can be inconsistent.
- Variability in RMP serum levels necessitates understanding factors influencing its absorption.
- Rifadin (RFD) served as the reference drug in this bioavailability program.
Purpose of the Study:
- To compare the bioavailability of experimental rifampicin (RMP) lots against marketed preparations.
- To identify how formulation variations and food affect RMP absorption.
- To establish a reliable reference standard for RMP bioavailability.
Main Methods:
- Conducted 14 studies over 3 years with 45 healthy volunteers.
- Administered single oral doses (600 mg) of 2-5 RMP preparations in a crossover design.
- Assessed pharmacokinetic parameters under fasting conditions and an additional study with food.
Main Results:
- Rifadin (RFD) capsules demonstrated consistent pharmacokinetic parameters across batches and testing periods.
- Experimental RMP preparations and other manufacturers' capsules showed marked bioavailability changes due to formulation differences.
- RMP absorption was reduced when administered with food.
Conclusions:
- Manufacturing processes and excipients significantly impact rifampicin (RMP) capsule bioavailability.
- Food intake negatively affects RMP absorption, potentially reducing therapeutic efficacy.
- Patients with poor RMP absorption may receive ineffective treatment, especially with suboptimal drug products or food consumption.