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Summary
New controlled-release formulations of indomethacin, Indocin SR and Indos, offer improved dosing convenience and potentially fewer side effects, especially in elderly patients. Both are therapeutically equivalent to standard indomethacin capsules.
Area of Science:
- Pharmacology
- Drug Delivery Systems
Background:
- Indomethacin, an indole derivative NSAID, has been available since the 1960s.
- Sustained-release (Indocin SR) and controlled-release (Indos) formulations have been developed.
- Enterohepatic cycling complicates bioavailability interpretation for indomethacin dosage forms.
Purpose of the Study:
- To evaluate the characteristics and therapeutic equivalence of new indomethacin formulations.
- To compare the safety and efficacy of Indocin SR and Indos with conventional indomethacin capsules.
Main Methods:
- Pharmacokinetic analysis of Indocin SR and Indos.
- Comparison of plasma concentration-time profiles.
- Assessment of therapeutic equivalence and side effect profiles, particularly in elderly patients.
Main Results:
- Indocin SR exhibits 80% absolute bioavailability but lacks ideal sustained-release characteristics.
- Indos demonstrates 85% bioavailability with good zero-order controlled-release properties.
- Both Indocin SR and Indos are therapeutically equivalent to indomethacin capsules.
- Indos showed fewer side effects in elderly patients compared to Indocin.
Conclusions:
- Indocin SR and Indos offer the advantage of once or twice daily dosing.
- Indos presents a unique drug delivery system with favorable controlled-release characteristics.
- New formulations provide therapeutic equivalence with potential benefits in dosing frequency and side effect profiles.
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