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In vitro evaluation of extemporaneously compounded slow-release capsules containing morphine sulfate or oxycodone
Dana L Glowiak1, Julie L Green, Bill J Bowman
1Department of Pharmaceutical Sciences.
International Journal of Pharmaceutical Compounding
|August 9, 2013
Summary
Extemporaneously compounded slow-release capsules containing morphine sulfate and oxycodone hydrochloride demonstrated reproducible in vitro drug release profiles. The formulation using Methocel E4M Premium showed consistent performance, though release varied from manufactured tablets.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Pharmacokinetics
Background:
- Extemporaneous compounding of modified-release dosage forms is crucial for personalized medicine.
- Morphine sulfate and oxycodone hydrochloride are commonly used analgesics requiring controlled release for efficacy and safety.
- Methocel E4M Premium is a hydrophilic polymer used to modify drug release.
Purpose of the Study:
- To evaluate the in vitro performance of extemporaneously compounded slow-release capsules containing morphine sulfate and oxycodone hydrochloride.
- To assess the impact of formulation variables on drug release kinetics.
- To compare the dissolution profiles with commercially available controlled-release tablets.
Main Methods:
- Compounding of morphine sulfate (15-200 mg) and oxycodone hydrochloride (10-200 mg) slow-release capsules with 40% Methocel E4M Premium.
- In vitro dissolution testing using USP Apparatus II over 24 hours with pH adjustments.
- Spectrophotometric determination of released drug concentrations.
- Analysis of release data using the simplified Higuchi model.
Main Results:
- Compounded capsules released 14-23% at 0.5h, 67-85% at 4h, and 93-98% at 12h.
- Release profiles adhered to the simplified Higuchi model (r²=0.9409-0.9999).
- Minimal intrabatch variation (<10% RSD) and limited interbatch variation were observed, indicating robust formulation, except for one batch of 200mg oxycodone HCl capsules.
Conclusions:
- Extemporaneous compounding with 40% Methocel E4M Premium effectively creates slow-release morphine sulfate and oxycodone hydrochloride capsules.
- The in vitro performance demonstrated reproducibility and robustness, with some variations compared to manufactured tablets.
- Further clinical studies are necessary to ascertain the clinical significance of observed in vitro differences.
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