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Suspensions as a Valuable Alternative to Extemporaneously Compounded Capsules
Eli Dijkers1, Valerie Nanhekhan2, Astrid Thorissen2
1Fagron BV, Rotterdam, The Netherlands. eli.dijkers@fagron.com.
International Journal of Pharmaceutical Compounding
|March 28, 2017
Summary
Compounded oral liquids containing 74 active pharmaceutical ingredients (APIs) demonstrated excellent content uniformity over 90 days. These findings suggest oral liquids are a reliable alternative for individualized patient medications.
Area of Science:
- Pharmaceutical Science
- Drug Formulation
- Quality Control
Background:
- Extemporaneous compounding of medications is crucial for personalized patient care.
- Previous studies indicated potential variability in compounded capsules, necessitating further investigation into alternative dosage forms.
- Ensuring content uniformity is paramount for the safety and efficacy of compounded medications.
Purpose of the Study:
- To assess the content uniformity of 74 different active pharmaceutical ingredients (APIs) in extemporaneously prepared oral liquid formulations.
- To compare the content uniformity of these oral liquids with established literature data for compounded capsules.
- To evaluate the stability and content variation of APIs in oral liquids over a 90-day period under different temperature conditions.
Main Methods:
- Quantification of 74 APIs using high-performance liquid chromatography (HPLC) with a stability-indicating method.
- Analysis of 5,190 samples prepared as oral liquids and stored at room temperature (15°C–25°C) or refrigerated (2°C–8°C) for 90 days.
- Evaluation of content uniformity data against United States Pharmacopeia (USP) and British Pharmacopoeia (BP) standards.
Main Results:
- All analyzed oral liquid formulations exhibited mean acceptance values well within USP specifications for content uniformity.
- Suspensions consistently met the British Pharmacopoeia criteria for Content Uniformity of Liquid Dispersions at both tested temperatures.
- Minimal variation in API content was observed across all 74 ingredients over the 90-day study period.
Conclusions:
- Extemporaneously prepared oral liquids demonstrate robust content uniformity for a wide range of active pharmaceutical ingredients.
- Compounded oral liquids represent a suitable and reliable alternative dosage form for individualized medications.
- The findings support the use of oral liquids as a stable and consistent option in compounding pharmacy practice.
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