Stability Study of Baclofen in an Oral Powder Form Compounded for Pediatric Patients in Japan
Abstract
:1. Introduction
2. Materials and Methods
2.1. Reagents and Test Solution Preparation
2.2. Baclofen Powder Compounding
2.3. Drug Stability Study
2.3.1. Experimental Design
2.3.2. Instrumentation and Chromatographic Conditions
2.3.3. Assay for Known Baclofen Impurities (A and B)
2.3.4. Validation of Quantitative Analysis
Calibration Standards and Quality Control
Limit of Detection (LOD) and Lower Limit of Quantification (LLOQ)
Precision and Accuracy
2.4. Drug Release Study
2.5. Differential Scanning Calorimetry (DSC)
2.6. Powder X-ray Diffraction Analysis
2.7. Color Evaluation
3. Results
3.1. Liquid Chromatography Method and Validation
3.2. Stability Study
3.3. Impurity Study
3.4. Dissolution Test
3.5. The Thermal Behavior of the Various Samples
3.6. PXRD Analysis
3.7. Color Evaluation
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Study Methods | Storage Conditions | Storage Container | Test Periods (Days) | ||||
---|---|---|---|---|---|---|---|
0 | 30 | 60 | 90 | 120 | |||
Baclofen Concentrations * | |||||||
Bottle (closed) | 25 °C ± 2 °C/60% ± 5% relative humidity | Amber/PC bottle | 100.0% | 100.2 ± 3.2% | 99.8 ± 2.8% | 99.0 ± 1.6% | 99.6 ± 2.7% |
Bottle (in use) | Amber/PC bottle | 100.0% | 99.9 ± 2.9% | 98.9 ± 4.1% | 99.1 ± 2.5% | 98.7 ± 3.1% | |
Laminated paper | Amber/CP laminated paper | 100.0% | 101.0 ± 2.2% | 99.7 ± 1.3% | 100.3 ± 2.7% | 99.6 ± 1.2% |
Storage Periods | Color Difference (ΔEab) |
---|---|
0 days | 16.75 ± 0.102 |
60 days | 16.72 ± 0.208 |
90 days | 18.26 ± 0.046 |
120 days | 16.29 ± 0.128 |
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Saito, J.; Hanawa, T.; Ozawa, A.; Matsumoto, T.; Yoshikawa, N.; Harada, T.; Iwahashi, K.; Yamatani, A. Stability Study of Baclofen in an Oral Powder Form Compounded for Pediatric Patients in Japan. Children 2022, 9, 1313. https://doi.org/10.3390/children9091313
Saito J, Hanawa T, Ozawa A, Matsumoto T, Yoshikawa N, Harada T, Iwahashi K, Yamatani A. Stability Study of Baclofen in an Oral Powder Form Compounded for Pediatric Patients in Japan. Children. 2022; 9(9):1313. https://doi.org/10.3390/children9091313
Chicago/Turabian StyleSaito, Jumpei, Takehisa Hanawa, Ayuna Ozawa, Takahiro Matsumoto, Nozomi Yoshikawa, Tsutomu Harada, Kana Iwahashi, and Akimasa Yamatani. 2022. "Stability Study of Baclofen in an Oral Powder Form Compounded for Pediatric Patients in Japan" Children 9, no. 9: 1313. https://doi.org/10.3390/children9091313