Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial
| Autor: | Carole Dhelens, Christine Pivot, Samira Filali, Damien Salmon, E. Diouf, Charlotte Bergamelli, Fabrice Pirot, Diane Laleye, Mamadou Lamine Tall |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Autism
Stability-indicating method Pharmaceutical Science Pharmacy High-performance liquid chromatography Analytical Chemistry Melatonin 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Drug Discovery Electrochemistry medicine 0501 psychology and cognitive sciences Dissolution testing Original Research Article Spectroscopy Active ingredient Chromatography lcsh:RM1-950 05 social sciences Clinical trial Microcrystalline cellulose Formulation stability lcsh:Therapeutics. Pharmacology chemistry Multicomponent infrared analysis Forced degradation 030217 neurology & neurosurgery 050104 developmental & child psychology medicine.drug |
| Zdroj: | Journal of Pharmaceutical Analysis Journal of Pharmaceutical Analysis, Vol 7, Iss 4, Pp 237-243 (2017) |
| ISSN: | 2095-1779 |
| Popis: | A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate-release melatonin formulation in different regimens (0.5 mg, 2 mg, and 6 mg daily) for one month. The objectives of present study were to (i) prepare low-dose melatonin hard capsules for pediatric use controlled by two complementary methods and (ii) carry out a stability study in order to determine a use-by-date. Validation of preparation process was claimed as ascertained by mass uniformity of hard capsules. Multicomponent analysis by attenuated total reflectance Fourier transformed infrared (ATR-FTIR) of melatonin/microcrystalline cellulose mixture allowed to identify and quantify relative content of active pharmaceutical ingredients and excipients. Absolute melatonin content analysis by high performance liquid chromatography in 0.5 mg and 6 mg melatonin capsules was 93.6%±4.1% and 98.7%±6.9% of theoretical value, respectively. Forced degradation study showed a good separation of melatonin and its degradation products. The capability of the method was 15, confirming a risk of false negative Graphical abstract fx1 |
| Databáze: | OpenAIRE |
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