Amoxicillin chewable tablets intended for pediatric use: formulation development, stability evaluation and taste assessment
| Autor: | Paraskevi Kyriaki Monou, Irene Panderi, Maria S. Synaridou, Constantinos K. Zacharis, Catherine K. Markopoulou, Dimitrios G. Fatouros |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Taste Adolescent Chemistry Pharmaceutical Drug Compounding Drug Evaluation Preclinical Administration Oral Pharmaceutical Science Zea mays Maize starch Excipients Baby food Young Adult Drug Development Humans Medicine Food science Chocolate Aspartame Child business.industry Amoxicillin General Medicine In vitro digestion Anti-Bacterial Agents Milk Chocolate Mastication Female business Tablets medicine.drug |
| DOI: | 10.6084/m9.figshare.15164065.v2 |
| Popis: | To cover the unpleasant taste of amoxicillin (250 mg), maize starch (baby food) and milk chocolate were co-formulated. The raw materials and the final formulations were characterized by means of Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC) and Fourier-Transform Infrared (FT-IR) spectroscopy. To evaluate the taste masking two different groups of volunteers were used, according to the Ethical Research Committee of the Aristotle University of Thessaloniki. The optimization of excipients’ content in the tablet was determined by experimental design methodology (crossed D-optimal). Due to the matrix complexity, amoxicillin was extracted using liquid extraction and analyzed isocratically by HPLC. The developed chromatographic method was validated (%Recovery 98.7–101.3, %RSD = 1.3, LOD and LOQ 0.15 and 0.45 μg mL−1 respectively) according to the International Conference on Harmonization (ICH) guidelines. The physicochemical properties of the tablets were also examined demonstrating satisfactory quality characteristics (diameter: 15 mm, thickness: 6 mm, hardness 90) and in vitro digestion tests (%Recovery >95) were carried out. Stability experiments indicated that amoxicillin is stable in the prepared formulations for at least one year (%Recovery |
| Databáze: | OpenAIRE |
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