Controlled-Release Fine Particles Prepared by Melt Adsorption for Orally Disintegrating Tablets
| Autor: | Ryoichi Sonoda, Takao Oshima, Shigeru Itai, Yasunori Iwao, Shin-ichiro Kimura, Kai Shiino |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Glycerol
Orally disintegrating tablet Surface Properties Administration Oral Magnesium Compounds 010402 general chemistry 01 natural sciences Granulation Adsorption Drug Discovery Ultimate tensile strength Particle Size Aluminum Compounds Wax 010405 organic chemistry Chemistry Silicates Fatty Acids Esters General Chemistry General Medicine Controlled release 0104 chemical sciences Hydrophobe Chemical engineering visual_art Particle-size distribution visual_art.visual_art_medium Hydrophobic and Hydrophilic Interactions Tablets |
| Zdroj: | Chemical and Pharmaceutical Bulletin. 67:1152-1159 |
| ISSN: | 1347-5223 0009-2363 |
| DOI: | 10.1248/cpb.c19-00554 |
| Popis: | Melt adsorption is a manufacturing method that offers precise control of particle size distribution of granules and circumvents the disadvantages of conventional melt granulation. However, drug release from particles adsorbed with hydrophobic materials has not been fully investigated, and there are missing details as to whether particles manufactured by this technique can be applied to orally disintegrating tablets (ODT). In this report, we aimed to optimize process parameters and formulation to manufacture ODT containing melt adsorption-particles with the specific characteristic of sustained release. Melt adsorption particles containing Neusilin US2 as the adsorbent were prepared by using various waxes to determine the most suitable material for controlled release formulation. Glycerol fatty acid ester (Poem TR-FB: TR-FB) was the optimal wax examined because of its drug release pattern and tabletability. We then optimized manufacturing conditions by examining granulation time, disintegrant amount per tablet and compression force on the tablet for ODT that meet the criteria of controlled drug release, tensile strength and disintegration of the tablet. Multiple regression analysis revealed the effect of process parameters on tablet properties and drug release with increasing the granulation time affording sustained release of the drug. The analysis also showed that a high compression force crushed the granules coated by TR-FB, which impaired sustained drug release. From the regression model the optimal manufacturing conditions were determined, and the tablet prepared under these conditions concurred with the predicted values and met all criteria. This new technique should contribute to the development of ODT to improve medication adherence. |
| Databáze: | OpenAIRE |
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