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KMID : 0370220220660010016
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Yakhak Hoeji
2022 Volume.66 No. 1 p.16 ~ p.25
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Influence of Foam generated in Pharmaceutical Suspensions Manufacturing Process on Active Pharmaceutical Ingredient Contents of Finished Products
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Kang Shin-Kook
Song Min-Sub
Shin Kyung-Oh
You Kwang-Suk
Han Seong-Soo
Hong Jin-Tae
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Abstract
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This study aimed to investigate the influence of foam generated in the pharmaceutical suspension manufacturingprocess on finished products’ active pharmaceutical ingredient (API) contents. In particular, we aimed to evaluate thepossibility of having a higher API content in pharmaceutical suspensions containing a large amount of foam. We alsoinvestigated content analysis results based on prior studies related to the attachment of solid particles to bubbles. Each testtube was agitated at 1,200 rpm for 60 min to generate bubbles. To measure the API content, samples were collected fromeach layer (lower, middle, upper, foam). The API content analysis results were further analyzed by general properties (pHand density), surface hydrophobicity (contact angle), and morphological properties (particle size and shape). The APIcontent in five out of seven pharmaceutical suspensions increased toward the upper layer, and the API concentration ofthe foam layer was the highest. The other two suspensions showed an opposite trend. The contact angle of API particlesof products with an increased toward the upper layer was greater than 62o, the particle size exceeded 4μm, and theparticles were needle-shaped and had angular fragments. Our findings indicate that API particles are highly concentratedin the foam generated during the manufacturing process depending on various properties, including surface hydrophobicity,particle size, and shape. Therefore, improvements in formulations and the manufacturing process of pharmaceuticalsuspensions such as foam suppression or breakage rather than foam removal from the intermediate products are required.
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KEYWORD
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Bubble, Foam, Contents, Hydrophobicity, Particle size, Shape
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