کد مقاله کد نشریه سال انتشار مقاله انگلیسی ترجمه فارسی نسخه تمام متن
5521632 1545311 2017 10 صفحه PDF سفارش دهید دانلود رایگان
عنوان انگلیسی مقاله ISI
Research paperPreservative loss from silicone tubing during filling processes
ترجمه فارسی عنوان
از دست دادن محافظ از لوله های سیلیکون در طی فرایند پر کردن
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موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیوتکنولوژی یا زیست‌فناوری
چکیده انگلیسی

Significant loss of preservative was observed during filling of drug products during filling line stops. This study evaluated the losses of three commonly used preservatives in protein drugs, i.e. benzyl alcohol, phenol, and m-cresol. Concentration losses during static incubation were quantified and interpreted with regard to the potential driving forces for the underlying sorption, diffusion, and desorption steps. Partitioning from the solution into the silicone polymer was identified as the most decisive parameter for the extent of preservative loss. Additionally, the influence of tubing inner diameter, starting concentration as well as silicone tubing type was evaluated. Theoretical calculations assuming equilibrium between solution and tubing inner surface and one-directional diffusion following Fick's first law were used to approximate experimental data. Since significant losses were found already after few minutes, adequate measures must be taken to avoid deviations during filling of preservative-containing protein solutions that may impact product quality or antimicrobial efficacy. As a possible alternative to the highly permeable silicone tubing, a specific make of fluoropolymer tubing was identified being suitable for peristaltic pumps and not showing any preservative losses.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutics and Biopharmaceutics - Volume 112, March 2017, Pages 109-118
نویسندگان
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