کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2485772 | 1114366 | 2012 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A Generalized Relation for Solid-State Drug Stability as a Function of Excipient Dilution: Temperature-Independent Behavior
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله

چکیده انگلیسی
A proposed generalized relationship for the impact of excipients on the solid-state chemical stability of drug products is presented and shown to be consistent across multiple degradation products with two example drugs. In this model, when the number of drug particles is comparable to the number of excipient particles, the impact of the excipient on the degradant formation rate is independent of drug concentration. In contrast, when the number of drug particles is in excess of the number of excipient particles, a power-law relation (linear correlation between the logarithm of the degradant formation rate and the logarithm of the reciprocal of the drug concentration) is proposed based on a “quasi-liquid” model where drug particles fill in interstices between excipients. As predicted by this model, the experimental power-law lines have slopes of about 2/3 independent of temperature (0.61 ± 0.13 for n = 30 counting multiple degradation products and a range of temperatures and relative humidities for two drug products).
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 11, November 2012, Pages 4170-4177
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 11, November 2012, Pages 4170-4177
نویسندگان
Kenneth C. Waterman, Paul Gerst, Zhen Dai,