کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2487770 | 1114431 | 2007 | 14 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
High Concentration Formulation Feasibility of Human Immunoglubulin G for Subcutaneous Administration
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کلمات کلیدی
USP, united states pharmacopoeiaspray‐dryingATR, Attenuated total reflectance - ATR، انعکاس کل تضعیف شدهFTIR, Fourier transform infrared - FTIR، تبدیل فوریه مادون قرمزOD, optical density - OD، تراکم نوریPTH, parathyroid hormone - PTH، هورمون پاراتیروئیدRH, relative humidity - RH، رطوبت نسبیSC, subcutaneous - SC، زیر جلدیSEC, Size Exclusion Chromatography - SEC، اندازه خروج کروماتوگرافیBSA, bovine serum albumin - آلبومین سرم گاویHuman immunoglobulin G - ایمونوگلوبولین G انسانIgG, immunoglobulin G - ایمونوگلوبولین G، پادتن جیInjectables - تزریقیcircular dichroism - رنگ تابی دورانیCD, circular dichroism - رنگ تابی دورانیFDA, Food and Drug Administration - سازمان غذا و دارو (آمریکا)FTIR - طیف سنج مادون قرمزProtein formulation - فرمول پروتئینmAb, Monoclonal antibody - پادتنهای تَکتیرهMonoclonal antibodies - پادتنهای تَکتیرهStabilization - پایدارسازیHPLC, high performance liquid chromatography - کروماتوگرافی مایع با کارایی بالا،HPLC
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
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چکیده انگلیسی
The delivery of monoclonal antibodies (mAbs) as subcutaneous (sc) injections hinges on the high dose requirement of these usually low potency molecules. This necessitates their formulation as high concentration solutions or suspensions, which presents a formidable formulation challenge due to the concentrationâdriven protein aggregation and high solution viscosity generated at these conditions. The objective of this study was to evaluate the feasibility of sprayâdrying in preparing stable, high concentration formulations of mAbs. A model polyclonal antibody, human immunoglobulin G (IgG) was formulated as dry powder using Nektar's glass stabilization technology. Formulation in sugar glasses stabilized IgG during sprayâdrying and maintained the protein's secondary structure. Further, in contrast to the bulk material, the glassâstabilized powders successfully reconstituted at 200Â mg/mL IgG without loss of the protein monomer. Spectroscopic analysis confirmed that upon high concentration reconstitution, sprayâdried glassâstabilized IgG retained both its secondary and tertiary structure. Further, the sprayâdried powder reconstituted within a few minutes yielding clear, low viscosity solutions that syringed easily through narrow (28Â G) needles. The results of this study suggest that formulation in sprayâdried, glassâstabilized powders may enable the development of products suitable for sc administration of mAbs and other low potency protein therapeutics.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 6, June 2007, Pages 1504-1517
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 6, June 2007, Pages 1504-1517
نویسندگان
Bhas Dani, Robert Platz, Stelios T. Tzannis,