کاربردهای دارویی نوین پلیمرهای یودرژیت (Eudragit) در فناوری‌های Hot Melt Extrusion و چاپ سه‌بعدی

نوع مقاله : مقاله پژوهشی

نویسنده

گروه داروسازی، دانشکده داروسازی، دانشگاه موصل، موصل، عراق.

10.22103/jab.2025.25732.1747

چکیده

هدف: محیط تولید دارو به طور فزاینده‌ای روش‌های پیشرفته‌ای همچون اکستروژن ذوبی داغ (HME) و چاپ سه‌بعدی (3D) را برای گسترش سامانه‌های دارورسانی شخصی‌سازی‌شده، کارآمد و مقیاس‌پذیر به کار می‌گیرد. هر دو فناوری به‌شدت بر ماده جانبی یودرژیت (EUD) متکی‌اند که خانواده گسترده‌ای از پلیمرهای متاکریلاتی را دربر می‌گیرد. این مقاله مروری با هدف ارائه گزارشی جامع از کاربرد پلیمرهای EUD در HME و چاپ سه‌بعدی، با تمرکز بر نقش آن‌ها در سامانه‌های کنترل‌شده دارورسانی از نوع پایدار، فوری و هدفمند انجام شد.
مواد و روش‌ها: در این مقاله مروری، استفاده از گریدهای مختلف EUD نظیر EPO، RL، RS، L100، S100 و L100-55 در طراحی فرمولاسیون، بهینه‌سازی فرآیند و سازوکارهای رهایش دارو بررسی شد. بحث شامل ارزیابی راهبردهای فرمولاسیون، شرایط فرآیندی و پایداری پس از فرآیند است. نوآوری‌های اخیر، شامل سامانه‌های هوشمند و عملکردی مبتنی بر EUD با ویژگی‌های mucoadhesive، هدف‌گیری اختصاصی کولون و خصوصیات درمان-تشخیصی (theranostic)، نیز مورد توجه قرار گرفتند. همچنین ویژگی‌های مکانیکی و سازگاری دارو-پلیمر به‌عنوان عوامل تعیین‌کننده حیاتی موفقیت در فرمولاسیون تحلیل شدند.
نتایج: پلیمرهای EUD نشان داده‌اند که از طیف وسیعی از پلتفرم‌ها و اشکال دارورسانی پشتیبانی می‌کنند و قابلیت انعطاف‌پذیری و انطباق‌پذیری بالایی در فرآیندهای داروسازی دارند. مطالعات موردی و پیشرفت‌های اخیر بیانگر توانایی EUD در فراهم‌سازی مکانیزم‌های رهایش کنترل‌شده هستند، در حالی‌که به نیازهای درمانی خاص نیز پاسخ می‌دهند. عملکرد هوشمند پلیمرهای EUD ظرفیت آن‌ها را برای ایجاد ویژگی‌هایی همچون mucoadhesive، رهایش اختصاصی در محل و کاربردهای تشخیصی گسترش داده است. با این حال، چالش‌هایی همچون تخریب حرارتی طی فرآیند، ناسازگاری یا امتزاج ناکافی بین دارو و پلیمر و حساسیت به رطوبت همچنان باقی است. این محدودیت‌ها چالش‌های مهمی در فرمولاسیون ایجاد می‌کنند که باید از طریق راه‌حل‌های اختصاصی فرایند و فرمولاسیون مدیریت شوند.
نتیجه‌گیری: این مطالعه مروری بر نقش محوری پلیمرهای EUD در تولیدات دارویی نسل آینده، به‌ویژه در زمینه HME و ساخت افزایشی (چاپ سه‌بعدی)، تأکید می‌کند. اگرچه این پلیمرها نویدبخش توسعه سامانه‌های نوین دارورسانی هستند، اما چالش‌های فنی همچون ناسازگاری دارو-پلیمر، خطر تخریب حرارتی و حفظ یکپارچگی پس از فرآیند همچنان پابرجاست. رفع این مسائل برای بهره‌برداری کامل از پتانسیل پلیمرهای EUD در توسعه داروهای آینده ضروری است. با ادغام مطالعات موردی، راهبردهای فرمولاسیون و درک مکانیزمی، این مرور منبع ارزشمندی برای پژوهشگران و فرمولاتورها به‌شمار می‌رود تا بتوانند از قابلیت انطباق‌پذیری EUD در کاربردهای دارویی نوین بهره‌مند شوند.

کلیدواژه‌ها

عنوان مقاله [English]

Modern pharmaceutical applications of Eudragit polymers in Hot Melt Extrusion and 3D printing technologies

نویسنده [English]

  • Fahad Raad Salim Altalib
Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq.
چکیده [English]

Objective
The pharmaceutical production environment is increasingly adopting progressive methods like hot-melt extrusion (HME) and three-dimensional (3D) printing to expand personalized, effective, and scalable drug delivery systems. Both techniques rely heavily on the excipient Eudragit (EUD), which represents a broad family of methacrylate-based polymers. This review targets to supply a wide account of the application of EUD polymers in HME and 3D printing, with a centralization on their role in controlled drug release systems of sustained, immediate, and aimed types.
Materials and Methods
The review surveys the utilization of numerous grades of EUD, like EPO, RL, RS, L100, S100, and L100-55, in formulation design, process optimization, and drug release mechanisms. The discussion encompasses the evaluation of formulation strategies, processing situations, and post-processing stability. Innovations in recent years, containing smart and functionalized EUD-based systems with mucoadhesive, colon-specific, and theranostic properties, are also examined. Additionally, mechanical characteristics and drug–polymer compatibility are analyzed as critical determinants of successful formulation.
Results
EUD polymers have been demonstrated to support a broad spectrum of drug delivery platforms and dosage forms, proposing versatility and adaptability to pharmaceutical processing. Case studies and recent expansions show the capability of EUD to enable controlled release mechanisms, while also addressing particular therapeutic requirements. Smart functionalization of EUD systems has expanded their potential to include mucoadhesion, site-specific delivery, and diagnostic utilizations. However, challenges stay, containing issues of thermal degradation through processing, insufficient miscibility between drugs and polymers, and sensitivity to moisture. These limitations pose meaningful formulation challenges that must be managed carefully via process-specific and formulation-specific solutions.
Conclusions
This review underscores the central role of EUD polymers in next-generation pharmaceutical manufacturing, exclusively in the context of HME and additive manufacturing. While these polymers hold great promise for enabling progressive drug delivery systems, technical challenges persist, containing drug–polymer miscibility, risk of thermal degradation, and maintenance of post-processing integrity. Addressing these issues is crucial for unlocking the full potential of EUD polymers in future drug expansion. By integrating case studies, formulation strategies, and mechanistic perception, this review supplies a worth resource for researchers and formulators seeking to exploit the adaptability of EUD in modern pharmaceutical utilizations.

کلیدواژه‌ها [English]

  • 3D printing
  • Controlled drug release
  • Eudragit (EUD) polymers
  • Hot-melt extrusion (HME)
  • Methacrylate copolymers

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مجله بیوتکنولوژی کشاورزی
دوره 17، شماره 3
شهریور 1404
صفحه 345-384

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