Tổng quan về công nghệ bao tan trong ruột và ứng dụng trong bào chế viên nén chứa Bacillus clausii

Probiotics play a crucial role in maintaining gut health, with Bacillus clausii standing out due to its unique spore-forming nature, offering resilience against harsh environmental conditions. However, for these beneficial microorganisms to exert their therapeutic effects, they must survive the highly acidic gastric environment and be released effectively in the intestine. This necessitates sophisticated drug delivery systems. Enteric coating technology emerges as a vital solution, employing pH-sensitive polymers to protect the Bacillus clausii spores, thereby ensuring their viability and targeted release. This review aims to systematically explore the scientific principles, materials, and techniques of enteric coating technology and its application in the formulation of Bacillus clausii tablets, addressing the current gaps in domestic product development, especially in Vietnam.

Các nhà khoa học dược phẩm, kỹ sư bào chế, nhà sản xuất probiotic và cơ quan quản lý chất lượng dược phẩm.

This systematic review thoroughly examines enteric coating technology as a critical strategy for enhancing the therapeutic efficacy of Bacillus clausii probiotic tablets. The primary objective was to systematize the scientific principles, advanced polymer materials, and crucial manufacturing techniques pertinent to this application. The review methodology involved a comprehensive literature search across major databases like PubMed and ScienceDirect, utilizing keywords such as "Bacillus clausii", "enteric coating", and "probiotic tablet" to identify relevant studies on formulation, manufacturing, and evaluation methods.
The findings reveal that pH-sensitive polymers, exemplified by Eudragit® and HPMCP, combined with advanced techniques such as fluidized bed coating, represent an effective approach to safeguard Bacillus clausii spores from gastric acid degradation and ensure their targeted release in the intestinal tract. However, the formulation process faces significant challenges, including maintaining spore viability against compression forces, heat, moisture, and excipient interactions. The review details various technical solutions developed to mitigate these adverse effects. Specifically, it highlights the importance of selecting appropriate cryoprotectants, optimizing mixing and compression parameters to minimize CFU loss, and applying careful coating processes at controlled temperatures. This includes the use of a pre-coating layer with HPMC and the main enteric coat with Eudragit® L100-55 or HPMCAS. The study underscores the necessity of strict quality standards, including tests for dissolution, uniformity, and stability, to ensure high-quality and reliable probiotic products. Ultimately, this review not only synthesizes current knowledge but also proposes future research directions, such as advanced formulation optimization and the application of novel technologies, to establish robust quality standards, fostering the development of competitive probiotic products, particularly in Vietnam.