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Layer-by-Layer Encapsulation of Probiotics for Delivery to the Microbiome

Aaron C. Anselmo, Kevin J. McHugh, Jamie Webster, Robert Langer, and Ana Jaklenec
Abstract

Recent discoveries in biology and microbiology have highlighted the importance of the gastrointestinal (GI) microbiome in regulating human health and disease. Thus, the delivery of probiotics to influence and modulate microbiome compositions can potentially impact the treatment of a number of human diseases. Unfortunately, biological challenges encountered during oral delivery have limited the translation of many probiotic-delivering technologies. Here, we report a layer-by-layer (LbL) method for the encapsulation of probiotics to directly address these challenges by protecting probiotics from GI tract insults while facilitating both mucoadhesion and direct growth on intestinal surfaces. It has been established that the bacterial composition in the GI tract plays an essential role in the development and progression of a number of disorders, including cancer, obesity, diabetes, Clostridium difficile, and depression, among others. Given the diversity of an individual’s GI microbiome and how environmental differences in diet, medication usage (e.g., antibiotics), and other factors dramatically influence microbiome composition and subsequent disease progression, approaches, and technologies to introduce probiotic species into the microbiome are of pronounced interest. However, probiotic-introducing technologies face oral delivery challenges that are: (i) chemical-based, such as acidic stomach conditions and bile salts which are capable of deactivating probiotics, and (ii) physical-based, such as rapid GI transit times that limit retention of probiotics on intestines, thus preventing the adhesion and growth of probiotics. A number of technologies such as nanoparticles, pills, polymer gels, enteric coatings, and patches have been developed to address these challenges by preventing chemical degradation by acid or enzymes and facilitating mucoadhesion to ensure drug absorption and controlled release. While these approaches have been successful in improving the oral delivery of many small molecules and some biologics, few can address the specific challenges of delivering live-probiotics to the microbiome, due to their large size and viability/growth requirements.

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Keywords

EpiIntestinal, SMI-196, SMI-100-ABF, probiotics, microbiome, mucoadhesive layer, bacterial-intestinal adhesion

Materials Tested

Bacillus coagulans, bacteria, encapsulated probiotics

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