Delivery In Gastrointestinal Tract Research Articles

Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies.

BackgroundFecal microbiota transplantation (FMT) has shown excellent efficacy in treating Clostridioides difficile infection, as well as promise in several other diseases. The heightened interest is accompanied by concerns over adverse events (AE) and safety. To further understand that in FMT, we performed a systematic review of the literature and a meta-analysis of high-quality, prospective randomized controlled trials FMT.MethodsStudies were selected based on predefined exclusion criteria and were assessed for quality. Only prospective, randomized, controlled studies of high quality were included in the final analysis. Data were extracted on demographics, AE, indication, delivery method and follow-up duration.ResultsOut of 334 articles reviewed, 9 high quality studies with 756 FMTs were selected for final analysis. The pooled rate of AE was 39.3% (95% confidence interval [CI] 0.19-0.642) as they were reported by 112 patients who received FMT. The SAE rate was 5.3% (95%CI 3.1-8.8%). The most common AE reported was abdominal pain, followed by diarrhea. The most common SAE was Clostridium difficile infection. Upper gastrointestinal tract delivery was associated with a higher rate of total AE, but not SAE.ConclusionsBased on the selected studies, the AE rate of FMT is 39.3%, with most AE being mild and self-limiting. SAE were uncommon at 5.3%, and many were only possibly related to the FMT. Adherence to standardized reporting of AE as well as longitudinal studies and registries will help further clarify the safety of FMT in the future.

The Efficacy of Washed Microbiota Transplantation on Helicobacter pylori Eradication: A Pilot Study.

Aim The fecal microbiota transplantation by washed preparation was recently coined as washed microbiota transplantation (WMT). This pilot study is aimed at exploring the feasibility and efficacy of WMT on Helicobacter pylori eradication. Methods Consecutive patients who had been treated with WMT for various indications and who were positive for H. pylori infection before WMT treatment but had never received eradication therapy for H. pylori infection were invited to take a follow-up 13C-urea breath test. The associations of demographic, clinical factors, and laboratory indicators for gastric function and intestinal barrier function with the therapeutic effect were determined. Results A total of 32 eligible patients were included, and the overall H. pylori eradication rate was 40.6% (13/32). Patients with H. pylori eradication had a higher pepsinogen ratio (PGR) than those without (13.00 ± 6.97vs.8.31 ± 3.733; P = 0.02). Female patients had a higher, albeit not statistically significant, eradication rate than male patients (53.85% vs. 31.58%; P = 0.208). Compared with lower gastrointestinal tract delivery route, middle gastrointestinal tract delivery route seems to be a more suitable way for the treatment of H. pylori infection (58.33% vs 16.67%; P = 0.152). There was no significant difference in other demographic and clinical factors between patients with and without H. pylori eradication. Conclusion H. pylori infection is eradicated in a proportion of patients who have received WMT. An increased pre-WMT PGR appears to be associated with the therapeutic effect. Further studies are required to confirm the efficacy of WMT, especially in combination with currently recommended regimens in randomized controlled trials.

Modeling of ayurveda ghee based solid lipid nano particles and their comprehensive pharmacokinetics study

Several experiments have been done with solid lipid nanoparticles (SLNPs) module to produce a potential oral drug delivery system. However, the fate of the drug after its delivery in gastro-intestinal tract directly rely on the bioavailability. This study is focused on the problem concerned with the pre-prediction accuracies of the SLNPs formulation using in silico modeling and also an in vitro model for the synthesis of an efficient SLNPs carnitine complex. Carnitine is a molecule that helps in β- oxidation of fatty acids. Structure of carnitine and its nano complexes were modeled using Chemsketch tool. The pK/pB evaluation of these complexes was studied using ADMET predictor and GastroPlus tools. Further experiments were carried out with optimised ratio based on the drug:lipid ratio and surfactant: co-surfactant ratio. The mean particle size was measured to be 559.4 nm and higher density of particles size ranges between 68 nm and 458.7 nm. The entrapment efficiency of the SLNPs observed to be 65% and carnitine loading capacity was determined as 50%. The study of carnitine release kinetics by in vitro and ex vivo method was proved that the formulation possessed a sustained release of the carnitine with better bio-availability via oral delivery.

Recent trends and applications of polysaccharides for microencapsulation of probiotics

AbstractThe viability of probiotic bacteria is always questionable when they exposed to the harsh environment and thus microencapsulation of probiotic bacteria is generally applied to enhance the viability during processing, storage, and also for the target delivery in gastrointestinal tract. Polysaccharide is one of the most widely used wall material in the area of probiotic microencapsulation. However, with the increasing demand and new application areas for probiotic microcapsules, traditionally used polysaccharides can barely satisfy such challenges. Therefore, seeking for new kinds of polysaccharides with preponderant properties that suitable for probiotic microencapsulation is now catching the interest of researchers and has important implication. This review focuses on the application of polysaccharides in the area of probiotic microencapsulation, including to classify the traditional polysaccharides according to their characteristic properties used especially for microencapsulation of probiotics, as well as to give a critical perspective on emerging polysaccharides applied as wall materials to encapsulate probiotic bacteria.

Gastrointestinal Responsive Polymeric Nanoparticles for Oral Delivery of Insulin: Optimized Preparation, Characterization, and In Vivo Evaluation

Gastrointestinal responsive polymeric nanospheres (NPs) based on hydroxypropyl methylcellulose phthalate were prepared using spontaneous emulsification solvent diffusion method for improved oral administration of insulin. The NPs prepared under optimized conditions have an encapsulation efficiency of 90% and a particle size of about 200 nm. In vitro drug release experiments demonstrated that the NPs exhibited a gradient release profile of loaded drug when the pH value gradually increased from 3.0 to 7.4. Enzyme resistance experiments showed that under simulated gastrointestinal conditions, the NPs protected more than 60% of the drug from being degraded by trypsin. The oral hypoglycemic experiments revealed that insulin-loaded NPs could significantly reduce blood glucose levels in diabetic rats with a relative bioavailability of 8.6%. Ex vivo imaging investigation of rat tissues showed that the drug-loaded NPs could promote the absorption of insulin in the ileum and colon. The work described here suggests that the gastrointestinal responsive polymeric NPs may be promising candidates for improving gastrointestinal tract delivery of hydrophilic biomacromolecules. Accordingly, the results indicated that hydroxypropyl methylcellulose phthalate NPs with gastrointestinal stimuli responsiveness could be a promising candidate for oral insulin delivery.

Evaluation of kappa carrageenan as potential carrier for floating drug delivery system: Effect of cross linker

Genipin, a natural and non-toxic cross linker, was used to prepare cross linked floating kappa carrageenan/sodium carboxymethyl cellulose hydrogels and the effect of genipin on hydrogels characterization was investigated. Calcium carbonates were employed as gas forming agents. Ranitidine hydrochloride was used as drug. Fourier transform infrared spectroscopy (FTIR), X-ray diffraction (XRD) and thermogravimetric analysis (TGA) were carried out to study the changes in the characteristics of hydrogels. Furthermore, scanning electron microscope (SEM) was performed to study microstructure of hydrogels. The result showed that all formulated hydrogels had excellent floating behavior. It was discovered that the cross linking reaction showed significant effect on gel strength, porosity and swelling ratio compared to non-cross linked hydrogels. It was found that the drug release was slower and lesser after being cross linked. Microstructure study shows that cross linked hydrogels exhibited hard and rough surface. Therefore, genipin can be an interesting cross linking agent for controlled drug delivery in gastrointestinal tract.

FORMULATION, OPTIMIZATION AND EVALUATION OF STOMACH SPECIFIC IN-SITU GEL OF HYDROCHLOROTHIAZIDE

The objectives of this research work were preparation, optimization and evaluation of in situ gelling system of Hydrochlorothiazide based on pectin that retains in the stomach by adherence to gastric wall provi ding an increased gastric residence time resulting in prolonged drug delivery in gastrointestinal tract. Pectin was used as a polymer and CaCO 3 as a cross - linking agent. The in situ formulation exhibited the expectations, viscosity, drug content and sustai ned drug release. This study reports that oral administration of aqueous solutions containing pectin results in formation of in situ gel and such formulations are homogenous liquids when administered orally and become gel at the contact site. The results o f a 3 2 full factorial design revealed that the concentrations of pectin and CaCO 3 significantly affected the dependent variables of viscosity, drug content (%) and Q 18 . These in situ gels are, thus, suitable for oral sustained release of Hydrochlorothiazid e . Key word: Hydrochlorothiazide, In - situ, polymer, Pectin, viscosity.

Microencapsulação de probióticos: avanços e perspectivas

Devido aos seus efeitos benéficos, os probióticos têm sido incorporados nos mais diversos alimentos, incluindo iogurtes, queijos, sorvetes, leites fermentados e sobremesas congeladas. No entanto, existem ainda diversos problemas com relação à viabilidade e resistência das culturas probióticas nesses alimentos. Neste artigo de revisão, são abordados os aspectos tecnológicos utilizados na microencapsulação de probióticos que permitem aumentar a sua viabilidade durante a fermentação, processamento e utilização nos produtos comerciais. A microencapsulação de bactérias probióticas pode ser utilizada para aumentar a viabilidade durante o processamento, como também para liberá-las de maneira controlada no trato gastrointestinal.

Encapsulation of Probiotic Bacteria in Biopolymeric System

Encapsulation of probiotic bacteria is generally used to enhance the viability during processing, and also for the target delivery in gastrointestinal tract. Probiotics are used with the fermented dairy products, pharmaceutical products, and health supplements. They play a great role in maintaining human health. The survival of these bacteria in the human gastrointestinal system is questionable. In order to protect the viability of the probiotic bacteria, several types of biopolymers such as alginate, chitosan, gelatin, whey protein isolate, cellulose derivatives are used for encapsulation and several methods of encapsulation such as spray drying, extrusion, emulsion have been reported. This review focuses on the method of encapsulation and the use of different biopolymeric system for encapsulation of probiotics.

Impact of metal oxide nanoparticles on oral release properties of pH-sensitive hydrogel nanocomposites

In this article, modified κ-carrageenan hydrogel nanocomposites were synthesized to increase the release ability of carrageenan hydrogels under gastrointestinal conditions. The effect of MgO nanoparticle loading in a model drug (methylene blue) release is investigated. Characterization of hydrogels were carried out using Fourier transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), Field Emission Scanning Electron Microscope (FESEM) and Differential Scanning Calorimetry (DSC). Genipin was used to increase the delivery performance in gastrointestinal tract delivery by decreasing release in simulated stomach conditions and increasing release in simulated intestine conditions. It is shown that the amount of methylene blue released from genipin-cross-linked nanocomposites can be 67.5% higher in intestine medium and 56% lower in the stomach compared to κ-carrageenan hydrogel. It was found that by changing the nanoparticle loading and genipin concentration in the composite, the amount of drug released can be monitored. Therefore, applying nanoparticles appears to be a potential strategy to develop controlled drug delivery especially in gastrointestinal tract studies.

Formulation Evaluation and Optimization of Stomach Specific In situ Gel of Ranitidine Hydrochloride

The objectives of this research work were preparation, optimization and evaluation of in situ gelling system of Ranitidine. HCl based on sodium alginate that retains in the stomach by adherence to gastric wall providing an increased gastric residence time resulting in prolonged drug delivery in gastrointestinal tract. Sodium alginate was used as a polymer and CaCO3 as a cross-linking agent. The in situ formulation exhibited the expectations, viscosity, drug content and sustained drug release. This study reports that oral administration of aqueous solutions containing sodium alginate results in formation of in situ gel and such formulations are homogenous liquids when administered orally and become gel at the contact site. The results of a 32 full factorial design revealed that the concentrations of sodium alginate and CaCO3 significantly affected the dependent variables of viscosity, Q50 and Q80. These in situ gels are, thus, suitable for oral sustained release of Ranitidine HCL.

An Interactive Regulatory Network Controls Stress Response inBifidobacterium breveUCC2003

Members of the genus Bifidobacterium are gram-positive bacteria that commonly are found in the gastrointestinal tract (GIT) of mammals, including humans. Because of their perceived probiotic properties, they frequently are incorporated as functional ingredients in food products. From probiotic production to storage and GIT delivery, bifidobacteria encounter a plethora of stresses. To cope with these environmental challenges, they need to protect themselves through stress-induced adaptive responses. We have determined the response of B. breve UCC2003 to various stresses (heat, osmotic, and solvent) using transcriptome analysis, DNA-protein interactions, and GusA reporter fusions, and we combined these with results from an in silico analysis. The integration of these results allowed the formulation of a model for an interacting regulatory network for stress response in B. breve UCC2003 where HspR controls the SOS response and the ClgR regulon, which in turn regulates and is regulated by HrcA. This model of an interacting regulatory network is believed to represent the paradigm for stress adaptation in bifidobacteria.

Chitosan/polyethylene glycol-alginate microcapsules for oral delivery of hirudin

A mild chitosan/calcium alginate microencapsulation process, as applied to encapsulation of biological macromolecules such as albumin and hirudin, was investi- gated. The polysaccharide chitosan was reacted with sodium alginate in the presence of calcium chloride to form microcapsules with a polyelectrolyte complex membrane. Hirudin-entrapped alginate beads were further surface coated with polyethylene glycol (PEG) via glutaraldehyde functionalities. It was observed that approximately 70% of the content is being released into Tris-HCl buffer, pH 7.4 within the initial 6 h and about 35% release of hirudin was also observed during treatment with 0.1MHCl, pH 1.2 for 4 h. But acid-treated capsules had released almost all the entrapped hirudin into Tris-HCl, pH 7.4 media within 6 h. From scanning electron microscopic and swelling studies, it appears that the chitosan and PEG have modified the alginate microcapsules and subsequently the protein release. The microcapsules were also prepared by adding dropwise albumin-containing sodium alginate mixture into a PEG- CaCl 2 system. Increasing the PEG concentration resulted in a decrease rate of albumin release. The results indicate the possibility of modifying the formulation to obtain the desired controlled release of bioactive peptides (hirudin), for a convenient gastrointestinal tract delivery system.© 1998 John Wiley & Sons, Inc. J Appl Polym Sci 70: 2143-2153, 1998

Chitosan/calcium?alginate beads for oral delivery of insulin

A mild chitosan/calcium alginate microencapsulation process, as applied to encapsulation of biological macromolecules such as albumin and insulin, was investigated. The microcapsules were derived by adding dropwise a protein-containing sodium alginate mixture into a chitosan–CaCl2 system. The beads containing a high concentration of entrapped bovine serum albumin (BSA) as more than 70% of the initial concentration were achieved via varying chitosan coat. It was observed that approximately 70% of the content is being released into Tris-HCl buffer, pH 7.4 within 24 h and no significant release of BSA was observed during treatment with 0.1M HCl pH 1.2 for 4 h. But the acid-treated beads had released almost all the entrapped protein into Tris-HCl pH 7.4 media within 24 h. Instead of BSA, the insulin preload was found to be very low in the chitosan/calcium alginate system; the release characteristics were similar to that of BSA. From scanning electron microscopic studies, it appears that the chitosan modifies the alginate microspheres and subsequently the protein loading. The results indicate the possibility of modifying the formulation in order to obtain the desired controlled release of bioactive peptides (insulin), for a convenient gastrointestinal tract delivery system. © 1996 John Wiley & Sons, Inc.

Chitosan/calcium—alginate beads for oral delivery of insulin

A mild chitosan/calcium alginate microencapsulation process, as applied to encapsulation of biological macromolecules such as albumin and insulin, was investigated. The microcapsules were derived by adding dropwise a protein-containing sodium alginate mixture into a chitosan–CaCl2 system. The beads containing a high concentration of entrapped bovine serum albumin (BSA) as more than 70% of the initial concentration were achieved via varying chitosan coat. It was observed that approximately 70% of the content is being released into Tris-HCl buffer, pH 7.4 within 24 h and no significant release of BSA was observed during treatment with 0.1M HCl pH 1.2 for 4 h. But the acid-treated beads had released almost all the entrapped protein into Tris-HCl pH 7.4 media within 24 h. Instead of BSA, the insulin preload was found to be very low in the chitosan/calcium alginate system; the release characteristics were similar to that of BSA. From scanning electron microscopic studies, it appears that the chitosan modifies the alginate microspheres and subsequently the protein loading. The results indicate the possibility of modifying the formulation in order to obtain the desired controlled release of bioactive peptides (insulin), for a convenient gastrointestinal tract delivery system. © 1996 John Wiley & Sons, Inc.