Effects of Diurnal Variation and Food on Gastrointestinal Transit of 111In-Labeled Hydrogel Matrix Extended-Release Tablets and 99mTc-Labeled Pellets in Humans

Kambayashi, Atsushi; Sako, Kazuhiro; Kondo, Hiromu

doi:10.1016/j.xphs.2019.09.025

Cited by 12 publications

(5 citation statements)

References 24 publications

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“…Although the impact of the circadian rhythm on gastrointestinal transit has been evaluated in different species, including humans, [36][37][38] to the best of our knowledge, it has never been addressed in laboratory animals using radiographic methods.…”

Section: X-ray Study Of Gastrointestinal Transit In Female Rats Under...mentioning

confidence: 99%

Radiographic assessment of the impact of sex and the circadian rhythm-dependent behaviour on gastrointestinal transit in the rat

et al. 2022

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Relatively little is known about the influence of sex and the circadian rhythm on gastrointestinal transit. However, these factors could have an important impact on aspects such as digestion, oral absorption of drugs or the clinical manifestation of gastrointestinal diseases, among others. Remarkably, preclinical models have scarcely taken these factors into consideration. In this study, we assessed the gastrointestinal transit of young adult Wistar Han rats of both sexes, under normal and inverted light cycle. To do this, serial radiographs were taken for 24 h (T0–T24) after intragastric barium administration and subsequently analysed to construct transit curves for each gastrointestinal region. Under a normal light cycle, transit curves were similar, except for a slower transit in females compared with males from T8 to T24. Under the inverted cycle, there was a significant acceleration in stomach emptying (similar in both sexes), emptying of the small intestine (even faster in females) and filling of the caecum and colon (which was also even faster in females). This study confirms, using X-ray non-invasive methods for the first time, that both sex and circadian rhythm (probably through its effect on behaviour) influence gastrointestinal transit in laboratory animals.

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Section: X-ray Study Of Gastrointestinal Transit In Female Rats Under...mentioning

confidence: 99%

Radiographic assessment of the impact of sex and the circadian rhythm-dependent behaviour on gastrointestinal transit in the rat

et al. 2022

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“…The imaging study revealed that the in vitro dissolution (erosion) rate estimated using a USP Apparatus II with 200 rpm or 100–150 rpm was closely similar to those in vivo in the fed and fasted states, respectively (data not shown in the original article). However, our recent study suggested that a compendial dissolution apparatus (such as Apparatus I, II, III, and IV) is inappropriate for precisely predicting the in vivo performance of hydrophilic matrix tablets (poly(ethylene oxide)), a formulation closely similar to that in our previous study . This might be because the two formulations had a different dissolution rate even though a qualitatively identical excipient was used to control the dissolution rate of drug.…”

Section: Orally Administered Dds Formulationsmentioning

confidence: 77%

“…Furthermore, Kambayashi et al 36 evaluated the erosion rate of a hydrophilic matrix tablet (poly(ethylene oxide)) in the in vivo gastrointestinal tract in humans in both the fed and fasted states using gamma-scintigraphy. The imaging study revealed that the in vitro dissolution (erosion) rate estimated using a USP Apparatus II with 200 rpm or 100−150 rpm was closely similar to those in vivo in the fed and fasted states, respectively (data not shown in the original article).…”

Section: Controlled Release Formulations 221 Sustained Release Formul...mentioning

confidence: 99%

“…However, our recent study 37 suggested that a compendial dissolution apparatus (such as Apparatus I, II, III, and IV) is inappropriate for precisely predicting the in vivo performance of hydrophilic matrix tablets (poly(ethylene oxide)), a formulation closely similar to that in our previous study. 36 This might be because the two formulations had a different dissolution rate even though a qualitatively identical excipient was used to control the dissolution rate of drug. SR tablets with faster dissolution would be more sensitive to in vitro conditions; accordingly, an original in vitro method with very limited volume of fluid� relevant to the small intestinal lumen�was appropriate for the SR tablet used.…”

Section: Controlled Release Formulations 221 Sustained Release Formul...mentioning

confidence: 99%

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In Silico Modeling Approaches Coupled with In Vitro Characterization in Predicting In Vivo Performance of Drug Delivery System Formulations

Kambayashi

2023

Mol. Pharmaceutics

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Optimization of the in vivo performance of dosage forms in humans is essential in developing not only conventional formulations but also drug delivery system (DDS) formulations. Although animal experiments are still useful for these formulations, in silico approaches have become increasingly important for DDS formulations with regard to species-specific differences in physiology that can affect the in vivo performance of dosage forms between animals and humans. Furthermore, it is also important to couple in vitro characterizations with in silico models to predict in vivo performance in humans precisely. In this review article, I summarized in vitro−in silico approaches to predicting the in vivo performance of oral DDS formulations (amorphous solid dispersions, lipid-based formulations, nanosized formulations, cyclodextrins-based formulations, sustained release products, enteric coat products, and orally disintegrating tablets) and parenteral DDS formulations (cyclodextrins-based formulations, liposomes, and inhaled formulations).

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“…A suspension of free cells was used as control. The cell viability was evaluated after 4 h of contact simulating the average contact time of food with bile salts in the human intestine (Kambayashi et al, 2020). The cell count was done in Man–Rogosa–Sharpe (MRS) agar at 37 °C and anaerobic conditions.…”

Section: Methodsmentioning

confidence: 99%

Improvement of probiotic viability through the design of novel biomaterials using coffee pulp wastes and Lactobacillus rhamnosus

Delgado

Arbeláez

Zapata

et al. 2022

Food sci. technol. int.

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The immobilization of bacteria cells has shown to be an efficient technology to improve cell viability. This study used lyophilized and pulverized coffee pulp (LPC) and LPC functionalized with theobromine at two concentrations, 3.1 w/w and 2.4 w/w named as LPF1 and LPF2, respectively, to immobilize Lactobacillus rhamnosus ATCC 53103 cells (biomaterials) and increase the viability of the cell at storage and gastrointestinal conditions. To characterize the biomaterials, SEM, Dynamic Light Scattering, TGA, , FTIR and Isoeletrc Point measurements (or zeta potential measurements) were carried out. To evaluate the effectiveness of immobilization, cell viability as a function of storage time and under simulated gastrointestinal conditions was evaluated. Regarding the characterization of the materials, the particle sizes were 21.7 to 334.4 nm and they experienced mass losses of less than 10% at 100°C. The FTIR indicated the presence of functional groups related to caffeine, chlorogenic acid, sucrose, arabinogalactans, carbohydrates, and proteins in all biomaterials. The sorption kinetic parameters showed an adsorptive capacity between 3.0 × 109 and 8.0 × 109 CFU.g−1, being LPF1 the best materials to immobilize the cells, associated with LPF1 surface properties. The viability was higher for immobilized cells than for free cells, when left in storage and under simulated gastric conditions. Finally, the biomaterials could be used in the preparation of probiotic diets based on lactobacilli. To the best of our knowledge, this is the first study regarding the use of waste from coffee agribusiness to develop probiotic biocarriers which opens up possibilities for future developments.

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Effects of Diurnal Variation and Food on Gastrointestinal Transit of 111In-Labeled Hydrogel Matrix Extended-Release Tablets and 99mTc-Labeled Pellets in Humans

Cited by 12 publications

References 24 publications

Radiographic assessment of the impact of sex and the circadian rhythm-dependent behaviour on gastrointestinal transit in the rat

Radiographic assessment of the impact of sex and the circadian rhythm-dependent behaviour on gastrointestinal transit in the rat

In Silico Modeling Approaches Coupled with In Vitro Characterization in Predicting In Vivo Performance of Drug Delivery System Formulations

Improvement of probiotic viability through the design of novel biomaterials using coffee pulp wastes and Lactobacillus rhamnosus

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