ENTERION CAPSULE PDF

Vudok The capsule is designed to release a drug in two modes according to the situation. The drug chamber is compressed by the upper head see the white arrow. Japan Inc Communications, Inc. Author information Copyright and License information Disclaimer. Differing from the first mode, in the polymeric drug-coating mode, even a highly viscous drug can be released because the abrupt compression of the drug chamber gives a strong fluidic force to the squeezed drug. J Magn Magn Mater.

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Email: pj. This article has been cited by other articles in PMC. Abstract Two studies in healthy subjects assessed the absorption of edoxaban when delivered to specific locations within the gastrointestinal tract using Enterion capsules. Peak and total exposure following targeted drug delivery to the distal gastrointestinal tract were significantly lower than with IR tablet delivery. In study 1, total exposure ratios of treatments B, C, and D compared with A were In study 2, relative total exposure was Time to peak concentration was longer with higher variability for edoxaban delivered to the distal gastrointestinal tract compared with the IR tablet.

These data indicate that edoxaban absorption occurs predominantly in the proximal small intestine. Keywords: edoxaban, Enterion capsule, absorption, pharmacokinetics, dissolution Edoxaban is a highly selective, direct, and reversible inhibitor of the serine protease factor Xa FXa. Capsule activation drug delivery is confirmed using a signal that is emitted from the capsule and is relayed to the activation unit.

Early in the clinical development program for edoxaban, the 2 studies described here were undertaken to assess if the absorption of edoxaban from the distal GI tract might facilitate improved oral drug bioavailability.

The primary objective of study 1 was to investigate the pharmacokinetics PK of edoxaban following release in the distal small intestine and ascending colon compared with the IR tablet formulation. Fumaric acid was added to modulate the pH of the colonic microenvironment and to potentially improve dissolution in the large bowel. Study 2 was approved by the Plymouth independent ethics committee. Both studies were conducted in healthy subjects and in accordance with the respective protocols, the International Conference on Harmonisation Good Clinical Practice guideline, the requirements of the Administration of Radioactive Substances Advisory Committee, and according to the ethical principles of the Declaration of Helsinki.

Written informed consent was obtained from all participants prior to screening. A dose of 60 mg was chosen to ensure sufficient plasma concentrations for analysis while minimizing the likelihood of any adverse events AEs. Subjects who were not willing or unable to eat the provided standard meals; had previously participated in earlier edoxaban studies; were allergic to anticoagulants or had ongoing allergic disease; had a history of GI disease, surgery, or injury; had a history of alcohol or drug abuse; or had any other illness or condition that would interfere with participation in the studies were excluded.

The aqueous suspension was prepared at the study site from the API powder. Enterion capsules were filled at the study site with the edoxaban powder formulation treatments B and C and the aqueous suspension formulation treatment D. For study 2, edoxaban tablets treatment E and the granulate fumaric acid formulation were supplied by Daiichi Pharmaceutical Co.

Enterion capsules were filled at the study site with the granulate formulation treatment F. In study 1, a treatment allocation list was employed, although treatment allocations for individual subjects could be revised during the study.

Treatments were administered at least 4 hours following consumption of a standard light breakfast. In study 2, participants were randomly assigned to 1 of 2 treatment sequences: treatment E followed by treatment F or vice versa. Treatments were administered following a fast commencing from midnight on the day prior to dosing and continuing until 5 hours postdose, at which time a standard lunch was provided.

Scintigraphic images were acquired every 10 minutes during study 1 until capsule activation, every 10 minutes until 4 hours after activation, then every 20 minutes until 8 hours after activation, and then at 12, 16, and 24 hours after activation or defecation whichever was sooner. In study 2, scintigraphic images were collected approximately every 20 minutes until 2 hours after gastric emptying, approximately every 10 minutes until device activation, and every 20 minutes until 4 hours after activation or defecation whichever was sooner.

In both studies, fecal collection occurred after capsule administration until capsule retrieval treatments B, C, D, and F only.

In study 2, blood samples were collected at predose, 0. The analyte and internal standard were detected and quantified using a SciexAPI tandem mass spectrometer. Safety Safety assessments included recording of vital signs, ECGs, physical examination, laboratory analyses, and recording of AEs as reported by the study investigator or subject.

AEs were coded according to the Medical Dictionary for Regulatory Activities version 5 in study 1 and version 8. Statistical Analyses All participants who received edoxaban and completed the treatment periods with evaluable data were included in the PK analysis. Tmax was analyzed similarly, but without transformation.

In study 1, all participants who received edoxaban were included in the analysis of safety. In study 2, all participants who received at least 1 dose of edoxaban and had at least 1 safety assessment were included in the safety population. Safety data were described by subject and summarized by treatment.

Results Demographics and Baseline Characteristics Study 1 included 8 healthy male subjects who enrolled and completed all treatments, and study 2 included 10 healthy male subjects who were randomly assigned to receive the study drug. One subject in study 2 did not receive edoxaban during treatment F because the capsule did not activate; he was therefore not included in the PK and biomarker analyses.

All participants in study 1 were white; 9 participants in study 2 were white and 1 was Asian. Scintigraphy Scintigraphic images and retrieved capsules obtained in study 1 confirmed the release of edoxaban at regional target locations in all 24 assessments Table 1.

Similarly, scintigraphic images in conjunction with retrieved Enterion capsules confirmed that 9 of the 10 capsules administered in study 2 were successfully activated.

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Email: pj. This article has been cited by other articles in PMC. Abstract Two studies in healthy subjects assessed the absorption of edoxaban when delivered to specific locations within the gastrointestinal tract using Enterion capsules. Peak and total exposure following targeted drug delivery to the distal gastrointestinal tract were significantly lower than with IR tablet delivery.

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