Evidence map›Paper›PMID 32140879›Full record

Trial reportPharmaceutical research2020

UniORV, a New Multi-Unit Dosage Form, Improved Biopharmaceutical Properties of Tacrolimus in Rats and Humans.

Wataru Hirasawa, Shunsuke Sei, Misuzu Mineda, Norimasa Endo, Yoshiharu Matahira, Keisuke Makino, Ryota Tsukada, Hideyuki Sato, Satomi Onoue

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 59% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Wataru HirasawaSunsho Pharmaceutical Co., Ltd., 533-2, Ooiwa, Fujinomiya, Shizuoka, 418-0013, Japan.
Shunsuke SeiSunsho Pharmaceutical Co., Ltd., 533-2, Ooiwa, Fujinomiya, Shizuoka, 418-0013, Japan.
Misuzu MinedaSunsho Pharmaceutical Co., Ltd., 533-2, Ooiwa, Fujinomiya, Shizuoka, 418-0013, Japan.
Norimasa EndoSunsho Pharmaceutical Co., Ltd., 533-2, Ooiwa, Fujinomiya, Shizuoka, 418-0013, Japan.
Yoshiharu MatahiraSunsho Pharmaceutical Co., Ltd., 533-2, Ooiwa, Fujinomiya, Shizuoka, 418-0013, Japan.
Keisuke MakinoLaboratory of Biopharmacy, School of Pharmaceutical Science, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan.
Ryota TsukadaLaboratory of Biopharmacy, School of Pharmaceutical Science, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan.
Hideyuki SatoLaboratory of Biopharmacy, School of Pharmaceutical Science, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan.
Satomi OnoueLaboratory of Biopharmacy, School of Pharmaceutical Science, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan. onoue@u-shizuoka-ken.ac.jp.
University of Shizuoka · JP

Funding

Japan Society for the Promotion of Science 17K08453Japan Society for the Promotion of Science 18K14885
6 · The paper itself

Abstract

purposeThe aim of the present study was to develop a new multi-unit dosage formulation, Universal ORbicular Vehicle (UniORV), to improve the biopharmaceutical properties of tacrolimus (TAC).

methodsTAC-loaded UniORV (UO/TAC) was produced by the dripping and gelling of a solution comprising TAC, gelatin, starch syrup, and triethyl citrate at 0.5 w/w% drug loading. Its microstructure was elucidated by polarized light microscopy and the Raman mapping technique. The pharmacokinetic profiles of TAC after the oral administration of UO/TAC were evaluated in rats and healthy humans.

resultsThe dissolution behavior of UO/TAC was similar to that of commercial capsules, and the formation of nanoparticles was detected by TEM in dissolved media. In a stability study on UO/TAC, only 2.6 and 4.7% decreases in TAC concentrations were observed at 40± 2°C/75 ± 5% relative humidity for 4 months and at 50± 2°C for 2 months, respectively. A pharmacokinetic study on rats revealed a 30-fold higher AUC than that with crystalline TAC. A randomized double-blind crossover study on 8 healthy males showed that UniORV achieved a 1.4-fold increase in AUC and 34% decrease in inter-individual variation from the reference formulation.

conclusionThe new dosage form UniORV is a promising approach to improve the dissolution, amorphous stability, and biopharmaceutical properties of TAC, which is a poorly water-soluble drug.

Indexed as

Administration, OralAdultAnimalsCitratesCross-Over StudiesDouble-Blind MethodDrug CompoundingDrug LiberationGelatinHumansImmunosuppressive AgentsMalePharmaceutical VehiclesRatsRats, Sprague-DawleyStarchCitratesethyl citrateGelatinImmunosuppressive AgentsPharmaceutical VehiclesStarchTacrolimusabsorptiondissolutionpharmacokineticsRaman imagingTacrolimus

Identifiers

PMID32140879
OpenAlexW3010222619

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.