Evidence map›Paper›PMID 30987131›Full record

ArticlePharmaceutics2019

Characterization of Amorphous Solid Dispersion of Pharmaceutical Compound with pH-Dependent Solubility Prepared by Continuous-Spray Granulator.

Ryoma Tanaka, Yusuke Hattori, Yukun Horie, Hitoshi Kamada, Takuya Nagato, Makoto Otsuka

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 41% 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

2 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Article
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

6 authors at 2 institutions in 2 countries.

Ryoma TanakaGraduate School of Pharmaceutical Sciences, Musashino University, 1-1-20 Shin-machi, Nishi-Tokyo, Tokyo 202-8585, Japan. g1878005@stu.musashino-u.ac.jp.
Yusuke HattoriGraduate School of Pharmaceutical Sciences, Musashino University, 1-1-20 Shin-machi, Nishi-Tokyo, Tokyo 202-8585, Japan. yhattori@musashino-u.ac.jp.
Yukun HorieFaculty of Pharmacy, Musashino University, 1-1-20 Shin-machi, Nishi-Tokyo, Tokyo 202-8585, Japan. s1343033@stu.musashino-u.ac.jp.
Hitoshi KamadaResearch & Development Department, Technical Division, Powrex Corporation, 5-5-5 Kitagawara, Itami, Hyogo 664-0837, Japan. kamada@powrex.co.jp.
Takuya NagatoResearch & Development Department, Technical Division, Powrex Corporation, 5-5-5 Kitagawara, Itami, Hyogo 664-0837, Japan. t-nagato@powrex.co.jp.
Makoto OtsukaGraduate School of Pharmaceutical Sciences, Musashino University, 1-1-20 Shin-machi, Nishi-Tokyo, Tokyo 202-8585, Japan. motsuka@musashino-u.ac.jp.
Musashino University · JPUniversity of Minnesota · US

Funding

JSPS Overseas Challenge Program for Young Researchers, Young Researcher Scholarship from Hosokawa Powder Technology Foundation, and PSJ Nagai Memorial Research Scholarship None
6 · The paper itself

Abstract

A continuous-spray granulator (CTS-SGR) is a one-step granulation technology capable of using solutions or suspensions. The present research objectives were, (1) to reduce the manufacturing operations for solid dosage formulations, (2) to make amorphous solid dispersion (ASD) granules without pre-preparation of amorphous solids of active pharmaceutical ingredients (API), and (3) to characterize the obtained SGR granules by comprehensive pharmaceutical analysis. Rebamipide (RBM), a biopharmaceutical classification system class IV drug, that has low solubility or permeability in the stomach, was selected as a model compound. Five kind of granules with different concentrations of polyvinylpyrrolidone/vinyl acetate copolymer (PVP-VA) were prepared using a one-step SGR process. All of the SGR granules could be produced in amorphous or ASD form and their thermodynamic stability was very high because of high glass transition temperatures (>178 °C). They were unstable in 20 °C/75%RH; however, their stability was improved according to the proportion of polymer. The carboxy group of RBM was ionized in the granules and interactions appeared between RBM and PVP-VA, with the formation of an ASD confirmed and the solubility was enhanced compared with bulk RBM crystals. The SGR methodology has the possibility of contributing to process development in the pharmaceutical industry.

Indexed as

amorphouscharacterizationcontinuous processinggranulationinteractionmolecular complexpolymerprocess developmentrebamipidesolid dispersionstability

Identifiers

PMID30987131
PMCPMC6523299
OpenAlexW2933036238

What OpenQuestion holds

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LicenceCC BY
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.