Evidence map›Paper›PMID 30349192›Full record

Trial reportDrug design, development and therapy2018

Immediate release tablet formulation of varenicline salicylate and comparative pharmacokinetic study in human volunteers.

Seong Shin Kwak, Eun Seok Lee, Ho Yub Yoon, Chang Hyun Kim, Yoon Tae Goo, Myung Joo Kang, Sangkil Lee, Bong Sang Lee, Hong Ryeol Jeon, Chang Hyun Oh and 1 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2018. 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
0.1field-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

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  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

11 authors at 4 institutions in 1 country.

Seong Shin KwakCollege of Pharmacy, Chung-Ang University, Heuksuk-ro, Dongjak-gu, Seoul 06974, Republic of Korea, ywchoi@cau.ac.kr.
Eun Seok LeeCollege of Pharmacy, Chung-Ang University, Heuksuk-ro, Dongjak-gu, Seoul 06974, Republic of Korea, ywchoi@cau.ac.kr.
Ho Yub YoonCollege of Pharmacy, Chung-Ang University, Heuksuk-ro, Dongjak-gu, Seoul 06974, Republic of Korea, ywchoi@cau.ac.kr.
Chang Hyun KimCollege of Pharmacy, Chung-Ang University, Heuksuk-ro, Dongjak-gu, Seoul 06974, Republic of Korea, ywchoi@cau.ac.kr.
Yoon Tae GooCollege of Pharmacy, Chung-Ang University, Heuksuk-ro, Dongjak-gu, Seoul 06974, Republic of Korea, ywchoi@cau.ac.kr.
Myung Joo KangCollege of Pharmacy, Dankook University, Dandae-ro, Dongnam-gu, CheonanChungnam 31116, Republic of Korea.
Sangkil LeeCollege of Pharmacy, Keimyung University, Dalgubeol-daero, Daegu 42601, Republic of Korea.
Bong Sang LeeCTCBIO INC., Hyundaikia-ro, Paltan, Hwaseong, Gyeonggi 18576, Republic of Korea.
Hong Ryeol JeonCTCBIO INC., Hyundaikia-ro, Paltan, Hwaseong, Gyeonggi 18576, Republic of Korea.
Chang Hyun OhCenter for Biomaterials, Korea Institute of Science & Technology (KIST), Hwarang-ro, Seongbuk-gu, Seoul 02792, Republic of Korea.
Young Wook ChoiCollege of Pharmacy, Chung-Ang University, Heuksuk-ro, Dongjak-gu, Seoul 06974, Republic of Korea, ywchoi@cau.ac.kr.
Chung-Ang University · KRHyundai Motor Group (South Korea) · KRKeimyung University · KRRBio (South Korea) · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo develop an immediate release-type tablet containing varenicline salicylate (VRC-S), a smoking cessation agent, formulation and stability studies were performed. The in vitro dissolution and in vivo pharmacokinetic (PK) behavior of the tablets were compared with those of the commercial product (Champix) as a reference. MATERIALS AND

methodsThe characteristics of the powder were investigated by particle morphology, size distribution, solubility, hygroscopicity, differential scanning calorimetry, and powder X-ray diffraction. Based on the drug-excipient compatibility test, different VRC-S tablets were prepared with the selected excipients through direct compression or wet granulation method and subjected to a dissolution test. The stability of the most promising VRC-S tablet (F4) was evaluated under accelerated conditions (40°C and 75% relative humidity). Further, the dissolution and human pharmacokinetic profiles of the F4 tablet and Champix were compared.

resultsVRC-S showed a positively skewed unimodal size distribution with a specific surface area of 2.02 m

conclusionVRC-S-containing F4 tablet might be a good candidate for smoking cessation treatment.

Indexed as

Drug CompoundingAdultChromatography, LiquidHealthy VolunteersHumansMaleMiddle AgedRepublic of KoreaSalicylatesSolubilityTabletsTandem Mass SpectrometryTherapeutic EquivalencyVareniclineYoung AdultSalicylatesTabletsVareniclinebioavailabilitydissolutionformulationsmoking cessationstabilityvarenicline salicylate

Identifiers

PMID30349192
PMCPMC6186768
OpenAlexW2895610191

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.