Evidence map›Paper›PMID 34079222›Full record

ArticleDrug design, development and therapy2021

Fixed Dose Single Tablet Formulation with Differential Release of Amlodipine Besylate and Simvastatin and Its Pharmacokinetic Profile: QbD and Risk Assessment Approach.

Ummarah Kanwal, Shahid Mukhtar, Muzzamil Waheed, Arifa Mehreen, Nasir Abbas, Rahat Shamim, Khalid Hussain, Fatima Rasool, Amjad Hussain, Nadeem Irfan Bukhari

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Drug design, development and therapy, 2021. 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
0.6field-weighted citation impact, top 39% 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, 9 citations in OpenAlex.

  1. 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

10 authors at 3 institutions in 1 country.

Ummarah KanwalPunjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.ORCID 0000-0003-4124-109X
Shahid MukhtarPunjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.
Muzzamil WaheedGovernment College University, Faisalabad, 38850, Pakistan.
Arifa MehreenUniversity of Lahore, Lahore, Pakistan.
Nasir AbbasPunjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.ORCID 0000-0003-1862-1609
Rahat ShamimPunjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.ORCID 0000-0003-3897-9421
Khalid HussainPunjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.ORCID 0000-0001-9627-8346
Fatima RasoolPunjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.
Amjad HussainPunjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.
Nadeem Irfan BukhariPunjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan.ORCID 0000-0001-5710-9574
University of the Punjab · PKGovernment College University, Faisalabad · PKUniversity of Lahore · PK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA differential release fixed dose matrix tablet of amlodipine besylate (AML-B) and simvastatin (SIM) was formulated to enhance patient compliance. MATERIAL AND

methodIn the first phase, release controlling parameters of AML-B and SIM granules were identified and in the second phase a fixed dose AML-B and SIM tablet formulation was prepared and optimized for a differential release of the drugs using a quality by design (QbD) and risk assessment approach. A validated HPLC method was employed for simultaneous determination of AML-B and SIM for FDC formulation. A pharmacokinetics of the above drugs was studied in healthy dogs in the third phase.

resultsIn QbD-based optimized formulation, Eudragit

conclusionThe pharmacokinetic study showed an immediate absorption of AML-B while that of SIM was withheld for 6 h, close to the desired delay time of 8 h.

Indexed as

AmlodipineDose-Response Relationship, DrugDrug CompoundingDrug DesignDrug LiberationHumansRisk AssessmentSimvastatinTabletsAmlodipineSimvastatinTabletsamlodipine besylateDCP-Eudragit blenddifferential releaseEudragit RSPOEudragit S100polymersquality by designsimvastatin

Identifiers

PMID34079222
PMCPMC8164448
OpenAlexW3164690724

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.