Evidence map›Paper›PMID 26047011›Full record

ArticlePloS one2015

Development of Sustained Release "NanoFDC (Fixed Dose Combination)" for Hypertension - An Experimental Study.

Anjuman Arora, Nusrat Shafiq, Sanjay Jain, G K Khuller, Sadhana Sharma, Samir Malhotra

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 34% 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

6 citing papers in PubMed, 21 citations in OpenAlex.

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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 1 institution in 1 country.

Anjuman AroraDept. of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Nusrat ShafiqDept. of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Sanjay JainDept. of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
G K KhullerDept. of Biochemistry, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Sadhana SharmaDept. of Biochemistry, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Samir MalhotraDept. of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Post Graduate Institute of Medical Education and Research · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe present study was planned to formulate, characterize and evaluate the pharmacokinetics of a novel "NanoFDC" comprising three commonly prescribed anti-hypertensive drugs, hydrochlorothiazide (a diuretic), candesartan (ARB) and amlodipine (a calcium channel blocker). BASIC

methodsThe candidate drugs were loaded in Poly (DL-lactide-co-gycolide) (PLGA) by emulsion- diffusion-evaporation method. The formulations were evaluated for their size, morphology, drug loading and in vitro release individually. Single dose pharmacokinetic profiles of the nanoformulations alone and in combination, as a NanoFDC, were evaluated in Wistar rats.

resultsThe candidate drugs encapsulated inside PLGA showed entrapment efficiencies ranging from 30%, 33.5% and 32% for hydrochlorothiazide, candesartan and amlodipine respectively. The nanoparticles ranged in size from 110 to 180 nm. In vitro release profile of the nanoformulation showed 100% release by day 6 in the physiological pH 7.4 set up with PBS (phosphate buffer saline) and by day 4-5 in the intestinal pH 1.2 and 8.0 set up SGF (simulated gastric fluid) and SIF (simulated intestinal fluid) respectively. In pharmacokinetic analysis a sustained-release for 6 days and significant increase in the mean residence time (MRT), as compared to the respective free drugs was noted [MRT of amlodipine, hydrochlorothiazide and candesartan changed from 8.9 to 80.59 hours, 11 to 69.20 hours and 9 to 101.49 hours respectively].

conclusionWe have shown for the first time that encapsulating amlodipine, hydrochlorothiazide and candesartan into a single nanoformulation, to get the "NanoFDC (Fixed Dose Combination)" is a feasible strategy which aims to decrease pill burden.

Indexed as

AmlodipineAnimalsAntihypertensive AgentsBenzimidazolesBiphenyl CompoundsCalcium Channel BlockersDrug CarriersDrug LiberationHalf-LifeHydrochlorothiazideHypertensionLactic AcidMicroscopy, Electron, TransmissionNanoparticlesPolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerAmlodipineAntihypertensive AgentsBenzimidazolesBiphenyl CompoundsCalcium Channel BlockerscandesartanDrug CarriersHydrochlorothiazideLactic AcidPolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerTetrazoles

Identifiers

PMID26047011
PMCPMC4457799
OpenAlexW1105212941

What OpenQuestion holds

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LicenceCC BY
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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.