Evidence map›Paper›PMID 41921709›Full record

ArticleInternational journal of pharmaceutics2026

Technical challenges and quality considerations for dissolving microneedles.

Nahid S Kamal, Samuel Acheampong, Rokon Uz Zaman, Caroline Strasinger, Andrew G Clark, Aiden Zhu, Yubing Tang, Ahmed Zidan, Muhammad Ashraf

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of pharmaceutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Nahid S KamalOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality (OPQ), CDER, FDA, USA. Electronic address: nahid.kamal@fda.hhs.gov.
Samuel AcheampongOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality (OPQ), CDER, FDA, USA.
Rokon Uz ZamanOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality (OPQ), CDER, FDA, USA.
Caroline StrasingerOffice of Pharmaceutical Quality Assessment II, OPQ, CDER, FDA, USA.
Andrew G ClarkdigiM Solution 500 West Cummings Park, Woburn, MA 01801, USA.
Aiden ZhudigiM Solution 500 West Cummings Park, Woburn, MA 01801, USA.
Yubing TangOffice of Pharmaceutical Quality Assessment III, OPQ, CDER, FDA, USA.
Ahmed ZidanOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality (OPQ), CDER, FDA, USA.
Muhammad AshrafOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality (OPQ), CDER, FDA, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Dissolving microneedles (DMNs) deliver therapeutic molecules by bypassing the stratum corneum upon skin insertion. While DMNs show potential for transdermal delivery, developing formulations with optimal critical quality attributes (CQAs), particularly mechanical properties ensuring effective skin insertion and drug release, remains challenging. Also, lack of standardized quality control methods has made product development difficult. This study investigates testing methods and how polymer-to-API ratio impacts key CQAs including microneedle formation, morphological characteristics, mechanical properties, spatial drug distribution, and drug release/permeation. DMNs were manufactured using varying polyvinyl alcohol (PVA) concentrations with metoprolol succinate as the model drug, maintaining constant drug content across formulations. Microscopic imaging with AI segmentation confirmed successful formation of pyramidal DMNs with consistent dimensions. Intensity-distance analysis provided a measure of the drug distribution from the supportive layer to the needle tips. The fracture force per needle increased proportionally with higher PVA content, enhancing structural integrity. However, the polymer-to-API ratio did not affect skin insertion capability or the needle disintegration kinetics. Higher PVA content resulted in slower drug release from DMN arrays, indicating that polymer content was a critical release-controlling parameter. Permeation profiles from the microneedles were consistent with the distribution of drug within the microneedles, suggesting that localization influences permeation behavior of drug across the skin. Optimizing PVA-to-drug ratio and controlling drug distribution in DMNs are necessary for improving performance, particularly regarding drug release and permeation characteristics. These findings provide insights for advancing DMN development and addressing quality control challenges in DMN systems.

Indexed as

MetoprololMicroneedle Drug DeliveryAdministration, CutaneousAnimalsDrug LiberationNeedlesPolyvinyl AlcoholQuality ControlSkinSkin AbsorptionSolubilityMetoprololPolyvinyl AlcoholArtificial intelligence assisted image analysisDissolving microneedlesIn vitro drug permeationIn vitro drug releaseMechanical propertiesMicroneedle disintegrationMicroneedles

Identifiers

PMID41921709
PMCPMC13186209

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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.