Evidence map›Paper›PMID 40050302›Full record

ArticleScientific reports2025

RSM and AI based machine learning for quality by design development of rivaroxaban push-pull osmotic tablets and its PBPK modeling.

Muhammad Talha Saleem, Muhammad Harris Shoaib, Rabia Ismail Yousuf, Fahad Siddiqui

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In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

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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

4 authors.

Muhammad Talha SaleemDepartment of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.
Muhammad Harris ShoaibDepartment of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan. mhshoaib@uok.edu.pk.
Rabia Ismail YousufDepartment of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.
Fahad SiddiquiDepartment of Pharmaceutics & Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, 75270, Pakistan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The study is based on applying Artificial Neural Network (ANN) based machine learning and Response Surface Methodology (RSM) as simultaneous bivariate approaches in developing controlled-release rivaroxaban (RVX) osmotic tablets. The influence of different types of polyethylene oxide, osmotic agents, coating membrane thickness, and orifice diameter on RVX release profiles was investigated. After obtaining the trial formulation data sets from Central Composite Design (CCD), an ANN-based model was trained to get the optimized formulations. The Physiological-based Pharmacokinetic (PBPK) modeling of the predicted formulation was performed by GastroPlus™ to simulate in vivo plasma profiles under fasting and fed conditions. In vitro release tests showed zero-order RVX release for up to 12 h. Using graphical and numerical methods, the predicted formulation generated by the prediction profiler was cross-validated by the CCD-based optimized formulation. Analysis of Variance (ANOVA) findings revealed no significant difference between the predicted and optimized formulations and these formulations have a shelf life of 22.47 and 17.87 months, respectively. The PBPK modeling of RVX push-pull osmotic pump (PPOP) tablets suggested enhanced bioavailability in the fasted (up to 82%) and fed (up to 98.5%) state compared to immediate-release tablets. The results indicated that ANN can be effectively used for osmotic systems due to their complex nature and nonlinear interactions between dependent and independent variables.

Indexed as

Machine LearningRivaroxabanBiological AvailabilityDelayed-Action PreparationsDrug LiberationHumansModels, BiologicalNeural Networks, ComputerOsmosisTabletsDelayed-Action PreparationsRivaroxabanTabletsArtificial neural networkGastroPlusOsmotic tabletsPBPK modelingQuality by designRivaroxaban

Identifiers

PMID40050302
PMCPMC11885842

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Registered trials

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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.