Pluronic F-127/Propylene Glycol Binary Building Blocks for Novel Solid Dispersion Matrix: Industrial and Ecological Paradigm to Enhance Dissolution Profile of Dapagliflozin

Background/Objectives: The limited aqueous solubility of therapeutically active drugs remains a significant challenge in their pharmaceutical application. This study presents a novel solid dispersion matrix (NSDM) that utilizes the inverted thermoresponsive behavior of Pluronic F127 to enhance drug dissolution while addressing the industrial and ecological limitations of conventional methods. Methods: For comparative assessment, a solid dispersion formulation of dapagliflozin was formulated using the NSDM approach and three conventional approaches: heat fusion (HFSD), microwave (MWSD), and lyophilization (LPSD). Differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), and X-ray diffraction (XRD) were used to characterize the prepared formulations. In vitro dissolution test was performed to compare the pharmaceutical performance of NSDM against conventional approaches. Results: The NSDM exhibited a unique thermal transition to the liquid state at 32.4 °C. Moreover, the physiological assessment revealed complete liquefaction within 81.7 s. DSC and XRD confirmed amorphization of dapagliflozin in all formulations. In addition, FTIR revealed that dapagliflozin was integrated within the formulation without any chemical interaction with the excipient. Dissolution studies showed remarkable superiority of NSDM, with 97.30 ± 2.26% dissolution efficiency and a mean dissolution time of 2.40 ± 0.80 min. A multi-criteria assessment of ecological impact, worker friendliness, industrial effectiveness, and pharmaceutical performance demonstrated NSDM’s comprehensive advantages. Conclusions: The present approach provides a sustainable paradigm compared to conventional solid dispersion approaches. It eliminates energy-intensive operations and post-processing steps through direct capsule filling. This affords superior pharmaceutical performance while supporting sustainability and industrial applicability.

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Publication Details

Journal
Pharmaceutics
Published
2026-04-30
DOI
https://doi.org/10.3390/pharmaceutics18050560
Primary Topic
Drug Solubulity and Delivery Systems
Type
article
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article

Pluronic F-127/Propylene Glycol Binary Building Blocks for Novel Solid Dispersion Matrix: Industrial and Ecological Paradigm to Enhance Dissolution Profile of Dapagliflozin

Mohammad A. Altamimi, Abdelrahman Y. Sherif, Ehab M. Elzayat
Pharmaceutics
Drug Solubulity and Delivery Systems
article

Pluronic F-127/Propylene Glycol Binary Building Blocks for Novel Solid Dispersion Matrix: Industrial and Ecological Paradigm to Enhance Dissolution Profile of Dapagliflozin

Mohammad A. Altamimi, Abdelrahman Y. Sherif, Ehab M. Elzayat
article en

Abstract

Background/Objectives: The limited aqueous solubility of therapeutically active drugs remains a significant challenge in their pharmaceutical application. This study presents a novel solid dispersion matrix (NSDM) that utilizes the inverted thermoresponsive behavior of Pluronic F127 to enhance drug dissolution while addressing the industrial and ecological limitations of conventional methods. Methods: For comparative assessment, a solid dispersion formulation of dapagliflozin was formulated using the NSDM approach and three conventional approaches: heat fusion (HFSD), microwave (MWSD), and lyophilization (LPSD). Differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), and X-ray diffraction (XRD) were used to characterize the prepared formulations. In vitro dissolution test was performed to compare the pharmaceutical performance of NSDM against conventional approaches. Results: The NSDM exhibited a unique thermal transition to the liquid state at 32.4 °C. Moreover, the physiological assessment revealed complete liquefaction within 81.7 s. DSC and XRD confirmed amorphization of dapagliflozin in all formulations. In addition, FTIR revealed that dapagliflozin was integrated within the formulation without any chemical interaction with the excipient. Dissolution studies showed remarkable superiority of NSDM, with 97.30 ± 2.26% dissolution efficiency and a mean dissolution time of 2.40 ± 0.80 min. A multi-criteria assessment of ecological impact, worker friendliness, industrial effectiveness, and pharmaceutical performance demonstrated NSDM’s comprehensive advantages. Conclusions: The present approach provides a sustainable paradigm compared to conventional solid dispersion approaches. It eliminates energy-intensive operations and post-processing steps through direct capsule filling. This affords superior pharmaceutical performance while supporting sustainability and industrial applicability.

PharmaceuticsVol. 18(5)
King Saud University (SA)
Industry, innovation and infrastructure
Openalex Percentile: Top 9%
Drug Solubulity and Delivery Systems
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