Development of oral paediatric furosemide liquid formulation using surfactant-rich micelles

Shiekmydeen Jailani; Anumol Joseph; Sideequl Akbar; Rajkumar Malayandi; Chindambaram Kannaiyan Dhanapal; Sampathkumar Madhusudhan; Noohu Abdulla Khan

doi:10.1515/tsd-2025-2689

Article

Development of oral paediatric furosemide liquid formulation using surfactant-rich micelles

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Rajkumar Malayandi is currently working as a Professor and Head in the Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur. He holds M. Pharm and a Ph. D in Pharmacy from the Government College of Pharmacy, Karad. He is a certified professional in areas such as lean process, six sigma black belt, AI and ML, advanced statistics, spectroscopic imaging, and model-informed pharmaceutical development. He has received an AICTE fellowship and a Suresh Kare Indoco research fellowship during his graduation days. He is a recipient of several awards, including the Prof. RL Nicore award (APTI), 2 IPDO awards (DRL), Sun Pharma Award, 4 Abbott Excellence Awards, and the EPD President Award. He has 7 granted patents and 16 patent applications, including US, EU, India, and PCT. He has more than 40 publications to his credit. He has delivered 150-plus talks at various national and international conferences. He has 15 years of industrial research experience from various companies such as FDC Ltd, Dr. Reddy’s, Sun Pharma, USV Ltd, and Abbott India. His last assignment was Head, Biopharmaceutics and Clinical Pharmacokinetics. His area of research includes analytical science, complex products, and clinical development.
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Published/Copyright: December 5, 2025

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From the journal Tenside Surfactants Detergents Volume 63 Issue 1

Abstract

Furosemide, a diuretic for managing edema in premature neonates and infants with congestive heart failure, is often formulated with alcohol and preservatives, posing risks like neurotoxicity and cardiovascular complications. This study aimed to develop a safe, alcohol-and preservative-free micellar liquid formulation of furosemide for pediatric use. Drug-loaded micelles were prepared using Kolliphor RH 40 (polyoxyl 40 hydrogenated castor oil) as a surfactant and hydroxypropyl-beta-cyclodextrin as a solubiliser and characterized for size, morphology, zeta potential, polydispersity, critical micelle concentration, stability, and microbiological quality. Of the twelve formulations, F11 and F12 were selected for their visual clarity and physical properties. The optimised batch (F11) formed nanosized micelles (19.16 ± 0.06 nm) with uniform distribution (PDI 0.292 ± 0.02) and steric stabilisation (zeta potential −0.43 ± 0.01 mV). Entrapment efficiency exceeded 98 %, and transmittance was >97 %, confirming high clarity. The formulation remained stable in SGF and SIF for 12 h with >99 % assay retention and complies with the stability protocol. The data obtained from stability studies indicate the physical, pharmaceutical, and microbial stability of the developed formulation. This alcohol- and preservative-free micellar formulation may offer a safe and effective treatment option for paediatric populations.

Keywords: furosemide; surfactant micelles; paediatric; ethanol-free; solubility enhancement

Corresponding author: Rajkumar Malayandi, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur, Export Promotion Industrial Park (EPIP), Zandaha Road, NH322, Hajipur, Bihar 844102, India, E-mail: rajkumar.ceutics@niperhajipur.ac.in

About the author

Rajkumar Malayandi

Rajkumar Malayandi is currently working as a Professor and Head in the Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur. He holds M. Pharm and a Ph. D in Pharmacy from the Government College of Pharmacy, Karad. He is a certified professional in areas such as lean process, six sigma black belt, AI and ML, advanced statistics, spectroscopic imaging, and model-informed pharmaceutical development. He has received an AICTE fellowship and a Suresh Kare Indoco research fellowship during his graduation days. He is a recipient of several awards, including the Prof. RL Nicore award (APTI), 2 IPDO awards (DRL), Sun Pharma Award, 4 Abbott Excellence Awards, and the EPD President Award. He has 7 granted patents and 16 patent applications, including US, EU, India, and PCT. He has more than 40 publications to his credit. He has delivered 150-plus talks at various national and international conferences. He has 15 years of industrial research experience from various companies such as FDC Ltd, Dr. Reddy’s, Sun Pharma, USV Ltd, and Abbott India. His last assignment was Head, Biopharmaceutics and Clinical Pharmacokinetics. His area of research includes analytical science, complex products, and clinical development.

Acknowledgments

We acknowledge the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India.

Research ethics: Not applicable.
Informed consent: Not applicable.
Author contributions: Jailani S: conceptualization, writing original draft, supervision. Anumol Joseph: writing original draft, review & editing. Sideequl Akbar: writing original draft, review & editing. Rajkumar Malayandi: conceptualization, writing original draft, supervision. C.K. Dhanapal: writing, review & editing. Madhusudhan S: writing, review & editing. Noohu Abdulla Khan: writing, review & editing. All authors discussed the results and contributed to the final manuscript.
Use of Large Language Models, AI and Machine Learning Tools: None declared.
Conflict of interest: The author states no conflict of interest.
Research funding: None declared.
Data availability: Not applicable.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/tsd-2025-2689).

Received: 2025-06-30

Accepted: 2025-10-24

Published Online: 2025-12-05

Published in Print: 2026-01-23

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Keywords for this article

furosemide; surfactant micelles; paediatric; ethanol-free; solubility enhancement