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Formulation Development and Evaluation of Cost-Effective Sucralfate Oral Suspension: A Comprehensive Review
Subject area: Biological & Medical Sciences · Area of research: Pharmacy
Abstract
Sucralfate, a basic aluminium salt of sucrose octasulfate, remains one of the most widely prescribed locally acting cytoprotective agents for peptic ulcer disease, gastro-oesophageal reflux, and radiation- or chemotherapy-induced oral and gastrointestinal mucositis. Because the drug is practically insoluble in water and is required in gram-scale doses, an oral suspension is the pharmaceutical form of choice for patients who cannot swallow tablets, including paediatric, geriatric, post-surgical, and enterally fed patients. This review synthesises current literature on the chemistry, mechanism of action, and clinical indications of sucralfate; the formulation science underlying suspension dosage forms, including the selection of suspending agents, sweeteners, preservatives and buffers; the application of Quality-by-Design (QbD) methodology to rationally engineer a robust suspension; and, most importantly, the strategies available to formulation scientists for developing a sucralfate suspension that is cost-effective without compromising quality, safety, or efficacy. Evaluation parameters recommended for such a suspension, spanning physical, chemical, microbiological, and stability testing consistent with ICH and pharmacopoeial expectations, are discussed and summarised in tabular form. The review concludes that a deliberately planned, low-cost excipient strategy, anchored in QbD principles and rigorous evaluation, can deliver an affordable, stable, and patient-acceptable sucralfate suspension suitable for resource-constrained healthcare settings.
Keywords
Sucralfate; oral suspension; cost-effective formulation; suspending agents; Quality by Design; peptic ulcer; oral mucositis; stability evaluation
How to cite this paper
@article{1722920,
author = {Vicky Banargy, Dr. Rajeev Ranjan, Dr. Dharmendra Kumar},
title = {Formulation Development and Evaluation of Cost-Effective Sucralfate Oral Suspension: A Comprehensive Review},
journal = {Iconic Research And Engineering Journals},
year = {2026},
volume = {10},
number = {3},
pages = {892-908},
issn = {2456-8880},
url = {https://www.irejournals.com/formatedpaper/1722920.pdf},
abstract = {Sucralfate, a basic aluminium salt of sucrose octasulfate, remains one of the most widely prescribed locally acting cytoprotective agents for peptic ulcer disease, gastro-oesophageal reflux, and radiation- or chemotherapy-induced oral and gastrointestinal mucositis. Because the drug is practically insoluble in water and is required in gram-scale doses, an oral suspension is the pharmaceutical form of choice for patients who cannot swallow tablets, including paediatric, geriatric, post-surgical, and enterally fed patients. This review synthesises current literature on the chemistry, mechanism of action, and clinical indications of sucralfate; the formulation science underlying suspension dosage forms, including the selection of suspending agents, sweeteners, preservatives and buffers; the application of Quality-by-Design (QbD) methodology to rationally engineer a robust suspension; and, most importantly, the strategies available to formulation scientists for developing a sucralfate suspension that is cost-effective without compromising quality, safety, or efficacy. Evaluation parameters recommended for such a suspension, spanning physical, chemical, microbiological, and stability testing consistent with ICH and pharmacopoeial expectations, are discussed and summarised in tabular form. The review concludes that a deliberately planned, low-cost excipient strategy, anchored in QbD principles and rigorous evaluation, can deliver an affordable, stable, and patient-acceptable sucralfate suspension suitable for resource-constrained healthcare settings.},
keywords = {Sucralfate; oral suspension; cost-effective formulation; suspending agents; Quality by Design; peptic ulcer; oral mucositis; stability evaluation},
month = {September},
}