Sucralfate paste for treating chemotherapy-induced oral mucositis
Journal name: World Journal of Pharmaceutical Research
Original article title: Formulation and evaluation of sucralfate paste for chemotherapy induced oral mucositis
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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M. F. Farzana Affrin and Grace Rathnam
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Formulation and evaluation of sucralfate paste for chemotherapy induced oral mucositis
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20219-21044
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Oral mucositis is a prevalent and painful complication faced by patients undergoing chemotherapy, significantly impacting their quality of life and the delivery of cancer treatment. The study conducted by Affrin et al. aimed to develop a mucoadhesive sucralfate paste through a polymerization method, providing a targeted, controlled approach for treating oral mucositis. By applying this formulation to affected areas, the researchers aimed to alleviate pain and promote healing in the oral mucosa of male Wistar rats, providing a preclinical evaluation of the paste's efficacy.
Polymerization Method for Formulation
The sucralfate paste was created using a polymerization technique that incorporated various excipients such as mucoadhesive polymers, viscosity-increasing agents, and preservatives. The formulation process involved the combination of sucralfate with other chemicals, including citric acid, calcium carbonate, and magnesium sulfate, mixed in a planetary mixer. This meticulous approach ensured a paste with favorable physical properties, such as appropriate viscosity and spreadability, which are crucial for effective topical application on the damaged mucosa.
Efficacy of Sucralfate Paste
In the evaluation of its efficacy, the best formulation (SP 8) was selected based on superior characteristics like increased viscosity and extrudability. The in vivo studies involved inducing oral mucositis in Wistar rats using 5-fluorouracil and glacial acetic acid. The results indicated a significant reduction in mucositis scores in treated animals compared to those that received no treatment. Weight measurements in group three revealed a stabilization and recovery of the animals following treatment, underscoring the paste's effectiveness in healing mucosal lesions.
Stability and Safety Assessment
A stability analysis of the prepared sucralfate paste established that the formulated product maintained consistent physical properties, such as color, odour, and pH, over a three-month storage period under accelerated stability conditions. The paste exhibited a non-irritant nature for the buccal cavity, making it suitable for direct application in patients suffering from oral mucositis. This assessment further solidifies the formulation’s robustness and safety profile for potential clinical application.
Conclusion
The findings from Affrin et al. suggest that the polymerized sucralfate paste offers a promising solution for managing chemotherapy-induced oral mucositis. By providing a protective barrier and promoting healing, this formulation could play a crucial role in improving patient comfort and treatment adherence during cancer therapy. The successful in vitro and in vivo results indicate that ongoing research and development are warranted to explore clinical applications, ultimately benefiting the overall survival and well-being of oncology patients suffering from this debilitating condition.
FAQ section (important questions/answers):
What is the main purpose of sucralfate paste in this study?
The study aimed to develop sucralfate paste for treating chemotherapy-induced oral mucositis, utilizing mucoadhesive polymers for targeted healing in the oral mucosa.
How was oral mucositis induced in the animal model?
Oral mucositis was induced in male Wistar rats using 5-Fluorouracil and glacial acetic acid, followed by treatment with sucralfate paste.
What were the key ingredients used in formulating the sucralfate paste?
Key ingredients included sucralfate, citric acid, calcium carbonate, magnesium sulfate, xanthan gum, and various excipients like glycerin and propylene glycol.
How effective was the SP 8 formulation in treating mucositis?
The SP 8 formulation showed significant efficacy, resulting in improved healing of oral mucositis compared to untreated groups, with a statistically significant P value of 0.0069.
What stability studies were performed on the sucralfate paste?
Stability studies evaluated various parameters like color, odor, pH, viscosity, and drug content over three months, indicating no significant physical or chemical changes.
What conclusion did the study reach regarding sucralfate paste?
The study concluded that sucralfate paste effectively prevents and treats oral mucositis, enhancing patient health during chemotherapy by forming a protective barrier.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Sucralfate paste for treating chemotherapy-induced oral mucositis”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Animal:
The word 'animals' is a general term that encompasses the test subjects used in the study, specifically referring to the Wistar rats. The use of animals in research is paramount for gaining insights into drug efficacy and safety before human testing, adhering to ethical guidelines for animal research.
2) Drug:
The term 'drug' pertains to sucralfate, the active compound formulated into a paste for treating oral mucositis. Sucralfate plays a vital role in creating a protective barrier on the oral mucosa, thus reducing discomfort and promoting healing. It demonstrates the drug's clinical relevance in addressing chemotherapy side effects.
3) Water:
Water is a crucial solvent used during the preparation of the sucralfate paste. Proper hydration of ingredients ensures a uniform mixture and optimal drug bioavailability. Additionally, the pH determination and some formulation processes require distilled water, emphasizing its importance in pharmaceutical formulations and quality control.
4) Table:
The term 'table' appears in the context of showcasing formulation compositions and results of various evaluations. Tables are essential in scientific reports for organizing data clearly, facilitating comparison, and enhancing the reader's understanding of formulation quantities, physicochemical properties, and experimental findings.
5) Study (Studying):
The term 'study' encompasses the entire research process aimed at investigating the formulation and effectiveness of sucralfate paste in treating oral mucositis. It signifies a systematic investigation characterized by design, methodology, data collection, and analysis aimed at contributing to existing knowledge in pharmaceutical sciences.
6) Gujarat:
Gujarat is the geographical location from where some raw materials, like citric acid and magnesium sulfate, were sourced for the formulation of sucralfate paste. The significance of this location indicates the supply chain and resource availability vital for pharmaceutical research and development.
7) Chemotherapy:
Chemotherapy refers to the medical treatment for cancer involving powerful drugs to kill or slow the growth of cancer cells. It is essential in this study because chemotherapy often causes side effects like oral mucositis, leading to discomfort. Addressing these side effects is critical for maintaining patient quality of life during treatment.
8) Glass:
Glass is used in the context of laboratory equipment, referenced during the measurement of the paste's spreadability and other physical parameters. The precision of glassware ensures accurate measurements, which are important for maintaining experimental integrity and reproducibility in pharmaceutical research.
9) Inflammation:
Inflammation is a biological response to harmful stimuli, pivotal in the context of oral mucositis, which consists of symptoms like pain and swelling. Understanding inflammation helps researchers develop therapeutic interventions, like sucralfate paste, aimed at alleviating these symptoms and promoting healing in affected individuals.
10) Filling (Filled):
The term 'filled' refers to the process of aggregating the sucralfate paste into collapsible tubes for storage and application. Proper filling techniques are necessary to ensure the consistency and integrity of the formulation, which is critical for efficacy and user safety.
11) India:
India is the country where the research and development of the sucralfate paste were conducted, highlighting the local context of pharmaceutical innovation. The geographical focus provides background on regulatory standards, ethical approvals, and the local pharmaceutical industry supporting research endeavors.
12) Male:
The term 'male' designates the sex of the Wistar rats used in the study. Male models are often chosen for initial research due to their uniformity in physiological responses, ensuring a consistent baseline for evaluating the efficacy of the treatment.
13) Chennai:
Chennai is the city where the research was conducted at C.L. Baid Metha College of Pharmacy. It serves as the institutional framework within which the study was performed, representing both the academic and practical aspects of pharmaceutical research in a rapidly developing region.
14) Cancer:
Cancer refers to the array of diseases characterized by uncontrolled cell division. It directly correlates with the rationale behind chemotherapy treatment, which induces various side effects, including oral mucositis. Understanding cancer pathways is integral for developing supportive treatments to improve patient outcomes.
15) Ulcer:
The plural 'ulcers' illustrates the prevalence of multiple sore lesions that can develop in cancer patients undergoing chemotherapy. This highlights the necessity of developing effective topical treatments like sucralfate paste to alleviate the pain and discomfort associated with such conditions.
16) Cina:
China is noteworthy as the origin of sucralfate from Zhejiang Haisen Pharmaceutical Co. Ltd, emphasizing the international collaboration in pharmaceutical research. The sourcing of active pharmaceutical ingredients reflects the global nature of drug development and the importance of quality standards.
17) Measurement:
The term 'measurement' signifies the act of quantifying specific properties of the sucralfate paste that are critical for evaluation. Accurate measurements validate the formulation's consistency and ensure compliance with established standards, thereby supporting the overall reliability of the research findings.
18) Observation:
'Observation' underscores the importance of closely monitoring physiological and behavioral changes in rats post-treatment. Effective observation allows researchers to gauge therapeutic efficacy and the safety profile of sucralfate paste, based on clinical signs and mucositis scoring.
19) Discussion:
The discussion section is where researchers interpret their findings in relation to previous studies. It allows for critical analysis of the results obtained, provides context for the significance of the data, and highlights implications for clinical practice and future research directions.
20) Developing:
Developing pertains to the process of formulating and optimizing the sucralfate paste. This involves experimentation with various ingredients and methods to achieve the desired therapeutic effect, signifying the innovation and application of pharmaceutical sciences in real-world contexts.
21) Transformation (Transform, Transforming):
Transform indicates the process by which sucralfate undergoes polymerization to create a paste suitable for therapeutic use. This transformation is essential for enhancing the drug’s bioavailability and its protective action on mucosal surfaces, improving treatment outcomes for oral mucositis.
22) Zhejiang:
Zhejiang is the province in China where sucralfate was sourced from Zhejiang Haisen Pharmaceutical Co., Ltd. This geographical reference is essential, as it highlights international partnerships and supply chains that are crucial for collaborations in pharmaceutical research.
23) Quality:
Quality refers to the standards of the formulated sucralfate paste, emphasized through evaluations like drug content, viscosity, and stability. Maintaining high quality is critical for ensuring safety, efficacy, and patient satisfaction, underlying the significance of rigorous quality control in pharmaceutical development.
24) Heating:
Heating refers to the process involved in certain analytical techniques, such as differential scanning calorimetry (DSC), where sample components are subjected to heat to analyze their thermal properties. This analysis contributes to understanding the stability and behavior of the active components in formulations.
25) Burning (Burn, Burned, Burnt):
Burning characterizes one of the discomforting sensations experienced by patients with oral mucositis. This symptom necessitates effective treatments to alleviate pain and discomfort, reinforcing the need for formulations like sucralfate paste specifically designed to soothe mucosal injuries.
26) Surface:
Surface refers to the mucosal layer that sucralfate paste aims to protect and heal. The interaction of the paste with the ulcerated surface is crucial for its therapeutic action, providing a physical barrier that prevents further injury and promotes the healing process.
27) Repair:
Repair pertains to the healing process of the oral mucosa affected by chemotherapy-induced mucositis. The study evaluates how effective the sucralfate paste is in facilitating repair, highlighting its function in promoting regeneration and restoration of normal mucosal integrity.
28) Madhu:
Madhu, in this context, refers to Madhu Silica Pvt. Ltd, a supplier of silica used in the formulation of sucralfate paste. The mention of suppliers signifies the importance of sourcing quality raw materials for developing effective pharmaceutical products.
29) Death:
Death underscores the severity of cancer as it remains a leading cause of mortality worldwide. It brings attention to the necessity of supportive care measures, such as the management of chemotherapy side effects like oral mucositis, in improving the overall quality of life and survival rates.
30) Hair:
Hair, similar to 'hairs,' relates to the adnexal structures within skin and mucosal tissues. Maintaining hair follicles' integrity can be affected during inflammatory processes or drug-induced changes, showcasing the complex interactions within epithelial layers subject to conditions like oral mucositis.
31) Food:
Food plays a significant role in the overall health and comfort of patients undergoing chemotherapy. Pain and difficulty swallowing due to oral mucositis can impair nutrition, highlighting the importance of effective treatments to relieve symptoms and support dietary intake during treatment.
32) Pain:
Pain is a predominant symptom associated with oral mucositis, severely impacting patients' comfort and quality of life during cancer treatment. Understanding pain mechanisms is essential for developing effective analgesic and topical formulations, such as available treatments that can minimize discomfort during recovery.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Sucralfate paste for treating chemotherapy-induced oral mucositis’. Further sources in the context of Science might help you critically compare this page with similair documents:
Oral mucositis, Fourier transform infra-red spectroscopy, Differential scanning calorimetry, Therapeutic efficiency, Stability Studies, PH determination, Spreadability, Animal Study, Histopathological change, Mucoadhesive polymer, In vivo evaluation.