What is it about?
The article "Quality Criteria Establishment for Dissolution of Ascorbic Acid from Sustained Release Pellets" by Mostafa Essam Ahmed Mostafa Eissa delves into the critical importance of establishing rigorous quality control measures to ensure the safety and efficacy of ascorbic acid sustained release pellets. The study focuses on the dissolution rate of ascorbic acid in hard gelatin capsules from a food supplement manufacturing firm in Asia, employing statistical process control (SPC) techniques to meticulously monitor and analyze the dissolution profile. Through this comprehensive analysis, the research uncovers a sigmoidal four-parameter mathematical model, known as the Morgan-Mercer-Flodin (MMF) model, that accurately describes the dissolution rate of ascorbic acid. These findings underscore the necessity for consistent quality in both raw materials and manufacturing processes to prevent deviations and ensure the reliability of the final product.
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Why is it important?
"Quality Criteria Establishment for Dissolution of Ascorbic Acid from Sustained Release Pellets" is an important article for several reasons: Ensuring product quality: This article helps to ensure the quality of ascorbic acid sustained-release pellets, which are a type of food supplement. By establishing quality criteria for the dissolution of ascorbic acid from these pellets, the article can help prevent the production of defective products. Protecting consumer health: Defective food supplements can pose a risk to consumer health. By ensuring the quality of ascorbic acid sustained release pellets, this article can help to protect consumers from harm. Improving manufacturing processes: The article provides insights into the factors that can influence the dissolution of ascorbic acid from sustained release pellets. This information can be used by manufacturers to improve their manufacturing processes and ensure that their products meet quality standards. Advancing scientific knowledge: This article contributes to the scientific knowledge base by providing information about the dissolution of ascorbic acid from sustained-release pellets. This information can be used by other researchers to conduct further studies on this topic. Overall, this article is important because it helps to ensure the quality and safety of ascorbic acid sustained-release pellets. This is important for protecting consumer health and for maintaining the reputation of the food supplement industry.
Perspectives
Subject: Enhancing Pharmaceutical Quality Control through Rigorous Dissolution Testing The article, "Quality Criteria Establishment for Dissolution of Ascorbic Acid from Sustained Release Pellets," offers a valuable contribution to the field of pharmaceutical quality control by demonstrating the importance of rigorous dissolution testing in ensuring the quality and efficacy of sustained-release products. The author's comprehensive analysis provides insights into the factors influencing dissolution rates and offers recommendations for improving product quality. Key Points and Recommendations: Comprehensive Dissolution Testing: Emphasize the importance of conducting comprehensive dissolution testing to assess the release profile of sustained-release products. This includes evaluating the dissolution rate under various conditions to simulate different physiological environments. Statistical Process Control (SPC): Utilize SPC techniques to monitor and analyze dissolution data, identifying trends, variations, and potential issues in the manufacturing process. SPC can help ensure consistent product quality and facilitate timely corrective actions. Robustness Testing: Conduct robustness testing to evaluate the impact of different factors, such as temperature, pH, and excipients, on the dissolution profile of the product. This can help identify potential risks and ensure the product's performance under varying conditions. Method Validation: Ensure the validation of dissolution methods according to relevant regulatory guidelines to establish the accuracy, precision, and specificity of the testing procedures. Continuous Improvement: Foster a culture of continuous improvement in pharmaceutical quality control, regularly reviewing and updating dissolution testing protocols to incorporate new technologies and address emerging challenges. The article effectively demonstrates the critical role of dissolution testing in ensuring the quality and efficacy of sustained-release products. By implementing the recommendations outlined above, pharmaceutical manufacturers can enhance their quality control practices, reduce the risk of product failures, and protect public health.
Independent Researcher & Consultant Mostafa Essam Eissa
Read the Original
This page is a summary of: Quality Criteria Establishment for Dissolution of Ascorbic Acid from Sustained Release Pellets, Novel Techniques in Nutrition & Food Science, May 2018, Crimson Publishers,
DOI: 10.31031/ntnf.2018.02.000531.
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