Is Gelatin safe?
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Is Gelatin Safe? A Comprehensive Review
Introduction to Gelatin Safety
Gelatin, a biopolymer derived from collagen, is widely used in various industries, including food, pharmaceuticals, and medical applications. Despite its extensive use, concerns about its safety persist, particularly when used as a resuscitation fluid or in medical procedures. This article synthesizes findings from multiple studies to provide a clear understanding of the safety profile of gelatin.
Gelatin in Medical Applications: Risks and Concerns
Adverse Effects in Resuscitation Fluids
Gelatin is commonly used as a synthetic colloid resuscitation fluid. However, a systematic review and meta-analysis of 60 studies, including randomized controlled trials and nonrandomized studies, revealed several risks associated with its use. The studies indicated increased risks of anaphylaxis, mortality, renal failure, and bleeding complications when gelatin was administered compared to crystalloids or albumin. Specifically, the risk ratios were 1.15 for mortality, 1.10 for requiring allogeneic blood transfusion, 1.35 for acute kidney injury, and 3.01 for anaphylaxis.
Volume Resuscitation in Critical Care
Another systematic review of 40 randomized controlled trials involving 3,275 patients assessed the safety of gelatin for volume resuscitation. The findings showed no statistically significant differences in mortality or exposure to allogeneic transfusion between gelatin and other fluids like albumin or crystalloids. However, the studies were not adequately powered to investigate patient-important outcomes, and only a few reported occurrences of acute renal failure. This suggests that while gelatin may not significantly increase mortality, its safety profile remains uncertain due to insufficient data.
Cardiopulmonary Bypass in Cardiac Surgery
In the context of cardiopulmonary bypass (CPB) priming in cardiac surgery, a systematic review and meta-analysis compared gelatin with hydroxyethyl starches (HES) and crystalloids. The review included 10 studies with a total of 824 adult patients. The results indicated no significant differences in postoperative blood loss, perioperative transfusion requirements, postoperative kidney function, ventilation times, or length of stay in the intensive care unit between gelatin and the other fluids. However, the evidence was rated low due to poor methodological quality and inconsistent outcome reporting.
Gelatin in Food and Pharmaceutical Applications
Food Packaging and Safety
Gelatin is also used in food packaging due to its film-forming ability, non-toxic nature, and cost-effectiveness. Studies have shown that gelatin-based films, especially when combined with other materials like TEMPO-oxidized cellulose, are safe, stable, and eco-friendly. These films can be completely decomposed by the environment after disposal, making them a sustainable option for food packaging. Additionally, gelatin films incorporated with natural antimicrobial agents like Clitoria ternatea-derived anthocyanins have been effective against foodborne pathogens, further enhancing food safety.
Drug Delivery Systems
Gelatin's long history of safe use in pharmaceuticals is well-documented. It is considered a Generally Regarded As Safe (GRAS) material by the FDA. Gelatin-based systems have been successfully used for ocular drug delivery, demonstrating its potential in overcoming barriers in drug administration. Moreover, gelatin's versatility allows it to be used in various drug delivery forms, including microparticles, nanoparticles, fibers, and hydrogels, providing controlled and targeted release of medications.
Fish Gelatin as an Alternative
Fish gelatin has emerged as a potential alternative to mammalian gelatin, particularly for those with dietary restrictions or concerns about zoonotic diseases. Fish gelatin is immunologically safe and offers economic and environmental benefits. However, its application in the food industry is limited due to inferior gelling ability compared to mammalian gelatin . Further research is needed to enhance its functional properties and expand its use in various applications.
Conclusion
The safety of gelatin varies depending on its application. While it is generally safe for use in food packaging and pharmaceuticals, its use as a resuscitation fluid in medical settings poses significant risks, including anaphylaxis, renal failure, and increased mortality. More well-designed randomized controlled trials are needed to conclusively determine its safety in these contexts. For now, caution is advised when using gelatin in critical care, and alternative fluids may be preferable.
Sources and full results
Most relevant research papers on this topic
How safe is gelatin? A systematic review and meta-analysis of gelatin-containing plasma expanders vs crystalloids and albumin.
Safety of gelatin for volume resuscitation—a systematic review and meta-analysis
Safety of gelatin solutions for the priming of cardiopulmonary bypass in cardiac surgery: a systematic review and meta-analysis
Eco-friendly biorefractory films of gelatin and TEMPO-oxidized cellulose ester for food packaging application.
Gelatin-based particulate systems in ocular drug delivery
Gelatine Film Incorporated with Clitoria ternatea-Derived Anthocyanin Microcapsules, A Food Packaging Material Effective Against Foodborne Pathogens
Drug delivery from gelatin-based systems
Cosmetic, Biomedical and Pharmaceutical Applications of Fish Gelatin/Hydrolysates
Fish gelatin as an alternative to mammalian gelatin for food industry: A meta-analysis
Gelatin-based composite films and their application in food packaging: A review
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