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Abstract

Healthy Nation can’t stand in a higher position without caring for health. Health can be maintained by supplementing all essential components. Nutraceuticals are substances that provide clinical as well as health benefits including preventive and precautionary means on human life and can be regarded as meals or ingredients of meals. Globalization has drastic changes, which led to a decrease in the quality and quantity of life. Nutraceuticals not only provide essential vitamins to humans but also have the power to boost immunity. Therefore, as the number of chronic illnesses rises, so does the demand for nutraceutical products, which is driving the growth of the nutraceutical substances market. The current review aims to validate nutraceuticals to guarantee that the products are of the highest caliber, fulfill all requirements, and are produced with the right procedures. Validation of the nutraceuticals helps to reduce the risks related to the products and processes. Despite being made of natural ingredients, nutraceuticals can nonetheless become contaminated before, after, or during manufacture. Therefore the goal of a quality system is to continuously produce things that are appropriate for the purpose for which they are intended. Rather than pharmaceutical law, safety, and labeling have been the primary focus of nutraceutical validation. Process validation is one of the integrated needs of a quality management system.

Keywords

Validation, nutraceutical, quality assurance, examination safety, clinical studies, merchandise

Reference

  1. Télessy, I.G., 2019. Nutraceuticals. In The role of functional food security in global health (pp. 409-421). Academic Press.
  2. Dudeja, P. and Gupta, R.K., 2017. Nutraceuticals. In Food safety in the 21st century (pp. 491-496). Academic Press.
  3. Lee, S. (2017). Strategic Design of Delivery System for Nutraceuticals. Nanotechnology Applications in Food, 65-86.
  4. Rajasekaran, A. Shivagnanam, G. and Xavier, R. Nutraceuticals as therapeutic agents A Review. J. Pharm. Sci. Technol, 2008: (1).
  5. Costagliola, G.; Nuzzi, G.; Spada, E.; Comberiati, P.; Verduci, E.; Peroni, D.G. Nutraceuticals in Viral Infections: An Overview of the Immunomodulating Properties. Nutrients 2021, 13, 2410.
  6. Nutraceutical Ingredients Market by Type, Application, and Region. https://www.marketsandmarkets.com
  7. Senior K. Pharmaceuticals from plants: promise and progress. Mol Med Today 1996:60-4.
  8. Dietary Supplement Health Education Act (DSHEA) of 1994. Public Law 103-417, available from FDA.
  9. Houston MC. Nutraceuticals, Vitamins, Antioxidants, and Minerals in the Prevention and Treatment of Hypertension. Progress in Cardiovascular Diseases.2005; 47: 396-449.
  10. Frydoonfar HR, McGrath DR, and Spigelman AD. The variable effect on proliferation of a colon cancer cell line by the citrus fruit flavonoid Naringenin. Colorectal Dis 2003; 5: 149- 152.
  11. Limer JL and Speirs V. Phyto-oestrogens and breast cancer chemoprevention. Breast Cancer Res. 2004; 6:119-127. Int. Conf. Mechanism of Action of Nutraceuticals. J. Nutritional Biochem. 2005; 16: 513-520.
  12. Kucuk O, Sarkar FH, Sakr W, et al. Lycopene in the Treatment of Prostate Cancer. Pure Appl. Chem. 2002; 74: 1443- 1450.
  13. Gulcin I, Mshvildadze V, Gepdiremen A, et al. The antioxidant activity of a triterpenoid glycoside isolated from the berries of Hedger colchica: 3-O-(Bdglucopyranosyl)-hederagenin. Phytother Res. 2006; 20:130-134.
  14. Nelson NJ. Purple carrots, margarine laced with wood pulp? Nutraceuticals move into the supermarket. J Natl CancerInst. 1999; 91: 755-757.
  15. Rissanen TH, Voutilainen S, Virtanen JK, Venho B,Vanharanta M, Mursu J and Salonen JT. Low Intake of Fruits, Berries, and Vegetables Is Associated with Excess Mortality in Men: the Kuopio Ischaemic Heart Disease Risk Factor (KIHD) Study. J Nutr. 2003; 133: 199-204.
  16. Whitman M. Understanding the perceived need for complementary and alternative nutraceuticals: lifestyle issues Clin J Oncol Nurs. 2001; 5: 190-194.
  17. Temple WJ and Gladwin KK. Fruits, vegetables, and the Prevention of Cancer: Research challenges. Nutrition. 2003; 19: 467-470.
  18. Nutraceutical Ingredients Market Global Opportunity Analysis and Industry Forecast (2019 – 2025). https://www.meticulousresearch.com/product/nutraceutical-ingredients-market-5044.
  19. Da Costa, J. P. (2017). A current look at nutraceuticals- Key concepts and prospects. Trends in Food Science and Technology, 62, 68-78.
  20. Brower B. Nutraceuticals poised for a healthy slice of the market. Nat Biotechnology, 1998; 16 728-33.
  21. Good Manufacturing Practices Guidance Document. Natural and non-prescription health products directorate. December 1, 2015. Version 3.0 https://www.canada.ca/en/health-canada/services/drugs-health-products/ natural-non-prescription/legislation-guidelines/guidance-documents/good-manufacturing-practices.html.
  22. Health Canada: Food and Nutrition. www.canada.ca/en/health-canada/services/food-nutrition; Aug 22, 2018.
  23. Compendium of Food Additive Specifications. In: FAO JECFA monographs. Joint FAO/WHO expert committee on food additives. 84th meeting 2017. Aug 22, 2018. Food and Agriculture Organization of United Nations, World Health Organization. http://www.fao.org/3/a-i8147e.pdf.
  24. US Food and Drug Administration. Food guidance and regulation. Aug 22, 2018. https://www.fda.gov/Food/ Guidance Regulation/.
  25. Tee ES, Tamin S, Ilyas R, Ramos A, Tan WL, Lai DK, et al. Current status of nutrition labeling and claims in the Southeast Asian region: are we in harmony? Asia Pac J Clin Nutr 2002; 11: 80–86.
  26. Tapsell LC. Evidence for health claims: a perspective from the Australia–New Zealand region. J Nutr 2008; 138: 1206–1209.
  27. Umegaki K. Positive and negative aspects of food with health claims in Japan. J Nutr Sci Vitaminol 2015; 61: S133–S135.
  28. Yang Y. Scientific substantiation of functional food health claims in China. J Nutr 2008; 138: 1199–1205.
  29. BHMA Scientific Committee, British Herbal Pharmacopoeia (British Herbal Medicine Association, Dorset, United Kingdom, vol.1, 1990).
  30. M. Blumenthal, W. Busse, A. Goldberg, J. Gruenwald, T. Hall, C. Riggins, and R. Rister. The Complete German Commission E Monographs (American Botanical Council, Austin, Texas, in cooperation with Integrative Medicine Communications, Boston, Massachusetts, 1998).
  31. Kathleen Pompliano M.S. 10.01.03 Quality Assurance - Nutraceuticals World. mhtml.
  32. Guidance for Industry: Process Validation: General Principles and Practices. U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Biologics Evaluation and Research (CBER), Centre for Veterinary Medicine (CVM), January 2011.
  33. Mohammed. SA; Pharmaceutical Process Validation: An Overview. Journal of Advanced Pharmacy Education and Research, 2012; 2 (4): 186-200.
  34. ASTM E2476-09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture.
  35. ASTM E2281-03 Standard Practice for Process and Measurement Capability Indices. Guidance for Industry: Process Validation: General Principles and Practices.
  36. U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Biologics Evaluation and Research (CBER), Centre for Veterinary Medicine (CVM), January 2011.
  37. Mohammed. SA; Pharmaceutical Process Validation: An Overview. Journal of Advanced Pharmacy Education and Research, 2012; 2 (4): 186-200.
  38. R. Charlie Thompson; Shayne Morris (2001). Vol- 19; Validation Viewpoint. Striving to Validate Nutraceuticals. 1142- 1149.
  39. Ross, S. Functional foods: the Food and Drug Administration perspective.     Am. J. Clin. Nut. 2000, 71, 1735-1738.
  40. Bergamini, E. Nutraceuticals: a valuable asset to be used carefully. G. Gerontol., 2010, 58, 255-258.   
  41. Borghi, C.; Cicero, A.F.G. Nutraceuticals and functional foods in preventive medicine; Bononia University Press: Italy, 2011.
  42. Bagchi, Debasis; Swaroop, Anand; Bagchi, Manashi (2015). Genomics, Proteomics, and Metabolomics in Nutraceuticals and Functional Foods (Bagchi/Genomics, Proteomics and Metabolomics in Nutraceuticals and Functional Foods). Metabolomics of Green Tea., 10.1002/9781118930458, 397-406.
  43. Pavlidis Cristiana; Patrinos George P; Katsila Theodora (2015). Nutrigenomics: A Controversy. Applied and Translational Genomics, 4, 50- 53.
  44. Augustin MA, Sanguansri L. Challenges and solutions to incorporation of nutraceuticals in foods. Annu Rev Food Sci Technol 2015; 6: 463–477              
  45. Santini A, Novellino E. Nutraceuticals: beyond the diet before the drugs. Curr Bioact Compd 2014; 10: 1–12.
  46. Abuajah CA, Ogbonna A, Osuji C. Functional components and medicinal properties of food: a review. J Food Sci Technol 2015; 52: 2522–2529.
  47. Dadhania VP, Trivedi PP, Vikram A, Tripathi DN. Nutraceuticals against neurodegeneration: a mechanistic insight. Curr Neuropharmacol 2016; 14: 627–640.
  48. Olaiya CO, Soetan KO, Esan AM. The role of nutraceuticals, functional foods, and value-added food products in the prevention and treatment of chronic diseases. Afr J Food Sci 2016; 10: 185–193.
  49. Yang N, Kaarunya Sampathkumar K, Joachim Loo SC. Recent advances in complementary and replacement therapy with nutraceuticals in combating gastrointestinal illnesses. Clin Nutr 2016; 36: 968–979.
  50. Wildman R, Keller M. Nutraceuticals and functional foods. In: Handbook of Nutraceuticals and Functional Foods, 2nd ed, Ed Wildman REC. Boca Raton: CRC press, 2016.
  51. Santini A, Tenore GC, Novellino E. Nutraceuticals: a paradigm of proactive medicine. Eur J Pharm Sci 2017; 96: 56–61.
  52. Burdock G. A.; Carabin I. G.; Griffiths J. C.; (2006). The Importance of GARS to the functional food and nutraceutical industries. 221(1), 17- 27.

Photo
Ashwini Ashok Didore
Corresponding author

Department of Pharmaceutics, LBYP College of Pharmacy, Aurangabad, Maharashtra, India

Photo
Dr. D. K. Vir
Co-author

Department of Pharmaceutics, LBYP College of Pharmacy, Aurangabad, Maharashtra, India

Photo
Dr. Gajanan Sanap
Co-author

Department of Pharmaceutics, LBYP College of Pharmacy, Aurangabad, Maharashtra, India

Ashwini Ashok Didore*, Dr. D. K. Vir, Dr. Gajanan Sanap, Validation Of Neutraceuticals For Quality Assurance, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 140-152. https://doi.org/10.5281/zenodo.10083065

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