RONCEA Florentina1, MIRESAN Horatiu1,2, ROSCA Adrian Cosmin1, CAZACINCU Radu1,2
1„Ovidius” University of Constanta, Faculty of Pharmacy,Cpt. Av. Al. Serbanescu 6, Constanta, Romania
2Magistra C&C, 87, A. VlaicuBdv, Constanta, Romania
Corresponding author: horamires@yahoo.com
Abstract
Based on the scientific information from research work about nutricosmetics, nutraceuticals and cosmeceuticals of different natural origin we concluded there is a need to regulate some aspects regarding a proper definition, guidelines for „green” methods for extraction, isolation, identification and quantification and most of all to develop validated new in vitro methods to assess safety and obtaining of “cruelty-free” products used to develop old and new concepts of health and wellness.
Keywords: nutricosmetics, nutraceuticals, cosmeceuticals, health, validate guidelines worldwide
Introduction
Nowadays, health and wellness represent a common targetof the young and ageing population and is reflected inconsumption of differentnutrients such as (collagen, peptides, proteins, vitamins, minerals, marine algae, omega‐3 fatty acids, sterol esters, enzymes,botanical extracts, and antioxidants(β-carotene, lycopene, lutein, zeaxanthin, and astaxanthin) and polyphenols (anthocyanidins, catechins, flavonoids, tannins, and procyanidins) marketed as nutricosmetics, nutraceuticals and cosmeceuticals [1].
Nutricosmetics
Starting from the concept of beauty in Ayurveda, or “science of life,” is not limited to external beauty but also to inner beauty, nutricosmetics, as a result of intersection between „Nutraceuticals” and “Cosmeceuticals „are described as oral natural health products, „oral cosmetics”, „beauty pills” that support the function and the structure of the skin, nails, and hair [2], [3]. Nutricosmetics are marketed as a liquid, pill, capsule, powder, or tablet form and are mostly sold as over‐the‐counter products [4].
Under the Dietary Supplement Health and Education Act (1994), the Food and Drug Administration regulates the nutricosmetic market in the United States. In Europe, the framework of Regulation 1924/2006 guidelines of the European Food Safety Authority “guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health” delimits health claims relating to“maintaining the normal structure of the skin, its hydration, elasticity, or appearance.” Nutricosmetics are evaluated by each member states of Europe on acase‐by‐case basis [5]. Before nutricosmetics can be marketed for health uses, clinical trials are needed.
In this regard, in a double blind, placebo-controlled trials, 60 woman aged between 40-60 years were randomized to receive a combination of hydrolysed collagen and vitamins A, C, E and zinc (Group A) or the placebo (Group B), once daily for 90-days period. The results obtained showed significant effects in the improvement of skin hydration, elasticity, density and reduction of wrinkles and pores, on the skin of the group A when compared with placebo group. These results concluded that oral supplementation under study present itself as a potential to act effectively on aged skin [6].
Nutricosmetics are considered to be eco-friendly, but until now there was no concern about pro-environmental behaviour developed a valid and reliable scale to measure pro-environmental behaviour in nutricosmetics purchase (PEB-NP) [7].
Based on an Exploratory factor analysis (EFA) to purify the scale, and on a confirmatory factor analysis (CFA) using SmartPLS (version 3) to validate the scale, the results revealed that, PEB-NPis a third-order factor model in which conservation dimension consisted of two sub-dimensions, namely, to “reduce” and “recycle” behaviour.[7].
Nutraceuticals
“Nutraceutical” is a term coined in 1989 by dr. Stephen DeFelice. It is defined “as a food or parts of food that provide medical or health benefits, including the prevention and treatment of disease [8].” Nutraceuticals may range from isolated nutrients, dietary supplements, and diets to genetically engineered “designer” food, herbal products, and processed products such as cereals, soups, and beverages. A nutraceutical is any nontoxic food extract supplement that has scientifically proven health benefits for both the treatment and prevention of disease [8], [9],[11].
In the development of nutraceuticals of plant and animal sources, chromatographic methods used for identification and quantification are the same as those used in pharmaceutical field (HPLC, GC, CCC, TLC)[12].
From this definition is not clear if medical or health benefits are supported by safety and efficacy information or in vitro and in vivo data, so an officially and accepted definition of nutraceuticals is still missing [13].
The current European regulations (EC Regulation No. 1924/2006 of the European Parliament and of the Council, recently updated by EU Regulation2015/2283) define food categories and include a definition of food supplements, they do not officially mention or recognize the term nutraceutical [4],[5].
In this regard, Santini A. &all. proposed a different approach for use and definition of nutraceuticals taking in account safety, mechanism of action supporting any claims contained on the labels, efficacy by clinical studies, evaluation of possible unwanted side effects, evaluation of possible interactions with other products (e.g. food, food supplements and drugs). They even suggested that the existing methodology for pharmaceutical products may be considered as a starting point for nutraceutical assessment [10].
Santini A. &all. suggested a differentiation between food supplements and nutraceuticals based on these assessments and to define nutricosmetics as (phyto-complex for food of vegetal origin) and the pool of secondary metabolites for food of animal origin, both concentrated and administrated in a proper pharmaceutical form [10].
Cosmeceuticals
Although generally the term cosmeceutical is attributed to Dr. Albert Kligman, Raymond E. Reed in the 1960s identified a hybrid category of products between drugs and cosmetics that are used externally, exert esthetical properties and comply with physico-chemical and medical standards. For Dr.Kligman, cosmeceutical represented “a topical preparation that is sold as a cosmetic but has performance characteristics that suggest pharmaceutical action.” [11], [14]. Cosmeceutical categories as per their indication based on aetiology of the target condition exert functions such as protection, whitening, tanning, anti-wrinkling, deodorants, sunscreens, moisturizing agents, antioxidants, antiaging and nail and hair care[14], [15].
Rich content of antioxidants of plants extracts used in development of a cosmeceutical, acts dual as preservatives by preventing the oxidation of oils from the cosmeceutical product and presents also anti-aging, anti-inflammatory, and antimicrobial activities. Conventional cosmeceuticals (lotions, gels, ointments) evolved to delivery systems that facilitate penetration of the skin barrier by the active ingredients to reach appropriate sites, such as vesicular forms (liposomes, microsomes, transferosomes), lipid nanoparticles, polymeric micro particles and nanoparticles[20].
Active ingredients (synthetic vitamins, extracts from plants, macro- and micro-algae, microorganisms, and animals) that are recognized as safe and that provide some beneficial effect are used to formulatecosmeceuticals.
Because most of the active ingredients used as cosmeceuticals are so called botanicals, some authors [15] proposed guidelines to obtain and characterise them.
The extraction process of active cosmeceuticals from different geographical areas (Europe, Africa, Asia, Northern America) and sources (vegetal, marine) using common extraction solvents related to the solubility of the active ingredients (water or organic solvents) andcommon techniques(sonification, heating under reflux, Soxhlet extraction, maceration, and percolation) and modern “green” ones such as, solid-phase,supercritical-fluid, pressurized-liquid, microwave-assisted, and surfactant-mediated techniques.As for the used solvents, they also must comply to „natural”, “green” or “environmentally friendly, „trends in industry, by replacing themwith ones like water and agro- or bio-solvents obtained from biomass [15],[18].
The isolated compounds with biological activities tested by in vitro methods wereidentified by different chromatographic techniques like thin-layer chromatography, column chromatography, flash chromatography, and high-performance liquid chromatography [15].
After confirmation that the isolated compounds has cosmeceutical activity, are tested in vitro by different methods, that are validated and recognized by the international scientific community and sectorial regulating bodies in different countries and in vivo in human clinical trials which involve volunteers, to assess efficacy[15],[16], [17],[19]. The best formulations can then be released to the marketplace [15].
For different types of cosmeceuticals (anti-aging, anti-wrinkle, anti-acne, moisturizing agents, solar-protective agents, skin lightening agents, wound healing) are used in vitro (enzymatic and cellular) tests to assess these claims. As for the cellular test, monolayer cell culture systems (keratinocytes, dermal fibroblasts, melanocytes, endothelial cells) co-cultures of different skin cell types and organotypic 3D cultures test models can be used (seeding and culturing of keratinocytes on dermis equivalents).
In vitro permeation assays are also performed on cell culture for skin penetrability, dermatome tissues, skin stem cells [21].
For instance, for antioxidant efficacy (ROS, biochemical methods), anti-aging(anti-collagenase test, anti-elastase test, hyaluronidase activity, vitality, and proliferation of cultivated fibroblasts and keratinocytes), anti-acne (Agar disk-diffusion method, minimum inhibitory concentration, anti-inflammatory activity), solar protection (SPF measurement, UVA-PF evaluation (ISO 24443; Colipa 2011), skin whitening (tyrosinase inhibition), skin pigmentation (monoculture models),wound healing (scratchassay, co-culture of keratinocytes and fibroblasts)[15], [17], [21], [22].
Since banned animal tests in Europe in 2004 for cosmetics and in 2009 for cosmetic ingredients, due to changes in cosmetic European Union legislation, there have been encouraged the creation of in vitro tests to assess safety and obtaining of “cruelty-free”products [15].It is important to point out that the guidelines used for cosmetics can be employed to test the safety of cosmeceuticals.
Conclusions
Nutricosmetics, nutraceuticals and cosmeceuticals represent nowadays and in the future the proper solution for problems related to health, wellbeing for a large group of people.
There are still problems to be solved by authorities related to proper identification of these marketed products for their users, in relation to the information and any health claims labelled.
Different types of active ingredients (plants, marine, animal origin) are used as active ingredients in nutricosmetics, nutraceuticals and cosmeceuticals presented in conventional dosage form or as delivery systems. In this regard, the authorities ‘worldwide need to regulate some aspects regarding a proper definition, guidelines for „green” methods for extraction, isolation, identification and quantification and to develop validated new in vitro methods to assess safety and obtaining of “cruelty-free „products.
REFERENCES
1. Dini,I. Laneri,S. (2019).Nutricosmetics: A brief overview, Phytotherapy Research,33 (12), pp. 1–10.
2. Mahale, D.,Gondkar, S.,Saudager, R., (2017).Neutricosmetics: Review article, International Journal of Universal Pharmacy and Bio Sciences,6 (2), pp. 1 – 22.
3. Taeymans, J., Clarys, P., O. Barel, A.(2015), Handbook of Cosmetic Science and Technology , chapter 55, Use of Food Supplements as Nutricosmetics in Health and Fitness – A Review, pp. 583 – 597.
4. Regulation EC No 1924/2006 of the European Parliament and of the Council of 30 December 2006 on nutrition and healthclaims made on foods. 2006.
5. Regulation EU 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. Off J Eur Union 2015; L327/1–22.
6. Campos MBG, P., M.,Maísa O Melo, M., Calixto L., S., Fossa, M., M., (2015) An Oral Supplementation Based on Hydrolyzed Collagen and Vitamins Improves Skin Elasticity and Dermis Echogenicity: A Clinical Placebo-Controlled Study, ClinPharmacolBiopharm, 4 (3), pp. 1 -6.
7.Quoquab, F., Mohammad, J., Shahrin, R. (2020), Pro-environmental behavior in nutricosmetics product purchase context: Scale development and validation, International Journal of Pharmaceutical and Healthcare Marketing, 14 (2), pp. 217-250.
8. DeFelice, S. L. Nutraceuticals: (1992).Opportunities in an Emerging Market. Scrip Mag; 9.
9. Dillard, C. J., German, J. B. (2000). Phytochemicals:nutraceuticals and human health. J. Sci.FoodAgric; 80, pp. 1744-1756.
10. Antonello Santini, A.,Cammarata, S., M., Capone, G., Ianaro, A., Tenore,G., C.,Pani, L., Novellino, E., (2018). Nutraceuticals: opening the debate for a regulatory framework, Br. J. Clin. Pharmacol. 84, pp. 659–672.
11.Ramasubramania, R. (2016). Nutraceuticals and Cosmeceuticals for Human Beings–An Overview. American Journal of Food Science and Health, 2 (2), pp. 7-17.
12. Ganesh, G., N., K, Ramachandran, A., Suresh, K., R., Senthil, V., Priyadharshini, R., B., (2015).
Nutraceuticals – A regulatory review, International Journal of Drug Regulatory Affairs; 3(2), pp. 22-29.
13. Souyoul, S., A., Saussy, K., P.,Lupo, M., P. (2018). Nutraceuticals: A Review, DermatolTher (Heidelb) 8, pp. 5–16.
14. Brandt, F., S., Cazzaniga, A., Hann, M. (2011). Cosmeceuticals: current trends and market analysis, SeminCutan Med Surg, 30(3), pp. 141-143.
15.Espinosa-Leal, C., A., Garcia-Lara, S., (2019). Current Methods for the Discovery of New Active Ingredients from Natural Products for Cosmeceutical Applications, Planta Med.; 85 (07), pp. 535-551.
16. Almeida A, Sarmento B, Rodrigues F. (2017).Insights on in vitromodels for safetyand toxicity assessment of cosmetic ingredients.Int J Pharm; 519, pp. 178–185.
17. Vinardell, M.,P., Mitjans, M. (2017).Alternative methods to animal testing for thesafety evaluation of cosmetic ingredients: an overview. Cosmetics, 4, pp. 1–14.
18. Chemat F., Vian, M., A.,Cravotto, G. (2012). Green extraction of natural products:concept and principles. Int. J. Mol. Sci.; 13, pp. 8615–8627.
19.Pandey, A., Jatana, G., K., Sonthalia, S.[Updated 2019 Nov 11].Cosmeceuticals. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK544223/.
20.Costa, R., Santos, L. (2017).Delivery systems for cosmetics – from manufacturing to the skin of natural antioxidants,PowderTechnol; 322, pp. 402–426.
21. Ramata-Stunda, A., Boroduskis, M., Vika Vorobjeva, V., Ancans, J., (2013).Cell and tissue culture-based in vitro test systems for evaluation of natural skin care product ingredients,Environmental and Experimental Biology, 11, pp. 159–177.
22. Method for In Vitro Determination of UVA Protection, 2011, COLIPA (European Cosmetic, Toiletry and Perfumery Association). In Vitro Method for the Determination of the UVA Protection Factor and “Critical Wavelength” Values of Sunscreen Products, Guidelines, 2011.