Recent Advancements In Formulation Approaches And Regulatory Aspect Of Nutraceutical Products.pptx

The field of nutraceuticals has seen significant advancements in formulation approaches and regulatory aspects in recent years. These advancements aim to improve the efficacy, safety, and quality of nutraceutical products, which are food-derived products that provide health benefits beyond basic nutrition. Here’s a detailed overview:

Recent Advancements in Formulation Approaches
Nanotechnology

Nanoparticles: Enhancing bioavailability and stability of active ingredients by reducing particle size to nano-scale.
Nanoemulsions: Providing improved solubility and controlled release of bioactive compounds.
Liposomes: Encapsulating nutrients in lipid bilayers to protect them from degradation and enhance absorption.
Encapsulation Techniques

Microencapsulation: Protecting sensitive ingredients from environmental factors and controlling their release.
Coacervation: Encapsulating bioactive compounds in a polymer matrix to enhance stability and mask unpleasant tastes.
Spray Drying and Freeze Drying: Preserving the potency of bioactives and extending shelf life.
Advanced Delivery Systems

Controlled Release Systems: Providing a sustained release of nutrients over time to maintain optimal levels in the body.
Targeted Delivery: Using specific carriers to deliver nutrients directly to the desired site of action, enhancing efficacy and reducing side effects.
Biotechnological Approaches

Fermentation: Enhancing the bioavailability and efficacy of nutrients through fermentation processes.
Genetic Engineering: Producing bioactive compounds in microorganisms or plants through genetic modification.
Probiotics and Prebiotics: Developing formulations that support gut health and improve nutrient absorption.
Synergistic Formulations

Combination Products: Creating synergistic blends of vitamins, minerals, and phytochemicals to enhance overall health benefits.
Herb-Drug Synergies: Combining herbal extracts with conventional drugs to enhance therapeutic effects and reduce side effects.
Regulatory Aspects
Global Regulatory Frameworks

United States (FDA): Regulation under the Dietary Supplement Health and Education Act (DSHEA). Nutraceuticals are classified as dietary supplements and must meet specific labeling and manufacturing standards.
European Union (EFSA): Stringent regulations for health claims, requiring scientific substantiation. The European Food Safety Authority (EFSA) evaluates the safety and efficacy of nutraceuticals.
Japan: Foods for Specified Health Uses (FOSHU) are approved based on scientific evidence demonstrating their health benefits.
Harmonization and Standardization

Codex Alimentarius: International food standards, guidelines, and codes of practice to ensure safety, quality, and fairness in the international food trade.
Good Manufacturing Practices (GMP): Ensuring products are consistently produced and controlled according to quality standards.
ISO Standards: International standards for quality management systems (ISO 9001)

1. Recent Advancements In Formulation Approaches And Regulatory Aspect Of Nutraceutical Products Guided By: Mr. Prakash K. Soni Associate Professor Presented By: Naveen Patidar 0801PY23MP08 M Pharm (1 st year) Department Of Pharmacy Shri G.S. Institute Of Technology And Science 1

2. Introduction to Nutraceuticals Nutraceutical is the hybrid of ‘Nutrition’ and ‘Pharmaceutical ’, are a broad class of products derived from natural sources, such as foods and herbs, that provide health benefits beyond basic nutrition. These innovative supplements can help support overall well-being and target specific health concerns. 1.

3. Difference between Food Supplement and Nutraceuticals Composition Food supplements are concentrated sources of vitamins, minerals, or other substances with a nutritional or physiological effect. whereas Nutraceuticals are food or food-derived ingredients that provide medical or health benefits, including the prevention and treatment of disease. Regulation Food supplements are regulated as a subset of foods. whereas Nutraceuticals are regulated more like drugs, with stricter requirements for safety and efficacy. Intended Use Food supplements are intended to supplement the normal diet. whereas Nutraceuticals are intended to provide therapeutic or preventive benefits beyond basic nutrition. 2.

4. Difference between Food Supplement and Nutraceuticals Composition Food supplements are concentrated sources of vitamins, minerals, or other substances with a nutritional or physiological effect. whereas Nutraceuticals are food or food-derived ingredients that provide medical or health benefits, including the prevention and treatment of disease. Regulation Food supplements are regulated as a subset of foods. whereas Nutraceuticals are regulated more like drugs, with stricter requirements for safety and efficacy. Intended Use Food supplements are intended to supplement the normal diet. whereas Nutraceuticals are intended to provide therapeutic or preventive benefits beyond basic nutrition. 2.

5. Difference between Food Supplement and Nutraceuticals Composition Food supplements are concentrated sources of vitamins, minerals, or other substances with a nutritional or physiological effect. whereas Nutraceuticals are food or food-derived ingredients that provide medical or health benefits, including the prevention and treatment of disease. Regulation Food supplements are regulated as a subset of foods. whereas Nutraceuticals are regulated more like drugs, with stricter requirements for safety and efficacy. Intended Use Food supplements are intended to supplement the normal diet. whereas Nutraceuticals are intended to provide therapeutic or preventive benefits beyond basic nutrition. 2.

6. 3.

7. 4.

8. Applications of nutraceuticals in disease management 5.

9. Nutraceutical Dose/ Duration Effect Allenic carotenoid fucoxanthin (brown seaweeds) 2.4 mg /day Improves insulin resistance and decreases blood glucose levels through the regulation of cytokine secretions from WAT (white adipose tissues) n-3 PUFAs (polyunsaturated fatty acids) No data Prevents several disorders affecting lungs and airways MUFAs (monounsaturated fats) No data Lowers CVD (cardiovascular disease) risk and MS (metabolic syndrome) Calcitriol 200–600 IU/day Contributing in the DNA repair mechanism Resveratrol No data Chemosensitizes tumor by modulating drug transporters, cell survival proteins, cell proliferative proteins, and members of the NF- κ B and STAT3 signaling pathways Fortified wheat flour 100 to 150 μg /day Reduces prevalence of NTDs (neural tube defect) at birth and increasing blood folate concentrations Applications of nutraceuticals in disease management 6.

10. Substances with established Nutraceutical Functions Antioxidants Compounds like vitamins C and E, carotenoids, and polyphenols that help neutralize free radicals and protect against cellular damage. Probiotics Live microorganisms that can improve gut health, boost immunity, and support overall wellbeing when consumed in adequate amounts. Omega-3s Essential fatty acids like EPA and DHA that have anti-inflammatory properties and support heart, brain, and eye health. Dietary Fiber Indigestible plant-based compounds that promote digestive regularity, feed gut microbiome, and may help lower cholesterol. 7.

11. Substances with established Nutraceutical Functions Antioxidants Compounds like vitamins C and E, carotenoids, and polyphenols that help neutralize free radicals and protect against cellular damage. Probiotics Live microorganisms that can improve gut health, boost immunity, and support overall wellbeing when consumed in adequate amounts. Omega-3s Essential fatty acids like EPA and DHA that have anti-inflammatory properties and support heart, brain, and eye health. Dietary Fiber Indigestible plant-based compounds that promote digestive regularity, feed gut microbiome, and may help lower cholesterol. 7.

12. Substances with established Nutraceutical Functions Antioxidants Compounds like vitamins C and E, carotenoids, and polyphenols that help neutralize free radicals and protect against cellular damage. Probiotics Live microorganisms that can improve gut health, boost immunity, and support overall wellbeing when consumed in adequate amounts. Omega-3s Essential fatty acids like EPA and DHA that have anti-inflammatory properties and support heart, brain, and eye health. Dietary Fiber Indigestible plant-based compounds that promote digestive regularity, feed gut microbiome, and may help lower cholesterol. 7.

13. Substances with established Nutraceutical Functions Antioxidants Compounds like vitamins C and E, carotenoids, and polyphenols that help neutralize free radicals and protect against cellular damage. Probiotics Live microorganisms that can improve gut health, boost immunity, and support overall wellbeing when consumed in adequate amounts. Omega-3s Essential fatty acids like EPA and DHA that have anti-inflammatory properties and support heart, brain, and eye health. Dietary Fiber Indigestible plant-based compounds that promote digestive regularity, feed gut microbiome, and may help lower cholesterol. 7.

14. Routes of Nutraceuticals Delivery Oral Delivery Oral administration is the most common and convenient way to deliver nutraceuticals, allowing for easy incorporation into daily routines and optimal absorption through the digestive system. Topical Application Nutraceuticals can also be applied topically, absorbing directly through the skin to target specific areas and provide localized benefits like improved skin health or pain relief. Inhalation Nutraceuticals can be delivered via inhalation, such as through nasal sprays or nebulizers, allowing for rapid absorption into the bloodstream and targeting of the respiratory system. 8.

15. Advancement in Drug Delivery System Innovative Formulation Approaches Recent advancements in drug delivery systems have revolutionized the formulation of nutraceutical products. Novel approaches like liposomes, nanoparticles, and phytosome delivery have enhanced the bioavailability and efficacy of herbal supplements. Improved Stability and Efficacy Innovative techniques like microencapsulation and nanoemulsions have also improved the stability and controlled release of nutraceutical compounds, ensuring optimal therapeutic benefits. 9.

16. Advancement in Drug Delivery 1) Nanoparticles Nanoparticles are tiny particles (1-100 nm) with unique properties. They are increasingly used in nutraceutical delivery. Many nutraceuticals (like EGCG in green tea) degrade easily, limiting their effectiveness. These can be unstable due to factors like temperature, pH, and oxygen exposure. 10.

17. Benefits of Nanoencapsulation: Protects nutraceuticals from degradation and improves stability. Enhances delivery and solubility of poorly soluble nutraceuticals (e.g., b-carotene). Offers controlled release of nutraceuticals. Examples: EGCG (green tea): Nano-assemblies with b-lactoglobulin protein protect EGCG from oxidation and improve its suitability for beverages. β-carotene: Nanoencapsulated with casein or casein+dextran for improved delivery. Vitamin C: Sodium tripolyphosphate (STPP)-chitosan nanoparticles improve shelf-life and extend release time. Melatonin: Solid lipid nanoparticles (SLN) enable sustained plasma levels via transdermal delivery. Resveratrol: SLN formulation offers sustained release, improved skin permeation, and enhanced anti-cancer effect. Vitamin E: Nanocapsules protect vitamin E from degradation and improve stability. 11.

18. Patent filled: Curcumin: Encapsulated with chitosan to improve solubility, bioavailability, and anti-cancer properties (Facchi et al., 2017). Genistein: Loaded into dextran nanoparticles to enhance bioavailability and solubility (Semyonov et al., 2017). General Preparation Method: 12.

19. 2) Liposomes Liposomes are microscopic spheres used to deliver nutraceuticals like vitamins and minerals. Key factors influencing delivery: vesicle size, surface charge, lipid concentration, and nutraceutical composition. Advantages: Facilitate transport across the skin barrier (stratum corneum). Protect nutraceuticals from UV exposure. Shown to increase deposition of vitamins in skin (e.g., vitamin E). Improve solubility, stability, and bioavailability for hydrophobic drugs 13.

20. Examples of Nutraceutical Delivery Resveratrol Improved stability, bioavailability, and efficacy. Melatonin (oromucosal spray) Improved bioavailability compared to tablets. Other Nutraceuticals Echinacea, glucosamine, kava kava, milk thistle, St. John's wort, DHEA. 14.

21. Patent filed: Gao et al. (2017): loaded crocin, curcumin, ginseng extract, etc. for potential cancer treatment and health benefits. Underwood et al. (2017): encapsulated whole fruits (blackberry, cherry, etc.) for pain, diabetes, and gout management. Richard et al. (2017): used for skin rejuvenation, acne treatment, and anti-wrinkling with coffee, aloe vera, etc. 15.

22. 3) Electrospun Fibers for Nutraceutical Delivery (Skin) Carriers Electrospun nanofiber mats made from cellulose acetate (CA) are used for dermal delivery of nutraceuticals. Examples Vitamins E and A: Gradual release over time. Curcumin: Potential for topical/transdermal delivery with antioxidant, anti-inflammatory, and anti-tumor benefits. Combined Effects A system combining vitamin C (ascorbyl palmitate) and silver nanoparticles was developed using polycaprolactone (PCL) nanofiber mats, offering enhanced stability of vitamin C and antibacterial properties from both AP and silver nanoparticles, with a high surface area for improved delivery. 16.

23. 4) Transferosomes for Nutraceutical Delivery Definition Ultra-deformable vesicles with a self-optimizing lipid bilayer. Benefits Enhanced penetration through skin for improved delivery. Examples Colchicine: Improved treatment of gout. Curcumin: Increased anti-inflammatory effect with enhanced entrapment efficiency and intensified permeation through the skin. 17.

24. Steps to consider when developing a new Nutraceuticals 1 Identify Target Condition Clearly define the health condition or nutritional need that the nutraceutical aims to address. This helps guide the formulation and development process. 2 Select Active Ingredients Research and identify the most effective natural or bioactive compounds that can provide the desired health benefits. Ensure quality, purity, and safety of the ingredients. 3 Optimize Delivery System Choose the appropriate dosage form, such as capsules, tablets, or liquids, to ensure optimal bioavailability and efficacy of the nutraceutical. 18.

25. Challenges in Nutraceutical Development Regulatory Hurdles Nutraceuticals face complex regulatory requirements that vary across countries, making global commercialization challenging. Navigating ingredient approvals, labeling, and safety testing can be time-consuming and costly. Quality Control Ensuring consistent quality, potency, and purity of nutraceutical ingredients is crucial but often difficult due to variability in raw materials and manufacturing processes. Efficacy Validation Providing robust scientific evidence to support the health benefits of nutraceuticals can be complicated, requiring extensive clinical trials and research studies. Market Acceptance Gaining consumer trust and educating the public on the advantages of nutraceuticals over traditional medicines can be a significant barrier to widespread adoption. 19.

26. Challenges in Nutraceutical Development Regulatory Hurdles Nutraceuticals face complex regulatory requirements that vary across countries, making global commercialization challenging. Navigating ingredient approvals, labeling, and safety testing can be time-consuming and costly. Quality Control Ensuring consistent quality, potency, and purity of nutraceutical ingredients is crucial but often difficult due to variability in raw materials and manufacturing processes. Efficacy Validation Providing robust scientific evidence to support the health benefits of nutraceuticals can be complicated, requiring extensive clinical trials and research studies. Market Acceptance Gaining consumer trust and educating the public on the advantages of nutraceuticals over traditional medicines can be a significant barrier to widespread adoption. 19.

27. Challenges in Nutraceutical Development Regulatory Hurdles Nutraceuticals face complex regulatory requirements that vary across countries, making global commercialization challenging. Navigating ingredient approvals, labeling, and safety testing can be time-consuming and costly. Quality Control Ensuring consistent quality, potency, and purity of nutraceutical ingredients is crucial but often difficult due to variability in raw materials and manufacturing processes. Efficacy Validation Providing robust scientific evidence to support the health benefits of nutraceuticals can be complicated, requiring extensive clinical trials and research studies. Market Acceptance Gaining consumer trust and educating the public on the advantages of nutraceuticals over traditional medicines can be a significant barrier to widespread adoption. 19.

28. Challenges in Nutraceutical Development Regulatory Hurdles Nutraceuticals face complex regulatory requirements that vary across countries, making global commercialization challenging. Navigating ingredient approvals, labeling, and safety testing can be time-consuming and costly. Quality Control Ensuring consistent quality, potency, and purity of nutraceutical ingredients is crucial but often difficult due to variability in raw materials and manufacturing processes. Efficacy Validation Providing robust scientific evidence to support the health benefits of nutraceuticals can be complicated, requiring extensive clinical trials and research studies. Market Acceptance Gaining consumer trust and educating the public on the advantages of nutraceuticals over traditional medicines can be a significant barrier to widespread adoption. 19.

29. Commercial Nutraceuticals The global nutraceuticals market is vast and diverse, featuring a wide range of commercial products. These include dietary supplements, functional foods and beverages, and personalized nutrition solutions tailored to address specific health needs. Some of the most popular and well-known commercial nutraceuticals include turmeric, omega-3 fish oils, probiotics, and plant-based protein powders. Innovative product formulations and delivery methods continue to drive growth in this rapidly evolving industry. 20.

30. List of commercial nutraceutical of USA:- 21.

31. Nutraceutical Regulations Food regulation goals: Protect consumers, boost economies, and promote fair trade. Challenges for nutraceuticals: Unclear regulations and misleading labels. India's food regulations: Previously complex with multiple laws, now governed by the Food Safety and Standards Act (FSSA). Regulatory categories: Divided into Asian and European countries. Nutraceutical Regulation Act and issues Market Boom: Nutraceutical consumption is rising globally due to perceived safety and health benefits. Nano Delivery: Nanotechnology is being explored to improve nutraceutical delivery (bioavailability, safety, targeting). 22.

32. Regulation Challenges: No universal definition of "nutraceutical" exists. Regulations vary by country, creating confusion. Some regions lack clear safety and efficacy guidelines. Global Examples: US: Responsible for safety and labeling, but no pre-market approval needed. Japan: Classifies nutraceuticals based on health claims (pre-marketing approval for some). China: Growing market with regulations similar to the US. India: FSSAI regulates nutraceuticals with a focus on manufacturing and labeling. EU: EFSA assesses health claims and potential risks. The Need for Consistency: Consistent global regulations are crucial for consumer safety and industry growth. 23.

33. Regulatory Landscape for Nutraceuticals Regulatory Framework Nutraceuticals face a complex regulatory landscape, with varying requirements across different countries and regions. Safety and Efficacy Regulatory bodies focus on ensuring nutraceutical products are safe for consumption and their claimed benefits are substantiated. Approval Process Nutraceutical manufacturers must navigate rigorous approval processes to bring their products to market, often requiring extensive clinical trials. 24.

34. Nutraceutical consumption is rising due to perceived safety and effectiveness. Nanotechnology is gaining traction in nutraceutical delivery for improved bioavailability, safety, targeting, and stability. Various delivery systems like nanoparticles, liposomes, and nanoemulsions are being explored. Challenges include unclear definitions, lack of global regulations, and questions about efficacy and safety. Nutraceuticals offer potential health benefits for preventing and treating various diseases. Quality, safety, long-term effects, and toxicity testing are crucial for nutraceutical development. More human studies are needed to confirm the effectiveness of nutraceuticals. Enzymes, probiotics, and fortified foods may be helpful in preventing some genetic disorders. Strict regulations are necessary to ensure nutraceuticals have a positive impact on health. Conclusion 25.

35. References Palthur , M. P., Palthur S. S. S. and Chitta, S. K., Nutraceuticals: Concept and regulatory scenario,. Int. J. Pharm. Pharm. Sci, 2: 14-20, (2010) Burditt, M. G., Esq., The History of Food Law, Food Drug L.J. 50th, 197-200. Acosta, E. (2009). Bioavailability of nanoparticles in nutrient and nutraceutical delivery. Current Opinion in Colloid & Interface Science, 14, 3–15. Witkamp RF, Van Norren K. Let thy food be thy medicine when possible. Eur J Pharmacol 2018; 836: 102-14. Ruchi S. Role of nutraceuticals in health care: A review. Int J Green Pharm 2017; 11(3): DOI: http://dx.doi.org/10.22377/ijgp. v11i03.1146 Petrovska BB. Historical review of medicinal plants' usage. Pharmacogn Rev 2012; 6(11): 1-5. Xiang YZ, Shang HC, Gao XM, Zhang BL. A comparison of the ancient use of ginseng in traditional Chinese medicine with modern pharmacological experiments and clinical trials. Phytother Res 2008; 22(7): 851-8. 26.

36. 27.