Preprint / Version 1

Nutraceuticals’ Novel Formulations: The Good, the Bad, the Unknown and Patents Involved

Authors

  • Nada Helal Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Egypt; , 2Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy for Girls, Al Azhar University, Cairo, 11651, Egypt; , 3Research and Development Department, Medizen Pharmaceutical Industries Company, Alexandria, Egypt; , 4Department of Microbiology, Faculty of Pharmacy, Misr International University, Cairo, 11757, Egypt; , 5Department of Pharmaceutical Sciences (DPS), School of Pharmacy and Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, CT, 06103, USA
  • Heba Eassa Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Egypt; , 2Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy for Girls, Al Azhar University, Cairo, 11651, Egypt; , 3Research and Development Department, Medizen Pharmaceutical Industries Company, Alexandria, Egypt; , 4Department of Microbiology, Faculty of Pharmacy, Misr International University, Cairo, 11757, Egypt; , 5Department of Pharmaceutical Sciences (DPS), School of Pharmacy and Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, CT, 06103, USA
  • Ahmed Amer Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Egypt; , 2Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy for Girls, Al Azhar University, Cairo, 11651, Egypt; , 3Research and Development Department, Medizen Pharmaceutical Industries Company, Alexandria, Egypt; , 4Department of Microbiology, Faculty of Pharmacy, Misr International University, Cairo, 11757, Egypt; , 5Department of Pharmaceutical Sciences (DPS), School of Pharmacy and Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, CT, 06103, USA
  • Mohamed Eltokhy Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Egypt; , 2Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy for Girls, Al Azhar University, Cairo, 11651, Egypt; , 3Research and Development Department, Medizen Pharmaceutical Industries Company, Alexandria, Egypt; , 4Department of Microbiology, Faculty of Pharmacy, Misr International University, Cairo, 11757, Egypt; , 5Department of Pharmaceutical Sciences (DPS), School of Pharmacy and Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, CT, 06103, USA
  • Ivan Edafiogho Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Egypt; , 2Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy for Girls, Al Azhar University, Cairo, 11651, Egypt; , 3Research and Development Department, Medizen Pharmaceutical Industries Company, Alexandria, Egypt; , 4Department of Microbiology, Faculty of Pharmacy, Misr International University, Cairo, 11757, Egypt; , 5Department of Pharmaceutical Sciences (DPS), School of Pharmacy and Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, CT, 06103, USA
  • Mohamed Nounou Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Egypt; , 2Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy for Girls, Al Azhar University, Cairo, 11651, Egypt; , 3Research and Development Department, Medizen Pharmaceutical Industries Company, Alexandria, Egypt; , 4Department of Microbiology, Faculty of Pharmacy, Misr International University, Cairo, 11757, Egypt; , 5Department of Pharmaceutical Sciences (DPS), School of Pharmacy and Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, CT, 06103, USA

Keywords:

Nutraceuticals, adulteration, counterfeiting, novel drug delivery, nanocarriers, fortified foods, toxicity, regulatory affairs

Abstract

Traditional nutraceuticals and cosmeceuticals hold pragmatic nature with respect to their definitions, claims, purposes and marketing strategies. Their definitions are not well established worldwide. They also have different regulatory definitions and registration regulatory processes in different parts of the world. Global prevalence of nutraceuticals and cosmeceuticals is noticeably high with large market share with minimal regulation compared to traditional drugs. The global market is flooded with nutraceuticals and cosmeceuticals claiming to be of natural origin and sold with a therapeutic claim by major online retail stores such as Amazon and eBay. Apart from the traditional formulations, many manufacturers and researchers use novel formulation technologies in nutraceutical and cosmeceutical formulations for different reasons and objectives. Manufacturers tend to differentiate their products with novel formulations to increase market appeal and sales. On the other hand, researchers use novel strategies to enhance nutraceuticals and cosmeceuticals activity and safety. The objective of this review is to assess the current patents and research adopting novel formulation strategies in nutraceuticals and cosmeceuticals. Patents and research papers investigating nutraceutical and cosmeceutical novel formulations were surveyed for the past 15 years. Various nanosystems and advanced biotechnology systems have been introduced to improve the therapeutic efficacy, safety and market appeal of nutraceuticals and cosmeceuticals, including liposomes, polymeric micelles, quantum dots, nanoparticles, and dendrimers. This review provides an overview of nutraceuticals and cosmeceuticals current technologies, highlighting their pros, cons, misconceptions, regulatory definitions and market. This review also aims in separating the science from fiction in the nutraceuticals and cosmeceuticals development, research and marketing. Keywords: Nutraceuticals, adulteration, counterfeiting, novel drug delivery, nanocarriers, fortified foods, toxicity, regulatory affairs

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