Stable Liposome in Cosmetic Platforms for Transdermal Folic acid delivery for fortification and treatment of micronutrient deficiencies

Abstract

Oral folate fortification has been successful in many developed nations, however, developing countries still face low compliance and high incidence of folate deficiency associated with low birth weight infants and preterm deliveries. We report safe and efficient approach for transdermal systemic folate delivery using fluidising liposomes (120 ± 4 nm) stabilised within 3D matrix of naturally occurring cosmetic bases: Fuller’s earth and henna with room temperature stability. The proof of stratum corneum fluidisation was established ex-vivo by Langmuir-Blodgett film, FTIR and confocal imaging in rat skin. In-vivo topical application in rats showed 11-fold increase in plasma folate within 2 hr, confirming systemic delivery through skin. Efficacy study in folate deficient rats over 4 weeks showed significantly higher plasma levels compared to oral delivery with significant skin depot. Sub-acute toxicity studies in rats at 750-fold higher doses showed safety after 4 weeks daily application. Primary irritation patch test on 25 healthy human volunteers proved non-irritant nature of the nutricosmetics. The technology is first demonstration of transdermal folate fortification with nanosized liposome incorporated in cosmetics, without synthetic surfactants/ethanol or need of external energy. The platform technology opens the possibility of delivering multiple nutrients systemically through skin and can be scaled for affordable community fortification.

Development and Implementation of Liposomal Encapsulated Micronutrient Fortified Body Oil Intervention for Infant Massage: An Innovative Concept to Prevent Micronutrient Deficiencies in Children

“…The technology for transdermal delivery of nutrients using fluidizing phospholipid based liposomes has been developed by Banerjee et al from Nanomedicine laboratory, Department of Biosciences and Bioengineering, IITB, Mumbai, India and has been patented ( 17 ). The technology has demonstrated safety and efficacy in in vitro and in vivo animal models for transdermal delivery of nutrients at supplemental doses ( 18 ). The technology has also demonstrated no irritation potential during irritation patch testing in healthy human volunteers ( 19 ).…”

“…There is no published literature on transdermal supplementation of folate or vitamin B12 in clinical studies. Our earlier studies have reported the proof of concept preclinical studies for delivery of folate trans-dermally through cosmetics ( 18 ). Thus, this was one of the first attempts to develop and scale up a technology-based intervention for transdermal supplementation of multiple micronutrients through a body oil platform.…”

Dermal and Transdermal Drug Delivery through Vesicles and Particles: Preparation and Applications

“…They performed ex-vivo experiments using Franz diffusion cells to check the skin permeation. 32 Mithun G. Maniyar et al developed lopinavir encapsulated liposomes for use in anti-HIV therapy. They formed these liposomes using the spray drying method.…”

Title: Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: Results of a randomized placebo controlled clinical trial

“…We developed an innovative formulation of body oil containing soya phosphatidylcholine and oleic acid-based liposomes encapsulating iron, folate, vitamin B12, and vitamin D using a patented platform for increased permeation across the stratum corneum barrier (21,22). The liposomes showed high permeation through the stratum corneum and showed 40-50% encapsulation e ciency for ferrous bisglycinate, 20-40% for folate and B12, and 90-95% for vitamin D. The technology has demonstrated safety and e cacy in in-vitro and in-vivo animal models for transdermal delivery of nutrients at supplemental doses (23). The technology was also found to be non-irritant in healthy human volunteers and children (24)(25).…”