MK-VitFe – Transdermal Liposomal Lotion for Topical Massage

Product contains API of Ferrous Bisglycinate (Elemental Iron), Vitamin B12, Vitamin D3, Folic acid

Benefits of Transdermal Liposomal Lotion:

  • Easy for application
  • Skin friendly, Non-irritant
  • Bypass first pass effect
  • Liposomal based formulation possesses advantage over conventional lotion, due to very small particle size they can easily penetrate through the skin uppermost layer.
  • Convenient for unconscious patients or patients to have difficulty in oral administration.


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Description

Deficiency of micronutrients in infancy can lead to failure of full growth potential. Deficiency of iron and vitamin D is prevalent in India and supplements have been recommended. While oral fortification or supplementation of micronutrients is limited by issues of taste, stability, poor absorption and gastrointestinal disturbances, transdermal delivery using innovative nanotechnology allows easy delivery of micronutrients through skin.

MKPPL have developed safe nanoparticles that encapsulate micronutrients and interact with the outermost layer of skin to enhance penetration and can be delivered through a lotion platform This technology is relatively inexpensive and has a potential for scaling up. This innovative intervention can address the problem of micronutrient deficiency in infants and improve physical and neurodevelopment.

Prevalence of iron and vitamin D deficiency in India

Nutritional anemia is due to iron deficiency is one of the commonest deficiencies in Indian infants. Timely correction of iron deficiency is important as it adversely affects cognitive performance, behaviour and physical growth of infants, preschool and school-age children and also the immune status and morbidity from infections of all age groups. The prevalence of anemia in children aged 6- 35 months was estimated to be as high as 78.9% in NFHS-3. Subclinical vitamin D deficiency is prevalent in 40-80% Indian infants and toddlers as documented in various studies. Timely supplementation of these micronutrients can prevent their deficiencies in future.

Role of micronutrients in brain growth

Iron deficiency is associated with poor neurodevelopment and iron supplementation has been associated with improved outcomes. Animal studies have shown that maternal deficiency of vitamin D is associated with profound alteration in infant brain. Folate and Vitamin B12 are also crucial for neurological development while calcium is essential for growth of infants. Thus regular supplementation of these micronutrients in infants can potentially improve their nutritional status and have significant impact on neurocognitive development.

Transdermal delivery of nanoparticles using fortified lotion

The skin represents a large surface area which is easily accessible and can potentially serve as a very attractive non-invasive route of delivery of drugs. The stratum corneum layer of skin has a “brick and mortar” structure which acts as a defensive wall that needs to be overcome in order to achieve efficient transdermal drug delivery. Nanoparticles can penetrate through the stratum corneum for deeper penetration into the dermis thereby reaching rich capillary network beneath and systemic circulation. Oral delivery of Iron is always a very tedious task as only 15% of the iron is absorbed into the system and there has been signs of gastrointestinal irritation. The iron needs to be available in the Ferrous form in order to be bioavailable in the system.

Why Liposomes?

  • A liposome is a spherical vesicle having at least one lipid bilayer. Therefore, it will be helpful to penetrate through the skin brick and mortar model.
  • Liposomes are non-toxic, flexible, biocompatible, completely biodegradable, and non immunogenic for systemic and non-systemic administrations.
  • Liposomes can entrap both hydrophobic and hydrophilic molecules, prevent the entrapped combinations from decomposing, and release the entrapped at specific targets.

Importance of Liposomal lotion formulation?

  • Liposomes protect some drugs against chemical and immunological breakdown, as well as protecting them against the effect of enzymes.
  • Liposomal formulation is a commercially possible approach to solving the poor solubility as well as poor bioavailability problems of the nutrients.
  • This formulation allows such nutrients like iron, vitamin (B12, D3, Folate) which having low absorption ability and susceptible to first pass hepatic metabolism.
Additional information
Documentation Available:

DMF in CTD Format

Dosage Form

Topical Massage lotion

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