Abstract

Background/Objective: Methylcobalamin Nasal Spray (NasoB12®, Troikaa, India) has been recently developed to overcome the drawbacks of currently available therapeutic routes. This study was designed to compare pharmacokinetics, safety and tolerability of methylcobalamin nasal spray with intramuscular injection.

Highlights

  • Vitamin B12 (B12) known as cobalamin is a cofactor for major reactions in the body which are critical for DNA synthesis, red blood cell formation and for neurologic function [1]

  • Higher Cmax for intranasal spray was observed as compared to intramuscular injection without dose normalization (197.49%); upon dose normalization Cmax was 39.50%

  • Vitamin B12 is adequately absorbed after intranasal application of methylcobalamin nasal spray and can be used as a safe and effective alternative to current options

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Summary

Introduction

Vitamin B12 (B12) known as cobalamin is a cofactor for major reactions in the body which are critical for DNA synthesis, red blood cell formation and for neurologic function [1]. B12 deficiency is traditionally treated with oral formulations, or, preferably, repeated intramuscular injections of cobalamin. The intramuscular injections are painful, inconvenient and often associated with adverse reactions (e.g. abscess formation, erythema, and hematoma) [4,5]. Administration of injectables requires health care professionals, which increases the economic burden on the healthcare system. This may impact patient compliance and result in discontinuation of the treatment [6,7]. Oral supplementation of Vitamin B12, dependent on Intrinsic Factor (IF),

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