Abstract

Vishwa Patel*, Drashti Patel, Hemil Patel, Abhi Prajapat, Prinsi Rajput, Dr. Bhumi R. Patel

ABSTRACT

Vitamin B12 is an essential micronutrient required for DNA synthesis, neurological function, and red blood cell maturation. Deficiency of Vitamin B12 is a global health concern, leading to anaemia, neuropathy, and neurocognitive impairment. Conventional therapy involves oral supplementation and intramuscular injections, but these routes face significant challenges. Oral absorption is limited by gastrointestinal factors, while parenteral injections are painful, inconvenient, and associated with poor patient compliance. Therefore, alternative delivery approaches are urgently needed. The nasal route of administration is an attractive option due to its large surface area, high vascularization, and avoidance of hepatic first-pass metabolism. Nasal sprays are patient-friendly, non-invasive, and capable of delivering therapeutically effective drug concentrations. In this study, a Vitamin B12 nasal spray formulation was developed using solubilizers, stabilizers, and absorption enhancers. The formulation was subjected to extensive evaluation, including physicochemical properties, spray performance, drug content, in-vitro diffusion, and stability studies. The optimized spray demonstrated a pH compatible with the nasal cavity, low viscosity for easy actuation, and uniform drug content. Spray characterization revealed consistent droplet size and spray angle, while in-vitro diffusion studies confirmed enhanced permeation compared to plain Vitamin B12 solution. Stability studies over three months under ICH accelerated conditions demonstrated retention of drug content, clarity, and performance. This study highlights the potential of Vitamin B12 nasal spray as a practical alternative to oral and injectable dosage forms. Further in-vivo studies and clinical trials are warranted to confirm its therapeutic effectiveness and potential commercialization.