REGULATORY PERSPECTIVE AND CHALLENGES OF ADVANCED NOSE – TO- BRAIN DRUG DELIVERY SYSTEMS IN CNS THERAPEUTICS
1 Research Scholar, Siddhis Institute of Pharmacy Nandgaon, Murbad 421401.
2 Assistant professor, Department of Pharmacology, Siddhis Institute of Pharmacy Nandgaon, Murbad 421401.
* Corresponding Author
Received on 19 September 2026; revised on 29 October 2026; accepted on 02 November 2026
The central nervous system (CNS) which includes the brain and spinal cord controls vital functions of the human body. Treating CNS disorders is still hard because the blood–brain barrier (BBB) blocks medicines from reaching the brain. Conventional ways to give medicine, such as pills or injections often fail to deliver drug to the right spot. That is why nose to brain drug delivery has become a non invasive way to bring medicines straight to the CNS.
The close anatomical and physiological connections between the nose and the brain through the olfactory and trigeminal nerves allow the drug to reach the CNS directly and reduce dependence on the bloodstream. This approach can also avoid first pass liver metabolism. May make treatment easier for patients. New formulations like nanoparticles, liposomes, solid lipid nanoparticles, nanostructured lipid carriers and nano emulsions are being studied to improve drug stability, nasal absorption and CNS targeting.
These advances face many obstacles: the nose’s mucociliary clearance, limited drug spread difficulty proving direct nose to brain movement, identifying nanocarrier properties, standardizing formulations, batch variation and checking long term safety. From a point of view a detailed evaluation of quality, safety and effectiveness is essential. Key elements such as quality features, analytical tests, stability studies, manufacturing control, validated preclinical models, pharmacokinetic and pharmacodynamic data and appropriate clinical trials are needed for product development. Harmonized regulations and consistent testing methods are also critical to bring these formulations into clinical use
To-Brain Drug Delivery; Nervous System (CNS); Blood-Brain Barrier (BBB); Tiny Delivery Vehicles; Intranasal Drug Delivery
