Nasal delivery of Almotriptan for effective treatment of Migraine

"An Aqueous Composition suitable for Intranasal Drug Delivery” has been granted by the Patent Authority of India. The applicants for the patent were Dr. Bala Prabhakar and Dr. Varsha Pradhan of NMIMS Shobhaben Pratapbhai patel School of Pharmacy & Technology Management. This is an outcome of Ph.D. research work carried out by Dr. Varsha Pradhan under the guidance of Dr Bala Prabhakar at SPPSPTM, Mumbai.

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Migraine is a throbbing one sided headache with unknown or undefined triggers. It is believed to occur due to anomalous brain response leading to generation of irregular nerve signals, chemicals and blood flow in the brain.

The patient suffering from migraine experiences extremely sensitive headache that may be accompanied by the nausea, vomiting, flashes of light, blind spots, tingling in the arms or legs along with increased sensitivity to light and sound. Migraine causes the agonizing pain which may last for several hours to even days and could lead to loss of man hours. WHO has rated migraine amongst the top 20 leading causes of disability; wherein 77% of primary headache patients account for migraine in India.

Dr. Bala Prabhakar
Dr. Bala Prabhakar, Dean – NMIMS Shobhaben Pratapbhai School of Pharmacy & Technology Management

Sumatriptan was a break through molecule in 1990 for the treatment of migraine. Nevertheless the amount of drug reaching to blood circulation upon oral administration of this drug is very low. Almotriptan is a relatively newer molecule which has been studied and found to have effectiveness comparable to sumatriptan with an improved patient tolerability profile. These drugs are given by oral route in the form of tablets. However in case of oral therapy, tablets may not be suitable for migraine patients suffering from nausea or vomiting hence there is a serious unmet need in this treatment regime.

The limitations of oral drug delivery were required to be addressed by exploring the alternate route. With respect to nasal route, the mucosal lining has a rich supply of blood vessels and can carry the drug across the nasal membrane quickly. It can bypass the liver metabolism, has advantage of low enzyme levels compared to digestive tract or liver; resulting in increased drug level in blood. Nasal drops can be self administered as compared to injections and hence improves patient compliance. Nasal route also has potential benefit because of the direct nose to brain delivery and may help to relieve the symptoms of migraine.

Dr. Varsha Pradhan receiving her Doctorate Degree during convocation
Dr. Varsha Pradhan receiving her Doctorate Degree during convocation

A meticulous research work of 4 years by Dr. Varsha Pradhan under guidance of Dr. Bala Prabhakar led to the development of novel aqueous compositions for nasal delivery of Almotriptan for effective treatment of Migraine. Elaborate studies were performed in laboratory animals to ensure the safety and effectiveness of the formulations. The formulations were evaluated for its shelf-life and the expiry period was determined. The above project resulted in development and evaluation of innovative strategy for delivery of Almotriptan to treat migraine patients.

A patents entitled “An Aqueous Composition suitable for Intranasal Drug Delivery” has been granted by the Patent Authority of India.