Intellectual Property India Publishes Patent Application for An Aqbd-Driven Rp-Uplc Method For Quantification Of Shikonin In A Mucoadhesive Microemulsion And Pharmacokinetic Evaluation For Nose-To-Brain Delivery

MUMBAI, India, Sept. 7 -- Intellectual Property India has published a patent application (202641104347 A) filed by Dr. Lalitha Repudi; Dr. Kumaraswamy Gandla; and Pavan Kumar Inuganti on August 31, 2026, for An Aqbd-Driven Rp-Uplc Method For Quantification Of Shikonin In A Mucoadhesive Microemulsion And Pharmacokinetic Evaluation For Nose-To-Brain Delivery.

Inventors include Dr. Lalitha Repudi; Dr. Kumaraswamy Gandla; and Pavan Kumar Inuganti.

The application for the patent was published on September 04, 2026, under issue no. 36/2026.

Abstract: The present invention relates to an Analytical Quality by Design (AQbD)-driven reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method for quantification of Shikonin in a mucoadhesive microemulsion and biological matrices and its application in pharmacokinetic evaluation for nose-to-brain delivery. The method comprises risk assessment using an Ishikawa diagram and failure mode and effects analysis, screening of analytical variables using a Taguchi L8 orthogonal array and optimization using Box–Behnken response surface methodology. The optimized chromatographic conditions comprise a C18 column, an acetonitrile and 0.1% v/v formic acid in water mobile phase in an 80:20 v/v ratio, a flow rate of 1.0 mL/min, a column temperature of 30°C and detection at 254 nm. The method exhibits linearity over 2–12 µg/mL with a correlation coefficient of 0.9997, limit of detection of 0.396 µg/mL and limit of quantification of 1.191 µg/mL. The mucoadhesive microemulsion comprising Shikonin, castor oil in an amount of 5–10%, a surfactant–cosurfactant mixture in an amount of 20–40% comprising Tween 80 and propylene glycol in equal proportions, distilled water and chitosan as a mucoadhesive polymer. The optimized microemulsion exhibits a droplet size of 73.8 ± 0.63 nm and Shikonin entrapment efficiency of 87.9 ± 0.25%. The present invention provides a Pharmacokinetic evaluation following intranasal administration demonstrates enhanced brain and plasma exposure of Shikonin.

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