Speaking to WhatPackaging?,  P Srinivas Naidu, senior general manager - packaging development, Sun Pharmaceutical Industries, said, “Sun Pharma is the first company to design and execute this machine and we have filed critical products for regulated markets by generating data on this machine. This machine will be a benchmark to generate equivalency data in the future.”

Ophthalmic products are generally packed in a three-piece plastic container. It is important to design a perfect nozzle tip, which will deliver exact volume of the drug when the user squeezes the bottle and dispenses the drug into the eye.

In regulated markets for ophthalmic products, the generic pharma companies need to show the equivalency of drop size as it has direct impact of drug assay.

Naidu explained, “The industry practice has been to squeeze the bottle manually, dispense a drop and then weigh it. Since the squeezing force varies from person to person there’s a lot of variation in the drop weight results. Secondly, the drop size largely depends on the angle of dispensing. If both squeezing force and angle of dispensing are not harmonised we will end up with a variation in drop size data. In order to arrive at reliable and consistent results we designed this machine.”

The machine consists of two servo motors, a sensitive weighing balance, a printer, special probes to simulate human finger forces, pressure gauge, PLC and MMI.

The two micro servo motors fitted with special squeezing probes simulate the human finger operation. It has the capabilities to adjust both angle of dispensing and the squeeze force in order to measure the drop size of branded products and use that data to design the nozzle tip cap. The machine is also programmed to shake the bottle every time before it dispenses the drop to get uniform results.

Naidu: "This machine will be a benchmark to generate equivalency data in the future"

“We have studied the human practices of dispensing eye drops at different age groups and at different conditions and collated the normal and abnormal ways of dispensing. Based on this data we have derived range of squeeze force limits and angle of dispensing,” added Naidu.

Sun Pharma Industries was recognised with Pacmachine Award 2017 for the  drop size testing machine on 28 October 2017 at Hotel Eros, New Delhi.