The Mumbai-based Electrolab, a leading manufacturer of dissolution tester for pharma industry in the country, will introduce an online connectivity software in November 2007 to co-ordinate its dissolution tester with High-Performance Liquid Chromatography (HPLC) machines for drug development and analysis in pharma sector. The company is the first in Asia to introduce the technology, which is widely followed in regulated market, claim the company officials.
The product will be launched on November 24, 2007, at the Pharmaceutical Machinery and Equipment Convention (P-MEC) India to be held in Mumbai.
The connectivity software for Electrolab's dissolution tester is designed by the UK-based Icalis Data Systems. This would also work with the HPLC machines manufactured by Agilent Technologies and Waters Corporation.
The new software - IDISis dissolution software - would automate the entire dissolution, sampling analysis calculation and reporting process to carry out the complete process within short time than of the conventional method. The software will perform complete real time collection, dilution, injection and measurement and sample collection within 24 hour's time.
The system also has a built-in relational database to organize, store and retrieve data with full 21 CFR Part 11 compliance within short time, averred an official.
The module uses a computer-controlled array of syringe pumps to take dissolution samples from single or dual 6 or 8 vessel dissolution baths simultaneously, and transfers the samples into the sample collector for diluting the sample. The sample will be automatically injected directly into the HPLC after dilution.
The product will help the pharmaceutical companies to satisfy the FDA requirement of specific dissolution rate (the amount of active released vs. time) of all solid dosage forms during the development of the formulation, says a company source. He added that the software would also work as a part of quality control during drug production.
The company has a network of over 30 distributors and agents serving clients interests in the world and enjoys 50 per cent of its production in exports to 51countries worldwide.