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Closing The ‘Knowing-Doing’ Gap In R&D Using USP <1062> Data

Impact of Punch Cup Depths on USP Graph

One of the most rewarding things about being a science technician is being able to easily measure your impact. And for many in the pharmaceutical industry today, measuring this impact begins with analytics. As an R&D scientist, accessing your analytics is essential to determining whether your formulation’s purpose can be realized, i.e. if the product’s stated goal, according to your marketing and product development teams, can actually be pulled off, and the new tablet can satisfy customer demand. In other words, can your formulation realistically accomplish the goals you want it to?

The only way to know the (preliminary) answer to this is to conduct some trial runs on a small-scale R&D press. These trial runs generate the valuable data you need to accept or fail to accept your hypothesis: Can your formulation be compacted into a robust, viable, marketable tablet? To ascertain these answers, you have to turn raw USP <1062> data into valuable insights.

More Trial, less Error with USP <1062> DATA

There are many data points that your tablet press may track by default, but to deploy it in a meaningful way, some post-compaction data must be considered, such as tablet hardness, thickness, or weight. With most of today’s computer technology available, most of this raw data (automatically) generated by your tablet press will be sent to the press’s data acquisition and analysis system. That data can be processed and served, almost instantly, visually or packaged as a CSV file which you can then deploy to a spreadsheet for further analysis.

np-rd30 tablet compression machine
The NP-RD30’s integrated AIM™ Pro data acquisition and analytical software is designed to ease formulation and process development and minimize production issues during scale-up.

For example, on a Natoli NP-RD30 press using the Natoli AIM Pro™ software, peak force compaction data is shown in a histogram chart that helps the scientist to calculate compactability, dwell time, and pressure at each critical stage of the compaction process on a rotary tablet press. The reporting interface on your tablet press is by far the most efficient way to begin to work with USP <1062> compaction data. They allow operators and technicians alike (even at different data literacy skill levels) to see information about tablet compressibility and manufacturability. The Natoli AIM Pro software leads the way for the IT evolution in our industry, and it can even be retrofitted to most makes and models of presses when they undergo refurbishment.

On the graphic user interface, you’ll have access to a treasure trove of context, data, and information at your fingertips. This USP <1062> data could potentially lead you to discover insights and opportunities for continued product improvements—perhaps even on ones that you thought were previously impossible to manufacture. Knowledge is power, you just have to know how to leverage your analytics.

Data acquisition system tools have come a long way and they can be integrated and utilized to track just about everything that’s happening in each station of your tablet press. While commercial force collection has been available since the 1980s, it became prevalent in the 1990s for R&D applications. Provided today’s state-of-the-art computer software, scientists have ‘instant insight’ capabilities that would have been almost unheard-of decades ago.

These systems can help to create the type of data-driven processes your operations need to evolve your tablet development from an art to a science. By minimizing cycles of trial and error during tablet development, it could even aid in troubleshooting tablet defects. Therefore, leveraging your USP <1062> data will streamline your formulation development efforts, allowing you to make more robust tablets, and accelerate their speed to market.

For those who can harness all of this compaction data, they can unlock a whole new level of mastery in their professions. By deepening their skill set in data literacy, they can serve an invaluable role in their organization because they can make the connection between research and product development, rather than seeing them as siloed efforts.

Looking for a research partner? Natoli Scientific offers a full-range of services, all optimized to help you turn your USP <1062> data into insights. Contact us today to learn more!


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