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Pregelatinized Maize Starch in Pharmaceuticals: A Guide

July 2, 2024

Pregelatinized maize starch is a versatile excipient widely used in the pharmaceutical industry for its excellent binding and disintegration properties. As the industry continually seeks to optimize formulations, understanding the role and benefits of pregelatinized maize starch is important for manufacturers who want to enhance their product performance. 

To provide insights into this essential excipient, we spoke to Russell Prestipino, Global Business Manager at Colorcon. In the following Q&A, Russell will discuss the properties of pregelatinized maize starch, its applications in pharmaceutical formulations, and the advantages it offers to the industry. 

Q: What is pregelatinized maize starch? 

A: We start our manufacturing process with a native corn starch, which, in itself, has general binding capabilities when it's cooked and the bonds are broken. For example, when you’re cooking food, as you heat up starch, it gets thicker and thicker as you whisk. We are basically doing part of the bond breaking before it becomes a finished product for the customer. 

On one end of the spectrum, you have native corn starch with no binding capabilities and on the other end you have fully gelatinized starch, which has full binding capabilities. Pregelatinized starch is where we've broken the bonds to some extent – gelatinization through mechanical processes. Pregelatinized starch doesn’t have to be heated to have binding capabilities; the pregelatinized part of the starch base dissolves in the water at normal temperatures.

So that gives pregel starch some binding capabilities, but the non-gelatinized part also provides disintegration properties. Pregel starch can be a multi-facetted tool. It can provide binding in formulations, and it can also provide disintegration. It’s kind of an all-in-one excipient. 

Q: How does pregelatinized maize starch impact the bioavailability and stability of APIs? 

A: Starch 1500, our pregelatinized maize starch product aids with the disintegration of the tablet, making active ingredients more readily available for dissolution. 

But when it comes to stability, Starch 1500 is a very strong moisture scavenger. Starch 1500 will keep the water that is absorbed in the tablet away from the active ingredient because of its low water activity. So, if you have a moisture-sensitive drug, Starch 1500 is a good option allowing for longer stability. 

Q: Are there specific types of medications or drug delivery systems where you'd want to use this? 

A: I think there's a lot of opportunity to use pregelatinized maize starch in all types of tablets and capsules because of its flowability, compressibility, and moisture protection properties. 

Is there any specific type of API it’s best suited for? No. It’s unique in that it’s a starch, a natural product, and it doesn’t have anything you should worry about or shy away from. It can be formulated in pretty much every solid dose API on the market. 

Q: Are there any interesting recent developments or innovations when it comes to pregelatinized maize starch? 

A: At Colorcon, we’ve already made two other products with Starch 1500. We have StarCap, which was designed for capsules. With StarCap, we changed the morphology of the particles themselves. They flow better into the capsule during the encapsulation process. This combines the advantages of both native cornstarch and pregelatinized cornstarch. It allows for good binding, but also good compression and disintegration properties. 

Then we also did the same thing with a product called StarTab, which is a flowable, directly compressible corn starch for tablets that provides significant advantages in continuous processing and continuous manufacturing. Many of the struggles manufacturers face when it comes to continuous manufacturing is the blending aspect of that process. Because StarTab flows well and compresses well, it's a very good excipient to use in the feeding and compression parts of the continuous manufacturing process. 

Q: Why is Colorcon a good choice if you want to work with pregelatinized maize starch? 

A: We have our core excipients, we have our coating products (Opadry), and we now have our functional packaging division. That means Colorcon can be a one-stop shop for everything from core to coating to packaging solutions. When it comes to something like moisture protection, we have a solution in each of those categories, and we can provide both commercial and technical support in every aspect of the oral solid dose manufacturing process. 

In addition, our technical and commercial support teams are everywhere touching all of our customers. We have constant contact with them which allows us to be able to respond to any questions or concerns and provide on-site or in-the-lab technical support. We have a global presence that is co-located with our customers all over the world with technical service capabilities and formulation centers of excellence. If the customer cannot or does not want to do the work at their facility, they can come to us, or we can go to their facilities and do that work pretty much at the drop of a hat. 

So, because of our technical support, robust supply chain, and global co-location with our customers, we really are the best possible supplier to work with.

About the author: Russell Prestipino is Global Business Manager at Colorcon.

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