Starch 1500 is a unique pharmaceutical excipient combining several properties in a single product. Starch 1500 performs the multiple functions of a binder, disintegrant, and flow-aid while having lubricant properties. It is extremely versatile, being effective in a variety of processing methods for solid oral dosage forms, such as direct compression, wet granulation, dry granulation/roller compaction and encapsulation. Starch 1500 is particularly effective with moisture sensitive actives and low dose applications and exhibits synergy, enhancing the functionality of other commonly used excipients in formulations.
In addition to providing a unique range of functions and flexible performance in a variety of applications, Starch 1500 cuts process and material costs by reducing or eliminating:
- Polymeric binders
- Superdisintegrants
- High levels of lubricants and glidants
- Manufacturing steps
Unique Manufacturing Process
Starch 1500 is a partially pregelatinized maize starch manufactured exclusively for the pharmaceutical industry in dedicated cGMP facilities (ISO 9000 certified). The process involves a physical modification of the starch (no chemical additives or surfactants are used), resulting in the combined benefits of the soluble and insoluble functionality of Starch 1500.
Partial pregelatinization provides Starch 1500 with its unique properties. The process results in partial solubility, increased particle size, improved flow properties and compactability compared to alternative “starches.” Starch 1500 has a mixture of properties of both native and fully gelatinized starches. This makes it useful as both a binder and a disintegrant in wet granulated formulations.
Starch 1500 can be hydrated with cold water to produce viscous slurries or, alternately, can be added directly to the granulator bowl and water can be utilized to granulate.
Product Range
Starch 1500 products are designed to meet regulatory needs worldwide.
Starch 1500:
- Meets PhEur and USP/NF specifications for pregelatinized starch.
Starch 1500 LM:
- Low moisture product (less than 7% moisture).
- Meets PhEur and USP/NF specifications for pregelatinized starch.
Starch 1500 G:
- Meets PhEur and USP/NF specifications for pregelatinized starch and JPE requirements for partly pregelatinized starch.
Contact Colorcon® to learn how Starch 1500 can improve your formulation and lower your costs.
