Pregelatinized starches have been used for a long time in the food industry, so does in Pharmaceutical industries. Starch 1500 is a unique pharmaceutical excipient combining several properties in a single product.
Starch 1500 had multiple functions, such as 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.
The Advantages of Pregelatinized Starch (Starch 1500)
Starch 1500 also has self-lubricating properties, which reduces the need for high levels of lubricants, thus improving mechanical strength and dissolution of the product.
Pregelatinized starches had ability to thicken or gel promptly without the application of a substantial amount of heat necessary with normal starches. However, this ability to rapidly thicken or gel creates problems when these materials are used in dry products to be reconstituted in small portions by the ultimate consumer.
Cost savings : By replacing PVP (Polymeric binders), CCS (both generally higher priced excipients) and half of the MCC with the mutifunctional Starch 1500, less glidant and lubricants the company achieved a substantial reduction in the raw material cost as well as in the cost of manufacture, comprise up to 70% of the total excipient cost of a tablet. Replacing the PVP, CCS and half of the MCC with Starch 1500 can result in a formulation cost savings of more than 60%.
Starch 1500 formula demonstrated excellent tablet properties and dissolution. While providing comparable binding, the Starch 1500 formula exceeded the disintegration and dissolution performance of the PVP formulation that included a super disintegrant.
The Disadvantages of Pregelatinized Starch (Starch 1500)
Moisture content of pregelatinized starch (starch 1500) is relative high. Loss on drying specification for starch 1500 in USP is not more than 13-14%. But, many suppliers produce this excipient with loss on drying lower than 13-14%. Because of its high moisture content, tablet using starch 1500 as one of the excipient lean to stick on the dies when the bulk compressed.
Manufacturing Process of Pregelatinized Starch (Starch 1500)
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 compactibility 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.