Starch 1500® Partially Pregelatinized Maize Starch
Starch 1500 is a unique pharmaceutical excipient combining several properties in a single product : binder, disintegrant, filler and flow-aid while having lubricant properties.
It is versatile and used in variety of processing methods for solid oral dosage forms:
- Direct compression
- Wet granulation
- Dry granulation/roller compaction
Starch 1500 is particularly effective with moisture sensitive actives and low dose applications. 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 and manufacturing steps.
Unique Manufacturing Process
Starch 1500 is manufactured exclusively for the pharmaceutical industry in dedicated cGMP facilities (ISO 9001:2008 certified). The process results in partial solubility, increased particle size, with improved flow properties and compactibility compared to alternative starches.
- 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.
Product Application Data
- Assessment of Low Dose Content Uniformity of Indomethacin
- Direct Compression Formulation of Loratadine (10 mg) Tablets
- Direct Compression using Starch 1500® with Ranitidine HCL (150mg) Tablets, Film Coated with Opadry II
- Increasing the Compactability of Echinacea Purpurea Powder using Starch 1500®
- Lactose Replacement with Starch 1500® in a direct compression formula
- Replacement of Di Basic Calcium Phosphate with Starch 1500® in a DC Formula
- Starch 1500® as a Binder and Disintegrant in XCH (Xiaochaihu) Herbal Extract/Powder Tablet
- Starch 1500® used as a Binder Disintegrant in High Shear Wet Granulation Comparison to Povidone and Croscarmellose Sodium
- Wet Granulation of Acetaminophen with Starch 1500®
- AAPS 2005 - Particle Swelling and Coalescence to Gel Layer Formation
- AAPS 2006 - Modulation of Drug Release from Hypromellose (HPMC) Matrices: Suppression of the Initial Burst Effect
- AAPS 2008 - Narrowing the Gap Between Clinical and Commercial Formulations
- AAPS 2010 - Effect of Filler Type on Low Dose Acetaminophen Hydrophilic Matrix Formulations
- AAPS 2010 - Influence of Filler Type in the Blend Uniformity of Micronized Drugs
- AAPS 2011 - Barrier Membrane Coating of Hydrophilic Matrices of Sparingly Soluble Drug, Acetaminophen: A Strategy to Reduce Possible Food Effect
- AAPS 2011 - Effect of Drug Particle Size on Blend Segregation and Content Uniformity of Low Dose Tablets
- AAPS 2012 - Barrier Membrane Coated Hydrophilic Matrices: Robustness of Metoprolol Tartrate Release under Biorelevant Test Conditions – Impact of Media Composition
- AAPS 2012 - Investigation of Synergistic Behavior of Excipients in Direct Compression Using a Rotary Press Simulator
- AAPS 2012 - Stability of Ethylcellulose Barrier Membrane Coated Hydrochlorothiazide Matrices Comprising Starch 1500® or Lactose as Filler
- AAPS 2015 - Eliminating Burst Release of Highly Soluble Drug from Hydrophilic Matrix Tablets Using Venlafaxine as a Model Drug
- AAPS 2015 - Enhancing the Stability of a Famotidine Tablet Formulation through Use of Starch 1500®
- CRS 2010 - Effect of Processing Conditions on Hypromellose Matrix Formulations of Acetaminophen Prepared by a High Shear Wet Granulation Process
- CRS 2011 - Use of Starch 1500® to Minimize Variability on Drug Release from Hypromellose Matrices
- Effect of Filler Type on the Stability of Polyethylene Oxide in a Hydrophilic Matrix Tablet
Published White Papers / Articles
- Formulating TCMs; East meets West
- Formulation of Acetylsalicylic Acid Tablets for Aqueous Enteric Film Coating
- Formulation of Low Dose Medicines - Theory and Practice
- Influence of Excipients on Drug Release from Hydroxypropyl Methylcellulose Matrices
- Multifunctional Excipients
- Starch Contrasts
- The Effect of Core Design and Formulation on the Quality of Film Coated Tablets