Tablet Binders and Disintegrants
Tablet binders are used in the formulation of solid oral dosage forms to hold the active pharmaceutical ingredient and inactive ingredients together in a cohesive mix. Binder products are usually differentiated based on the manufacturing process to be used.
- Dry tablet binders used for direct compaction must exhibit cohesive and adhesive forces so that when compacted the particles agglomerate.
- Binders used for wet granulation are hydrophilic and soluble in water and are usually dissolved in water to form a wet mass that is then granulated.
Disintegrants may be added to a drug formulation as functional fillers. These excipients assist in the disintegration of the capsule or tablet when it is introduced to moisture. The efficacy of a drug mixture can be dependent on the rate at which the tablet or capsule disintegrates in the patient’s gastrointestinal tract.
Starch 1500® Partially Pregelatinized Maize Starch functions as binder for both direct compression and wet granulation.
- As a dry binder, it compresses well, predominately deforming plastically.
- Produces cohesive dry blends due to its granular morphology and superior adhesive characteristics.
- As a result of its partial cold water solubility, it functions exceptionally well in wet granulation applications and performs dual functions of both a disintegrant and a binder.
In capsule filling processes, Starch 1500 and StarCap 1500® Co-Processed Starch Excipient function as effective binders improving the uniformity of the capsule fill as well as forming a stable capsule plug. They also promote formulation flexibility by complementing and enhancing the functionality of other excipients.
METHOCEL™ Premium Cellulose Ethers can be used as binders in the wet granulation of tablets to produce hard tablets with low friability and consistent disintegration rates. They are extremely versatile and can be used in both aqueous and solvent systems.
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
- StarCap1500® utilized in Capsule Formulation of Gabapentin
- 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 - Evaluation of StarCap 1500® in a Propranolol Hydrochloride Capsule
- AAPS 2007 - Development of a Common Cyclobenzaprine Formulation for Both Encapsulation and Tabletting Using StarCap 1500®
- AAPS 2010 - Application of StarCap1500® as Filler/Binder/Disintegrant in a Roller Compaction Dry Granulation Formulation
- AAPS 2010 - Evaluation of StarCap1500® as an Excipient in Extended Release Hydrophilic Matrix Systems
- AAPS 2010 - Influence of Filler Type in the Blend Uniformity of Micronized Drugs
- AAPS 2011 - Effect of Drug Particle Size on Blend Segregation and Content Uniformity of Low Dose Tablets
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
- Multifunctional Excipients
- Narrowing the Gap Between Clinical Capsule Formulations and Commercial Film Coated Tablets
- Starch Contrasts
- The Effect of Core Design and Formulation on the Quality of Film Coated Tablets