Granulation

Used at low concentrations in the granulation process, METHOCEL* Premium cellulose ethers and ETHOCEL* Premium ethylcellulose produce hard tablets with low friability. Yet, they won’t negatively affect tablet disintegration. Because they can be used in a variety of solvent systems (aqueous, hydroalcoholic, or nonaqueous), they are extremely versatile in wet granulation formulations.

Conventional Wet Granulation

METHOCEL Premium cellulose ethers are widely used with many conventional wet granulation technologies — fluid bed, high shear, low shear, and roller compaction processing. When METHOCEL Premium cellulose ethers are used in low concentrations tablet size is minimized; this maximizes your ability to use excipients to control other tablet characteristics.

As a binder, METHOCEL Premium allows the reduction of compression force, an important factor in reducing wear and extending the life of tooling and compression equipment.

Solvent-based Granulation

Premium grade ETHOCEL polymers are often used for solvent granulation of water-sensitive materials. Tablets made with ethylcellulose-granulated materials are strong and have good dissolution properties. ETHOCEL polymers are also used for extrusion granulation because of the thermoplastic nature of ethylcellulose. Dissolution times may be extended or modified by varying the amount of ETHOCEL resin in a granulation or by adding water-soluble binders to the granulating fluid containing the ETHOCEL cellulose ether.

Solvent-free Direct Compression Granulation

Three Fine Particle (FP) grades of ETHOCEL Premium polymers are available to allow their use as direct compression binders without the use of solvents.

The FP grade ETHOCEL Premium polymer is uniformly mixed with the other system components. Then the solid dose form is produced using economical direct compression. Upon compression, the finely-milled particles of ETHOCEL Premium polymer fuse into a semi-continuous, water-insoluble matrix. No solvents, heat, or additives are required.

Upon ingestion, the water-soluble components of the system are released via diffusion from the water-insoluble structure. Since three fine particle grades of ETHOCEL Premium polymer are available, the formulator can achieve a range of diffusion path sizes and lengths. The result is a solid dose form with excellent integrity and repeatable dissolution performance that you can control.

Dow Excipients in Granulation Binder Applications

Application	Products Recommended	Typical Use Level	Advantages
Conventional Wet Granulation	METHOCEL E5LV, E15LV, A15LV, K3 Premium	2 – 6%	Low concentrations provide good hardness, low friability, and good disintegration
Direct Compression Granulation	ETHOCEL Standard 7 FP, 10 FP, 100 FP Premium	5 – 40%	Solvent-free route to achieving water-insoluble matrices Offers many possible approaches to controlling release profiles
Solvent-Based Granulation	ETHOCEL Standard 10, 20 or 45 Premium	1 – 6%	Used for solvent granulation of water-sensitive materials to produce strong tablets with good dissolution Thermoplastic nature of ETHOCEL Premium assists in extrusion granulation

®™*Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow.