In the Spotlight February 2009

Oral solid dosage forms of small-molecule drugs represent the majority of pharmaceutical manufacturers' final products. Tablets are made by blending and granulating powdered ingredients. Coating is sometimes required to protect the active ingredient or control its release. Although tableting is a well-established process, production equipment for this dosage form continues to be refined. The products from Vector, Charles Ross and Son, and Diosna Dierks and Söhne featured this month are designed to assist different aspects of the granulation process.

Fluid-bed system offers flexibility

Vector's (Marion, IA) "VFC-LAB Mini" laboratory development fluid-bed system performs granulating, coating, and drying operations. The device provides top-spray granulating and drying and includes a bottom-spray Wurster system for fine-particle coating. The flexible VFC-LAB Mini machine can dry and granulate 2.5 L of top-sprayed material and process as little as 0.8 L of bottom-sprayed material.

VFC-LAB Mini system Vector, www.vectorcorporation.com

The unit's touch-screen control system allows the operator to direct the unit manually and enter process parameters for semiautomatic control. The system also has data-collection capabilities.

The VFC-LAB Mini is rated for aqueous and solvent applications and produces 0.5–1.5-kg quantities that can be scaled up to pilot-level systems. The self-contained, mobile system features quick utility connections and is easily dismantled for cleaning and inspection.

Blenders break up agglomerates

Charles Ross and Son (Hauppauge, NY) provides its twin-shell V-blenders in 5-, 10-, and 15-ft³ capacities. The units perform dry blending of free-flowing solid granulations in preparation for tableting. Each blender includes a high-speed intensifier bar for delumping, explains Warren Ang, Ross's product manager. The bar can be activated to break up agglomerates.

Twin-shell V-blender Charles Ross and Son, www.mixers.com

The machines are charged and discharged through a manually operated butterfly valve located 24 in. from the floor. While the twin shell rotates, granulated materials are continuously split and recombined during the cycle. Each blender's motor, belts, and drive train are fully integrated with Ross's control system.

System integrates granulation equipment

The "Compact Granulation System" (CGS) from Diosna Dierks and Söhne (Osnabrück, Germany) incorporates a high-shear granulator, wet mill, fluid-bed dryer, transport system, dry-mill system, and integrated container mixer or bin blender. The CGS "is the first commercially available optimization of these processes in one package," according to Marc Kaufman, president of ServoLift (Wharton, NJ), the exclusive distributors of Diosna in North America.

Compact Granulation SystemDiosna Dierks and Söhne, www.diosna.com

The CGS unit provides high containment and can limit operator exposure to < 0.4μg/m³ over 8 h of processing. Manufacturers can thus produce Category 4 potent compounds with the unit.

New Product Announcements may be sent to New Products Editor, Pharmaceutical Technology, 485 Route One South, Building F, First Floor, Iselin, NJ 08830, fax 732.596.0005, ptpress@advanstar.com.