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
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
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.
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