FACTORS INFLUENCING THE PHYSICAL CHARACTERISTICS OF TABLETS
Publication Date: 2003-Aug-12
The IP.com Prior Art Database
FACTORS INFLUENCING THE PHYSICAL CHARACTERISTICS OF SODIUM HYDROGEN BIS(2-PROPYLVALERATE) TABLETS
Sodium hydrogen bis(2-propylvalerate) is available as enteric-coated tablets with delayed-release properties. The formulation is prepared in a high-shear mixer and a fluidized bed dryer followed by milling and mixing. The tabletted core receives an enteric coating (which imparts delayed-release properties) followed by a cosmetic coating.
The active ingredient, which is the major component of this tablet, has pronounced physical characteristics which influence the workability of the formulation during manufacturing as well as the dissolution behavior of the final product.
A prominent physical characteristic of this active ingredient is its 'waxiness'. This very distinct texture predominates the entire tablet cores formulation and interferes with its workability - especially during the tabletting process. Waxy buildups on tablet punches can severely affect the quality and appearance of the finished product as well as impede the process itself. Similarly, this waxiness interferes with the smooth application of the enteric coating to the tablet resulting in a grainy appearance. A non-uniform enteric coating can seriously influence the dissolution profile and pharmacokinetics of the finished product. These problems are further compounded by the hygroscopicity of the active material which can further alter the physical properties of the formulation during manufacture.