PURE PARACETAMOL FOR DIRECT COMPRESSION .1. DEVELOPMENT OF SINTERED-LIKE CRYSTALS OF PARACETAMOL

The widespread distribution of Paracetamol on the market is the reason why it would be preferable to use the fastest, simplest and least exp ensive method of preparing Paracetamol tablets, that is, through direc t compression. Yet, it is well known that this drug exhibits bad flow properties, and poor compression ability which causes capping. Several manufacturers have prepared Paracetamol powders for direct compressio n. Unquestionably these materials have good compressibility but all th ese Paracetamols for direct compression are not pure Paracetamol. They are mixtures of Paracetamol with either starch, carboxymethylstarch, pre-gelatinized starch, PVP or gelatin added. After noting the good co mpression ability of some sintered-like crystals, we prepared a pure P aracetamol for direct compression (FGH Paracetamol) through the recrys tallizing of crystals from a dioxane solution or suspension. The Parac etamol interacts with this solvent to form a 'solvate'. The desolvatio n of these solvate crystals led to the production of sintered-like cry stals exhibiting a polyhedric habit.