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 expensive method of preparing Paracetamol tablets, that is, through direct 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 compression. Unquestionably these materials have good compressibility but all these 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 compression ability of some sintered-like crystals, we prepared a pure Paracetamol for direct compression (FGH Paracetamol) through the recrystallizing of crystals from a dioxane solution or suspension. The Paracetamol interacts with this solvent to form a 'solvate'. The desolvation of these solvate crystals led to the production of sintered-like crystals exhibiting a polyhedric habit.