abstract |
One aspect of the invention is a method of preparing a composition which is suitable for direct tablet compression and which comprises crystals containing a mixture of paracetamol and a polymer, said method which comprises providing a hot aqueous solution containing paracetamol and from 1 to 15%, by weight on the weight of the paracetamol, of a polymer selected from homopolymers and copolymers of vinyl acetate and vinyl pyrrolidone, cooling said solution with gentle stirring and recovering said composition. Preferred compositions are obtained using the polymer in an amount from 2 to 6% by weight on the weight of the paracetamol and using as the polymer a copolymer of vinyl pyrrolidone and vinyl acetate in a weight ratio of from 70:30 to 50:50. The composition is preferably dried to a moisture level of from 0.4 to 1.4% by weight. Another aspect of the invention is the said composition of paracetamol and polymer, a preferred embodiment containing from 1.5 to 5% by weight of a copolymer of vinyl pyrrolidone and vinyl acetate in a weight ratio of from 70:30 to 50:50. Still another aspect of the invention is the tablet formed by direct tablet compression of said composition. |