Apotex Pharmachem Inc.

Eduardo Gustavo Cammisa

Gamini Weeratunga

Carlos Zetina-Rocha

Mohammed Abdul Raheem

There is provided a crystalline form of Lapatinib, termed APO-I, and methods for making APO-I. There is also provided a crystalline solvate form of Lapatinib, termed APO-II, and methods for making APO-II.

Polymorphic forms of Lapatinib ditosylate and processes for their preparation

There is provided processes for preparing Lapatinib and pharmaceutically acceptable salts thereof by the reductive amination of the aldehyde of Formula II by treatment with 2-methanesulphonylethylamine followed by catalytic hydrogenation in the presence of a suitable hydrogenation catalyst.

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Oshawa, Canada

Eduardo Gustavo Cammisa