Complexes of lumacaftor and its salts and derivatives, process for the preparation thereof and pharmaceutical compositions containing them

A stable complex comprising

• i. Lumacaftor;
• ii. At least 50% by weight of a complexation agent which is a copolymer of vinylpyrrolidone and vinyl acetate;
• and
• iii. Sodium lauryl sulfate;
• wherein the ratio of the copolymer:sodium lauryl sulfate:Lumacaftor is 9:1.2:2, and
• wherein said complex has a particle size is between 10 nm and 500 nm, and possesses one or more among the following features:
• a) has an apparent solubility in water of at least 1 mg/mL;
• and
• b) has a PAMPA permeability of at least 2×10˜1 2 3 4 cm/s when dispersed in FaSSIF or FeSSIF biorelevant media, which does not decrease in time at least for 12 month.