CRYSTALLINE POLYMORPHIC FORMS OF MONOSODIUM N-8-(2-HYDROXYBENZOYL)AMINO CAPRYLATE, AMORPHOUS MONOSODIUM N-8-(2-HYDROXYBENZOYL)AMINO CAPRYLATE, A PHARMACEUTICAL COMPOSITION, USE OF A PHARMACEUTICAL COMPOSITION IN THE PREPARATION OF A MEDICAMENT AND A METHOD OF PREPARING FORM III OF MONOSODIUM N-8-(2-HYDROXYBENZOYL)AMINO CAPRYLATE

摘要

The present invention relates to crystalline polymorphic forms of monosodium N-[8-(2-hydroxybenzoyl)amino] caprylate ('SNAC'), including two hydrates, a methanol solvate, and an ethanol solvate, of SNAC. More specifically, the present invention provide six polymorphic forms of SNAC (hereafter referred to as Forms I-VI). The present invention also provides an amorphous form of SNAC.