Crystalline polymorphic forms of monosodium N-[-8-(2-hydroxybenzoyl)amino]caprylate
AssigneeEmisphere Technologies, Inc.
InventorsHalina Levchik, Shingai Majuru, Brahma Singh, Jamila Harris
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Abstract
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.
Claims23
A pharmaceutical composition comprising a milled mixture of (a) crystalline anhydrous monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate exhibiting an X-ray powder diffraction pattern having a peak at 2.98±0.2° 2Θ and (b) at least one active agent, wherein the active agent is a peptide.
A pharmaceutical composition comprising a milled mixture of (a) crystalline anhydrous monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate exhibiting a melting point onset at about 198° C. according to differential scanning calorimetry and (b) at least one active agent, wherein the active agent is a peptide.
A process for preparing a pharmaceutical composition comprising wet granulating monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate exhibiting an X-ray powder diffraction pattern having a peak at 2.98±0.2° 2Θ with or without one or more active agents and/or pharmaceutically acceptable additives.
A process for preparing a pharmaceutical composition comprising wet granulating monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate exhibiting a melting point onset at about 198° C. according to differential scanning calorimetry with or without one or more active agents and/or pharmaceutically acceptable additives.
Dependencies are inferred from the claim text.