Type a gelatin capsule containing pufa in free acid form

Abstract

A pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form or a pharmacologically acceptable derivative thereof is contained in a soft gelatin capsule characterised in that the capsule comprises gelatin extracted by an extraction process comprising acid pre-treatment of a collagen source. One advantage of the present invention over a soft to gelatin capsule containing the same formulation but comprising gelatin extracted by an extraction process comprising alkali pre-treatment of the collagen source is that the present invention does not harden significantly over time and thus has a longer shelf life.

1 . A pharmaceutical dosage form, comprising:
 a) a pharmaceutical formulation comprising at least one omega-3 polyunsaturated fatty acid in free acid form;   b) a soft gelatin capsule containing the formulation inside the capsule; and   c) a coating on the outside of the capsule;   wherein the capsule comprises sufficient porcine Type A gelatin such that, when containing the formulation, the uncoated capsule disintegrates within a time period of no longer than 30 min in purified water at 37° C. after storage for 3 months at 40° C.   
     
     
         2 - 34 . (canceled)