Compositions for colonic delivery of drugs
View Patent ↗Described herein are controlled release oral pharmaceutical compositions for delivering active pharmaceutical ingredients to the colon and methods for making the same. In particular, an oral pharmaceutical composition comprising a soft capsule and a controlled release matrix for delivering active pharmaceutical ingredients to the colon are described.
1. An oral pharmaceutical dosage form comprising a soft capsule shell and a flowable matrix comprising:
(a) about 40% to about 55% by weight oleic acid;
(b) about 1% to about 6% by weight carbomer polymer;
(c) about 2% to about 8% by weight of polyvinylpyrrolidone;
(d) about 1% to about 10% by weight of a poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) non-ionic surfactant; and
(e) about 25% to about 33% by weight of mesalamine;
wherein the matrix dissolves in the colon.
2. The composition of claim 1 , wherein the soft capsule shell comprises:
(a) a film forming polymer;
(b) a plasticizer; and
(c) a solvent.
3. The composition of claim 2 , wherein the soft capsule shell is an enteric soft capsule shell further comprising:
(F) an enteric acid insoluble polymer; and
(g) an alkali neutralizing agent.
4. The composition of claim 3 , wherein the enteric soft capsule shell comprises: gelatin, a methacrylic acid copolymer, glycerol, triethyl citrate, ammonium hydroxide, and water.