Polymer based formulation for release of drugs and bioactives at specific git sites

Abstract

The present invention is related to polymer-based formulation for release of drugs and bioactives at gastrointestinal tract specific sites including stomach, intestine and colon.

What is claimed is: 
     
         1 . A pharmaceutical composition in a solid oral unit dosage form comprising:
 a drug or bioactive; and   a sodium alginate polymer chemically crosslinked with bivalent ions, trivalent ions, or a combination thereof, for controlling the release of the drug or bioactive at specific time and at specific sites.   
     
     
         2 . A pharmaceutical composition in a solid oral unit dosage form comprising:
 a drug or bioactive; and   a sodium alginate polymer chemically crosslinked with bivalent ions, trivalent ions, or a combination thereof for controlling the release of the drug or bioactive at specific time and at specific sites,   wherein the said pharmaceutical composition is free from tableting process of granulation or coating.   
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the said specific site is gastrointestinal (GIT) site. 
     
     
         4 . The pharmaceutical composition of  claim 1 , comprising a capsule formulation selected from the group consisting of capsules, tablets in capsules, bilayer tablet, single-layered capsule, or multi-layered capsule. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the capsule formulation is delivered as immediate drug release, extended-drug release, sustained-drug release, lag-drug release, pulsatile-drug release, delayed-drug release, modified drug release (MDR), or any combinations of profiles at specific time and site. 
     
     
         6 . The pharmaceutical composition of  claim 4 , wherein the capsule formulation is selected from the group consisting of powder, pellets, enteric-coated granules, and tablets. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the said drug is selected from a group consisting of water-soluble, water-insoluble, acid-labile, non-acid labile, proteins and peptides. 
     
     
         8 . The pharmaceutical composition of  claim 4 , wherein the said capsule comprises a shell made of blended natural polymer, blended synthetic polymer, cross-linked natural polymer, cross-linked synthetic polymer, or a combination thereof. 
     
     
         9 . The pharmaceutical composition of  claim 4 , wherein the said capsule formulation comprises capsule shell comprising 0.1-6% w/v aqueous solution of sodium alginate, 0.05 to 18% w/v of bivalent ions, trivalent ions, or a combination thereof, in the form of their salts and 0.01 to 10% w/v of polymers. 
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the said polymer is cross-linked with bi- and/or trivalent ions in the form of their salts and or blended with natural or semi-synthetic or synthetic polymer or their combination. 
     
     
         11 . The pharmaceutical composition of  claim 4 , wherein the said capsule is tough and thick and wherein the said strength and toughness is achieved by increasing the number of capsule layers. 
     
     
         12 . A method of treating irritable bowel disease or cancer, the method comprising administering a pharmaceutical composition in a solid oral unit dosage form comprising:
 a drug or bioactive; and   a sodium alginate polymer chemically crosslinked with bivalent ions, trivalent ions, or a combination thereof for controlling the release of the drug or bioactive at specific time and at specific sites,   wherein the drug or bioactive is delivered in colon and is effective for the treatment of irritable disease or cancer.