Pharmaceutical formulations

Abstract

The present invention is directed to novel pharmaceutically acceptable polymeric compositions suitable for melt extrusion and injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form.

1 - 47 . (canceled) 
     
     
         48 . A multi-component pharmaceutical dosage form which comprises a plurality of sub-units, and wherein at least one sub-unit is:
 a) a drug substance-containing capsule compartment which is soluble or disintegrable in a patient's gastro-intestinal environment for release of the drug substance contained in the capsule compartment,   and at least a second sub-unit is:   b) a solid matrix comprising Ammonio methacrylate Copolymer Type A or Ammonio methacrylate Copolymer Type B present in an amount ranging from about 10% to about 80% w/w; and a blend of hydroxypropylcelluloses having different molecular weights in an amount ranging from about 20% to about 65% w/w,   and in which the plurality of sub-units are welded together or mechanically joined in an assembled dosage form.   
     
     
         49 . The dosage form according to  claim 48  wherein the copolymer is Ammonio methacrylate Copolymer Type A. 
     
     
         50 . The multi-component pharmaceutical dosage form according to  claim 48 , wherein the blend of hydroxypropylcelluloses comprises a low molecular weight hydroxypropylcellulose and a high molecular weight hydroxypropylcellulose. 
     
     
         51 . The dosage form according to  claim 50  wherein the blend of hydroxypropyl cellulose polymers comprises a hydroxypropylcellulose having a molecular weight of about 80,000 and a hydroxypropylcellulose having a molecular weight of about 140,000. 
     
     
         52 . The dosage form according to  claim 50  wherein the blend of hydroxypropyl cellulose is a hydroxypropylcellulose having a molecular weight of about 80,000 and a hydroxypropylcellulose having a molecular weight of about 370,000. 
     
     
         53 . A multi-component pharmaceutical dosage form according to  claim 48 , in which the solid matrix further comprises a lubricant present in an amount ranging from about 5% to about 25% w/w. 
     
     
         54 . The multi-component dosage form according to  claim 53 , wherein the lubricant is stearyl alcohol. 
     
     
         55 . The dosage form according to  claim 48  further comprising a dissolution modifying excipient selected from the group consisting of non-reducing sugars, low molecular weight solutes, and water soluble fillers. 
     
     
         56 . The dosage form according to  claim 55  wherein the dissolution modifying excipient is selected from the group consisting of xylitol, mannitol, lactose, starch, sodium chloride, and combinations thereof. 
     
     
         57 . The dosage form according to  claim 48  further comprising a disintegrant, wherein the disintegrant is selected from the group consisting of sodium starch glycollate, croscarmellose sodium, crospovidone (cross-linked polyvinyl pyrrolidone), copovidone, polyvinyl pyrrolidone, and combinations or mixtures thereof. 
     
     
         58 . The dosage form according to  claim 48 , further comprising a plasticizer wherein the plasticizer is selected from the group consisting of triethyl cifrate (TEC), tributyl cifrate, acetyl triethyl citrate (ATEC), acetyl tributyl citrate (ATBC), dibutyl phthalate, dibutyl sebacate (DBS), diethyl phthalate, vinyl pyrrolidone glycol triacetate, polyethylene glycol, polyoxyethylene sorbitan monolaurate, propylene glycol, castor oil; and combinations or mixtures thereof. 
     
     
         59 . The dosage form according to  claim 48  further comprising a processing agent in an amount ranging from about 1% to about 5% w/w. 
     
     
         60 . The dosage form according to  claim 48  further comprising an absorption enhancer, wherein the absorption enhancer is selected from the group consisting of chitosan, lecithin, lectin, a sucrose fatty acid ester, Vitamin E-TPGS, and combinations or mixtures thereof. 
     
     
         61 . The dosage form according to  claim 48  comprising a dissolution modifying excipient which is a wicking agent. 
     
     
         62 . The dosage form according to  claim 61  wherein the wicking agent is lactose. 
     
     
         63 . The dosage form according to  claim 62  wherein the lactose is present in an amount of about 13% w/w. 
     
     
         64 . The dosage form according to  claim 48 , further comprising a surfactant. 
     
     
         65 . The dosage form according to  claim 64 , wherein the surfactant is selected from sodium dodecyl sulphate or a block copolymer of ethylene oxide and propylene oxide. 
     
     
         66 . The multi-component pharmaceutical dosage form according to  claim 48 , wherein the solid matrix further comprises a dissolution modifying excipient selected from the group consisting of a disintegrant present in an amount ranging from about 10% to about 40% w/w; a water soluble filler present in an amount ranging from about 5% to about 70% w/w; a low molecular weight solute present in an amount ranging from about 2.5% to about 70% w/w; and a non-reducing sugar present in an amount ranging from about 2.5% to about 15% w/w. 
     
     
         67 . The multi-component dosage form according to  claim 48  wherein each sub-unit has different release characteristic. 
     
     
         68 . The multi-component dosage form according to  claim 67 , in which at least one of the sub-units is a substantially immediate release sub-unit.