Packaging for amorphous statins and compositions thereof

Abstract

The present publication relates to a vacuum-sealed pack comprising an amorphous statin or a pharmaceutical composition thereof and at least one stabilizer such as, for example, an oxygen absorber, a moisture absorber or a combination thereof.

1 . A vacuum sealed pack comprising an amorphous statin and at least one stabilizer selected from the group consisting of an oxygen absorber or a moisture absorber or a combination thereof. 
   
   
       2 . A vacuum sealed pack comprising a solid pharmaceutical composition comprising an amorphous statin wherein the pack comprises at least one stabilizer selected from the group consisting of an oxygen absorber or a moisture absorber or a combination thereof. 
   
   
       3 . The vacuum sealed pack according to  claim 1  or  2  wherein the statin is selected from the group consisting of pravastatin, simvastatin, lovastatin, fluvastatin, atorvastatin and cerivastatin or pharmaceutically acceptable salts thereof. 
   
   
       4 . The vacuum sealed pack according to  claim 1  or  2  wherein the oxygen absorber is selected from group consisting of inorganic oxygen absorber, ascorbic acid based absorber, enzymatic absorber and polymer based oxygen absorber or combination thereof. 
   
   
       5 . The vacuum sealed pack according to  claim 1  or  2  wherein the moisture absorber is selected from the group consisting of activated carbon, silicas, zeolites, molecular sieves, hydrogels, calcium oxide and diatomaceous earth. 
   
   
       6 . The vacuum sealed pack according to  claim 1  or  2  wherein the statin is packaged in oxygen and moisture impermeable package. 
   
   
       7 . The vacuum sealed pack according to  claim 6  wherein the package is made up of material selected from Polyethylene (PE), bi-axially oriented polypropylene (BOPP) or PET (polyethylene terpthalate) or oriented polyamide (OPA) or aluminum foil, or a blend of thereof or a laminated structure of these polymers. 
   
   
       8 . The vacuum sealed pack according to  claim 6  wherein the package is bag. 
   
   
       9 . The vacuum sealed pack according to  claim 8  wherein the package is vacuum sealed in another package. 
   
   
       10 . The vacuum sealed pack according to any of the preceding claim wherein the amorphous statin or composition and the stabilizer are packaged in first impermeable bag under vacuum, the first impermeable bag and the stabilizer is put in second bag and vacuum sealed. 
   
   
       11 . The vacuum sealed pack according to  claim 10  wherein the second bag is put in rigid container and sealed using heat induction. 
   
   
       12 . The vacuum sealed pack according to  claim 11  wherein the rigid container is non-airtight/air-tight plastic/metal drums, corrugated shipper or fiberboard drum for amorphous statin and HDPE (high density polyethylene), PP (polypropylene), LDPE (low density polyethylene), PET, PVC (polyvinyl chloride) bottle for composition. 
   
   
       13 . The vacuum sealed pack according to  claim 2  wherein the pharmaceutical composition is tablet, capsule, pills, dry powder, dragees or granulate.