Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids

Abstract

Pharmaceutical compositions that have excellent storage stability even though they include a active component that is susceptible to degradation in an acidic environment are disclosed. The stabilized pharmaceutical composition of the invention includes a ring-opened 7-substituted-3,5-dihydroxyheptanoic or a ring-opened 7-substituted-3,5-dihydroxyheptenoic acid, or a pharmaceutically acceptable salt thereof, as an active component and a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof; wherein the stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers. The pharmaceutical composition may optionally include one or more pharmaceutically acceptable excipients such as a filler, a disintegrating agent and one or more lubricants such as magnesium stearate to aid compression where a tablet dosage form is desired.

What is claimed is: 
     
       1. A stabilized method of stabilizing an active component in a pharmaceutical composition for the treatment of dyslipidemia, comprising combining: 
 an active component consisting essentially of one or more compounds selected from the group consisting of (i) an HMG-CoA reductase inhibiting ring-opened  7 -substituted- 3 , 5 -dihydroxyheptafloic 7-substituted-3,5-dihydroxyhepatonic acid or a pharmaceutically acceptable acid salt thereof, and (ii) an HMG-CoA reductase inhibiting ring-opened  7 -substituted- 3 , 5 -dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
 a stabilizing effective amount of at least one amido-group tertiary amide group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof, to form a stabilized pharmaceutical composition, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers. 
 
     
     
       2. The composition method of  claim 1 , wherein the at least one amido-group tertiary amide group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof, comprises between about  10  and about  99  percent by weight of the composition. 
     
     
       3. The composition method of  claim 2 , wherein the at least one amido-group tertiary amide group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof, comprises between about  30  and about  80  percent by weight of the composition. 
     
     
       4. The composition method of  claim 1 , wherein the active component comprises between about 0.05 and about 70 percent by weight of the composition. 
     
     
       5. The composition method of  claim 4 , wherein the active component comprises between about  1  and about  60  percent by weight of the composition. 
     
     
       6. The composition method of  claim 1 , wherein the active component is a pharmaceutically acceptable acid salt of pravastatin. 
     
     
       7. The composition method of  claim 6 , wherein the pharmaceutically acceptable acid salt is pravastatin sodium. 
     
     
       8. The composition method of  claim 1 , wherein the active component is a pharmaceutically acceptable acid salt of atorvastatin. 
     
     
       9. The composition method of  claim 8 , wherein the pharmaceutically acceptable acid salt is atorvastatin calcium. 
     
     
       10. The composition method of  claim 1 , wherein the composition is in the form of a solid. 
     
     
       11. The composition method of  claim 10 , wherein the composition is in the form of a tablet. 
     
     
       12. The composition method of  claim 11 , wherein the tablet contains a lubricant. 
     
     
       13. The composition method of  claim 12 , wherein the lubricant is selected from the group consisting of magnesium stearate, sodium stearyl fumarate, polyethylene glycol, stearic acid, hydrogenated vegetable oil and talc. 
     
     
       14. The composition method of  claim 10 , wherein the composition is in the form of granules. 
     
     
       15. The composition method of  claim 14 , wherein the granules are constituents of a dispersion. 
     
     
       16. The composition method of  claim 10 , wherein the composition is in the form of a suspension. 
     
     
       17. The composition method of  claim 10 , wherein the composition is in the form of a capsule. 
     
     
       18. The composition method of  claim 10 , wherein the composition is in the form of a cachet sachet. 
     
     
       19. The composition method of  claim 1 , wherein the amido group in the amido-group containing polymeric compound or the amino group in the amino-group tertiary amide group in the tertiary amide group containing polymeric compound is present either in a pendant group attached to the backbone of the polymeric compound or as a component of the backbone of the polymeric compound. 
     
     
       20. The composition method of claim  19  1, wherein the amido-group tertiary amide group containing polymeric compound is selected from the group consisting of polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, copolymers of vinylpyrrolidone and vinyl acetate, and polynoxylin. 
     
     
       21. The composition method of  claim 1 , wherein the amido-group tertiary amide group containing polymeric compound or amino-group containing polymeric compound, or combination thereof, imparts a pH of not more than about 10 to an aqueous dispersion of said composition. 
     
     
       22. The composition method of  claim 21 , wherein the amido-group tertiary amide group containing polymeric compound or amino-group containing polymeric compound, or combination thereof, imparts a pH of not more than about 8 to an aqueous dispersion of said composition. 
     
     
       23. The composition of  claim 19 , wherein the amino-group containing polymeric compound is a quaternary ammonium group-containing polymeric compound. 
     
     
       24. The composition of  claim 23 , wherein the quaternary ammonium group-containing polymeric compound is cholestyramine. 
     
     
       25. The composition method of  claim 21 , wherein the ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or ring-opened 7-substituted-3,5-dihydroxyheptenoic acid, or pharmaceutically acceptable acid salt thereof, is a HMG-CoA reductase inhibitor medicament that is sensitive to a low pH environment. 
     
     
       26. A stabilized method of stabilizing an active component in a pharmaceutical composition for the treatment of dyslipidemia, comprising, in admixture, combining: 
 (a) an active component consisting essentially of about  0 . 05 % to about  70 % by weight of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened  7 -substituted- 3 , 5 -dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof or and  
 (ii) an HMG-CoA reductase inhibiting ring-opened  7 -substituted- 3 , 5 -dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
 
 (b) about  30 % to about  99 % by weight of a stabilizing effective amount of an amido-group a tertiary amide group containing polymeric compound or a stabilizing effective amount of an amino-group containing polymeric compound, or combination thereof; to form a stabilized pharmaceutical composition, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers. 
 
     
     
       27. The composition method of  claim 26 , wherein the ring-opened 7-substituted  3 , 5 -dihydroxy heptanoic 7-substituted 3,5-dihydroxyheptanoic acid salt is pravastatin sodium. 
     
     
       28. The composition method of  claim 26 , wherein the ring-opened 7-substituted  3 , 5 -dihydroxy heptanoic 7-substituted 3,5-dihydroxyheptanoic acid salt is pravastatin sodium and the amido-group tertiary amide group containing polymeric compound is cross-linked polyvinylpyrrolidone. 
     
     
       29. The composition method of  claim 26 , wherein the ring-opened 7-substituted  3 , 5 -dihydroxy heptanoic 7-substituted 3,5-dihydroxyheptanoic acid salt is pravastatin sodium and the amido-group tertiary amide group containing polymeric compound is polyvinylpyrrolidone. 
     
     
       30. The composition of  claim 26 , wherein the ring-opened  7 -substituted  3 , 5 -dihydroxy heptanoic acid salt is pravastatin sodium and the amino-group containing polymeric compound is cholestyramine. 
     
     
       31. The composition method of  claim 26 , wherein the ring-opened 7-substituted  3 , 5 -dihydroxy heptanoic 7-substituted 3,5-dihydroxyheptanoic acid salt is atorvastatin calcium. 
     
     
       32. The composition method of  claim 26 , wherein the ring-opened 7-substituted 3,5-dihydroxy heptanoic 7-substituted 3,5-dihydroxyheptanoic acid salt is atorvastatin calcium and the amido-group tertiary amide group containing polymeric compound is cross-linked polyvinylpyrrolidone. 
     
     
       33. The composition method of  claim 26 , wherein the ring-opened 7-substituted  3 , 5 -dihydroxy heptanoic 7-substituted 3,5-dihydroxyheptanoic acid salt is atorvastatin calcium and the amido-group tertiary amide group containing polymeric compound is polyvinylpyrrolidone. 
     
     
       34. The composition method of  claim 26 , wherein the composition is in a solid tablet dosage form which further comprises a lubricant. 
     
     
       35. The composition method of  claim 34 , wherein the lubricant is magnesium stearate. 
     
     
       36. A The method of claim 1, wherein the stabilized pharmaceutical composition comprising comprises an active component consisting essentially of pravastatin sodium and about  40 % or greater by weight of the composition of an amido-group or amino-group a tertiary amide group containing polymeric stabilizer. 
     
     
       37. A The method of claim 1, wherein the stabilized pharmaceutical composition comprising comprises an active component consisting essentially of atorvastatin calcium and about  40 % or greater by weight of the composition of an amido-group or amino-group a tertiary amide group containing polymeric stabilizer. 
     
     
       38. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of  claim 1 . 
     
     
       39. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of  claim 26 . 
     
     
       40. The stabilized pharmaceutical composition method of  claim 36 , wherein the amount of pravastatin sodium ranges from about  7  to about  11  percent by weight of the composition. 
     
     
       41. The stabilized pharmaceutical composition method of  claim 37 , wherein the amount of atorvastatin calcium ranges from about  7  to about  11  percent by weight of the composition. 
     
     
       42. A method of stable stabilizing an active component in a solid pharmaceutical composition for the treatment of dyslipidemia comprisingconsisting essentially of combining:
 an active component consisting essentially of one or more compounds selected from the group consisting of
 (a) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof and   (b) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and      at leastone pharmaceutically acceptable excipient selected from the group consisting of a lubricant, a glidant, a binder, a filler, a disintegrant, a diluent, a carrier, a colorant, a coating material, and a preservative;   to form a stable pharmaceutical composition, wherein the pH of the stable composition in water, if dispersed in a concentration of 1 mg active component per 1 ml water, would be about 5.4 to about 8, and   wherein the composition does not contain a stabilizing effective amount of one or more buffering agents and does not contain a stabilizing effective amount of one or more basifying agents.    
     
     
       43. The stable solid pharmaceutical compositionmethod of claim 42, wherein the pH would be about 6.5 to about 8.  
     
     
       44. The stable solid pharmaceutical compositionmethod of claim 42, wherein the pH would be about 6.5 to about 7.4. 
     
     
       45. The stable solid pharmaceutical composition of claim 42, wherein the basifying agents are selected from the group consisting of inorganic alkaline salts, inorganic alkaline oxides, inorganic alkaline hydroxides, alkaline metal salts, alkaline metal oxides, and alkaline metal hydroxides. 
     
     
       46. The stable solid pharmaceutical composition of claim 42, wherein the composition does not contain a buffering agent. 
     
     
       47. A method of stablestabilizing an active component in a pharmaceutical composition for the treatment of dyslipidemia, comprising combining an active component consisting essentially of one or more compounds selected from the group consisting of atorvastatin, pravastatin, and pharmaceutically acceptable acid salts thereof, and
 at least one pharmaceutically acceptable excipient selected from the group consisting of a lubricant, a glidant, a binder, a filler, a disintegrant, a diluent, a carrier, a colorant, a coating material, and a preservative; to form a stable composition, wherein the pH of the stable composition in water, if dispersed in a concentration of 1 mg active component per 1 ml water, would be about 5.4 to about 8, and wherein the composition does not contain a stabilizing effective amount of one or more buffering agents and does not contain a stabilizing effective amount of one or more basifying agents.    
     
     
       48. The stable solid pharmaceutical compositionmethod of claim 42 or claim 47, wherein no more than about 10% of the active component initially present in the composition would degrade into the corresponding lactone if (i) tabletted, (ii) packaged in a PVDC/PVC blister package and (iii) stored for six months at 40° C. and 75% relative humidity. 
     
     
       49. The stable solid pharmaceutical compositionmethod of claim 48, wherein no more than about 5% of the active component initially present in the composition would degrade into the corresponding lactone. 
     
     
       50. The stable solid pharmaceutical compositionmethod of claim 48, wherein no more than 1% of the active component initially present in the composition would degrade into the corresponding lactone.  
     
     
       51. The stable solid pharmaceutical compositionmethod of claim 48, wherein no more than about 1% of the active component initially present in the composition would degrade into the corresponding lactone if (i) tabletted, (ii) packaged in packing equivalent to or better than a PVDC/PVC blister package and (iii) stored for six months at 40° C. and 75% relative humidity. 
     
     
       52. A stablemethod of stabilizing an active component in a solid pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 an active component consisting essentially of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof and   (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and     a stabilizing effective amount of a stabilizing compound to form a stable pharmaceutical compostion, with the proviso that the composition does not contain a stabilizing effective amount of one or more buffering agents and does not contain a stabilizing effective amount of one or more basifying agents.    
     
     
       53. The stable solid pharmaceutical compositionmethod of claim 52, wherein the pH of the stable composition in water, if dispersed in a concentration of 1 mg active component per 1 ml in water, would be about 5.4 to about 8.  
     
     
       54. The compositionmethod of claim 52, wherein the active component consists essentially of one or more compounds selected from the group consisting of atorvastatin, pravastatin, fluvastatin, cerivastatin, itavastatin and pharmaceutically acceptable acid salts thereof.  
     
     
       55. A stablemethod of stabilizing an active component in a solid pharmaceutical composition for the treatment of dyslipidemia comprising combining: an active component consisting essentially of one or more compounds selected from the group consisting of atorvastatin, pravastatin, fluvastatin, cerivastatin and pharmaceutically acceptable acid salts thereof, and means for preventing degradation of the active component into the corresponding lactone ,to form a stable composition, wherein the pH of the stable composition in water, if dispersed in a concentration of 1 mg active component per 1 ml water, would be about 5.4 to about 8, and wherein the composition does not contain a stabilizing effective amount of one or more buffering agents and does not contain a stabilizing effective amount of one or more basifying agents.  
     
     
       56. The method of claim 11, wherein the composition further comprises an excipient selected from the group consisting of lubricants, glidants, binders, disintegrants, diluents, carriers, colorants, and encapsulating material.  
     
     
       57. A method of stabilizing an active component in a pharmaceutical composition for the treatment of dyslipidemia, comprising combining:
 an active component consisting essentially of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof, and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
   a stabilizing effective amount of at least one amido-group containing polymeric compound   
       to form a stabilized pharmaceutical composition, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers.  
     
     
       58. The method of claim 57, wherein the at least one amido-group containing polymeric compound comprises between about 10 and about 99 percent by weight of the composition.  
     
     
       59. The method of claim 58, wherein the at least one amido-group containing polymeric compound comprises between about 30 and about 80 percent by weight of the composition.  
     
     
       60. The method of claim 57, wherein the active component comprises between about 0.05 and about 70 percent by weight of the composition.  
     
     
       61. The method of claim 60, wherein the active component comprises between about 1 and about 60 percent by weight of the composition.  
     
     
       62. The method of claim 57, wherein the active component is a pharmaceutically acceptable acid salt of pravastatin.  
     
     
       63. The method of claim 62, wherein the pharmaceutically acceptable acid salt is pravastatin sodium.  
     
     
       64. The method of claim 57, wherein the active component is a pharmaceutically acceptable acid salt of atorvastatin.  
     
     
       65. The method of claim 64, wherein the pharmaceutically acid acceptable salt is atorvastatin calcium.  
     
     
       66. The method of claim 57, wherein the composition is in the form of a solid.  
     
     
       67. The method of claim 66, wherein the composition is in the form of a tablet.  
     
     
       68. The method of claim 67, wherein the composition further comprises an excipient selected from the group consisting of lubricants, glidants, binders, disintegrants, diluents, carriers, colorants, and encapsulating material.  
     
     
       69. The method of claim 67, wherein the tablet contains a lubricant.  
     
     
       70. The method of claim 69, wherein the lubricant is selected from the group consisting of magnesium stearate, sodium stearyl fumarate, polyethylene glycol, stearic acid, hydrogenated vegetable oil, and talc.  
     
     
       71. The method of claim 66, wherein the composition is in the form of granules.  
     
     
       72. The method of claim 71, wherein the granules are constituents of a dispersion.  
     
     
       73. The method of claim 66, wherein the composition is in the form of a suspension.  
     
     
       74. The method of claim 66, wherein the composition is in the form of a capsule.  
     
     
       75. The method of claim 66, wherein the composition is in the form of a sachet.  
     
     
       76. The method of claim 57, wherein the amido-group in the amido-group containing polymeric compound is present in a pendant group attached to the backbone of the polymeric compound.  
     
     
       77. The method of claim 57, wherein the amido-group containing polymeric compound imparts a pH of not more than about 10 to an aqueous dispersion of said composition.  
     
     
       78. The method of claim 77, wherein the amido-group containing polymeric compound imparts a pH of not more than about 8 to an aqueous dispersion of said composition.  
     
     
       79. The method of claim 77, wherein the ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or ring-opened 7-substituted-3,5-dihydroxyheptenoic acid, or pharmaceutically acceptable acid salt thereof, is a HMG-CoA reductase inhibitor medicament that is sensitive to a low pH environment.  
     
     
       80. The method of claim 57, wherein the stabilized pharmaceutical composition comprises an active component consisting essentially of pravastatin sodium and about 40% or greater by weight of the composition of an amido-group containing polymeric stabilizer.  
     
     
       81. The method of claim 80, wherein the amount of pravastatin sodium ranges from about 7 to about 11 percent by weight of the composition.  
     
     
       82. The method of claim 57, wherein the stabilized pharmaceutical composition comprises an active component consisting essentially of atorvastatin calcium and about 40% or greater by weight of the composition of an amido-group containing polymeric stabilizer.  
     
     
       83. The method of claim 82, wherein the amount of atorvastatin calcium ranges from about 7 to about 11 percent by weight of the composition.  
     
     
       84. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 57.  
     
     
       85. A method of stabilizing an active component in a pharmaceutical composition for the treatment of dyslipidemia, comprising combining
 an active component consisting essentially of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof, and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
   a stabilizing effective amount of at least one amino-group containing polymeric compound   
       to form a stabilized pharmaceutical composition, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers.  
     
     
       86. The method of claim 85, wherein the at least one amino-group containing polymeric compound comprises between about 10 and about 99 percent by weight of the composition.  
     
     
       87. The method of claim 86, wherein the at least one amino-group containing polymeric compound comprises between about 30 and about 80 percent by weight of the composition.  
     
     
       88. The method of claim 85, wherein the active component comprises between about 0.05 and about 70 percent by weight of the composition.  
     
     
       89. The method of claim 88, wherein the active component comprises between about 1 and about 60 percent by weight of the composition.  
     
     
       90. The method of claim 85, wherein the active component is a pharmaceutically acceptable acid salt of pravastatin.  
     
     
       91. The method of claim 90, wherein the pharmaceutically acceptable acid salt is pravastatin sodium.  
     
     
       92. The method of claim 85, wherein the active component is a pharmaceutically acceptable acid salt of atorvastatin.  
     
     
       93. The method of claim 92, wherein the pharmaceutically acceptable acid salt is atorvastatin calcium.  
     
     
       94. The method of claim 85, wherein the composition is in the form of a solid.  
     
     
       95. The method of claim 94, wherein the composition is in the form of a tablet.  
     
     
       96. The method of claim 95, wherein the composition further comprises an excipient selected from the group consisting of lubricants, glidants, binders, disintegrants, diluents, carriers, colorants, and encapsulating material.  
     
     
       97. The method of claim 95, wherein the tablet contains a lubricant.  
     
     
       98. The method of claim 97, wherein the lubricant is selected from the group consisting of magnesium stearate, sodium stearyl fumarate, polyethylene glycol, stearic acid, hydrogenated vegetable oil, and talc.  
     
     
       99. The method of claim 94, wherein the composition is in the form of granules.  
     
     
       100. The method of claim 99, wherein the granules are constituents of a dispersion.  
     
     
       101. The method of claim 94, wherein the composition is in the form of a suspension.  
     
     
       102. The method of claim 94, wherein the composition is in the form of a capsule.  
     
     
       103. The method of claim 94, wherein the composition is in the form of a sachet.  
     
     
       104. The method of claim 85, wherein the amino-group in the amino-group containing polymeric compound is present in a pendant group attached to the backbone of the polymeric compound.  
     
     
       105. The method of claim 85, wherein the amino-group containing polymeric compound imparts a pH of not more than about 10 to an aqueous dispersion of said composition.  
     
     
       106. The method of claim 105, wherein the amino-group containing polymeric compound imparts a pH of not more than about 8 to an aqueous dispersion of said composition.  
     
     
       107. The method of claim 85, wherein the amino-group containing polymeric compound is a quaternary ammonium group-containing polymeric compound.  
     
     
       108. The method of claim 107, wherein the quaternary ammonium group-containing polymeric compound is cholestyramine.  
     
     
       109. The method of claim 105, wherein the ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or ring-opened 7-substituted-3,5-dihydroxyheptenoic acid, or pharmaceutically acceptable acid salt thereof, is a HMG-CoA reductase inhibitor medicament that is sensitive to a low pH environment.  
     
     
       110. The method of claim 85, wherein the stabilized pharmaceutical composition comprises an active component consisting essentially of pravastatin sodium and about 40% or greater by weight of the composition of an amino-group containing polymeric stabilizer.  
     
     
       111. The method of claim 110, wherein the amount of pravastatin sodium ranges from about 7 to about 11 percent by weight of the composition.  
     
     
       112. The method of claim 85, wherein the stabilized pharmaceutical composition comprises an active component consisting essentially of atorvastatin calcium and about 40% or greater by weight of the composition of an amino-group containing polymeric stabilizer.  
     
     
       113. The method of claim 112, wherein the amount of atorvastatin calcium ranges from about 7 to about 11 percent by weight of the composition.  
     
     
       114. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 85.  
     
     
       115. A method of stabilizing an active component in a pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 (a) an active component consisting essentially of about 0.05% to about 70% by weight of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
   (b) about 30% to about 99% by weight of a stabilizing effective amount of an amido-group containing polymeric compound   
       to form a stabilized pharmaceutical composition, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers.  
     
     
       116. The method of claim 115, wherein the pharmaceutically acceptable acid salt of the ring-opened 7-substituted 3,5-dihydroxyheptanoic acid is pravastatin sodium.  
     
     
       117. The method of claim 115, wherein the pharmaceutically acceptable acid salt of the ring-opened 7-substituted 3,5-dihydroxyheptanoic acid is atorvastatin sodium.  
     
     
       118. The method of claim 115, wherein the composition comprises an excipient selected from the group consisting of lubricants, glidants, binders, disintegrants, diluents, carriers, colorants, and encapsulating material, and wherein the composition is in the form of a tablet.  
     
     
       119. The method of claim 115, wherein the composition is in a solid tablet dosage form which further comprises a lubricant.  
     
     
       120. The method of claim 119, wherein the lubricant is magnesium stearate.  
     
     
       121. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 115.  
     
     
       122. A method of stabilizing an active component in a pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 (a) an active component consisting essentially of about 0.05% to about 70% by weight of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
   (b) about 30% to about 99% by weight of a stabilizing effective amount of an amino-group containing polymeric compound   
       to form a stabilized pharmaceutical composition, wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers.  
     
     
       123. The method of claim 122, wherein the pharmaceutically acceptable acid salt of the ring-opened 7-substituted 3,5-dihydroxyheptanoic acid is pravastatin sodium.  
     
     
       124. The method of claim 122, wherein the amino-group containing polymeric compound is cholestyramine.  
     
     
       125. The method of claim 122, wherein the pharmaceutically acceptable acid salt of the ring-opened 7-substituted 3,5-dihydroxyheptanoic acid is atorvastatin sodium.  
     
     
       126. The method of claim 122, wherein the composition comprises an excipient selected from the group consisting of lubricants, glidants, binders, disintegrants, diluents, carriers, colorants, and encapsulating material, and wherein the composition is in the form of a tablet.  
     
     
       127. The method of claim 122, wherein the composition is in a solid tablet dosage form which further comprises a lubricant.  
     
     
       128. The method of claim 127, wherein the lubricant is magnesium stearate.  
     
     
       129. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 122.  
     
     
       130. A method of stabilizing an active component in a stabilized pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 (a) an active component consisting essentially of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof, and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
   (b) a stabilizing effective amount of at least one tertiary amide group containing polymeric compound   
       to form a stable composition, wherein the composition consists of (a) and (b), and wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizer.  
     
     
       131. A method of stabilizing an active component in a stabilized pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 (a) an active component consisting essentially of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof, and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, 
   (b) a stabilizing effective amount of at least one tertiary amide group containing polymeric compound, and   (c) a lubricant   
       to form a stable composition, wherein the composition consists of (a), (b), and (c), and wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizer.  
     
     
       132. A method of stabilizing an active component in a stabilized pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 (a) an active component consisting essentially of about 0.05% to about 70% by weight of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof, and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
   (b) about 10% to about 99% by weight of a stabilizing effective amount of tertiary amide group containing polymeric compound   
       to form a stable composition, wherein the composition consists of (a) and (b), and wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizer.  
     
     
       133. A method of stabilizing an active component in a stabilized pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 (a) an active component consisting essentially of about 0.05% to about 70% by weight of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof, and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, 
   (b) about 10% to about 99% by weight of a stabilizing effective amount of tertiary amide group containing polymeric compound, and   (c) a lubricant   
       to form a stable composition, wherein the composition consists of (a), (b), and (c), and wherein said stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizer.  
     
     
       134. A method of stabilizing an active component in a stabilized pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 (a) an active component consisting essentially of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof, and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, and 
   (b) a stabilizing effective amount of a stabilizing compound   
       to form a stable composition, wherein the composition consists of (a) and (b), and wherein the composition does not contain a stabilizing effective amount of one or more buffering agents and does not contain a stabilizing effective amount of one or more basifying agents.  
     
     
       135. A method of stabilizing an active component in a stabilized pharmaceutical composition for the treatment of dyslipidemia comprising combining:
 (a) an active component consisting essentially of one or more compounds selected from the group consisting of
 (i) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptanoic acid or a pharmaceutically acceptable acid salt thereof, and 
 (ii) an HMG-CoA reductase inhibiting ring-opened 7-substituted-3,5-dihydroxyheptenoic acid or a pharmaceutically acceptable acid salt thereof, 
   (b) a stabilizing effective amount of a stabilizing compound, and   (c) a lubricant   
       to form a stable composition, wherein the composition consists of (a), (b), and (c), and wherein the composition does not contain a stabilizing effective amount of one or more buffering agents and does not contain a stabilizing effective amount of one or more basifying agents.  
     
     
       136. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 130.  
     
     
       137. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 131.  
     
     
       138. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 132.  
     
     
       139. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 133.  
     
     
       140. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 134.  
     
     
       141. A method for the treatment of dyslipidemia, comprising the step of orally administering to a patient in need of such treatment a therapeutically effective unit dosage of the pharmaceutical composition made by the method of claim 135.