Stable pharmaceutical formulation comprising a hmg-coa reductase inhibitor

A process for the preparation of a stable solid pharmaceutical formulation containing as an active ingredient a HMG-CoA reductase inhibitor, the process comprising the steps of:

• a) homogenizing a mixture of an active composition consisting of said active ingredient and a buffering agent, wherein the active composition has a pH in the range from 7 to 11, with at least one constituent selected from the group consisting of a filler binder, buffering agent, disintegrating agent and optionally surfactant and other commonly used ingredients for solid pharmaceutical formulations in suitable mixers,
• b) adding glidants and/or lubricants,
• c) re-homogenizing the mixture and
• d) compressing the resulting mixture into tablets, or filling the resulting mixture into capsules;
• e) optionally film-coating the tablets,
• wherein said HMG-CoA reductase inhibitor is selected from the group consisting of pravastatin and atorvastatin and a pharmaceutically acceptable salt thereof, and wherein the pharmaceutical formulation has a pH in the range from 6 to 9.

A process for the preparation of a stable solid pharmaceutical formulation the process comprising the steps of:

• a) homogenizing a mixture of an active composition consisting of an active ingredient and a buffering agent, wherein said active ingredient is a HMG-CoA reductase inhibitor selected from the group consisting of pravastatin and atorvastatin and a pharmaceutically acceptable salt thereof, and wherein the active composition has a pH in the range from 7 to 11 with at least one constituent selected from the group consisting of a filler, binder, buffering agent, disintegrating agent and optionally surfactant and other commonly used ingredients for solid pharmaceutical formulations in suitable mixes,
• b) granulating the mixture with a suitable solvent,
• c) drying the resulting granulation in suitable dryers,
• d) adding the dried granulations glidants and/or lubricants and optionally other ingredients for solid pharmaceutical formulations,
• e) re-homogenizing the mixture, and
• f) compressing the resulting mixture into tablets, or filling the resulting mixture into capsules;
• g) optionally film-coating the tablets,
• wherein the pharmaceutical formulation has a pH in the range from 6 to 9.

A process for the preparation of a stable solid pharmaceutical formulation the process comprising the steps of:

• a) homogenizing a mixture of an active composition consisting of an active ingredient and a buffering agent, wherein said active ingredient is a HMG-CoA reductase inhibitor selected from the group consisting of pravastatin and atorvastatin and a pharmaceutically acceptable salt thereof, and
• wherein the active composition has a pH in the range from 7 to 11, and said buffering agent is present in an amount less than 1% based on the total weight of the pharmaceutically active substance, with at least on constituent selected from the group consisting of a filler, binder, buffering agent, disintegrating agent and optionally surfactant and other commonly used ingredients for solid pharmaceutical formulations in suitable mixers,
• b) adding glidants and/or lubricants,
• c) re-homogenizing the mixture and
• d) compressing the resulting mixture into tablets or filling the resulting mixture into capsules;
• e) optionally film-coating the tablets,
• wherein the pharmaceutical formulation has a pH below 9 and a lower pH limit of 6.

A process for the preparation of a stable solid pharmaceutical formulation containing as an active ingredient a HMG-CoA reductase inhibitor, the process comprising the steps of:

• a) mixing a combination of said active ingredient and a buffering agent, wherein the active composition has a pH in the range from 7 to 11, with at least one constituent selected from the group consisting of a filler binder, buffering agent, disintegrating agent and optionally surfactant and other commonly used ingredients for solid pharmaceutical formulations in suitable mixers to form a mixture;
• b) adding glidants and/or lubricants,
• c) combining said mixture from (a) and said ingredients added in (b), and
• d) compressing the resulting mixture into tablets, or filling the resulting mixture into capsules;
• e) optionally film-coating the tablets,
• wherein said HMG-CoA reductase inhibitor is selected from the group consisting of pravastatin and atorvastatin and a pharmaceutically acceptable salt thereof, and wherein the pharmaceutical formulation has a pH in the range from 6 to 9.