Pharmaceutical formulation containing an hmg-coa reductase inhibitor and method for the preparation thereof
AssigneePharmathen S.A.
InventorsEvangelos Karavas, Efthimios Koutris, Elisavet Ioannidou, Eleni Stathaki, Dimitrios Bikiaris
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Abstract
The present invention relates to improved pharmaceutical formulation for oral administration comprising a therapeutically effective quantity of an HMG-CoA reductase inhibitor, and more particularly Fluvastatin, Atorvastatin or salts thereof in combination with a linear sulphated polysaccharide such as Carrageenan and a method for the preparation thereof.
Claims20
A pharmaceutical composition for oral administration comprising a HMG-CoA, reductase inhibitor or a pharmaceutical acceptable salt thereof, as an active ingredient, and an effective amount of a linear sulphated polysaccharide or mixtures thereof such as Carrageenan as a stabilizer to inhibit isomerization and/or elimination and/or oxidation and/or re-crystallisation.
A process for the preparation of a solid dosage form for oral administration such as a tablet, capsule or sachet containing a HMG-CoA reductase inhibitor or a pharmaceutical acceptable salt thereof as an active ingredient and an effective amount of a linear sulphated polysaccharide or mixtures thereof such as Carrageenan as a stabilizer to inhibit isomerization and/or elimination and/or oxidation and/or re-crystallization, which comprises:
- Forming a homogenous mixture by mixing the total quantity of said active ingredient with the total quantity of said linear sulphated polysaccharide or mixtures thereof;
- Kneading the above mixture with a suitable water-free solvent such as absolute ethanol, acetone or mixtures thereof;
- Drying the wetted mass;
- Sieving the dried mass and adding to the sieved mixture the total quantities of at least one optional excipient such as a binder, a diluent, a disintegrant, a lubricant and/or a glidant and mixing until uniform, and—Formulating the resulting mixture in a solid dosage form either by compressing it into a desired tablet form or by filling capsules or sachets.
A process for the preparation of a solid dosage form for oral administration, such as a tablet, a capsule or a sachet, containing a HMG-CoA reductase inhibitor or a pharmaceutical acceptable salt thereof as an active ingredient and an effective amount of linear sulphated polysaccharide or mixtures thereof such as Carrageenan a stabilizer to inhibit isomerization and/or elimination and/or oxidation and/or re-crystallization, which comprises:
- forming a homogenous mixture by mixing the total quantity of said active ingredient with the total quantity of said linear sulphated polysaccharide or mixtures thereof such as Carrageenan;
- Sieving the above mixture through a sieve;
- Adding to the sieved mixture the total quantities of at least one optional excipient such as binder, a diluent, a disintegrant, a lubricant and/or a glidant and mixing until uniform, and
- Formulating the resulting mixture in a solid dosage form either by compressing it into a desired tablet form with a force more than 400 kp.
Dependencies are inferred from the claim text.