UNIT DOSE PACK (07-May-2009)

Abstract:

All the statins are relatively unstable, and their degradation may be catalyzed by several parameters like oxygen, humidity, light, acidity and temperature. Impurities generated upon degradation of active substances may reduce the therapeutic effects of an active substance and unnecessarily burden the body with degradation products. For example, oxidative degradation of atorvastatin may lead to impurities such as Atorvastatin diepoxide, dihydroxy epoxide and diketoepoxide.

We have developed a unit dose pack made up of a multilayer laminate for a pharmaceutical composition of atorvastatin wherein a desiccant is embedded in the said laminate, leading to the reduction in the oxidative degradation of atorvastatin.

The unit does pack could be a cold form blister made up of a multilayer laminate for a pharmaceutical composition of atorvastatin wherein a desiccant is embedded in the said laminate. The desiccant is selected form group consisting of sodium silicate, calcium oxide, magnesium oxide, barium oxide, strontium oxide, aluminum oxide, partially hydrated aluminum oxide, magnesium sulfate, sodium phosphate di-basic, ammonium chloride, potassium carbonate, potassium aluminum disulfate, magnesium chloride, diammonium sulfate, sodium nitrate, calcium chloride, calcium sulfate, sodium chloride and said desiccant is embedded in the laminate.

Specifically, the cold form blister made up of a multilayer laminate for a pharmaceutical composition of atorvastatin wherein multilayer laminate comprises:

a.       an outer layer of oriented polyamide;

b.      a barrier layer of aluminum strip;

c.       an inner layer of polyethylene and calcium oxide; and

d.      an innermost layer of high-density polyethylene.

As used herein the term “atorvastatin” refers to include atorvastatin free acid and pharmaceutically acceptable salts thereof such calcium, magnesium, potassium etc. Atorvastatin may exist in any of the solid state forms available such as amorphous or any other polymorphic form. Atorvastatin may be present alone or in combination with other active ingredients such as amlodipine, ezetimibe, niacin, ramipril, aspirin and other cardiovascular agents.

Pharmaceutical composition of atorvastatin may be in the form of tablet, capsule or the like. Tablets may include monolayered, bilayered or trilayered tablet.

Desiccant as used herein may be present in any of the layer of laminate, in particular desiccant is not in direct contact with atorvastatin pharmaceutical composition. Multilayer laminate as used herein means combination of different or same material present in different layers, in particular aluminum based laminates are used. These laminates f...