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Polymorphic form K of Pitavastatin calcium: an advance in stability and pharmaceutical applications


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Abstract

Pitavastatin’s ability to effectively lower LDL-C and TG levels, while increasing HDL-C, has made it a potent option for lipid control. Polymorphism affects the drug’s solubility, stability, and bioavailability, and while several polymorphic forms of pitavastatin calcium have been identified, including forms A, B, C, D, E, F, and amorphous forms, they present challenges in large-scale production due to sensitivity to processing conditions. Polymorphic form K overcomes these challenges, demonstrating superior chemical and physical stability under stress, high humidity, mechanical forces, and elevated temperatures. This form’s low hygroscopicity improves storage and handling, making it a prime candidate for solid pharmaceutical formulations such as tablets and capsules. With remarkable resilience to degradation, polymorphic form K enhances both the shelf life and efficacy of pitavastatin-based medications, offering improved outcomes in the treatment of cardiovascular diseases.

Keywords

pharmaceutical applications, cardiovascular diseases, pitavastatin calcium, hypercholesterolemia

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