Lasofoxifene tablet and its coating

Abstract

Pharmaceutical compositions having uniform drug distribution and potency utilizing laxofoxifene as an active ingredient and containing a silicon dioxide to reduce loss of the active ingredient during the manufacturing process and methods for manufacturing such compositions are disclosed.

Description

field of invention [0001] The present invention relates to a pharmaceutical composition which makes drug distribution and potency uniform by using lasofoxifene as an active ingredient, and contains silicon dioxide capable of reducing loss of the active ingredient during production. Methods of producing such compositions are also disclosed. Background technique [0002] US5552412 describes a class of potent and orally acting selective estrogen receptor modulators (SERMS) (such as derivatives of tetralin-2-ol), which can be used for the treatment or prevention of breast cancer, osteoporosis obesity, cardiovascular disease, hypercholesterolemia, endometriosis and prostate disease. These specific SERMS are of interest due to their improved oral bioavailability over currently marketed SERMS (eg raloxifene). The SERMS described in US5552412 is very effective and can therefore be used in low dosage forms. However, formulation of the composition at lower dose ranges presents chal...

AI Technical Summary

Problems solved by technology

While manual brushing steps can be effectively implemented in small-scale facilities to recover active ingredients adhered to metal surfaces, manual brushing steps are neither effective nor ideal in large-scale production environments

Liquid processes minimize drug loss issues during drug product manufacturing; however, oxidation-sensitive compounds such as derivatives of tetralin-2-ol make liquid processes particularly difficult to perform without degradation of the active ingredient

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