Rottapharm Spa

Rottapharm Bv

Rotta Research B.v.

Antonino Santoro

Lucio C Rovati

Francesco Makovec

Antonio Giordani

Walter Peris

Paolo Senin

Matteo Ghirri

Ivo Setnikar

Paola Gilotta

Gunter Cordes

Luigi Angelo Rovati

Described is a new crystalline Form A of Andolast disodium salt, triclinic, displaying a thermal event at 98-112&#xb0; C. and melting with decomposition at about 400&#xb0; C. (DSC). Andolast disodium Form A is a not hygroscopic solid, surprisingly stable to several humidity conditions in a temperature range acceptable for ordinary storage conditions. In addition its stability allows both chemical manufacturing and pharmaceutical manufacturing process consistency and reproducibility under conditions more viable and less expensive when compared to those used for highly hygroscopic solids.

Crystalline and stable form of andolast

The present invention refers to a transdermal patch for the release of Estradiol and at least one progestogen agent through the skin, comprising or consisting of an outer backing foil, a matrix and a protective liner wherein a) the Estradiol and the progestogen agent(s) are present in the matrix in an oversaturated solution, b) the matrix contains 1 to 5 wt% activated SiO2, and c) the matrix has a moisture content of less than 0.7 wt.-%. The patch can be used for hormonal replacement therapy.

Matrix-type transdermal patch for steroid hormones

Transdermal estradiol/progestogen agent patch and its production

Growing community of inventors

Monza, Italy

Antonino Santoro