A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/57 (2006.01) A61K 9/70 (2006.01) A61K 31/56 (2006.01)
Patent
CA 2172738
Transdermal therapeutic systems, also called TTS or skin plasters, are a relatively new drug form with which it is possible with certain medicinal substances to deliver the active ingredient through the human skin into the systemic circulation. However, the skin has a barrier and protective function for the body so that it is often a problem to deliver a sufficient amount as required for the treatment of diseases through the skin from a TTS which is not excessively large. In these cases it is necessary to incorporate the medicinal substance in a high concentration into the TTS so that a high thermo- dynamic activity results and, as a consequence, the permeation rate through the skin is increased. However, there is a risk that with such high active ingredient concentrations crystallization takes place after storage, and this, if it takes place to a considerable extent, in turn results in a reduction in the thermodynamic activity and thus in the rate of absorption through the skin. It has been found in the present invention that by adding the substance octyldodecanol to the polymer layer of a TTS with the active substances oestradiol and norethisterone acetate it was possible to reduce or avert crystal formation after storage. The use of octyldodeca- nol thus makes it possible to produce a storage-stable TTS with the active ingredients oestradiol and norethis- terone acetate with a high thermodynamic activity.
Pendant le stockage, un système thérapeutique présentant une concentrations élevée en principe actif risque de cristalliser. Selon l'ampleur de cette cristallisation, l'activité thermodynamique et par conséquent le taux de résorption à travers la peau sont réduits. L'adjonction d'octyldodécanol à la couche polymère d'un système thérapeutique transdermique comportant comme principes actifs de l'estradiol et de l'acétate de noréthistérone, permet de réduire ou d'éviter la cristallisation pendant le stockage. L'utilisation de l'octyldodécanol permet de ce fait de produire un système thérapeutique transdermique stable au stockage comportant comme principes actifs de l'estradiol et de l'acétate de noréthistérone, et ayant une activité thermodynamique élevée.
Cordes Gunter
Rovati Lucio C.
Fetherstonhaugh & Co.
Rotta Research Laboratorium S.p.a.
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