TRANSDERMAL THERAPEUTIC SYSTEM FOR ADMINISTERING FENTANYL AND METHOD FOR THE PREPARATION THEREOF
申请(专利)号:
EA20140000628
申请日期:
2012-11-22
公开/公告号:
EA032150B1
公开/公告日期:
2019-04-30
申请(专利权)人:
LUYE PHARMA AG
摘要:
The invention discloses a transdermal therapeutic system for the administration of an active ingredient through the skin comprising or consisting of a back layer, an adhesive matrix layer containing the active ingredient and a stripping layer in the form of a release liner, wherein the active ingredient is fentanyl or an analogue thereof selected from alfentanil, carfentanil, lofentanil, remifentanil and trefentanil or a salt of one of these active ingredients, the matrix layer contains a mixture of a polyisobutylene A and a polyisobutylene B, wherein the polyisobutylene A has a storage modulus G' the value of which is substantially constant in the temperature range of from 10 to 40°C and the polyisobutylene B has a storage modulus G' the value of which continuously decreases with increasing temperature in the temperature range of from 10 to 40°C, the storage modulus G' is measured in the linear viscoelastic range at a frequency of 10 rad/sec using a rheometer with parallel plate geometry and parallel plates according to the regulations of DIN EN ISO 6721-1:2011, the adhesive matrix layer contains an undissolved active ingredient in the form of active ingredient particles used to alleviate pain, wherein the matrix layer after application to the skin and wearing during 3 to 7 days has a residual content of the active ingredient below 35% of the initial content of the active ingredient. The invention also discloses a method for the preparation of the provided transdermal therapeutic system.
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