Current status of product development of transdermal drug delivery preparations

Author: Sharo

Transdermal drug delivery system (TDDS) refers to a new formulation that is administered on the surface of the skin.

Overview of transdermal drug delivery regulations

To provide regulatory support to promote the application and listing of TDDS products, FDA and China have issued TDDS guidelines

FDA: In August 2011, the FDA issued the "Industry Guidelines for Residual Drugs in Transdermal and Related Drug Delivery Systems", which provides for the development, production and life cycle management of topical patches for TDDS and TMDS (transmucosal drug delivery systems) It is recommended to ensure that the amount of drug remaining at the end of the label's use period is minimized

European Union: In July 1999, the European Union issued the "Guidelines for Quality Control of Sustained and Controlled Release Products (A Oral Formulation; B Transdermal Patch)".

China: On July 11, 2018, CDE issued the "Technical Evaluation Requirements for Dermatology Generic Drugs under the New Registration Classification" (draft for comments), mainly from the rationality of the topic, the selection of reference preparations, pharmaceutical research and bioequivalence evaluation The basic principles of CDE's evaluation of skin medications are described in other aspects, which can provide reference for the research on the imitation and marketing of TDDS products

Development status of transdermal drug delivery products

The mainstream global transdermal drug delivery products are mainly in the United States, Japan and the European Union.

Central nervous system drugs: The anti-sickness drug scopolamine patch was approved by the FDA in 1979 and was produced and marketed by Novartis Consumer Health.

Antipyretic and analgesic: Transdermal analgesic patch is a relatively mature type of transdermal patch with a wide range of applications.

Cardiovascular disease drugs: Transdermal patches for cardiovascular disease drugs have been used earlier.

Hormonal drugs: Hormonal transdermal patches began to be used in the 1980s, occupying a large proportion in the transdermal preparation market, and the number of products is also large

Transdermal preparations are a new preparation field to be fully developed, which can avoid gastrointestinal irritation and liver first-pass effects of oral administration routes, and can maintain a constant and lasting effective blood drug concentration; it is convenient to use

references:

[1] Wang Xiujie.

[2] Liu Mengsi, Jiang Dianzhuo, Yue Zhihua, Zhou Yu.

[3] You Chunna, Song Zonghua, Zhang Qiming, Li Youxin, Liu Wanhui.