{"id":9587,"date":"2023-09-07T17:19:49","date_gmt":"2023-09-07T17:19:49","guid":{"rendered":"https:\/\/amarintech.com\/?p=9587"},"modified":"2025-12-09T13:50:54","modified_gmt":"2025-12-09T13:50:54","slug":"how-do-we-control-the-quality-of-transdermal-patches","status":"publish","type":"post","link":"https:\/\/amarintech.com\/es\/how-do-we-control-the-quality-of-transdermal-patches\/","title":{"rendered":"How do we control the quality of transdermal patches?"},"content":{"rendered":"
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How do we control the quality of transdermal patches?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Florencia Cafisi<\/strong>– Chief Analytical Development<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Transdermal patches present certain attributes that make the efficacy, safety, and quality of the product and must be controlled in the laboratory through analytical techniques to ensure the performance and safety of the transdermal delivery system (or TDS). Some of them correspond to tests that are common to other pharmaceutical forms. However, due to the particular characteristics of transdermal patches, there are specific procedures that apply to TDSs and that are described in internationally recognized regulations and pharmacopoeias.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Regulatory framework<\/h4>

Due to the increasing use of transdermal patches for the treatment of certain pathologies and the advantages that this route of administration represents in terms of patient compliance with the treatment and the absence of characteristic side effects, for example, of oral forms; Pharmacopoeias and international regulations have shown interest in defining those critical attributes that should be considered for quality control of transdermal patches.<\/p>

USP has got \u00a0an exclusive section for the Control of Topical and Transdermal Products (<3> USP), in addition to encompassing some monographs such as Rotigotine, Clonidine, Estradiol and Nicotine transdermal patches. Patches are also referred to in the General Notes 07. Dosage Forms of the European Pharmacopoeia.<\/p>

Besides, there are FDA and EMA guidelines and, in the region, ANVISA guide No. 20\/2019, which also include to the development of these pharmaceutical forms and define considerations to be taken into account for registration of these products.<\/p>

Amarin Technologies specializes in the development and production of matrix-type transdermal drug-in-adhesive delivery systems (drug dissolved in the adhesive matric) and has got Development and Quality Control Laboratories with specific equipment and personnel qualified and trained for this type of analysis.<\/p>

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Universal Tests\u00a0<\/h4>

The ICH Q6A guide defines the general guidelines for the Specifications of New Drugs and Products, including the following general quality attributes (which apply to all dosage forms):<\/p>