The Medical Converter and Transdermal Deivery Systems
Wednesday, September 19, 2012

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The Medical Converter and Transdermal Delivery for Cosmeceuticals, Neutraceuticals, and Aromatherapy

Transdermal drug delivery technology has grown in popularity and application over the past decade. The pursuit to widen its usage has seen a corresponding complexity in design, manufacture, and regulatory monitoring. Methods to successfully overcome the transdermal delivery device functionality barrier the skin are being perfected on several fronts, including engineered manufacturing processes, device design, material structure, and formulation. This paper focuses on the cautions that startups and established organizations must consider when daring to enter into the transdermal drug delivery market, with emphasis on choosing a manufacturing partner and a brief description of recent transdermal delivery applications.

Recent Applications

Complexities in developing Transdermal Drug delivery patches and their attendant risks have made it quite visible to regulatory authorities. While that is the case for certain applications, very low risk transdermal delivery applications are not subject to the same level of scrutiny. The applications that are of low risk include cosmeceuticals,   neutraceuticals, and aromatherapy. These are fast growing segments utilizing transdermal delivery technology and have little or no regulatory hurdles.

Broadly speaking, cosmeceuticals are associated with the use of active ingredients for purposes of skin toning. A transdermal delivery device for cosmeceutical application delivers active ingredients through the skin to improve appearance; an example would be anti-aging products.  Neutraceuticals include nutritional supplements. Transdermal delivery device for neutraceuticals are used to deliver nutritional supplements through the skin in the form of a patch. Similarly, aromatherapies are essential oils, aromatic compounds, etc. formulated to affect moods, relieve stress, relax muscles, etc. Transdermal delivery devices are used to deliver these oils and compounds through the skin.

The Right Converter

It is common knowledge that transdermal delivery devices are mostly in the form of patches containing several layers of flexible materials and the active ingredient. In each application, the materials are carefully chosen for compatibility, device integrity, and functionality. Understanding the critical parameters necessary to make the decision on what material to choose and having the expertise to derive these parameters are critical to a successful design and manufacture of any patch for any application. Medical device companies may be better off approaching organizations with the right experience for assistance.

Manufacturing patches for any application described in this paper is one of the most challenging tasks. Besides errors in formulation, malfunctions resulting from material selection and manufacturing could lead to terrible outcomes for users. One cannot over-emphasize the need to choose the right medical converter with the right experience when deciding on a transdermal drug delivery device project. Working with startups, contract design and manufacturing companies as well as OEMs, it is obvious that many still struggle with selecting the right converter. The decision must be made with great caution.

The most commonly used device for transdermal delivery in the areas of cosmeceuticals, neutraceuticals, and aromatherapy are patches. Irrespective of the application, formulation, design, material composition and structure, the manufacturing process of a patch requires much expertise and experience. The experienced medical converter is capable of deriving critical parameters that are a necessary input to decisions on material selection and manufacturing process design. Failure to choose the right manufacturer does increase the probability of product failure with possible severe outcomes.

Light Fabrications

Light Fabrications is a medical contract converter with ISO 13485 certification and operates from a large facility with two certified class 10,000 clean rooms. Light Fabrications provides experienced personnel and chooses technologies that are best suited for the product, all in an effort to make the product affordable.

Having invested in state-of-the-art converting equipment, Light Fabrications is committed to servicing the needs of startups and companies seeking to develop and manufacture transdermal delivery devices for cosmetics, nutrients, and aromatherapy.

 

 

Author:

 

Christian Yorgure

Director of Research & Development

Light Fabrications, A DIVISION OF EIS Inc.