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Skin Deep

 

At the current time, when companies from all sectors, including those from the pharmaceutical industry, are experiencing the impact of recession, it is critical that they make optimal use of available resources. In a recent presentation at the annual meeting of the Controlled Release Society, it was proposed that the way out of this situation is for companies to invest wisely in the areas driven by the importance of therapy, molecule and use of efficient novel techniques (1). Some of the areas demanding attention and investment include oncology, immunology, endocrinology, central nervous system, cardiology and diabetes. Drug molecules for the treatment of most of these indications happen to be therapeutic proteins, macromolecules and biopharmaceuticals. Furthermore, investment in the use of novel and efficient drug delivery techniques to enable the delivery of these molecules is needed. Among the possible delivery routes, topical and transdermal drug delivery systems seem to be a promising route for the delivery of biopharmaceuticals.

Transdermal is the third most common route of drug delivery, behind oral and parenteral routes. It offers several advantages over other routes: for example, it bypasses hepatic metabolism (first pass effect), provides protection from harsh GIT conditions (especially beneficial for proteins), reduces systemic drug exposure, simulates intravenous infusion, allows less frequent administration for drugs with short half life, provides ease of termination of therapy in case of overdose, offers high patient compliance and acceptability, reduced drug usage and improved use of resources. As is true with any other technique, transdermal drug delivery systems (TDDS) have some limitations as well. Due to the excellent barrier properties of the skin, only moderately lipophilic (log P between 1 and 3.5), highly potent (dose ~10mg per day from a 10cm2 patch) and small drug molecules (MW < 500Da) can diffuse passively for systemic or local action. As a result of these limitations, most of the transdermal products in the market today are for small, moderately lipophilic molecules. These include the scopolamine patch (TDDS on market indicated for motion sickness), nicotine patch (smoking cessation), fentanyl patch (postoperative pain management) and others. Ongoing research is expected to expand the range and type of drug molecules that can be delivered via this route. A number of enhancement techniques have been tried to achieve this goal. These include use of chemical enhancers, electrical and ultrasound energy assisted enhancement techniques such as iontophoresis and sonophoresis, respectively (second generation), and the most recent (third generation) technology is microporation (mechanical, thermal, laser and radiofrequency ablation) (2). This article will discuss second and third generation enhancement techniques with a primary focus on their practical aspects, major challenges in their development, and progress towards commercialisation for the delivery of biopharmaceuticals. These biopharmaceuticals do not normally diffuse passively through the skin as they are water soluble molecules. Furthermore, many are macromolecules, which present further challenges for transdermal delivery.


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Vishal Sachdeva completed his Bachelors of Pharmacy from Delhi University, India. He is currently pursuing his PhD in Transdermal Drug Delivery under Dr Ajay K Banga at Mercer University College of Pharmacy and Health Sciences, Atlanta, US, and is in the third year of the programme. He has been working in the areas of conventional patch technology, iontophoresis for enhanced delivery of small drug molecules and microneedles assisted delivery of macromolecules. He has been an active student member of the American Association of Pharmaceutical Scientists (AAPS), Controlled Release Society (CRS) and Modified Release Focus Group (MRFG) in AAPS. He has presented his research work as posters and podiums in various conferences of AAPS, GRASP and CRS. As a student member in the steering team of MRFG, he has been writing articles for the newsletter on topics related to different areas of drug delivery.

Dr Ajay K Banga is Professor and Chair in the Department of Pharmaceutical Sciences at the College of Pharmacy and Health Sciences, Mercer University, Atlanta, US. His research expertise is in non-traditional approaches to transdermal drug delivery, especially for water-soluble drugs including small conventional molecules and macromolecules. Ajay has a PhD in Pharmaceutics from Rutgers University, US. He currently serves on the Editorial Board of seven journals and has served as Editor-in-Chief for a drug delivery journal. He has written two books in the areas of delivery of proteins and transdermal delivery. He has served on over 30 thesis/dissertation advisory committees and as a referee for over 28 journals. He is a Fellow of the American Association of Pharmaceutical Scientists.

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Vishal Sachdeva
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Ajay K Banga
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