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India hub for derma clinical trials; sponsors find US FDA norms on TDS useful

Nandita Vijay, Bengaluru
Monday, July 26, 2021, 08:00 Hrs  [IST]

India is a key market for derma clinical trials and the new US FDA norms on assessment of adhesion for transdermal and topical delivery systems (TDS) submitted in New Drug Applications are seen to be helpful for sponsors of human studies in the country. The guidance in its draft form recommends clinical trials designed to assess the adhesion performance of TDS.

Adhesion performance is whether the TDS fully sticks to applied location on the subject for the duration of use. This is because adhesion failures can result in reduced effectiveness caused by suboptimal dosing or potentially increased exposure and a new TDS needs to be applied sooner than the scheduled dose, said the regulator.

Topically administered liquid and semisolid drug products like gels, creams, lotions, foams, ointments, or sprays are not considered to be TDS even though they can be formulated to provide local, or, transdermal delivery of the drug and so is not covered under this guidance.

Additionally, partial or full detachment of a TDS from a patient’s skin may result in unintentional exposure of the active pharmaceutical ingredient to a partner, child, or other individual, potentially exposing them to the drug’s toxicity. Therefore the sponsors need to coordinate with the clinical review to discuss specific design and methodology issues.

Skin diseases like psoriasis, eczema, skin cancer, and vitiligo are the 4th leading cause of non-fatal disease burden worldwide, as per the Global Burden of Disease Project. WHO estimates annual diagnosis of around 3 million cases of non-melanoma skin cancer and 132,000 cases of melanoma skin cancer globally.  Psoriasis prevalence worldwide ranges between 0.09% and 11.43%, making it a serious as at least 100 million are affected. It is here TDS is the first line of treatment for the majority of skin diseases and the demand for advanced topical products is expected to increase in the coming years.

Keeping this is in view, the US FDA guidance provides details on TDS which are designed to deliver an API across the skin and into systemic circulation. Topical delivery systems are designed to deliver the same to local tissue.  The amount of drug delivered into and through the patient’s skin from a TDS depends on the surface area in direct contact with the TDS.

Moreover the TDS according to the global regulator should remain uniformly adherent to the patient’s skin throughout the duration of wear. During the product’s wear period, a TDS is expected to encounter torsional strains arising from body movements, changes in environmental temperature or humidity such as daily exposure to water during routine showering, and contact with clothing, bedding and other surfaces. When a TDS loses its adhesion during wear, the amount of drug delivered to the patient may be reduced, potentially compromising effectiveness.

The development of TDS has evolved over the years, especially with expected adhesion performance. Those currently developed could use technologies that were not available when the first TDS products were approved. Hence the guidance takes these developments into consideration, said the regulator.

While TDS is now largely a focus of global pharma majors, from an India pharma stand point companies like Sun Pharma, Lupin, Dr Reddy’s and Torrent are also developing the same.


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