Almost a year back, in February 2008 Mr. Rashmi Mohile and Mr. S. R. Vaidya had first meeting in Mumbai with Dr. Vinod P. Shah, Scientific Secretary of FIP in which idea of having a very focused approach for organizing Conference on Transdermal and Cosmeceuticals was discussed.

It was agreed to have a Conference under the agreement of IPA with AAPS / FIP / APSTJ and FPTI addressing upcoming issues and challenges facing Topical and ‘Skin related’ formulation development and to invite Prof. Howard Maibach as a key note speaker for this event.

It was then that ‘To & Thru the Skin’ started taking shape. Dr. V. P. Shah Prof. Howard Maibach rendered their full support in conceptualizing the scientific program and identifying ‘Experts Speakers’ in various areas of Topical and Transdermal formulations. The hard work put in by Local Organizing Committee of Indian Pharmaceutical Association comprising of Dr. B. Suresh, President, IPA, Mr. S. D. Joag, Hon Gen secretary, IPA Mr. T. B. Nair, Executive Secretary, IPA, Dr. Alka Mukne Scientific program coordinator and Mr. S. R. Vaidya In-charge Venue management made this event successful.

After formal inauguration of the conference Prof. Maibach delivered Key Note Address to the august gathering. In his keynote address, Prof. Maibach touched upon various dimensions, beginning with historical perspectives evolution of Transdermal delivery systems thru 1960’s & 70’s taking us thru development of 1st, 2nd and 3rd generation of Transdermals.

He also shared his interesting experience in generating preliminary data in early stage of Transdermal development, where he himself participated in the trial to get first hand feel of its result.

The keynote address was followed by first scientific session on regulatory and legal requirement pertaining to Transdermal delivery systems.

‘The Indian take’ as spelt out by Dr. Venkateswarlu was that for dermaceuticals and transdermals, requirements are the same as that for ‘drugs’ i.e. mainly safety & efficacy. He also emphasized the need to substantiate the ‘claims’ being made an ‘efficacy’ with respect of cosmetic pdts.

U.S. regulatory point of view was presented by Mr. Kurt Karst and Dr. Shah

Mr. Karst sited various examples where product could be classified as cosmetic or drug depending on the ‘claim’ it would make. He also touched upon three statutory paths of Drug Approval i.e. – 505 (b) (1), 505 (b) (2) & 505 (j). Dr. Shah explicably explained various regulatory aspects associated with transdermals, depending on whether they are classified as NDA on ANDA. He highlighted the regulatory challenges associated with transdermals since manufacturers had to meet requirements with respect to both drug & drug delivery device.

Formulation aspects were presented by Dr. Tom Spenser & Dr. Dange.

Dr. Tom Spencer elucidated various factors that can affect transdermal absorption. Dr. Spencer also stated that one must take into consideration the fact that the skin characteristic differ from animal to animal species and certainly with that of ‘human skin’. Hence, any preliminary work done on animal skin need to be extrapolated with great caution.

He additionally emphasized the need to do skin adhesion tests and submission of this data from ANDA application. Dr. Dange, while taking about the clinical importance and development of transdermals brought out the importance of design, concept, flux & adhesion.

Innovative new methods & technologies to enhance delivery transdermally was presented by Dr. Sivamani. Use of micro-needles for delivery of larger and complex molecules gave us insights into the future, thus go to come on this front.

Patent issues were then comprehensively addressed by Mr. Kevin Murphy making discussion on transdermals complete.

Dr. (Mrs.) Mukta Sachdev, Consultant Dermatologist from Manipal Hospital, Bangalore delivered Key Note address at the beginning of the second day. Dr. Sachdev in her inspiring speech covered Indian scenario with respect to emergence of derma-cosmetics in India and Challenges & Opportunities therein. She in her presentation touched upon various issues like challenges faced by Dermatologists in prescribing cosmeceuticals as ‘Adjunt’ with therapeutical or prescription products. She in her presentation also highlighted challenges which need to be addressed in developing cosmeceuticals products from Dermatologist perspective. She strongly emphasized the need for having evidence based ‘claims’ so as to enhance ‘Respectability’ which is lacking with many cosmetic products in market place, today.

The keynote address was followed by highly visionary, futuristic and thought – provoking presentation, again from Prof. Maibach on need for personalized skin care product centric approach. He concluded his presentation by emphasizing the need to give the right product, to the right patient in the right dosage. He too, emphasized that the future of cosmetic development depends on ability to customize evidence based personalized skin care products and bringing in much desired credibility.

Dr. Vinod Shah in his presentation comprehensively covered all regulatory requirements for Topical Drug Products. He also cited specific examples like anti-fungal products where in vitro release can be used for BE determination.

Dr. Johann Wiechers in his presentation ‘Formulating for better efficacy’ revealed various secrets (if I may say so) for formulating ‘Do good’ product rather than ‘Feel good’ approach often relied upon by cosmetic chemists. He also discussed his novel approach for formulating ‘MICMAC’ products.

Dr. Shah, standing for Dr. Avi Yacobi who unfortunately could not be present, covered number of issues in developing multi-source dermatological products.

Mr. Aki Immonen, in his very interesting presentation, explained non-invasive measurement technique for estimating transepidermal water loss., skin hydration of stratus corneum and dipper tissue fluids using instruments such as Moisturemeter SC, Moisturemeter D and Vapometer. These instruments can be used to generate objective data for quantification of various parameters. This data, along with systematic clinical quotations can be used to substantiate product claims there by bringing credibility to these claims. He cited various examples where data was generated for products such as moisturizers etc.

Dr. Johann Wiechers who is expert in this area of Claim substantiation explained basic approach and steps involved in making credible claims. He explained different claims relevant to cosmetic products – emotive claims, ingredient based claim, product claim and quality of life claim. Cosmetic claims are controlled in countries like U.K. Dr. Johann also explained four basic rules of Cosmetic Claims substantiation.

Developing transdermal and topical products require multi-dimension and systematic approach where as Dr. Johann Wiechers said one has to use their brains before using their brands. Also, there was an urgent need to bring credibility to product claims by doing systematic evidence based trials.

Reviewed by: S D Joag, Hon Gen secretary, IPA
Date: 28th February 2009