**12. Regulations on dermal and transdermal delivery systems**

Safety and toxicological issues are the most important issues for a drug delivery system. Safety is an obvious concern for the fast growth of nanoparticles mediated drug delivery [152]. Governmental regulatory agencies such as the United States Food and Drug Agency (USFDA) have established guidelines describing the kind of safety tests that should be conducted in animals in order to have a new drug approved for use in clinical trials and in order to get approval of a new drug application (NDA) for marketing. The rationale and circumstances for conducting reproductive, mutagenicity, carcinogenicity, irritation, and sensitization studies have already been mentioned. The requirements for acute, subacute, and chronic toxicity studies for pharmaceutical products intended for use in humans as described according to are the requirements of the United States, Japan, and Europe because these areas represent the largest pharmaceutical markets in the world today. These requirements have been developed at the International Conference on Harmonization to provide uniformity among the three regions [153]. Phases I, II, and III refer to the different phases of human clinical trials. Phase I refers to the initial trials, limited to one or a few doses to determine absorption, pharmacoki‐ netics, and an initial estimate of safety. Phase II refers to larger scale studies to establish safety and to get an initial estimate of clinical efficacy. Phase III refers to the final, large-scale, multicenter trials aimed at establishing efficacy.

**13. Dermal and transdermal formulations on the market**

are presented in Table 3.

**Drug Trade name Type of**

NTS patch Rim

Clonidine Catapres-TTS

A lot of dermal and transdermal drug delivery systems have been licensed for manufacture after passing through the regulatory approval and trials as specified by different countries example FDA (United States of America). Some of the drugs currently available on the market

Fentanyl Duragesic Reservoir Alza/Janssen Pharmaceutica Moderate/ Severe pain

Nitroglycerine Deponit Drug in adhesive Schwarz Pharma Angina Pectoris

**Manufacturer Indication**

Nanoparticles for Dermal and Transdermal Drug Delivery

http://dx.doi.org/10.5772/58672

221

Bolar, Major, Qualitest, Bio-Line, Goldline, Geneva, Rugby WarnerChilcott Lab

males

**transdermal patch**

Minitran Drug in adhesive 3M Pharmaceuticals

Nitrodur Matrix Key Pharmaceuticals

Nitrodisc Micro reservoir Searle, USA

TransdermNitro Reservoir Alza/Novartis Nitroderm TTS Face Novartis

Diafusor Matrix Schering-Plough Transdermal-NTG Rim Warner Chilcott Lab Nitrocine Rim Kremer Urban Nitro patch Rim Adria Lab

Isosorbide dinitrate Frandol Tape Matrix Toaeiyo, Yamanouchi Pharm.

Nicotinell Matrix Novartis Nikofrenon Matrix Novartis Habitraol Drug in adhesive Novartis

Testoderm TTS Reservoir Alza

Nicotine Prostep Reservoir ElanCorp/Lederie Labs Smoking Cessation Nicotrol Drug in adhesive Cygnus Inc./McNeil Consumer

Testosterone Androderm Reservoir Thera Tech/ GlaxoSmithKline Hypogonadism in

Membrane matrix

Lidocaine Lidoderm Drug in adhesive Cerner Multum, Inc. Anesthetic

Products Ltd.

hybrid type Alza/Boehinger Ingelheim Hypertension

The Food and drug agency (FDA) paradigm for regulation of new products is based on the concepts of risk management, which includes identification, analysis and control of risk [154]. The regulation and approval by the FDA is on a ''product by product'' basis, with the overall regulation process falling into three stages: premarket approval, premarket acceptance and post-market surveillance.

Premarket approval: Prior to market introduction of any new pharmaceuticals, high-risk medical devices, food additives, colors, and biologicals, FDA approval is required. The producer/sponsor of the product is responsible for identifying and assessing the risks pre‐ sented by the product. This party will also be responsible for indicating means to minimize the risks in a product application.

Premarket acceptance: This category refers to products that are often copies of similar products that were approved previously or are products prepared according to approved specifications. For these products, the FDA receives and reviews some form of notice that the products will be marketed and the products undergo a more rapid review process than premarket approval.

Postmarket surveillance: In this category, FDA manages the risks of GRAS products like foods, cosmetics, radiation emitting electronic products and materials such as food additives and food packaging. For products in this category, market entry, and distribution are at the discretion of the manufacturer/producer. These products are generally regulated by the application of good manufacturing practices. FDA takes regulatory action if adverse events that threaten public or individual health occur.

The FDA coordinates policies within itself and with other government agencies. As and when new toxicological risks that derive from the new materials and/or new conformations of existing materials are identified, the FDA will require new tests.

The FDA regulations are for products, not technologies. In addition, the FDA regulates only the claims made by the product sponsor. If the manufacturer makes no nanotechnology claims regarding the manufacture or performance of the product, the FDA may be unaware at the time that the product under review employed nanotechnology. Finally, the FDA has only limited authority over some potentially high-risk products, such as cosmetics. Many products are regulated only if they cause adverse health-related events in use. To date there have been few resources available to assess the risks of these products.
