Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 5, Issue 3, 2018

Background: Nanoscience is the section of science related to the study of minute particles on an atomic or molecular scale, whose size is measured in nanometres. Nanotechnology serves as one of the most capable technologies and accomplished approaches of the 21st century which is safe and efficacious for novel drug delivery systems. Now, nanotechnology is used widely in the field of cosmetics and dermatology due to the improved properties of the atoms at the nano level. Objectives: This mini-review article has been planned to discuss basic facts regarding nanotechnology as well as various nanotechnology drug delivery systems used in cosmetics and dermatology, applications of nanotechnology and overview of patents published recently in the field of nanocosmetics. The current status of regulatory as well as safety and quality aspects for the use of nanotechnology in cosmetics and dermatology will also be discussed. Discussion: Cosmetics industry is the sixth largest industry among United States patent holders in nanotechnology. Nanotechnology has transfigured the treatment of several skin diseases. Possible applications of nanotechnology in dermatology and cosmetology include sunscreens, moisturizers, anti-aging formulations, anti-sepsis, nails and hair care. The recent studies to date suggest that the nano-cosmeceuticals have no safety issues with skin as well as human health, although the nano-cosmeceuticals are beneficial for human health in a number of ways such as guarding against UV rays which may cause skin cancer. The regulatory bodies had performed an active debate on the potential risk of nano-cosmeceuticals on human health and steps have been taken for thecoordination of regulatory rules.

Herbals have been explored worldwide from ancient times for their innumerable therapeutic applications. Despite the advantages, phytomedicines encounter several drawbacks like toxicity, lower bioavailability, stability problem and patient compliance. To overcome these constraints researchers came up with the introduction of Novel Drug Delivery Systems (NDDS). These included polymeric liposomes, nanolipid carriers, colloidosomes, solid lipid nanoparticles, aquasomes, niosomes, proliposomes, nanocapsules, ethosomes, phytosomes, nanoparticles, nanoemulsions, and transferosomes. Nanotechnology is being ventured as an emerging trend in the field of medicines eliciting improved therapeutic benefits. It reflects the interface between new technology and herboceuticals. These upcoming herbal formulations are being patented too. Since nanotechnology is slowly creeping into every aspect of life, a concern has been generated related to the human safety. Hence, the present time demands the regulations to be set up for nanomaterials. In this paper, an effort has been made to compile various herbal nanoformulations and patents and a glance on the regulatory aspects of various regulatory bodies on nanotechnology have been provided.

Medical devices are the tool, machine, apparatus, instrument, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, treatment or prevention of an illness. Demand for medical devices around the world has drawn the attention of government agencies to make sure the effectiveness and safety of these products. The United States and European Union have established regulatory systems for medical devices, which have been constantly modified to adapt to changing security requirements. Medical devices regulation has become a most important regulatory initiative in the United States and European Union. It needs to ensure that medical devices are of high quality, obviously due to nature. In the present paper, the regulatory approval process in the United States and the European Medical Union is reviewed, with the medical device classification, competent authorities, standards, regulations, quality management systems, labeling requirements, time required for approval, post-marketing surveillance and medical device vigilance system, top 20 medical devices companies in 2016 and 2017.

Sublingual route increases the efficacy of the drug by dissolving in few seconds in the oral cavity. Being a fast dissolving tablet the sublingual tablet is mostly acceptable in an emergency because it does not require chewing as well as water for administration. An important advantage of the sublingual route is that it bypasses the hepatic circulation of the drug ultimately increasing the bioavailability of the drug with rapid onset of action and patient compliance. It is a very suitable route of administration especially for pediatric, geriatric and psychiatric patients having difficulty in swallowing (dysphagia). Sublingual route is more permeable as compared to buccal and gingival route due to the rapid onset of action of the drug when administered by sublingual route. In the developing countries vaccination for the prohibition of various diseases is routinely done so sublingual route is the most preferable because of the large surface area and immunological competence. Mucosal tissues are attractive administration and target sites for vaccination. This review focused on the different sublingual dosage forms, advantages, and factors affecting sublingual absorption, methods of preparation and various in vitro and in vivo evaluation parameters of the sublingual tablet.