P. Venkatesh

The majority of pharmaceuticals used today are chiral. A brief summary of various chiral separation principles and associated separation methods is provided in this review. Liquid chromatography (LC), capillary electrophoresis (CE), high-performance liquid chromatography (HPLC), and gas chromatography (GC) are only a few of the recent advancements addressed. The creation of competent analytical techniques is essential for compliance with the numerous regulatory obligations. The rapid development of chiral separation technologies has been fueled by the current situation in which chirality factors are taken into account in therapeutic benefit and drug development. High-performance liquid chromatography (HPLC) and gas chromatography (GC) have unquestionably made important advancements in chiral chromatographic technology, opening the door to the quantification of specific enantiomers of a number of racemates in biological fluids such plasma, serum, urine, etc. Chiral compound separations and analyses are crucial in a variety of industries, such as biology, pharmaceutical manufacturing, and the creation of chemical intermediates.

Pharmaceutical R&D is failing with an era of triple obstacles – increased timelines for approval, high cost and even higher failure rates. The world around us is constantly putting pressure on creating completely new solutions for about 4000 diseases with known molecular basics and many other diseases without basic intellect. There comes a need to remove the wide gap in innovation showcasing a challenge for drug discovery. The shockingly tedious drug development process is forcing us to find more effective solutions and drug repurposing can be a starting point where the clear understanding of the de novo pathway for an existing drug essentially unlocks the full potential for repurposing a drug for other diseases. Drug repositioning (also known as drug repurposing, re-profiling, re-tasking or therapeutic switching) is the application of known  drugs and compounds to new indications (i.e., new diseases). This idea dates back with cases like Viagra, Thalidomide, and Aspirin etc. There are a number of approaches to drug repurposing, but these are ultimately an expedition into new area. Scientists have to justify examining a compound in a different disease state, so they often make a hypothesis based on possible associations between mechanisms. A significant advantage of drug repositioning over traditional drug development is that since the repositioned drug has already passed a significant number of toxicity and other tests, its safety is known and the risk of failure for reasons of adverse toxicology are reduced. The possibilities are endless, and animal models are elevating drug repurposing's potential.

A tattoo is a form of body modification by inserting indelible ink into the dermis of the skin to change the pigment. Permanent makeup is a cosmetic technique which employs tattoos as a means of producing designs that resemble makeup. In the United States, the percentage of adults with minimum one tattoo has increased from 21% in 2012 to around 38% in 2016. The process of tattooing exposes the recipient to risks of infections with various pathogens, which are serious and difficult to treat. Other risks include allergic reactions, swelling and burning, granulomas, keloid formation and complications with MRI. Removal of tattoo is cumbersome. The pigments used in the inks are color additives, which are subject to premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other competing public health priorities and a previous lack of evidence of safety problems specifically associated with these pigments, FDA traditionally has not exercised regulatory authority for color additives on the pigments used in tattoo inks. FDA only monitors problems from tattoos and permanent make-up and alerts the public when they become aware of a problem. Consumers should be aware of the risks involved in order to make an informed decision. FDA urges consumers and healthcare providers to report adverse reactions from tattoos, permanent makeup, and temporary tattoos, as well as problems with tattoo removal. But it’s high time that FDA takes a strong call on this matter and strictly regulates these practices to prevent further harm to public.

  The imminent patent expiration of many biopharmaceutical products will produce the possibility for generic versions of these therapeutic agents (i.e. biosimilars). However, there are a number of issues that will make approval of biosimilars much more complicated than the approval of generic equivalents of conventional pharmaceuticals. These issues center on the intrinsic complexity of biopharmaceutical agents, which are recombinant proteins in most cases, and the heterogeneity of proteins produced by different manufacturing processes. The increased occurrence of antibody (Ab)-mediated pure red cell aplasia (PRCA) associated with change in the formulation of one particular epoetin-α product highlights the potential for increased immunogenicity of recombinant proteins with different formulations, or those manufactured by different processes. The subsequent production of ‘biosimilars’ has aroused interest within the pharmaceutical industry as biosimilar manufacturers strive to obtain part of an already large and rapidly growing market. The potential opportunity for price reductions versus the originator biopharmaceuticals remains to be determined, as the advantage of a slightly cheaper price may be outweighed by the hypothetical increased risk of side effects from biosimilar molecules that are not exact copies of their originators. This review focuses on the issues surrounding biosimilars, including quality control, clinical efficacy and side effects.