Pharmacovigilance is that the science and activities associated with the gathering, detection and assessment of adverse event data. Major purpose of pharmacovigilance is to gauge the benefit- risk profile of drug for better efficacy and safety to be used in patients. Pharmacovigilance plays a major role in rationale use of drug which provides the information about the adverse drug reactions which seen in patients. In terms of volume Indian Pharma industry is third largest in world and in terms of value id thirteen largest in world. India is also known as a hub for clinical research and drug development. There is a requirement of a global and standardized pharmacovigilance system in India for better safety assessment in India. In drug development process the only priority of clinical trials is to make sure patient safety during and after the trials. A critical component throughout the drug development life-cycle is monitoring patient safety. Patient must be treated consistent with the requirements and illness of patient therefore the utmost value is given to monitoring of patient safety in the least levels of drug development. Such monitoring may be a dynamic process so to approach safety monitoring. To ensure a systematic approach to safety monitoring pharmaceutical sponsor must work proactively and collaboratively with all stakeholders. We have to focus upon all the aspects of drug safety in clinical trials including basics of drug safety, regulatory aspects of drug safety, patient suitability for safety in trials, post marketing safety and causality risk assessment of the drug products.

Introduction: Parkinson's disease is a neurological disorder in which there is a gradual loss of brain cells that make and store dopamine. Ropinirole hydrochloride (ROPH) is an anti-Parkinson's drug which undergoes extensively first-pass metabolism, with oral bioavailability 45%. Aim: The study aimed to formulation, optimization, and evaluation of ROPH buccal patch using xanthan gum (XG). Materials and Methods: Solvent casting method was used to prepare mucoadhesive buccal patch ROPH using XG as a mucoadhesive polymer, polyvinylpyrrolidone K90 as a film former and polycarbophil and hydroxypropyl methylcellulose K4M as a release retardant. Results and Discussion: The dissolution studies showed sustained release of drug about 97.86% for 8 h following Korsmeyer-Peppas model (r 2 =0.989, n = 0.199). The optimization of all prepared batches was carried out by 3 2 factorial designs, the optimized batch F3 showed acceptable physicochemical properties and having swelling index 286.10%, mucoadhesive strength 26.90 g, tensile strength 0.04±0.01 N/mm 2 , and in vitro drug release 97.86%. Ex vivo permeability was carried out using sheep buccal mucosa and it was found to be increased by five folds than that of formulation without penetration enhancer. After histopathological evaluation cellular membrane was found to be intact and did not show any signs of necrosis. Conclusion: Thus, an attempt to formulate a stable mucoadhesive buccal patch was made. The in vitro studies have shown that this is a potential drug delivery system for ROPH with good stability and release profile.

Nanostructured lipid carriers (NLCs) are innovative pharmaceutical formulations made up of physiological and biocompatible lipids, as well as surfactants and co-surfactant. The initial generation of lipid nanoparticles was Solid Lipid Nanoparticles (SLN), which had a longer-lasting activity and was better, suited to drug penetration. The NLC is a second-generation lipid nanoparticle designed to alleviate the limitations of SLN, such as limited drug loading capacity and solid lipid polymorphism. Many benefits of topical medication delivery include avoiding first-pass metabolism, focusing active components for a local effect, and patient compliance. When compared to typical topical dose forms, nanoparticles have a greater effect in transporting medications through the skin. The structure, composition, many formulation methods, and characterization of NLCs are all important aspects in formulating a stable drug delivery system, as discussed in this review paper. A variety of approaches are used to make solid lipid nanoparticles and nanostructured lipid carriers, which are discussed in this paper. Lipid nanoparticles have a variety of features that make them suitable for topical usage in cosmetics and medicinal formulations. Because of extensive positive benefits such as skin hydration, skin occlusion, and skin targeting, NLCs have a significant potential in the pharmaceutical market. Skin hydration is important for API topical distribution because it hydrates the skin, which causes the pores to open. Trans epidermal water loss decreases due to the occlusion nature of lipid nanoparticles, softening the skin. It is more suited since it uses biodegradable grade lipid, which does not cause toxicity like polymeric Nano formulations. Actually, because of their biodegradable composition, NLCs are a “Nano safe” carrier that has a lot of potential for overcoming the obstacles of topical distribution.

Due to the number of disorders associated with oral, parenteral, rectal and other routes of administration, Scientists are increasingly interested in exploring the potential nasal uses of various drugs. Intranasal drug delivery systems are commonly known to treat ailments such as colds, coughs, and rhinitis. This review therefore focuses on new research on nanostructured lipid transporters for nasal brain targets that are beneficial for various neurodegenerative disorders. Here highlighted one is Alzheimer disorder. The incorporation of drugs into nanoparticles selects drug delivery from the nose to the brain due to high drug absorption through the nasal mucosa and many benefits of brain-targeted drug delivery such as avoidance of BBB could be a talent approach. This is achieved by pathway mechanism. NLC as a lipid-containing drug delivery system, is an established method for pharmaceutical preparation for all major types of DDS in Nano science. NLC is a new type of DDS, stable in various environments and capable of forming centralized dispersions. This article covers various processes of NLC production/ preparation and its applications with current advances. NLC can increase drug delivery to target organs, alter the pharmacokinetics of drug carriers to enhance therapeutic effects and reduce harmful side effects.