The international conference on harmonisations is the invention of three regulatory agency USA, JAPAN, EUROPE. The ICH bringing together with regulatory affair for registration of product and scientific, technical aspect. The mission of the ICH is to improve worldwide harmonization with safety and efficacy also registration and development of high quality with good manner. The ICH in quality area which provide guidance to conduct stability study, impurity detection, pharmaceutical manufacturing and development, regulatory aspect, good manufacturing practices, quality risk management. The ICH quality guideline control and improve pharmaceuticals drug development with better harmonization.
Background: Solid lipid nanoparticles (SLN) have drawn increasing interest in recent years. These nanoparticles are formed from stable or solid lipid mixtures and then stabilized by emulsifiers. As nanoparticles, colloidal particles running in size somewhere in the 10 to 1000 nm range are known. SLN provides fascinating properties, such as minimal scale, massive surface area, high medication piling, correspondence of stages at the interface, and is interested in their ability to enhance drug execution. Main text: This paper provides a description of the choice of ingredients, the effect of lipids and their structure on the formulation, and the various methods of processing SLN. We explain the characteristics of SLN stability and the possibilities of SLN stabilization by lyophilization in this article. The relation between drug absorption and the complexity of SLN dispersions, which involves the existence of other colloidal structures and the physical state of the lipid, is uncommonly considered. We define the possible problems of SLN preparation and performance on the basis of characterization. First, the nasal route was known to accomplish the avoidance of first-pass hepatic metabolism in order to maximize absolute bioavailability, and secondly, the immediate nose-to-brain pathway to enhance the delivery of brain medicines. SLNs have been designated to increase drug permeability through the blood-brain barrier as a drug delivery device (BBB). Conclusion: To sum up, this article gives insight SLNs a colloidal drug carrier places together the compensations of polymeric nanoparticles, SLNs have numerous benefits such as easy incorporation of lipid and lipophilic as well as hydrophilic drugs, suitable physical stability, and available at low cost and easy to manufacture. The nasal route was accepted to exploit first its prevention of the hepatic first-pass metabolism to increase the absolute bioavailability, and second, the direct nose-to-brain pathway to enhance the brain drug delivery. SLNs were chosen as a drug delivery system to improve drug permeability across the blood-brain barrier (BBB) and consequently its brain delivery.
Dabigatran Etexilate Mesylate (DEM), a salt of prodrug dabigatran etexilate, is a potent, oral, reversible and direct thrombin inhibitor with low oral bioavailability. The present research investigation focused on the formulation of immediate release (IR) tablets of DEM cocrystals and evaluation of In vivo anticoagulant activity. The results of the study showed that the formulated IR tablets of DEM showed improved efficacy in comparison with the plain drug by enhancing the pre-compression parameters such as bulk density, tap density, Carr's index, angle of repose and Hausner's ratio and post-compression parameters like thickness and weight variation, hardness and friability, In vitro dissolution parameters. The improved efficacy was confirmed by improvement in the pharmacodynamic parameters such as cutaneous bleeding time and clotting time indicative of enhanced bioavailability of dabigatran. Thus, it can be concluded that the IR tablets of dabigatran cocrystals can be proven to be more effective in producing the anticoagulant effect in clinical practice as compared to the plain drug resulting in more patient compliance.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.