: The history of pharmacovigilance started back 169 years ago with the death of a 15- year-old girl, Hannah greener. However, the Thalidomide incident of 1961 brought a sharp change in the pharmacovigilance process, with adverse drug reaction reporting being systematic, spontaneous, and regulated timely. Therefore, continuous monitoring of marketed drugs was essential to ensure the safety of public health. Any observed adverse drug reaction detected by signals was to be reported by the health profession. Moreover, signal detection became the primary goal of pharmacovigilance based on reported cases. Among various methods used for signal detection, the Spontaneous Reporting System was most widely preferred; although, it had the limitation of "under- reporting”. Gradually, the World Health Organization collaborating centre and “Uppsala Monitoring Centre” were established in 1978 for international monitoring of drugs. The centre was responsible for operating various databases like vigiflow, vigibase, vigilyze, and vigiaccess. Recently, huge data could be generated through spontaneous reporting linked with computational methods, such as Bayesian Framework, E-Synthesis.: Furthermore, drug safety surveillance at an early stage prior to the official alerts or regulatory changes was made possible through social media. In addition, India created a National Pharmacovigilance Program, and Schedule Y of the Drug and Cosmetic Act 1945 was reviewed and amended in 2005. The collaboration of Information Technology and Pharmaceutical Company can further enhance the awareness regarding artificial intelligence in pharmacovigilance, which was in its infancy until 2017. Artificial intelligence helps improve the quality and accuracy of information much quickly.

Background: Cefpodoxime Proxetil (CPD) is a broad-spectrum cephalosporin indicated in respiratory and urinary tract infections. CPD is a BCS class IV drug with pH-dependent solubility and has poor bioavailability. This study investigated the challenges of developing ternary components based on solid SNEDDS of CPD for in vitro dissolution rate enhancement and self -solidifying behaviour. Methods: Tween 80, Transcutol and PEG6000 were employed as surfactants, solvents and solidifiers for a base of ternary components to develop self-solidifying solid SNEDDS, respectively. Ternary phase diagrams were used to characterize solidifying behaviour of ternary components in different proportions. S-SNEDDS formulations were drawn on the solidification areas available in the phase diagram and characterized for IR, XRD, DSC and in vitro drug release in various pH media. Results: Ternary components for the preparation of self-solidifying solid SNEDDS were selected based on drug solubility. FTIR and DSC characterization studies ruled out any drug interaction between CPD and components chosen to prepare S-SNEDDS. CPD was transformed from a crystalline into an amorphous state in ternary dispersions as revealed from XRD data. Optimized formulation (S-S 1) demonstrated more than 95% of drug release irrespective of the pH environments of the medium. Calculation of dissolution efficiency and similarity factors indicate that S SNEDDS resulted in a higher drug dissolution rate over binary dispersion (p<0.01). The stability studies showed that the S SNEDDS were stable in performances and CPD assay. Conclusion: The present investigation provides an alternative approach for enhancing the CPD dissolution rate using self-solidifying solid SNEDDS exhibited solidification behaviour at ambient temperature conditions and drug loading, which could be exploited over conventional dosage form.

In the present research, the potential of topical microemulsion delivery of poorly aqueous soluble drug, that is, Celecoxib, was investigated. Microemulsions are regarded as highly biocompatible topical carrier systems for the delivery of several anti-inflammatory, local anesthetics, anti-infective drugs. Microemulsion vehicles composed of various proportions of oleic acid, Lipoid E80, and Capryol 90/PEG 400 as oil phase, surfactant, and cosurfactant phase, respectively. A pseudo-ternary phase diagram was constructed at room temperature by titration method, and the oil-to-surfactant/co-surfactant volume ratios (O/SC) that exhibit the maximum solubilization of water were determined. Microemulsion formulations were physically characterized for globule size, thermal stability, centrifugation stress testing, specific gravity, pH, and in vitro permeation studies on rat abdominal skin. The permeation data showed that microemulsion formulation, ME-2, showed increased Celecoxib flux to several-fold over the control vehicle, that is, the self-prepared gel formulation. It was concluded from the above studies that microemulsions could be a promising dosage form to improve drug stability in topical formulations.

Background: This research aims to prepare a hydrogel of psoralen and capsaicin extract for topical application using various gelling agents like Carbopol 940, HPMC, Pluronic 127, and Pectin to minimize the side effect of synthetic drugs in treating psoriasis. Natural, synthetic, and semi-synthetic polymers were utilized for the treatment of psoriasis, and provide a number of benefits, including improved skin permeability, particularly for psoralen, and improved drug stability with improved therapeutic concentration gradients across the skin. Psoriasis is a T cell-mediated autoimmune disease affecting 2-3 % worldwide. Methods: FTIR and HPLC confirm the extract identification. pH, spreadability, homogeneity, extrudability, phase separation, viscosity, drug content, and stability analysis are all tested on all prepared hydrogels. The releases of psoralen from all prepared formulations are studied in phosphate buffer pH 6.8 using dialysis membranes at 37oC. Results: The net results conclude that hydrogels made using Carbopol-940 and HPMC (A1, A3, B2, B3) are the most superior and reliable formulations in terms of physicochemical parameters and in vitro permeation studies, out of which 1% carbopol 940 formulations (A3) showed maximum %CDR of 87.96 % much higher compared to other concentration used. Fitting data of the best formulations (A1, A3, B2, B3) obtained from in vitro drug permeation studies showed the release best fitted to the Korsmeyer-Peppas model as indicated by higher R2 value. The optimum formulation (A3) has a higher R2 value, which is then compared with the marketed formulation for the release of psoralen (in vitro), showing that %CDR of the A3 formulation (87.96%) is much higher than the %CDR of the marketed formulation (79.58%), due to the impact of capsaicin which acts as a penetration enhancer and therefore increases psoralen release from the hydrogel. Conclusion: As a result, the permeability issue with Psoralen for dermal drug administration has been overcome by using capsaicin as a permeability enhancer.

Most antihypertensive drugs have impaired dissolution rate and result from poorly aqueous solubility, polymorphic modifications, structure-based H-bond donor or acceptor anamolies. These physical attributes would have detrimental effects and may cause an entity out of the race from efficacious candidates. Nevertheless, compliance with the dissolution rate must be fulfilled under the regulatory mandate and serve as an assessment tool for product performance. The present reviews the niche technologies like electrospinning, spraying, or mesoporous methods that led to the generation of more dissolvable antihypertensives. Several drug delivery systems design allows the incorporation of surfactants, microenvironment dissolution rate modifiers, acidifiers that could improve the dissolution rate of antihypertensives are reviewed.