Regulatory approval pathway for COVID-19 vaccine in USA, Europe and India.

The coronavirus disease-2019 (COVID-19) outbreak has confused everyone, including healthcare experts, physicians and frontline workers. Monoclonal antibodies, anticoagulants and immunomodulatory therapy were initially used to treat COVID-19. However, they can only inhibit the virus from replicating, which is not enough to provide a lasting cure. As each month passes, a growing number of companies are working on vaccinations that will aid in the development of resistance against the corona virus. As a result, all regulatory bodies have stated that if a vaccine has high efficacy and low risk of adverse events, it will be approved through an emergency use application. However, there is one major hindrance: After completing phase II clinical trials with an emergency use application, the product can be released to the market. However, the firm should conduct phase III and phase IV trials at the same time, with peer review occurring after each cycle of clinical trials and also market data to be presented simultaneously to track adverse events. In this article, the author has compared the standard approval process (i.e. Standard Biological License application) with the emergency use application to describe how the COVID-19 vaccine was approved by the different regulatory bodies.

Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies.

Silybum marianum has been used for centuries by herbalists and physicians to treat different forms of liver diseases. It contains flavonoid, which has antioxidant, anti-inflammatory, antifibrotic and anticancer properties. The objective of this research was to develop a silymarin-based mucoadhesive gel for prolonged release in oral mucosa and to evaluate the same by using in vitro drug release kinetic models and ex vivo methods for drug permeation using chicken buccal mucosa. The mucoadhesive gel was formulated in different trials by varying the concentration of silymarin and polymer. Out of 10 formulation trials, the F10 optimized trial was characterized for in vitro physicochemical parameters such as pH, homogeneity, viscosity, stability, drug content, in vitro drug release, in vitro antioxidant assay and ex vivo permeation study. Trial 10 was chosen as the best trial formulation among the other trials and was marked as an optimal trial. The physicochemical properties observed were pH to be 6.4 ± 0.01, the gel free of lumps, spreadability of 23.75 ± 0.03 and drug content of 32.77 ± 0.20 mg/g. It had no physiological changes such as color shift or fluid exudate segregation after 6 months of storage at room temperature. In vitro drug release established the presence of a non-fickian mechanism and demonstrated dose-dependent antioxidant activity. Ex vivo findings indicated 21.97 ± 0.18% release, proving that the gel can permeate through the oral mucosal membrane. Our future research will concentrate on expanding the therapeutic scope by developing the formulation trial F10 to a nanoformulation and conducting clinical trials for its potential use in various oral diseases.

Applications of Chitosan Derivatives as Adjuvant for Nanoparticles Based Vaccines.

This review focuses on the applications of chitosan derivatives towards vaccine delivery for their role as adjuvants. Adjuvants have been used as one of the key components in modern-day vaccines to enhance the immune response or as a drug delivery carrier. Generally, vaccines are administered to protect the host against harmful disease-causing infectious pathogens. The area of vaccine delivery is reaching new heights day by day with the evolution of the strategies and tools used for vaccine development. Currently, the vaccines have created a great impact by saving the lives of many human beings. A narrative review of all the relevant papers were conducted across the databases of PubMed and ScienceDirect. Based on the various studies performed in various animal models, the chitosan nanoparticle (CNP) was reported to be a safe and effective adjuvant candidate for a wide range of prophylactic and therapeutic vaccines that require a balanced and potent stimulation of both the cellular and humoral responses, due to its natural origin and good biocompatibility, as well as its lack of lethal toxicity to humans and animals. There was a tremendous shift in the paradigm of vaccine drug delivery from the use of conventional to novel adjuvants. For the development of a promising vaccine delivery system, adjuvant plays an irreplaceable role, but the adjuvants have not been utilized to their full potential because of the limited number of approved adjuvants. Hence the search for novel adjuvants is highly increased. In the list of versatile adjuvants, chitosan derivatives occupy an important place because of their huge benefits. The chitosan derivatives are obtained by the chemical modification of chitosan. The studies performed on various animal models validate the potential use of chitosan dervatives as adjuvants for vaccine delivery.

Pharmacological evaluation of embelin - chitosan nanoparticles as an antidiabetic agent.

Embelin has been reported to possess variety of pharmacological activities such as androgenic antagonists, antiangiogenic, antibacterial, anticancer, anticonvulsant, antidiabetic, antidepressant, antihelmintic, antifertility, antihyperlipidemic, anti-inflammatory, antimalarial, antimitotic, antiobesity and antioxidant properties. The current research work aimed to study the hypoglycemic effect of embelin-chitosan nanoparticles (ECNPs) diabetic rats provoked by streptozotocin (STZ). Embelin nanoparticles (ENPs) were created by combining chitosan, a natural biopolymer, and glutaric acid, a new cross-linker. STZ 50 mg/kg was given intravenously into Sprague-Dawley rats weighing 250-300 g (75-90 days) to induce experimental diabetes. The antidiabetic efficacy of orally administered ECNPs in diabetic rats developed by STZ was investigated, as well as histological examination. When compared to diabetic control rats, ECNPs (25 mg/kg body weight and 50 mg kg body weight) and standard glibenclamide (10 mg/kg body weight) treated rodents exhibited a remarkable drop in glucose contents. Furthermore, histological research showed that ECNPs-treated rats were harmless up to amount of 25 mg/kg bwt. Thus current investigation reveals that ECNPs have antidiabetic potential and may be beneficial in treating hyperglycemia in people.