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.
Mefenamic acid (MFA) is a non-steroidal anti-inflammatory drug that belongs to the anthranilic acid derivative family. It is used to relieve mild to moderate pain. The present review article includes a compilation of articles on the various properties along with an extensive literature survey on the reported analytical methods of MFA. Using a comprehensive computer assisted literature review; this article discusses the analytical methodologies for quantifying MFA both in active pharmaceutical ingredient and pharmaceutical dosage forms. This is the first review article in this series with focus on the analytical profile of MFA. Although, several methods like High Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC), spectrophotometry, fluorimetry, turbidimetry, Atomic Absorption Spectroscopy (AAS), Mass Spectroscopy (MS) and electro analytical methods were reported in the literature, HPLC stands out first for the quantification of MFA.
The Food and Drug Administration has established fast track approval to speed the designation of drugs that efficiently treat serious conditions, in particular those that provide improved advantages over available therapy. Fast track designation was initiated to curtail the time period in the new drug approval procedure and to promote the drug discovery and commercialization of drug products for critical and life-threatening illness and expedite the approval of drug products demonstrating advanced efficacy toward the prevailing one. Single Phase II study is reviewed before approving the drug within fast track designation. This review article highlights the consequences, criteria for fast track designation, fast track designation process, and the timeline for fast track approval.
Background: 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 vaccine has created a great impact by saving the lives of enormous human beings. Methods: A narrative review of all the relevant papers were conducted across the databases of PubMed and ScienceDirect. Results: 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. Conclusion: 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 had 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 as an adjuvant for vaccine delivery.
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