Background: The most common vaginal disorders are within the uterus. According to the latest statistics, vaginal disorders occur in 50% to 60% of females. Although curative treatments rely on surgical therapy, still first-line treatment is a noninvasive drug. Conventional therapies are available in the oral and parenteral route, leading to nonspecific targeting, which can cause dose-related side effects. Vaginal disorders are localized uterine disorders in which intrauterine delivery via the vaginal site is deemed the preferable route to mitigate clinical drug delivery limitations. Objective: This study emphasizes the progress of site-specific and controlled delivery of therapeutics in the treatment of vaginal disorders and systemic adverse effects as well as the therapeutic efficacy Methods: Related research reports and patents associated with topics are collected, utilized, and summarized the key findings. Result: The comprehensive literature study and patents like (US 9393216 B2), (JP6672370B2), and (WO2018041268A1) indicated that nanocarriers are effective above traditional treatments and have some significant efficacy with novelty. Conclusion: Nowadays, site-specific and controlled delivery of therapeutics for the treatment of vaginal disorders is essential to prevent systemic adverse effects and therapeutic efficacy would be more effective. Nanocarriers have therefore been used to bypass the problems associated with traditional delivery systems for the vaginal disorder.

No abstract

A Drug Master File is a record that consists of detailed, correct data approximately an Active Pharmaceutical Ingredient (API) or Dosage Form of a Finished Product (FP). It is a classified document containing thorough, accurate, and up-to-date information regarding the active medicinal ingredient and medicament. A DMF is divided into two sections: (a) Open part (the Applicant's Part), which includes all of the details needed to determine the quality of a product. And (b) the Closed Part (Restricted Part). The Restricted Part (Closed Part) comprises openly undisclosed manufacturing method knowledge only given to authorized individuals. This compilation aims to offer a comparison of DMF regulatory necessities in addition to the exact data for the registration of lively pharmaceutical ingredients (API) for common drugs in various regulatory governments, including EUROPE (EDQM, EMA), BRAZIL (ANVISA), and SOUTH AFRICA (SAHPRA). This review will provide information on the differences and similarities in the DMF filing requirements in EUROPE, BRAZIL, and SOUTH AFRICA. The regulatory criteria for API registration vary by jurisdiction. Despite the existence and widespread adoption of an ICH-CTD standard format, there are also some limitations. There are a few particular requirements set provided to drug authorities along with the submission. The registration procedure is a regulatory undertaking that permits a person/organization/sponsor/innovator to get permission to participate in the regulation process for fetching marketing authorization/approval.

No abstract

Background: The distinct anatomy and physiology of the eye represent it as a specialized organ. The noumenal physiological barriers, whose prominent role is to prevent the entrance of extracellular substances, reduce the bioavailability of medicines taken locally. Nanocarriers offer many advantages, such as site-specific drug delivery, reduced dose-related side effects, more drug loading capacity, etc. Nanoparticles, nano micelles, Nanostructured Lipid Carriers (NLCs), Solid Lipid Nanoparticles (SLNs), liposomes, polymeric nanoparticles, microspheres, microemulsions, etc., have all undergone significant analysis to overcome numerous static and dynamic obstacles. Objective: Among the several methods of delivering drugs, one of the most captivating and demanding is ocular drug delivery (ODD). The intent of developing formulations for an extended period can be partially achieved via thermoresponsive hydrogels. It is feasible to store fluids inside a cross-linked gel system for efficient long-term administration owing to hydrogels, which are hydrophilic polymeric networks with excellent three-dimensional structures and water or biological fluid absorption capacities. Hydrogels can be incorporated into nanocarriers to achieve site-specific action and prolonged release. Method: Related patents and research reports with various platforms like Science Direct, Springer, PubMed, Google Scholar, Shodhganga, and Patseer were used to gather the data, and a search methodology was availed. Result: The paper thoroughly summarizes the strategies for incorporating drugs with hydrogel into a nanocarrier to provide sustained release and prolonged therapeutic effects. According to the comprehensive review of literature and patents like (US2015374633A1), (US10980882B2), and (WO2011018800A2), nanocarrier-loaded thermoresponsive hydrogels show promising results. Conclusion: Due to their propensity to alter state in reaction to temperature changes, thermoresponsive hydrogels can improve medication bioavailability. Intervening nanocarriers loaded hydrogels directly on the targeted site displays local intervention and site-specificity. Thus, the use of nanocarriers in ocular drug delivery is encouraging.