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Nowadays, cancer is one of the deadliest diseases affecting an annually enormous number of people. Around 9.6 million people had died from different cancer types in 2018. Chemotherapy is considered to be a mainline treatment, and systemic administration of a single anticancer agent is also considered a vital clinical debacle of chemotherapy in cancer management. The formulators have been focusing currently onto procuring maximum benefit with the lowest aftereffects and maximum safety and efficacy for the patients undergoing chemotherapy. This review offers a perspective on the future developments of encapsulating food bioactive compounds with anticancer agents in a multifunctional single nanoliposomal delivery system. In the last decade, the paradigm shift was seen in formulating drug delivery systems for cancer treatment. Currently, food bioactive compounds are being taken as a hot subject by researchers, especially for the treatment of cancer owing to both preventative and curative quality. This review collects the utilization of liposomes in the delivery of anticancer drugs by encapsulating with food bioactive compounds by the oral administration. The authors coined the name of this combination is “Combisomes” as a fourth generation liposomes. Authors opine that “Combisomes” can tackle cancer minimizing side effects encountered from the usual anticancer agents. “Combisomes” will purvey a safe platform for the delivery of food bioactive compounds and anticancer agents for managing cancer with better safety prospects.

Background: Vaccines are the-omit complex biological preparations that are meant to be used as a treatment or preventive measures against any specific disease condition. Vaccine research and development is a tedious, time and cost consuming process because of stringent quality assessment procedures. Every year approximately 80-85 % of the world’s children receive vaccines;however, regardless of this success rate each year, approximately more than 3 million die from vaccine-preventable diseases in most of the-omit developing countries. Today the entire world is facing a pandemic COVID-19 and the researchers are putting their best effort to bring a vaccine into the market. Developing a vaccine is a tedious process and emerging vaccine into the market requires a whole lot of process. Purpose: The current study aimed to evaluate the vaccine approval processes of two international pharmaceutical regulatory giants and develop a road map for the progress of vaccines in emerging countries to face the challenges posed by COVID-19. Methods: This article expresses the brief updated report of the regulatory approval pathways involved in the vaccines registration process in the United States of America (USA) the European Union (EU). The comparison study serves to understand the regulatory issues involved during the life-cycle of the vaccine approval process in the USA and the EU. Authors advocate the necessity of harmonised guidelines for the vaccine approval process in developing countries. Conclusion: Authors insist on broad global partnerships between the developed and emerging countries for the supply of affordable vaccines across the globe to face the pandemic called COVID-19. © 2021, Association of Pharmaceutical Teachers of India. All rights reserved.

Stability studies form a crucial aspect of the pharmaceutical development process and play a vital role in establishing the quality, safety and efficacy of the drug product. The core objective of a stability study is to ascertain the shelf-life of a drug product and to understand how best to design the drug product and its container-closure system so as to ensure that the same maintain suitable physical and chemical properties during the proposed shelf-life period. Since stability studies are inherently crucial to the lifecycle of a pharmaceutical formulation, the process and its requirements are subject to stringent regulations and specifications by regulatory authorities around the globe. A multitude of guidelines have been published in this regard by various regulatory authorities entailing concepts, techniques and protocols associated with stability testing, with the aim of aiding drug manufacturers generate accurate and viable stability data. Most of these guidelines, however, are based on the International Council for Harmonisation (ICH) stability guidelines and have been adapted by individual regulatory authorities to complement the climatic conditions of the respective regions, two such examples being the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC). Therefore, the present work aims to briefly discuss the stability guidelines applicable in each region and identify any similarities and differences, whilst examining the documentation requirements related to stability studies as well as the dossier requisites to be adhered to during drug product registrations.

Objective: Piroxicam is a long-acting potent nonsteroidal anti-inflammatory drug (NSAID) which has a very low solubility in Gastrointestinal (GI) fluids results in poor bioavailability after oral administration. The present investigation aimed to formulate and evaluate fast dissolving oral films containing piroxicam to overcome solubility and bioavailability problems thereby to facilitate the convenience of pediatric and geriatric patients. Method: The inclusion complexes of piroxicam with β-cyclodextrin were prepared. In vitro dissolution study was performed to fix the ratio with better dissolution rate. The selected inclusion complex was then utilized for the preparation of fast dissolving oral films by solvent casting method using sodium CMC/ chitosan as film-forming agents, sodium starch glycolate/crospovidone as super disintegrating agents. PEG 400 used as a plasticizer. Formulations (F1-F12) were prepared and evaluated for their physicochemical properties. In vitro disintegration, dissolution and permeation studies were also carried out. Results: Formulation F2 showed the minimum in vitro disintegration time (14.94±3.06 s), formulation F9 showed the maximum in vitro disintegration time (36.66±1.05 s). The formulations F6 and F4 showed better drug release of 94.4 % and 92.9 % respectively. Better drug permeation of 96.65 % was obtained from the formulation F6 in 40 s. Conclusion: The study concluded that the fast dissolving films achieved quicker onset of action compared to the conventional preparations. The formulation found promising to obtain better therapeutic efficiency. Key words: Fast dissolving film, Inclusion complex, β-cyclodextrin, Piroxicam.

Vaccines are credited with reducing or effectively eradicating a number of infectious diseases such as smallpox, measles, and diphtheria. Particularly in nations like the United States, where a large number of infectious diseases were prevalent, vaccines proved to be timely interventions. The approval procedure for vaccines in the United States is regulated by the Center for Biologics Evaluation and Research. Vaccine development is often found to be demanding and requires astute knowledge and understanding of recent developments by physicians and researchers to ensure that effective vaccines are made available to the masses with minimum risk. This article aims to illustrate the regulatory scenario with regards to vaccine development and licensure in the United States with a brief look at the origin of vaccines and their regulations in the nation. Also, it details the challenges faced by the United States vaccine industry to remain relevant in today's constantly evolving world.

Objectives Sulconazole is a broad spectrum antifungal agent of the imidazole class used against dermatophytes and other fungi to treat skin infections. The aim of the present work was to formulate and evaluate a microemulsion-based topical sulconazole gel. Materials and methods Microemulsion formulation of sulconazole nitrate was prepared by using oil, surfactant, cosurfactant and water at different ratios. This was then subjected to clarity and particle size analysis, a centrifugation test, a dilution test, and freeze thawing. Results The zeta potential of formulation F1 was -41.3 and stable. The pH of the microemulsion formulation was within the range of pH of skin. F1 showed a higher percentage amount of drug as compared with the other formulations. The viscosity showed that F1 was optimum. The freezing and thawing results showed there was no phase separation and the formulation was stable. In vitro drug release showed that the drug release from the microemulsion of F1 was higher when compared to the other formulations. It revealed F1 had the highest drug content of 95.88±0.3% and % cumulative drug release was 88.75% release in 8 h. The in vivo skin irritation study on rats confirmed that formulation was nontoxic and nonirritant. Conclusion The present study confirmed the safety of the formulated sulconazole loaded microemulsion gel for topical application.