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The use of conventional drugs for the treatment of pain and inflammation has largely resulted in various side effects. These challenges have triggered the search for alternative therapy such as herbal medication that may serve as a safe, effective, and alternate treatment approach to managing pain and inflammation. Vitex negundo, a potential lipophilic molecule, possesses limited solubility and permeability. Emulgels are either water-in-oil or oil-in-water type emulsions, mixed with a gelling agent to form a gel for the delivery of lipophilic active ingredients. Therefore the current study is undertaken for the effective delivery of vitex negundo locally in the form of oil-in-water emulgel for improving solubility and permeability. The emulgel was formulated from carbopol 934 with vitex negundo in mineral oil emulsion using tween 80 (surfactant), and triethanolamine (co-surfactant). The formulations were optimized using the design of experiment software. The optimized emulgel formulation containing Smix (tween 80 and triethanolamine) ratio of 61.90, mineral oil 50.58%, and carbopol 934 3% showed a pH of 6.5±0.3, a viscosity of 17793 – 939 cps, and spreadability of 7.07 g.cm/s. Data from in-vitro and ex-vivo diffusion studies demonstrated improved permeability properties. The stability of the optimized emulgel formulation was additionally examined at ambient temperature for 28 days. The emulgel remained stable for 28 days. Based on the overall results we can conclude that emulgel can be a promising and suitable formulation for the application of vitex negundo.

After a drug is granted a marketing license, its post-marketing surveillance is evaluated to ensure that it is continuously monitored for undesirable effects. This monitoring is achieved through an effective Pharmacovigilance system. In our review, we discuss the Pharmacovigilance systems of Europe, the United States, and India, along with several examples of effective Pharmacovigilance strategies, such as the Tracleer® Access Programme and Tracleer® Excellence programs for Bosentan, Merck’s Worldwide Adverse Experience System, the European and United States Varicella Zoster Virus Identification Programs for Varivax, the Siddha Initiative for Documentation of Drug Adverse Reaction, an android mobile app for AYUSH Pharmacovigilance, and the Global Pharmacovigilance Database by Sanofi Pasteur. This report demonstrates the importance of post-marketing surveillance in detecting rare adverse experiences that may go unnoticed during clinical trials. It also emphasizes the significance of highlighting the field of Pharmacovigilance to improve patient safety and offer them the best possible quality of life.

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.

Objectives: To formulate and investigate the role of various penetration enhancers in the transfersomal gel delivery of adapalene. Methods: Transfersomes were formulated by reverse-phase evaporation method and the influence of various parameters was investigated and optimized for particle size, PDI, zeta potential, and entrapment efficiency using the Design of Experiment approach. Optimized formulation was subjected to various characterizations such as Fourier Transform Infrared Spectroscopy, turbidity measurement, and deformability study, and then transfersomes were incorporated into a suitable gel (Carbopol 934). The transfersomal gel was then characterized for gel characteristics such as pH, spreadability, viscosity, homogeneity, extrudability, etc. Appropriate essential oils used as natural permeation enhancers like eucalyptus oil, menthol, peppermint oil, and turpentine oil were included in the transfersomal gel of adapalene, and then in vitro drug release, ex vivo permeation, and flux study was conducted and compared. Results: The adapalene loaded transfersomal gel showed particle size of 152.1 nm, PDI of 0.315, the zeta potential of -42.9 mV, and entrapment efficiency of 58.65 %. FTIR studies showed no interactions among the drug, lipids, and polymers used. Among the essential oils used as the permeation enhancers, the formulations containing peppermint oil displayed better in vitro drug release and ex vivo permeation than the other formulations containing remaining essential oils. Conclusion: From the present study, it can be concluded that the developed formulation can enhance the topical penetration of the drug and thereby improve therapy, which certainly adds quality to the transfersomal preparation. Key words: Transfersomes, Adapalene, Eucalyptus oil, Turpentine oil, Menthol oil, Peppermint oil.

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.

Background: Topical drug delivery system is dosage forms which are applied directly to the skin to cure various diseases. When we compare all the semisolid preparation for topical drug delivery, gels have been extensively used in cosmetics as well as pharmaceutical preparations. The major drawback of gels is in delivery of hydrophobic drugs which can be overcome by using emulgels. The dosage forms where gel and emulsion are combined together are known as emulgel. Emulgel is one of the modern technologies in novel drug delivery system for topical use having properties of dual control release i.e. emulsion and gel. Methods: In emulgel drug delivery system drugs are incorporated into globules which are then dispersed resulting in the formation of emulsion which is then mixed with the gel base. Results: It was seen that emulgels are better topical drug delivery systems compared to others owing to its advantages such as greaseless, smooth, homogeneous texture, glossy appearance, transparent, pH equivalent to pH of skin, high drug content and sustained release. Conclusion: This review article focuses on emulgel including its properties and formulation considerations with characterization parameters proving that emulgels are one of the most effective and convenient drug delivery systems. Key words: Dual control release, Emulgel, Novel drug delivery system, Thixotropic, Topical drug delivery system.

Pharmaceutical solid dosage forms are categorized into several types based on the purpose, usage, and route of administration. Some examples of frequently available solid dosage forms include tablets, capsules, lozenges, powders, and granules. A generic drug is one of usually intending to be interchangeable with the innovator product, thereby making it essential for them to mimic the innovator drug concerning their safety and efficacy profiles. The essential concept of making a generic drug available hinges on its economic benefits towards the patient population as well as its feasibility in the development of benefits the pharmaceutical companies. Additionally, generic drugs expand the market of a particular API, thereby ensuring that an adequate number of medications are made available to cater to the needs of every patient and further preventing any issues arising out of drug shortages. The USFDA and the EMA, being two of the leading regulatory agencies across the globe, have long been associated with the development and drafting of regulations about the approval of generic drug products. A firm understanding of the regulatory requirements associated with the preparation of a generic drug dossier will aid pharmaceutical manufacturers in attaining favourable outcomes when desiring multicounty submissions, thereby ensuring a smooth review process without any substantial delays.

Objectives: The main objective of the present investigation was to develop and compared conventional, chitosan-coated and electrosteric stealth liposomes of Rivastigmine Tartrate for the treatment of Alzheimer’s Disease. Methods: The solvent evaporation method was employed to prepare liposomes and optimized by the Design of Experiment approach. The effect of various process parameters was investigated and optimized on for particle size and percentage entrapment efficiency. The compatibility studies were carried out using Fourier Transform Infrared Spectroscopy. The optimized formulations were also characterized by Transmission Electron Microscopy and Atomic Force Microscopy for their surface morphology and in vitro percentage drug release study by comparing it with a standard solution of Rivastigmine Tartrate. The compatibility of drug and excipient mixtures was confirmed by Fourier Transform Infrared Spectroscopy. Results: The optimized formulation of conventional, chitosan-coated, stealth liposome of Rivastigmine Tartrate showed vesicle size of 111.8, 153.3, 136.3 nm respectively and entrapment efficiency of 75.27±0.8 %, 80.33±0.4 % 78.2±0.2 respectively. Clear surface morphology was observed through surface morphological images. The in vitro drug release studies showed a significant difference in percentage cumulative drug release pattern of chitosan-coated and stealth liposomes (81±0.3 % and 76±1.2 %) when compared with the conventional liposomes (69±0.8 %), after 24 h. On subjecting it to stability studies, the liposome preparations did not show any significant changes in particle size and entrapment efficiency. Conclusion: The developed formulations (chitosan-coated and stealth liposomes) can deliver the active moiety on the target site for the treatment of AD.

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.

Danio rerio, zebrafish, has been widely used as a non-mammalian vertebrate model organism in various studies. The present research describes to develop and characterize a new cell line from a wild strain Indian zebrafish native to Brahmaputra River, Assam, India. The new cell line designated as DRCF was developed from the caudal fin of D. rerio. The cell line was successfully subcultured up to 31 passages. Growth studies revealed that cell growth of DRCF was optimal at 28 °C in L-15 medium supplemented with 20% FBS. Molecular characterization of the DRCF cell line using mitochondrial genes namely cytochrome oxidase subunit I gene (COI) and 16S rRNA authenticated the true origin of the cell line. The chromosome analysis of the DRCF cell line expressed its 50 diploid chromosome number of D. rerio. The immunocytochemical characterization of the cell line exhibited its fibroblastic morphology. The expression of the green fluorescent protein (GFP) following transfection revealed the suitability of the cell line for transfection studies.

Background: This is the first detailed Indian electronic medical record (EMR)-based real-world observational study to understand the clinical characteristics, associated comorbidities/risk factors and treatment(s) of CAD patients across India.Methods: EMR data of adult Indians (aged ≥ 18 years) diagnosed with CAD was retrospectively analyzed.Results: The majority of the participants had stable IHD (93%), were men (68.5% in ACS, 59.8% in stable IHD), most common age group was 40-64 years in ACS (56.6%) and stable IHD (51.4%). Both are common in metros (ACS 52%, 62% stable IHD). There is a high frequency of hypertension (38.2% in ACS, 59% in stable IHD) and diabetes mellitus (32.3% in ACS, 57.6% in stable IHD). Most common treatments are antiplatelet drugs and lipid-lowering drugs (96%).Conclusions: In India, stable IHD is the most prevalent form in vast majority of patients. The patients with CAD are mostly males, are mainly located in metros and majority fall between the age group of 40-64. The major comorbidities are hypertension and diabetes mellitus. Sociodemographic and clinical characteristics for CAD in India may not be similar to what is reported from the west. There is a significant difference in drug usage and adherence to guidelines in India for CAD.

The spread of SARS-CoV-2 as an emerging novel coronavirus disease (COVID-19) had progressed as a worldwide pandemic since the end of 2019. COVID-19 affects firstly lungs tissues which are known for their very slow regeneration. Afterwards, enormous cytokine stimulation occurs in the infected cells immediately after a lung infection which necessitates good management to save patients. Exosomes are extracellular vesicles of nanometric size released by reticulocytes on maturation and are known to mediate intercellular communications. The exosomal cargo serves as biomarkers in diagnosing various diseases; moreover, exosomes could be employed as nanocarriers in drug delivery systems. Exosomes look promising to combat the current pandemic since they contribute to the immune response against several viral pathogens. Many studies have proved the potential of using exosomes either as viral elements or host systems that acquire immune-stimulatory effects and could be used as a vaccine or drug delivery tool. It is essential to stop viral replication, prevent and reverse the massive storm of cytokine that worsens the infected patients’ situations for the management of COVID-19. The main benefits of exosomes could be; no cells will be introduced, no chance of mutation, lack of immunogenicity and the damaged genetic material that could negatively affect the recipient is avoided. Additionally, it was found that exosomes are static with no ability for in vivo reproduction. The current review article discusses the possibilities of using exosomes for detecting novel coronavirus and summarizes state of the art concerning the clinical trials initiated for examining the use of COVID-19 specific T cells derived exosomes and mesenchymal stem cells derived exosomes in managing COVID-19., Graphical abstract Image, graphical abstract

Graphical abstract, Highlights • Soil physicochemical and biological properties were used for SQI development. • Major parameters studied were FDA, DHA, MBC, SOC, Av. NPK, AWC, MAS and SPR. • Highest SQI value of 0.90 was found in ZTDSR-ZTW at 0-10 cm soil depth., Rice-wheat cropping system (RWCS) is the most important system occupying around 26 M ha spread over the Indo Gangetic Plains in South Asia and China. Many long-term trials were led to assess the agronomic productivity and economic profitability of various combinations of conservation agricultural (CA) practices (zero tillage, residue management and crop establishment) in RWCS of Eastern Indo-Gangetic Plains (EIGP) of India. The purpose of this study was to investigate the best management practices involving different tillage-based crop establishment and residue retention techniques and their contribution to agricultural system sustainability through improvement in soil health by developing soil quality index (SQI). We have used SQI as an instrument based on physical [macro aggregate stability (MAS), available water capacity (AWC) and soil penetration resistance (SPR)], chemical [soil organic carbon (OC), available N, available P and available K] and biological [microbial biomass carbon (MBC), fluorescein diacetate (FDA) and dehydrogenase activity (DHA)] properties of soil, because these are very useful indicators of soil’s functions for agronomic productivity and soil fertility. Soil properties like MAS, OC, MBC, FDA and DHA were higher by 47, 18, 56, 48 and 53%, respectively, under ZTDSR-ZTW (T7: Zero-till direct seeded rice - Zero-till wheat) than RPTR-CTW (T1: Random puddled transplanted rice - Conventional till broadcasted wheat), at 0-10 cm. CA based treatment T7 also recorded lower SPR (126 N cm-1). SQI for different treatments were calculated by performing principal component analysis based on the total data set method. The higher system rice equivalent yield of 12.41 t ha-1 was observed at SQI value of 0.90 at 0-10 cm and 0.86 at 10-20 cm in T7. It can be concluded that crop residue retention on the surface with zero tillage is beneficial for the sustainability and productivity of the RWCS in EIGP of India.

Objective: Asiatic acid is a triterpene saponin and the main constituent of the species Centellaasiatica. The current study aimed to isolate, characterize and develop an analytical method for asiatic acid in the shorter run time with good efficiency. Methods: In this study isolation of asiatic acid was achieved by TLC and thus isolated asiatic acid was characterized by 1HNMR spectral analysis and LCMS. An isocratic RP-HPLC method was established for the assessment of asiatic acid from the methanol extract of Centellaasiatica. The chromatographic separations were achieved by RP-C18 column 250x4.6 mm (5µ Particle size) Shimadzu UFLC pump LC 20AD and mobile phase composed of 0.1% orthophosphoric acid: acetonitrile (50:50). The analysis of column effluents was achieved using a PDA detector (Photo Diode Array) at 210 nm, and the flow rate was recorded 1 ml/min. Results: Soxhlet extraction process followed by fractional extraction using different solvents was performed. Methnol extract was taken to isolate asiatic acid by TLC (RF 0.97) and base peak from mass spectra was found to be 489M+which was confirmed successful isolation. Retention time of asiatic acid was found to be 9.6±0.22 min. This method obeyed linearity over the concentration range of 10-50µg/ml and regression coefficient was obtained from the alinearity plot for asiatic acid which was found to be 0.9987 LoD and LoQ were obtained to be 0.784507µg/ml and 2.615µg/ml respectively. RSD of mean assay values was found to be 1.02%. Since there were no marked changes in the performance characteristics of the method. Conclusion: Isolation, characterization and identification of asiatic acid were achieved significantly which will be useful for the standardization of herbal formulation containing asiatic acid.

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.

Adapalene-loaded transfersome gel containing vitamin C as a combination therapy for the management of acne vulgaris was developed in the present study. The transfersome was prepared by reverse-phase evaporation, and the effect of various process parameters were investigated by the Design of Experiment (DOE) approach and optimized based on the particle size (PS), polydispersity index (PDI), zeta potential (ZP), and entrapment efficiency (EE). The selected tranfersomes were further evaluated for their thermal behavior and morphology by transmission electron microscopy and turbidity measurements and incorporated into a gel with/without vitamin C. The gel was evaluated and compared with the marketed product (Adiff gel) for various physicochemical parameters, and in vivo studies in testosterone-induced rat models of acne. The prepared transfersomes had PS in the range of 280 to 400 nm, PDI values of 0.416 to 0.8, ZP of − 38 to − 20 mV, and % EE of 32 to 70%. DSC studies confirmed a positive interaction of the components in the transfersome. Surface morphology confirmed that the vesicles were spherical, unilamellar, and discrete. A relative deformability study showed higher elasticity of the transfersomes compared with Adiff aqs gel. Ascorbyl-6-palmitate in adapalene-loaded transfersome gel containing vitamin C (ADVTG) was found to have a good antioxidant free radical–scavenging activity. An in vitro drug release study showed that the sustained release of the transfersomal formulations was attributed to the flexibility of the vesicles by which penetration was increased. ADVTG was found to be promising in treating acne compared with the marketed product.

Over time, nanotechnology has enabled a wide range of applications in the agricultural field due to the distinctive properties of nanoparticles, including high surface area, reactivity, agglomeration, penetration capability, size and structure. Nanoparticles have been by far advantageous for plant growth, development and protection. Nanoparticles bestow specificity in pesticide delivery, enhanced nutrient supply, managing pathogenicity, increasing photosynthetic capacity and germination rate. Apart from beneficial impacts on plants, there have been instances of toxicity and bioaccumulation of nanoparticles, which led to a few setbacks. Thus, it is necessary to have a complete knowledge of the positive and negative impacts of nanoparticles and to study all their characteristics in detail. This chapter highlights the impact of nanoparticles on the growth and development of plants.

This article discusses the challenges faced by fake news and disinformation disseminated through social media platforms in India, and the need for effective legislation and robust regulatory mechanism to deal with the said challenges. A line has to be drawn between the “free speech” that needs to be protected and “disinformation” that needs to be legislated by imposing reasonable restrictions on freedoms of speech and expression. This article, with the aid of Supreme Court judgments on the issue of subordinate legislation, further strives to argue that Indian government’s initiative to legislate the fake news and disinformation through subordinate legislation (Information Technology [Intermediaries Guidelines (Amendment) Rules, 2018) may not achieve the goal as subordinate legislations have their own limitation and cannot travel beyond the scope of enabling Act.

Rice-wheat cropping system (RWCS), one of the prominent agricultural production systems, at an area of ~26 M ha is confined to the Indo-Gangetic Plains (IGPs) in South Asia and China. Crop residues obtained from field crops are essential sources of nutrition and organic carbon (40% of total dry biomass constituted by C) for the next crops, and hence they not only increase the agricultural productivity but also are responsible for the better quality of soil, water, and air. Perhaps the most important challenge facing exhaustive RWCS in all regions of the world is effective management of post-harvest crop residues. Disposal of wheat residue is easy as it can be used to feed animals. However, due to the presence of high silica content, rice residue is usually burned. Residue burning is the main method of disposal in areas under combined harvesting in the IGPs of eastern India as it reduces cost. However, burning of crop residue (CR) is not eco-friendly as it results in fast degradation of soil organic matter and nutrients and increased CO2 emission creating intense air pollution as well as global warming. Therefore, exploitation of CR is a crucial element for a sustainable production system, and it has generated much interest in the recent years by reducing the consequence of residue burning and increasing the soil organic matter (SOM) and the nutrient-supplying capacity. CR retention infield can be considered a key element in promoting soil health with increased physical, chemical, and biological properties. In RWCS, residue management can be done by (1) wheat residue retention in rice and its residual effect in succeeding wheat crop, (2) rice straw retention in wheat and its residual impact in following rice, and (3) wheat straw retention in rice and rice straw retention in wheat (cumulative effect). All these crop residue management systems depend on a systematic understanding of the factors that control residue decomposition and their careful application. Significant factors, such as tillage/CR management, influence soil microbial activity and biomass, bulk density, soil moisture content, porosity, soil structure stability, and nutrient-supplying capacity of the soil. Thus, the variations in soil properties consequently bring change in soil C and N dynamics and have an impact on plants’ nutrient uptake capacity.

Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in September 2018. The Drug Technical Advisory Board (DTAB) recommended that 'there is no therapeutic justification' for the active ingredients in the banned FDCs and accordingly these combinations 'may involve a risk to human beings'. Areas covered: The review illustrates the present status of FDCs, its regulatory framework, approvals in India and discusses the substantive cause behind the ban on FDCs in India. Expert opinion: The expert stress to establish a robust regulatory system for the approval of FDCs in India. The pharmaceutical industries should not perceive the ban against irrational FDCs as an impediment; rather, they should view as an opportunity to establish a stronger healthcare system. The current review is an eye-opener for the section of people who consider that the ban on FDCs is irrational. However, the ban on 328 FDCs may prove a landmark decision for the development of stronger healthcare policy in India.

Adapalene-loaded transfersome gel containing vitamin C as a combination therapy for the management of acne vulgaris was developed in the present study. The transfersome was prepared by reverse-phase evaporation, and the effect of various process parameters were investigated by the Design of Experiment (DOE) approach and optimized based on the particle size (PS), polydispersity index (PDI), zeta potential (ZP), and entrapment efficiency (EE). The selected tranfersomes were further evaluated for their thermal behavior and morphology by transmission electron microscopy and turbidity measurements and incorporated into a gel with/without vitamin C. The gel was evaluated and compared with the marketed product (Adiff gel) for various physicochemical parameters, and in vivo studies in testosterone-induced rat models of acne. The prepared transfersomes had PS in the range of 280 to 400 nm, PDI values of 0.416 to 0.8, ZP of - 38 to - 20 mV, and % EE of 32 to 70%. DSC studies confirmed a positive interaction of the components in the transfersome. Surface morphology confirmed that the vesicles were spherical, unilamellar, and discrete. A relative deformability study showed higher elasticity of the transfersomes compared with Adiff aqs gel. Ascorbyl-6-palmitate in adapalene-loaded transfersome gel containing vitamin C (ADVTG) was found to have a good antioxidant free radical-scavenging activity. An in vitro drug release study showed that the sustained release of the transfersomal formulations was attributed to the flexibility of the vesicles by which penetration was increased. ADVTG was found to be promising in treating acne compared with the marketed product. Graphical Abstract.

The current study was aimed to develop an amphiphilic drug-lipid nano-complex of rutin:egg phosphatidylcholine (EPC) to enhance its poor absorption and bioavailability, and investigated the impact of the complex on hepatoprotective and antioxidant activity. Rutin nano-complexes were prepared by solvent evaporation, salting out and lyophilisation methods and compared for the complex formation. For the selected lyophilisation method, principal solvent DMSO, co-solvent (t-butyl alcohol) and rutin:EPC ratios (1:1, 1:2 and 1:3) were selected after optimisation. The properties of the nano-complexes such as complexation, thermal behaviour, surface morphology, molecular crystallinity, particle size, zeta potential, drug content, solubility, in vitro stability study, in vitro drug release, in vitro and in vivo antioxidant study, in vivo hepatoprotective activity and oral bioavailability/pharmacokinetic studies were investigated. Rutin nano-complexes were developed successfully via the lyophilisation method and found to be in nanometric range. Rutin nano-complexes significantly improved the solubility and in vitro drug release, and kinetic studies confirmed the diffusion-controlled release of the drug from the formulation. The nano-complex showed better antioxidant activity in vitro and exhibited well in vitro stability in different pH media. The in vivo study showed better hepatoprotective activity of the formulation compared to pure rutin at the same dose levels with improved oral bioavailability. Carbon tetrachloride (CCl4)-treated animals (group II) failed to restore the normal levels of serum hepatic marker enzymes and liver antioxidant enzyme compared to the nano-complex-treated animals. The results obtained from solubility, hepatoprotective activity and oral bioavailability studies proved the better efficacy of the nano-complex compared to the pure drug.

Rapidly growing nanotechnology industry leads to an increase in the exposure of different nanomaterials to biological organism. Human beings are constantly exposed to these nanoparticles, and its retention leads to several health hazards that include neurodegenerative diseases, circulatory diseases, cancer, and autoimmune diseases. Nanotoxicity to plant pathogenic microorganism have been attributed to its ability to interact with microbial membrane, altering transport phenomenon, oxidation of macromolecules, and disruption of the energy metabolism by damaging the membrane-associated enzymes. These nanoparticles have thus been successfully used to control several bacterial and fungal diseases in plants. The aquatic environment acts as sink for these nanoparticles and thus exerts nanotoxicity to exposed aquatic organisms present in freshwater, brackish water, or marine ecosystem. Several toxic effects of nanoparticles on aquatic organisms have been observed that include change in physiological mechanism, behavior pattern, respiratory distress, oxidative stress, organ pathologies, decrease in fertility, and an increase in mortality. Dose-dependent nanotoxicity has been observed with crustaceans, phytoplanktons, mollusks, and fish that warrant us against its unregulated application and release to environment.

Fish cell line has emerged as an important tool in fishery biotechnology. In recent years, various fish cell lines have been developed by different researchers across the country. National Repository on Fish cell lines, established with the aim to preserve fish cell lines for training and education to stakeholders, has started functioning at National Bureau of Fish Genetic Resources, Lucknow. This repository is supposed to characterize and preserve the fish cell lines developed across the country and serve as a national referral centre for Indian and exotic fish cell lines. Currently, the repository is maintaining 50 fish cell lines deposited by various research institutes in India, including the cell lines developed at cell culture facility of National Bureau of Fish Genetic Resources. The cell lines have been successfully cryopreserved after verifying its authenticity by sequence analysis of two mitochondrial genes, viz. 16S rRNA and cytochrome c oxidase sub-unit I. Chromosomal analysis, transfection efficiency and immunocytochemistry are also being used to characterize the cell lines. The facility is serviceable for the collection, deposition and distribution of fish cell lines. This paper discusses the status as well as the methodology adopted for fish cell lines development, characterization and storage at NRFC.

Advances in nanotechnology have led to the development of a plethora of commercial applications of diverse nanomaterials, thereby substantially increasing chances of exposure to nanomaterials. This has raised global concern regarding their fate in biological systems, resulting in a demand for parallel risk assessment. In view of this, it becomes essential to systematically and thoroughly analyze absorption, distribution, metabolism, and excretion (ADME) of nanomaterials for the development of safe nanomaterials. In this chapter, we present the current understanding regarding the ADME profile of nanomaterials. The chapter will highlight the current status of nanotoxicity evaluation considering the fate and effect of nanodrugs in biological systems using a pharmacokinetic approach.

Objective: The study was conducted to find out the correlation if any between the duration of wearing orthodontic appliances and the intensity of transient bacteremia. Materials and methods: Study has been carried out on 50 subjects (21 males and 29 females), age ranging from 11 to 21 years, categorized in the separate groups with 25 subjects in each group of fixed (E1) and active removable appliances (E2). Both groups have been further divided into two subgroups separately, according to treatment duration; subgroup A, where treatment duration was less than 1 year and subgroup B, where treatment duration was more than 1 year. To find out transient bacteremia, blood samples from median cubital vein were collected before and after 5 minutes of brushing in all groups. Blood was cultured to observe growth of aerobic and anaerobic bacterial strains. Results: Study indicates no association between treatment duration and transient bacteremia in Group E1 but there was significant association between treatment duration and aerobic bacterial growth in Group E2. Findings reveal that the transient bacteremia was found more in orthodontic patients wearing appliances less than 1 year than those wearing appliances more than 1 year. Conclusion: There is significant association between treatment duration and transient bacteremia in case of active removable appliances. Further the duration of fixed orthodontic appliances in patients following proper oral hygiene instructions has no effect on transient bacteremia.