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Abstract: Central nervous system disorders, particularly neurodegenerative disorders, are a serious public health concern that researchers must address to protect the persons against them. The prevalence of the blood-brain barrier (BBB), which segregates the blood from cerebral parenchyma and hence limits the brain uptake of most of the therapeutic agents, makes developing drug delivery systems for brain delivery one of the most challenging research subjects in pharmaceutical domains. The detailed description of BBB-crossing nanotechnology in this article is expected to pique the attention of researchers from a wide range of fields who want to help build powerful BBB-crossing nanosystems for highly effective brain targeting. Recent advances in nanotechnology have resulted in multifunctional nanosystems that can cross or circumvent the BBB, allowing for more accurate assessment and treatment of brain tumours. The application of nanotechnology in targeting different drugs across the brain is included in this review.

Abstract: Oral vaccines have been proposed as a potential vaccine against a variety of infections, particularly invading pathogens throughout the GIT. Oral vaccinations targeting the large intestine could be a viable alternative to intracorneal immunizations which have been shown to be effective against rectogenital infections but are impractical during mass vaccination. Furthermore, the oral route allows for the development of humoral and cellular immune responses in both systemic and mucosal locations, resulting in a larger and longer-lasting protective effect. Oral administration, on the other hand, is difficult, needing formulations to overcome the harsh GI efficiency and reduce tolerance induction to obtain adequate protection. This review article will highlight the mode of action of oral vaccines, the list of license oral vaccine, type of vaccines, and the physiological barriers and immunological barriers to oral transport of peptides and proteins.

Abstract: The systemic delivery of pharmacological substances generally exhibits several significant limitations associated with the bio-distribution of active drugs in the body. Human body’s defense mechanisms have been found to become impediments to drug delivery. Various technologies have evolved to overcome these limitations, including computational approaches and advanced drug delivery. As the body of a human has evolved to defend itself from hostile biological as well as chemical invaders, the biological barriers, such as ocular barriers, blood-brain barriers, intestinal and skin barriers, also limit the passage of drugs across desired sites. Therefore, efficient delivery remains an utmost challenge for researchers and scientists. The present review focuses on the techniques to deliver the drugs with efficient therapeutic efficacy at the targeted sites. This review article provides an insight into the main biological barriers along with the application of computational or numerical methods to deal with different barriers by determining the drug flow, temperature and various other parameters. It also summarizes the advanced implantable drug delivery systems to circumvent the inherent resistance exhibited by these biological barriers, and in turn, to improve the drug delivery process.

Abstract: Diabetes mellitus, an epidemic of the 21st century, is listed as one of the top ten causes of death around the world by the World Health Organization and is a complicated disease to deal with. Medically, a metabolic disorder characterized by elevated blood glucose levels and altered metabolism of biological macromolecules, mainly carbohydrates. Diabetes mellitus has a worldwide prevalence, and populations of all high, middle, as well as low-income countries, are affected by it. More than 400 million persons are currently living with diabetes. Many risk factors, such as lack of exercise, irregular diet, drinking, and smoking habits, as well as genetic factors, also contribute to the increased incidence of diabetes mellitus in the modern era. The conventional therapies for diabetes are based on insulin, insulin analogues, peptides, and oral hypoglycemics. The primary objective is to lower the elevated blood glucose levels and manage the distress to enhance the quality of life of the patient. The management of diabetes is very crucial to avoid complications having serious consequences such as the extra economic burden due to these complications. Conventional drug therapy has its own adverse effects, and its timely availability and cost are still an issue in many low and middle-income countries. Diabetes mellitus has been reported in various ancient kinds of literature along with various natural remedies (plants/herbals) useful in it. These plant-based remedies offer the benefits of lesser or no adverse effects, easy availability due to natural abundance, and low cost. Therefore, extensive research work is carried out in the past few decades to identify and understand the underlying principles of plant-based/herbal medicines to develop new potential lead molecules and a relatively safer, easily available and more economical alternative treatment therapy for diabetes mellitus.

Background: Silymarin is a flavonoid utilised in liver dysfunction for years; new studies have emphasised its potential utility as a therapy for nanoparticulate targeting in many other disorders. In order to establish the product quality of such compounds, researchers have been trying to develop a robust method of analysis, but the methods developed till now are too expensive and time-consuming. Here we proposed quality by design-assisted development and validation of the UV spectroscopic method using Design-Expert® software in the estimation of Silymarin for fabrication of nanoparticulate formulations, which is simple, accurate, cost-effective and non-tedious. Aim: The proposed method is a simple, new, robust, accurate, and precise UV visible spectroscopic technique for estimating silymarin produced in nano-formulations utilising an analytical quality by design (AQbD) approach. Methods: A UV spectrophotometric technique was established, as maximum absorption (287.7) was measured using a Shimadzu UV-1800 double-beam UV visible spectrophotometer. The characterization of silymarin was done by melting point, DSC and FTIR techniques. The two critical method variables chosen were scanning speed and sample interval to be analysed by the design of experiment methodology utilizing the central composite design principle, which shows robustness and optimized technique involved in this work. Results: The spectroscopy technique was developed and validated as per International Conference of Harmonization recommendations. The Beer's-Lambert rule was followed in a series of 2-12 µg/ml dilution increments, with a correlation value of R2 = 0.999. The method's linearity was shown to be excellent across the concentration range. The percent recovery of the current method approach was determined to be within the confidential limitations, i.e., less than 2% expressed as % RSD, and the methodology was proved to be precise at inter and intraday variations (% RSD). The LOD and LOQ were found to be 0.264 μg/ml and 0.801 μg/ml which were also determined correctly. During specificity testing, no interfering peaks were found. Conclusion: This UV approach has been used successfully to determine the quantity of silymarin present in the nanoparticulate formulation, which can be used for testing its other pharmaceutical dosage forms. other: No

Chitosan is a polysaccharide and is derived from chitin. Chitosan every now and then referred to as a soluble chitin. chitosan is strongly basic polysaccharide. chitosan shows physiochemical and biological properties. This review presents the common source for chitosan manufacturing that is crabs and shrimp. According to researchers it is just a fat inhibitor. some of the application of chitosan in pharmaceutics/drug delivery and in biomedical field are also highlighted. Chitosan act as a diluent, as mucoadhesive excipient, as permeation enhancer, in vaccines delivery, as parenteral delivery, chitosan as food additive, cosmetics industry. chitosan also has a number of medicinal benefits. Chitosan is employed in a variety of applications because it is soluble in acidic aqueous conditions (food, cosmetics, biomedical and pharmaceutical applications). We give a quick overview of the chemical modifications of chitosan, a field in which a number of syntheses have been proposed but not yet realised on a large scale. This review focuses on current articles on these materials' high-value-added applications in medicine and cosmetics.

Poor solubility of some medicinal compounds is a serious challenge that can be addressed by using a nano-suspension for improved delivery. The nanoparticles enhance the bioavailability along with the aqueous solubility of the drug, which is accomplished by increasing the active surface area of the drug. The gained attention of the nanosuspension is due to its stabilization facility, which is achieved by polymers, such as polyethylene glycol (PEG), having a particular size range of 10 - 100 nm. Hence, these nanoparticles have the capacity of binding to the targeted with very low damage to the healthy tissues. These are prepared by various methods, such as milling, high-pressure homogenization, and emulsification, along with melt emulsification. Moreover, surface modification and solidification have been used to add specific properties to the advanced therapies as post-processing techniques. For many decades, it has been known that water solubility hampers the bioavailability and not all drugs are water-soluble. In order to combat this obstacle, nanotechnology has been found to be of specific interest. For elevating the bioavailability by increasing the dissolution rate, the methodology of reduction of the associated drug particles into their subsequent submicron range is incorporated. For oral and non-oral administration, these nanosuspension formulations are used for the delivery of drugs.

Berberine is an anticancer medication that generates side effects due to its hydrophobicity and low cellular promiscuity as well as high dose requirement. Thus, have to prepare PEGylated dendrimer conjugates which increases the targeting and release of chemotherapeutic drugs at the tumor site although falling the adverse side effects. The circulation time of drug is enhanced by PEGylation. It is the covalent attachment of PEG to therapeutic protein or any molecule. PEGylated Berberine dendrimer was prepared by Biotinylation cross linking method and characterized by particle size, zeta potential, entrapment efficiency, in vitro release and stability study. The Structure validation of Berberine before and after grafting were confirmed by FTIR and NMR spectroscopy. Further prepared PEGylated complex were proceeded for the cellular uptake study in AMJ-13, and BT-20 cells line by fluorescent microscopy study and MTT assay cytotoxicity study in MCF-7 cell line. The prepared PEGylated formulation showed nanometric size, desired zeta potential, and 69.56 ± 23% entrapment efficiency. The prepared PEGylated particle showed 70.23% release at 72 h with good stability at 90 days. The cellular uptake of formulation was highly appreciable which is clearly observed in AMJ-13, and BT-20 cells line. In comparison to pure drug, developed formulation has 10.8M high efficiency for breast cancer cell line. PEGylation is easy and reasonable way, as it requires lesser time and is proved to be superior technique for treatment of cancer.

Abstracts: Computational fluid dynamics (CFD) is a feasible tool to examine and troubleshoot different types of equipment utilized in the pharmaceutical industry or healthcare. As a large number of fluids are processed by unit operations, even some increments in performance and efficiency may escalate profits and reduce costs. CFD methods are primarily used in the automobile and aerospace industries, but in the current era, this technology is extensively applied in the pharmaceutical and chemical industries and has become an important tool for process design scaleup and optimization. CFD is a numerical approach utilizing CFD software to solve equations numerically. This review focuses on the diverse utilization of CFD in the pharmaceutical field and current applications in the covid 19 pandemic, a recent health crisis that is intimidating the world.

The study was to extend systemic circulation and biological half-life (tRSV-SLN was prepared by solvent emulsification evaporation technique and proceeded for evaluation like particle size, PDI, zeta potential,Prepared SLN showed 126.85 ± 12.09 nm particle size, -24.23 ± 3.27 mV Zeta potential and 74.67 ± 4.76%. release at 48 h and haemocompatible. The cellular internalisation image showed the SLN reach in a cytoplasm and nucleus of PC3 prostate cells. RSV-SLN exhibited high tThe developed RSV-SLN can be applied as potential carrier for delivery of drug of chemotherapeutics at an extend systemic circulation and targeting efficiency at tumour site.

Genistien is a soy isoflavone phytoestrogen, BCS class IV drug that has been efficacious for treatment of melanoma. Therefore, prepared Genistien loaded nanostructured lipid carriers (GEN-NLCs) for controlled and target delivery to melanoma cells. GEN-NLCs were formulated by solvent diffusion method applied Thogonal Taguchi optimization. Prepared GEN-NLCs were characterized by their physicochemical quality like particle size, zeta potential, morphology (SEM and AFM), entrapment efficiency, in-vitro release, and incompatibility studied such as DSC, and XRD. In-vitro anticancer and cellular uptake studies were accomplished in MTT assay method and A-375 melanoma cell-line by fluorescence-microscopy technique. Nanogel was prepared by incorporating optimized batch of GEN-NLC in methocel and evaluated for particle size and mechanical properties, In-vitro and ex- vivo occlusion studies, in-vitro release and ex-vivo human cadaver skin permeation and retention studies. Prepared GEN-NLCs were found to be a smooth surface with particle size 189.90±2.45 nm, 89.50±4.52% EE, -14.98±1.4mV zeta potential, and sustained release. MTT assay revealed that nanoparticles were 15.37 times more effective against melanoma as compared to pristine drugs. There was no significant change in texture profile of nanogel after incorporating GEN-NLC. Moreover, a significant increase in occlusivity was observed with occlusion factor almost 3.75 times more than control gel at end of 24 h. Ex-vivo studies further confirmed decrease in flux across skin i.e. sustained release pattern of GEN from hydrogel and increased hydration and retention in epidermis. Therefore, topical delivery of GEN-NLC loaded gel showed potential delivery system to target skin epidermis for melanoma cancer cells with enhanced efficacy.

Migraine is a frequent neurological condition characterized by throbbing headaches, nausea, photophobia, and phonophobia, among other symptoms. Sumatriptan belongs to a BCS class III, which exhibits poor oral bioavailability and several side-effects. The objective of the present study was to develop solid lipid nanoparticles (SLNPs) of sumatriptan succinate for brain targeting by nasal route. Solvent injection method was used to increase the entrapment efficiency of hydrophilic drug. Thus, formulation was optimized by central composite design with minimum particle size, optimized zeta potential, and maximum entrapment efficiency, which was found to be 133.4 nm, -17.7 mV, and 75.5%, respectively. Optimized batch was further evaluated for surface morphology, Fourier-transform infrared spectroscopy

The research focussed on development and evaluation of ethosome as an effective delivery of antigen that eliminates need for frequent dose of antigen while improving patient compliance for Hepatitis B.Prepared a single dose HBsAg ethosomal vaccine using a cold method and applied a central composite design optimisation using particles size, zeta potential and entrapment efficiency as dependent variables. Further, selected batch was assessed for their morphology, in vitro release, interaction, haemocompatibility, histological (The prepared ethosome showed minimum particle size (93.98 ± 4.6), 15.0 ± 2.83 mV zeta potential, with maximum entrapment efficiency (66.25 ± 8.6%). Physicochemical characterisation reveal the sustained release, haemocampatibile, and stable nature of ethosome. Further, ex-vivo skin permeation showed safely administration of drug by nasal route without toxicity. TheA single dose of ethosome is sufficient for the complete immunological response not require booster administration. The potency of ethosomes have to produce a protective immune response, as well as their ability to explore and target the immunological environment through nasal route.

The current study focussed on the development and evaluation of aqueous core nanocapsules (ACNs) as an effective carrier to deliver an optimal synergistic combination of a highly water-soluble Vinorelbine bitartrate (VRL) and a poorly water-soluble Resveratrol (RES) for treatment of breast cancer.Various molar ratios of VRL to RES were screened against MCF-7 cell lines to determine the synergistic effects using the Chou-Talalay method. The synergistic ratio of therapeutic agents was then incorporated into aqueous core nanocapsules utilising a double emulsion solvent evaporation technique to yield dual drug-loaded nanocapsules (dd-ACNs). The dd-ACNs were optimised using Box-Behnken design and characterised for physicochemical parameters such as particle size, zeta potential, polydispersity index, total drug content and encapsulation efficiency, surface morphology, drug excipient compatibility by FTIR and DSC, release kinetics, toxicity studies and anticancer efficacy (Results demonstrated that the combination exhibited maximum synergy when higher doses of VRL were combined with smaller doses of RES (1:1, 5:1, and 10:1). The dual drug-loaded ACNs were found to be stable and depicted a core-shell structure, narrow size range (150.2 ± 3.2 nm) with enhanced encapsulation (80% for VRL and 99% for RES). Moreover, the dd-ACNs were 5 times more efficaciousThe developed dd-ACNs can be applied as a potential carrier for delivery of a combination of chemotherapeutics at a synergistic ratio at the tumour site.

Abstract: COVID-19, caused by the SARS-CoV-2 virus, has been expanding. SARS-CoV caused an outbreak in early 2000, while MERS-CoV had a similar expansion of illness in early 2010. Nanotechnology has been employed for nasal delivery of drugs to conquer a variety of challenges that emerge during mucosal administration. The role of nanotechnology is highly relevant to counter this “virus” nano enemy. This technique directs the safe and effective distribution of accessible therapeutic choices using tailored nanocarriers, as well as the interruption of virion assembly, by preventing the early contact of viral spike glycoprotein with host cell surface receptors. This study summarises what we know about earlier SARS-CoV and MERS-CoV illnesses, with the goal of better understanding the recently discovered SARS-CoV-2 virus. It also explains the progress made so far in creating COVID-19 vaccines/ treatments using existing methods. Furthermore, we studied nanotechnology- based vaccinations and therapeutic medications that are now undergoing clinical trials and other alternatives.

PEGylation is the covalent addition of PEG to one more molecule. PEGylation can improve the maintenance time of the therapeutics similar to proteins, liposomes, and nanoparticle through shielding them beside different debasing mechanisms dynamic in a body that improve beneficial properties. This skill is used to get better half-life and other pharmaceutical properties of a protein, peptide, or non-peptide molecule. Polyethylene glycol is harmless, non-immunogenic, non-antigenic, and extremely soluble in water and FDA accepted polymer. It shows a significant role in drug delivery. A variety of PEG-based formulations are available in the market. This paper represents the benefits of PEGylation over non-PEGylated products. Now a day, PEGylation plays an important role in the drug delivery system. PEGylation increases the therapeutic potential of drugs.

Worldwide immunization can save millions of peoples to lives year by using the vaccines. The subunit of antigen components is manufactured which can stimulate the immune system by providing specific immunity against specific diseases. Subunit vaccines have many advantages like as high safety profile but having limited ability to provide immunogenicity. These traditional subunit vaccines activate only innate immunity, encourage cell-mediated transport of antigen to lymphoid tissues. Newly nano-adjuvants based vaccines carrier systems like liposomes, virosome, micelles, polymeric particles, protein, and peptides are developed by using various substances like viral proteins, polymer and polystyrene having immanent adjuvanticity and also provide exalted capability in manufacturing subunit vaccines. It has chromospheres substances that have various properties such as targeted, anti-damaging and caliber to lead immune reactions towards Th1 and Th2 route, which is an important feature for humoral as well as cellular immunity. The whole thing based on the carrier system, the role of nano-adjuvants, its pharmacokinetics and distribution in the body system. It has the ability to provide antigen-specific immunity to both systemic as well as mucosal by different vaccination passage. Also, the nano-adjuvants based vaccine suggested that direct targeting of antigen to improve the vaccine potency without sacrificing safety.

Nanotechnology provides an excellent platform for the development of a new generation of vaccines. These are based on purified subunit proteins or polysaccharides, recombinant proteins, synthetic peptides, or nucleic acids. These types of vaccines may be insufficiently immunogenic, thus requiring adjuvants that augment their immunogenicity. Nanoparticles (NPs) can act as adjuvants for vaccines, hence they are referred to as a nano-adjuvant (NA). NPs can either encapsulate or adsorb the vaccine antigen or DNA in an appropriate formulation, thus increasing stability, cellular uptake, and immunogenicity. In addition, the biodistribution and systemic release of a vaccine can also be controlled by different NA formulations. This review provides an overview of the classification of NAs and also addresses factors influencing the stability, release, and immunogenicity of the formulated vaccine. A basic understanding of these factors enables a more rational design of NA formulations. Applications of NAs and key challenges in their formulation development are also discussed.

Abstract: The mucosal surfaces are the key site of the entrance, protection, and stability of several pathogens. Considering that >90% of pathogens gain access to the body via mucosal sites, using mucosal vaccination to generate protective immunity at mucosal sites could overcome. Some of the micro and nano carrier-based nasal delivery systems produce cellular, humoral and mucosal immun-ity. The nasal route vaccination may protect multiple distant mucosal sites like-rectal, vaginal, oral, and pulmonary. Also, it is a convenient and cost-effective vaccination mode with improved patient compliance. Several nasal vaccine delivery systems are currently being supplied in the form of lipo-somes, micro/nano particulates, which have shown immunity in animal models. Especially particu-late nanovaccine has a special character related to long-term immunogenicity and high efficiency. The significance and the ability of the nasal route vaccination programs are unexplained and com-plications; therefore, effective delivery strategies will promote the production of nasal vaccines. The present study focuses on vaccine delivery strategies and their effects on the immune system. Also, the study discusses the benefits of mucosal-associated immune response over the conventional de-livery system for vaccine via the nasal route.

Background: The pathogenesis of hepatic diseases involves several cells which makes the delivery of pharmaceutical agents complicated. Many severe liver diseases affecting the worldwide population cannot be effectively treated. Major hindrance or challenges faced are natural physiological barriers and non-specific targeting of drugs administered leading to inefficient treatment. Hence, there is an earnest need to look for novel therapeutic strategies which can overcome these hindrances. Kind of literature have reported when a drug is incorporated inside or attached, to a polymeric material of either hydrophilic or lipophilic nature, drug safety and efficacy are incredibly raised. This has given the driving force to the dynamic investigation for development of novel biodegradable materials, drug delivery carriers, target specific drug delivery systems and many other novels approach. Objective: Present review is devoted to summarizing receptor-based liver cell targeting by the use of different modified novel synthetic drug delivery carriers. It also highlights recent progress in drug targeting to diseased liver mediated by various types of receptors including asialoglycoprotein, mannose and, galactose receptor, Fc receptor, low-density lipoprotein, glycyrrhetinic, and bile acid receptor. The essential consideration is given to the treatment of liver cancer targeting by the use of nanoparticulate systems, proteins, viral, and non-viral vectors, homing peptides and gene delivery. Conclusion: Receptors based targeting approach is one such approach that was explored by researchers to develop novel formulations which can ensure site specific drug delivery. Several receptors are present on the surfaces of liver cells which are reported to be highly overexpressed in the various disease conditions. Its all are helpful for the treatment of the liver cancer.

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Serum albumin is the most abundant protein in blood. It shows a variety of activities including antioxidant activities and binding activity toward lipophilic hormones, marker for glucose intolerance and protective effects. Albumin is used for the treatment of many diseases such as cancer, liver disease, renal disease, inflammatory disease, and cardiovascular infection. Over the last decade, various drug delivery systems have been created to improve the treatment of various disorders and diseases. Albumin has been generally studied as a protein carrier for the delivery of the drug. Especially, in nanotechnology, it is utilized for the delivery of various drug molecules for the sustained, control release and enhancement of bioavailability. So, the demand for albumin increased annually worldwide due to the different applications of albumin.

Vaccines can help the body fight viruses by stimulating effective protective mechanisms, but they have disadvantages included low efficacy and immunogenicity, decreased stability, and the need for regular doses. Nanovaccines have been studied for their ability to induce a powerful immune reaction due to their nano-sized range, high antigen loading, improved immunogenicity, regulated antigen presentation, increased lymph node retention, and lower dosing frequency. Various forms of nanoparticles containing a variety of pathogenic or foreign antigens may help to reduce immunotolerance and eliminate the need for vaccinations, as is the case for conventional drugs. Nanovaccines can improve cell-mediated and antibody-mediated immunity, as well as immunologic memories over time. The different types of nanomaterials used in vaccine production, as well as their effects on immune system activation, have been explored, with a focus on their implications in various pathological conditions. In presented review articles discuss the different nanovaccine carriers (advantages and limitation), administration by transdermal route, its mechanism for stimulation of cellular and humoral immunity.

Objective The incredibly serious problem of Hepatitis B is virus-related chronic liver disease. The conventional preventive treatment of Hepatitis B requires booster dose, which requires repeated administration of the vaccine to the subject. Thus, there is a need to develop a formulation which can eliminate the need of frequent dosing and enhance patient's acquiescence. To prepare single dose nanovaccine of HBsAg by utilizing central composite design for optimization and interaction of independent variables effects on measured response. Methods Nanovaccines were characterized for particle size, morphology, integrity, internalization, proliferation response and haemocompatibility. Nanoparticles at single and multiple doses were compared with booster dose of alum-HBsAg vaccine and measure the immunological marker and cytokine (interleukin-2 and interferon-Y) levels by ELISA techniques in BALB/c mice. Results The designed nanoparticles were found to have nanometric size, high entrapment efficiency and retained antigen integrity. Nanoparticles showed maximum proliferation and efficiently internalized by lymph and spleen cell without eliciting significant toxicity and haemocampatible. Conclusion The comparable data of anti-HBsAg titre between nanovaccine and alum adsorbed HBsAg demonstrated that single dose of nanoparticles is sufficient for production of immunoglobulin plus cytokine levels, maintain immunogenicity at longer period of time and eliminate the booster dose. Nanovaccines trigger immune responses and showing adjuvant properties.

The surface of the mucosa is the biggest path through which pathogens enter the human body. We need an understanding of mucosal immune systems to use vaccines that generate protective mucosal and systemic immunity to regulate the outbreak of various infectious diseases. The better impact of the mucosal vaccine over traditional injectable vaccines are that not only do they induce efficient immune reactions to the mucosa but they are also comfortable in physical aspect & psychological aspect. The material of the vaccine includes pathogens antigens and adjuvants, which enable vaccination to be effective. Vaccines are classified into different criteria, including the used vaccine material and method of administration. Vaccines have traditionally been injected through a needle. However, as most of the pathogens first infect the mucosal surfaces, and growing interest is expressed in establishing protective immunity from the mucosa, which is accomplished through mucosal paths through vaccinosis. To improve the existing vaccines further, innovative strategies derived from interdisciplinary scientific research will need to develop new vaccine production, storage, and delivery systems. A distinctive & vast research and development platform has been set up for the growth of the next generation of mucosal vaccinations. The latest science and technological advancement in the areas of molecular biology, bio and chemical engineering, genome and system biology has provided accumulated understanding of the inborn and acquired multi-dimensional immune system. This review summarizes recent developments in the use of mucosal vaccines and their associated nanoadjuvants for the control of infectious diseases.

The present work is focused on the development and evaluation of single dose sustained-release Hepatitis B surface antigen (HBsAg) loaded nanovaccine for Hepatitis B. The conventional treatment suffers from repeated administration and hence requires a booster dose. Therefore, polymeric nanovaccine of HBsAg was developed by double emulsion solvent evaporation technique, utilizing central composite design for formulation optimization. The effects of independent variables (like polymer amount, stabilizer concentration, aqueous/organic phase ratio and homogenizer speed) were also studied on critical quality attributes like particle size and entrapment efficiency. Nanovaccine was characterized in terms of physicochemical parameters, release, internalization and in vivo immunological evaluation in BALB/c mice after administration by different routes such as oral, sub-cutaneous, nasal and intramuscular. The designed nanovaccine demonstrated nanometric size with smooth surface, negative zeta potential, maximum entrapment, sustained release and better internalization in macrophage and MRC-5 cell line. The immune-stimulating activity of nanovaccine administered by different routes was evaluated by measuring anti-HBsAg titre like specific immunoglobulin IgG and IgA response and cytokine level (interleukin-2, interferon-Y) measurement. The results indicated that the nanovaccine administered by intramuscular route produced better humoral as well as cellular responses and potential carriers for antigen delivery at single dose administration via intramuscular route.

Now a day, millions of people suffer from chronic Hepatitis B Virus globally. Presently, no well-established treatment is available for the chronic Hepatitis B virus infection; the available treatment is based on host mediated immunological control and reduction of HBV-DNA levels in blood serum. There is a constant demand for new and improved vaccines, scientist have continually developed a new vaccine technology. In this research article given a different approach for the preparation of Hepatitis B vaccine, utilizing a novel drug delivery system. In this regard developed a Hepatitis B antigen loaded polymeric and lipid particles. Prepared particles were further characterized for their particles size, entrapment efficiency, morphology and in vitro release. Further, compare the formulation on the basis of characterization. Results indicated that, polymeric particles showed high entrapment efficiency, and better release. This formulation is suitable for further clinical study.

Stable angina or angina pectoris is referred to as uneasiness/pain in the chest, resulting from coronary heart disease (CHD). Ivabradine Hydrochloride (IBH) is a recently approved drug to manage stable angina and heart failure symptoms. The approved IBH tablets exhibit some technical shortcomings i.e. short half-life (2 h), variable systemic absorption, and high first-pass metabolism (>50%). Therefore, utilizing a nanoformulation technique, we have designed a differentiated and innovative formulation of IBH. The IBH loaded polymeric nanoparticles (IBH-PNPs) are being developed for per-oral delivery by double emulsion method, using Poly lactic-co-glycolic acid (PLGA) as polymer, and d -α-tocopherol polyethylene glycol 1000 succinate (TPGS) as a stabilizer. The pre-formulation studies performed are UV spectroscopy, FT-IR, and X-ray diffraction. The Box-Behnken design was exploited for formulation optimization. The optimized formulation was characterized for its particle size, zeta potential, morphology, entrapment efficiency, in-vitro release, stability studies, ex-vivo permeability, and in-vivo pharmacodynamics study. The optimized IBH-PNPs were found to be spherical (

The objective of the present study was to develop polymeric nanoparticles (PNPs) of frovatriptan succinate for brain targeting by nasal route. Double emulsion method was used to increase the entrapment efficiency of hydrophilic drug, and formulation was optimized by central composite design to achieve critical quality attributes namely particle size, zeta potential, and entrapment efficiency. Optimized batch was evaluated for surface morphology, in vitro release, permeation across nasal mucosa, stability, histopathology, and brain tissue uptake study. Prepared PNPs were found to be smooth with particle size of 264.4 ± 0.04 nm, zeta potential −35.17 ± 0.07 mV, and 65.2 ± 0.06% entrapment efficiency. PNPs showed biphasic release pattern, initial burst release followed by sustained release up to 72 h. Ex vivo diffusion study using goat nasal mucosa at pH 6.8 revealed that PNPs permeation across nasal mucosa was about 3 times more than the pure drug solution, and quick delivery of PNPs in brain region was confirmed by fluorescence microscopic evaluation in male Wistar rats after intranasal administration. Histopathology studies further revealed integrity of nasal mucosa after treatment with PNPs. The investigation indicated that hydrophilic drug, frovatriptan succinate can be successfully entrapped in PNPs to target brain via nasal delivery, and thus it could be an effective approach for nose to brain delivery.

Background Vinorelbine bitartrate (VRL) is an antimitotic agent approved by FDA for breast cancer and non-small cell lung cancer (NSCLC) in many countries. However, high aqueous solubility and thermo degradable nature of VRL limited the availability of marketed dosage forms. Objectives The current work is focused on the development of lipid based aqueous core nanocapsules which can encapsulate the hydrophilic VRL in the aqueous core of nanocapsules protected with a lipidic shell which will further provide a sustained release. Methods The ACNs were prepared by double emulsification technique followed by solvent evaporation. Box Behnken Design was utilized to optimize the formulation and process variables. Thirteen batches were generated utilizing lipid concentration, surfactant concentration and homogenizer speed as dependent variables (at three levels) and particle size and encapsulation efficiency as critical quality attributes. The ACNs were characterized for particle size, zeta potential, polydispersity index (PDI), entrapment efficiency, morphology by Transmission Electron Microscopy (TEM) and in vitro release. The ACNs were further evaluated for safety against intravenous administration by haemocompatibility studies. Results Results demonstrated that lipidic nanocapsules enhanced the entrapment efficiency of VRL up to 78%. Transmission Electron Microscopy revealed spherical shape of ACNs with core-shell structure. The GMS-VRL-ACNs showed that release followed Korsemeyer peppas kinetics suggesting Fickian diffusion. Moreover, the compliance towards haemocompatibility studies depicted the safety of prepared nanocapsules against intravenous administration. Conclusion ACNs were found to be promising in encapsulating high aqueous soluble anticancer drugs with enhanced entrapment and safety towards intravenous administration.

Chronic Hepatitis B Virus (HBV) infections are severe with weak antiviral immune responses. The lack of an appropriate small animal model for chronic hepatitis, a major hurdle for studying the immunotolerance and immunopathogenesis induced by hepatitis B viral (HBV) infection. In this study, for enhancing the antibody production efficiency the prepared polymeric HBsAg-loaded nanoparticles (nanovaccine) will be tested in immune-deficit mice, which suffer from chronic Hepatitis B virus. Vaccination of Balb/c mice by this prepared nanoparticles that were engrafted with peripheral blood mononuclear cells (PBMCs), which was already lethally irradiated and transplanted by the bone marrow of NOD (knockout mice) mice. In the present study, after the vaccination detected the high frequencies of immunoglobulin G (IgG)-secreting B cells and mitogen-responsive interferon-Y (IFN-Y) secreting T cells in serum, determined by specific ELISA technique. During the entire observation period, unvaccinated animals showed lower concentration of specific IgG secreting B cells and IFN-Y secreting T cells found in comparison to vaccinated mice group. Chronic HBV carrier PBMCs transplanted into the chimera failed to produce antigen and increased the antibodies production due to vaccination. Furthermore, another advantage was that the viral gene expression and viral DNA replication was no longer observed in vaccinated group. This prepared nanovaccine formulations is better for the cure of Hepatitis B viral infection carrier. Therefore, specific memory responses were elicited by vaccination with Hepatitis B virus surface (HBsAg) antigen of chimeric mice transplanted with PBMCs derived from HBV donors.