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Hydrogels are three-dimensional crosslinked networks of hydrophilic polymers, capable of absorbing large quantities of water or aqueous fluids. Polysaccharide-based hydrogels (PBHs) offer several advantages over their synthetic counterparts. Their natural origin contributes to their non-toxicity, high biocompatibility, andSuch versatile characteristics have potentiated the use of PBHs for the delivery of drugs, vaccines, proteinpeptide therapeutics, genes, cells, probiotics, bacteriophages, and other therapeutic agents. Recent advances in hydrogel-based formulations such as nanogels, microgels, microneedles, hydrogel beads, nanocarrier-loaded hydrogels, and complexation hydrogels have enabled the precise delivery of a wide range of therapeutics. This review aims to give a holistic overview of hydrogels in the delivery of a variety of therapeutics through different routes, which is seldom covered in other reviews.PBHs have been used to enable the oral delivery of vaccines and other biologicals, thereby allowing self-administration of life-saving vaccines, saving countless lives, especially during public health emergencies. There is a lack of commercialized wound dressings for the treatment of chronic wounds. PBH-based wound dressings, especially those based on chitosan and loaded with actives and growth factors have the potential to help in the long-term treatment of such wounds. Recent developments in the 3D printing of hydrogels can enable the quick and large-scale production of drug-loaded hydrogels.

Purpose The purpose of this study is to enhance the understanding of the complete process of framing and implementing operational excellence in the pharmaceutical industry to ensure higher regulatory compliance. Design/methodology/approach A literature search was conducted using preferred reporting items for systematic reviews and meta-analyses guidelines. Strategies were set with different keywords and certain assessment criteria for the inclusion and exclusion of articles. A total of 46 articles were considered for a full review. Findings This study describes the impact of implementing operational excellence in day-to-day operations and the driving forces to achieve the same. Seven commonly used enablers are described can be used in combination to develop and validate an assessment model. Case studies are summarized to schematize operational excellence programs for the scope of their industry. Research limitations/implications This study is limited to Indian pharmaceutical manufacturers. It is implied toward small-scale manufacturers. It can be further extended to manufacturers from other regions. Practical implications This study guides quality assurance managers, regulatory agencies and other top management to implement operational excellence to ensure higher regulatory compliance. It guides to develop a roadmap to operational excellence in their scope. This study is applicable to any manufacturing industry bound to comply with pharmaceutical regulatory standards. Originality/value To the best of the authors’ knowledge, at the time of publication, there are regulatory guidelines and some articles on various key enablers to achieve operational excellence. There is no published systematic review on achieving regulatory compliance by using operational excellence.

The outbreak of the new coronavirus disease changed the world upside down. Every day, millions of people were subjected to diagnostic testing for Covid-19, all over the world. Molecular tests helped in the diagnosis of current infection by detecting the presence of viral genome whereas serological tests helped in detecting the presence of antibody in blood as well as contributed to vaccine development. This testing helped in understanding the immunogenicity, community prevalence, geographical spread and conditions post-infection. However, with the contagious nature of the virus, biological specimen sampling involved the risk of transmission and spread of infection. Clinic or pathology visit was the most concerning part. Trained personnel and resources was another barrier. In this scenario, microsampling played an important role due to its most important advantage of remote, contactless, small volume and self-sampling. Minimum requirements for sample storage and ease of shipment added value in this situation. The highly sensitive instruments and validated assay formats assured the accuracy of results and stability of samples. Microsampling techniques are contributing effectively to the Covid-19 pandemic by reducing the demand for clinical staff in population-level testing. The validated and established applications supported the use of microsampling in diagnosis, therapeutic drug monitoring, development of treatment or vaccines and clinical trials for Covid-19.

Ziprasidone (ZPR) is an antipsychotic agent having less solubility. It is used for the treatment of schizophrenia. Complexation of hydrophobic drugs with cyclodextrins leads to enhanced solubility and dissolution. In this study, inclusion complexes were prepared by different methods, using ZPR, β-cyclodextrin (β-CD), and different auxiliary agents like hydrophilic polymer and hydroxy acid (1:1:0.5) to improve the aqueous solubility. The characterization of the ternary complexes was carried out using solubility study, Differential scanning calorimetry (DSC), Powder X-ray diffraction (PXRD), Fourier transformation infrared spectroscopy (FT-IR) and in vitro dissolution studies. DSC, XRD, and FT-IR studies showed interaction in drug, cyclodextrin, and auxiliary agents which are confirmed by enhancement of solubility and dissolution. Spray-dried dispersion showed less crystallinity and higher solubility as compared to the kneading method for both citric acid and Lutrol® F-68. Thus, the investigation concludes that the presence of the auxiliary agent has a synergistic action on complexation with cyclodextrin, which helps to modify the physicochemical properties of the drug.

This study aimed to enhance the kinetic solubility of ACV by using microwave-assisted technique to form ACV co-crystals and overcome its limited aqueous solubility. Co-crystallization is one of the commonly used techniques to improve the dissolution rates of active pharmaceutical ingredients (APIs). Acyclovir (ACV) has a limited efficacy due to its low oral bioavailability resulted from its poor aqueous solubility and permeability. Acyclovir co-crystals were formulated by microwave assisted solvent extraction (MASE) in equimolar ratio of 1:1 with different co-formers. Physical and structural characterization by differential scanning calorimetry (DSC), powder x-ray diffraction (PXRD), and Fourier transform infrared (FTIR) spectroscopy were performed. Further evaluation of the co-crystals solubility, dissolution rate and content were carried out using the ultraviolet (UV) spectrophotometry. Co-crystals of acyclovir and tartaric acid (ACV-TA) in equimolar ratio of 1:1 produced by MASE using the glacial acetic acid as a solvent were more soluble compared to plain drug. The dissolution rate was increased from only 59.0% of pure acyclovir up to 85.0% of ACV co-crystals within 1 hour. DSC and PXRD patterns of co-crystals were distinguished from that of individual components. The UV-spectroscopic analysis represented 62.5% of acyclovir in the co-crystals, which was directly related to the theoretical percentage of the drug and its co-former (ACV: 60.01%, TA: 39.99%). This study revealed that the optimal ratio of the ACV-TA co-crystal is 1:1, which was successfully prepared using MASE technique. This method provides a promising alternative for enhancing the solubility of acyclovir with ultimately less time and solvent consumption.

Objective: The primary objective of the project was to formulate and evaluate hard capsule containing the solution of ibuprofen. It also included enhancement of solubility of ibuprofen in hydrophilic solvents to obtain a unit dose capsule acceptable for human consumption. Methods: Solution of ibuprofen was developed by the salt formation of partial drug using potassium hydroxide in PEG 600 and water. The solution was encapsulated in hard capsules with band sealing. The final formulation was evaluated for uniformity of weight, disintegration, drug content and stability. The dissolution profile was compared with that of available marketed tablets and softgels. Results: The capsules were evaluated and found compliant as per specifications mentioned in general monograph of capsules in IP 2014. The uniformity of weight of the batch of capsules was found to be 734.8 mg (±0.58). The disintegration time of these capsules was observed to be 4.45 min. The drug content was found to be 100.03% and the product is stable over three months of test period under room temperature as well as accelerated conditions. The dissolution profile showed that softgels take longer time to release the drug whereas marketed tablets showed a dissolution profile comparable with that of formulated capsules. Conclusion: The developed capsule is a unit dose of liquid containing solubilized ibuprofen delivering the drug directly into the gastrointestinal tract (GIT). These are newer solid oral dosage forms with higher patient compliance and ease in manufacturing. They require lesser steps and manufacturing area when compared to the manufacturing of compressed tablets.

Microneedles (MNs) are minimally invasive tridimensional biomedical devices that bypass the skin barrier resulting in systemic and localized pharmacological effects. Historically, biomaterials such as carbohydrates, due to their physicochemical properties, have been used widely to fabricate MNs. Owing to their broad spectrum of functional groups, carbohydrates permit designing and engineering with tunable properties and functionalities. This has led the carbohydrate-based microarrays possessing the great potential to take a futuristic step in detecting, drug delivery, and retorting to biologicals. In this review, the crucial and extensive summary of carbohydrates such as hyaluronic acid, chitin, chitosan, chondroitin sulfate, cellulose, and starch has been discussed systematically, using PRISMA guidelines. It also discusses different approaches for drug delivery and the mechanical properties of biomaterial-based MNs, till date, progress has been achieved in clinical translation of carbohydrate-based MNs, and regulatory requirements for their commercialization. In conclusion, it describes a brief perspective on the future prospects of carbohydrate-based MNs referred to as the new class of topical drug delivery systems., Highlights The transdermal route can be a promising approach for drug delivery. Microneedles (MNs), a novel and important transdermal drug delivery system (TDDS), are discussed. Prisma guidelines are utilized to review carbohydrate-based MNs for medical applications. More innovative applications are predicted owing to their physiological features.

The two main branches associated with Artificial Intelligence (AI) in medicine are virtual and physical. The virtual component includes machine learning (ML) and algorithms, whereas physical AI includes medical devices and robots for delivering care. AI is used successfully in tumour segmentation, histopathological diagnosis, tracking tumour development, and prognosis prediction. CURATE.AI, developed at the National University of Singapore, is a platform that automatically decides the optimum dose of drugs for a durable response, allowing the patient to resume a completely normal life. With the involvement of technology multinationals, such as Google and Microsoft, in AI and healthcare in association with leading healthcare companies, the future of AI in healthcare looks very promising.

Lurasidone hydrochloride (LHD) is an atypical antipsychotic drug has poor aqueous solubility and low bioavailability (9–19%). This study describes effect of different methods of complex formation with β-cyclodextrin (BCD) on enhancement of dissolution and on antidepressant, antipsychotic effects of LHD. Other purpose of this study is to compare pharmacodynamic effects of complexes with that of self microemulsifying drug delivery system of LHD (SMEDDS). Inclusion complexes (IC) of LHD and BCD were prepared by physical mixing (PM), kneading (KN) and spray drying (SD) in a 1:1 M ratio. These complexes were characterized by different techniques. KN and SD showing enhancement in dissolution, were compared with SMEDDS using Forced swim test (FST) and Tail suspension test (TST) for antidepressant action and Paw test for antipsychotic activity. Characterization of complexes confirmed interaction between LHD and BCD. Enhancement in dissolution is seen in following order SD > KN > PM > LHD. In all three animal models, SD, KN and SMEDDS showed statistically significant effect (p Complexation of LHD with BCD enhances dissolution which reflected in improvement of antidepressant and antipsychotic activity of drug. Solubility enhancement methods like complexation and self microemulsion improves pharmacodynamic activities of drug. Improvement of pharmacodynamic effect is seen in order, SD ≥ SMEDDS ≥ KN > LHD.

The rationale of this study was to formulate topically effective sustained release ophthalmic Methazolamide (MTA) liposomal in-situ gel. Lipid film hydration method was employed for the preparation of MTA liposomes consisting of lecithin and cholesterol. Optimization of the MTA liposomes by Design-Expert software was done to evaluate the effect of cholesterol and drug in varying concentrations using a 32 factorial design. Encapsulation efficiency and particle size were considered as dependent variables. Drug encapsulation was increased by increasing cholesterol as well as drug concentration. The optimized batch showed encapsulation efficiency of 74.12 ± 0.52% and particle size was found 193.2 ± 1.34 nm. The liposomal gel was prepared by incorporating MTA liposomes in Carbopol 934 gel.The final formulation showed a pH of 7.1 ± 0.05, spreadability of 0.8 ± 0.1. In vitro release studies of MTA liposomes and MTA liposomal gel were compared. In comparison to MTA solution, MTA liposomal gel showed a significant reduction (p

Breast cancer is considered the most prevalent disease among women worldwide. It is ranked second in the world in terms of mortality rate of women due to cancer, with lung cancer still being the first. The treatment option breast cancer becomes limited and stands therapeutically substantial due to its associated systemic toxicities. In spite the various advanced in treatment modalities, there is no reduction in the rate of mortality. Recent studies have shown more focus of the researchers towards the herbal medicines, their method of formulation and their usefulness in the prevention and treatment of breast cancer. It is observed that the herbal bioactives have less bioavailability and less therapeutic efficacy owing to their hydrophobic nature. This in turn led to the advancement in the formulation technologies like slight modification for the herbal nano-formulation to form targeted drug delivery system. These systems could have the potential to reduce the associated toxicities related to the anti-cancer drugs and conventional drugs with increase in the bioavailability and therapeutic efficacy. This review discusses the studies which focus on different nano carriers loaded with herbal molecules for the treatment of breast cancer with/without synthetic drug, systematically using PRISMA guidelines. These different nano-formulations can give the reader broad information on the delivery aspect and the techniques used for the preparation of the herbal nano-formulation and their in vivo study.

Paliperidone (PLPD) is approved for treatment and management of schizophrenia. The current study demonstrates the potential of in situ gel of PLPD for nasal delivery. The permeation of drug through sheep nasal mucosa was analyzed since the nose-to-brain pathway has been indicated for delivering drugs to the brain. The carbopol 934 (CP)- and hydroxypropyl methyl cellulose K4M (HPMC)-based in situ gels containing 0.2% CP and 0.4% w/v HPMC were optimized using experimental design software. The use of hydroxypropyl-β-cyclodextrin (HP-β-CD) in nasal permeation of drug was investigated. Transmucosal permeation of PLPD was examined using sheep nasal mucosa. The in situ gels of PLPD exhibited satisfactory mucoadhesion and showed sustained drug release. The mucocilliary toxicity and histopathological examination confirmed that the nasal mucosa architecture remains unaffected after treatment with PLPD in situ gel. The formulation containing HP-β-CD complex of PLPD exhibited higher rate of drug permeation through sheep nasal mucosa revealing the role of HP-β-CD as nasal absorption enhancer. Thus, CP- and HPMC-based pH-triggered in situ gel containing HP-β-CD-drug inclusion complex demonstrates a novel nasal delivery of PLPD.

Background Ginger and castor oil, both are used in traditional medicine to treat arthritis, the latter is also commonly used as a vehicle in these systems of medicine. The study was designed to prepare a nanostructured lipid carrier (NLC) of ginger extract using castor oil as a novel liquid lipid and evaluate its safety and efficacy in rheumatoid arthritis in experimental animals. Methods Ginger extract was standardized using High performance liquid chromatography (HPLC). The optimized NLC formulation was characterized and its therapeutic efficacy was evaluated in Chronic Freund's adjuvant (CFA) induced arthritis in experimental animals. Results Ginger extract contained 38.76 ± 3.01%w/w of 6-gingerol. The optimized NLC formulation showed a particle size of around 205 nm, a zeta potential of −33.7 and %entrapment efficiency of 76.59 ± 0.83%. Reduction in primary inflammation was significantly higher with NLC when compared with ginger extract and castor oil alone (p Conclusion Castor oil can be used as a novel lipid in the preparation of NLC. The NLC effectively enhanced the therapeutic value of poorly bioavailable ginger extract.

Nanomotors, multimetallic systems are biologically inspired self-propelled tiny engines able to perform difficult tasks of transporting cargos from one end to another in presence of hydrogen peroxide fuel. Nanomotors can revolutionize the drug delivery system at the desired target by converting chemical energy into mechanical energy. Nanomotors exhibit unique properties like moving at higher speed, self-propulsion and drilling into the complex cellular environment. The review focuses on fuel dependent and fuel-free nanomotors with their propulsion mechanism. Further, the review highlights the method of fabrication, biohybrid nanomotors, toxicities along with their application in the field of active drug delivery, diabetes, precise surgery, ischemic stroke therapy, diagnosis and treatment of coronavirus, microwave hyperthermia, zika virus detection, anti-bacterial activity, water treatment and sensing and challenges lying at the forefront in the development of these tiny nanomachines. Hydrogen peroxide is toxic to mankind; biohybrid motors give an extra edge of eliminating hydrogen peroxide as fuel for self-propulsion, this can be used for smart drug delivery by reducing toxicities as compared to artificial nanomotors. Cost-effective fabrication of nanomotors will extend their applications in commercial sector overcoming limitations like scale-up and regulatory approval. In near future, nanomotors will diversify in fields of restoring conductivity of electronic medical devices, 3D printing and theranostics.

Metformin hydrochloride is an antihyperglycemic drug, for treatment of type 2 diabetes. The therapeutic dose range is 250 mg–1000 mg in immediate release form. Due to bulky nature of the tablets, there may be difficulty in swallowing to some patients, especially for geriatric patients. A few liquid oral formulations are available in market containing 500 mg per 5 mL dose. However, considering the risk for some dysphagic patients, simple non viscous liquid formulation may pose aspiration and coughing problem which can be fatal and hence, an alternate, unit packaged oral jelly dosage form can be a very good option. Current research paper emphasizes on formulation development, evaluation and formula optimization of metformin hydrochloride oral jelly up to 1000 mg per 5 g strength. The formulations so prepared were palatable and easy for swallowing. The stability of the formulation was conducted in unit dose triple laminated aluminum sachets. The product was found stable at accelerated condition for six months. The oral jelly of metformin hydrochloride can offer good alternate option for use in geriatric patients to resolve swallowing difficulty. The oral jelly can be marketed in unit dosage sachets which are easy to carry, keep the product in stable state up to shelf life hence improve patient compliance.

The antipsychotic drug Iloperidone (ILO) suffers from drawbacks of low solubility and poor bioavailability. In order to overcome such problems, we proposed to prepare binary and ternary complexes using kneading method and further compared for their ability to improve the solubility of ILO. Based on preliminary studies and phase solubility diagram, 1:1 ratio of drug and Hydroxypropyl β-cyclodextrin (HPβCD) was selected. Tartaric acid (TA) and Kolliphor P-188 (KP) were selected as auxiliary agents (AAs) for ternary systems. Significant improvements in the stability constant and complexation efficiency were seen in the phase solubility studies for TA in comparison to KP. Complexation was studied using PXRD, DSC, FT-IR and NMR. Apparent changes in the crystallinity of ILO were observed from PXRD and DSC studies, suggesting formation of complexes. The interactions in the inclusion complexes were confirmed by FT-IR and 1HNMR. Saturation solubility and in vitro dissolution studies showed increase in the drug solubility and release from the complexes compared to the pure drug alone. These studies suggest some interaction between AAs, ILO and HPβCD in ternary complexes. Thus, the present study led to the conclusion that AAs positively enhance solubility of the drug ILO and consequently may improve bioavailability.

Cyclodextrins are cyclic oligosaccharides, having tyroid shape of the molecule which has a hydrophobic cavity and outer hydrophilic surface. This characteristic feature of the dextrins allows it to function as a functionalizing as well as a stabilizing agent. Polymer nanocomposites are nanoscale composites of polymers with enhanced and synergized properties of its components and have been known to have applications in various fields of chemistry, biomedical, pharmaceutical and environmental purposes to name a few. To impart specificity, thermal, mechanical stability, resistance to solvents and biodegradability to the polymers, cyclodextrins have been incorporated in the nanocomposites. The utilization of the aforementioned properties of cyclodextrins to the polymer nanocomposites, implications of the incorporation of cyclodextrins to polymer nanocomposites and their subsequent applications in various fields have been discussed in this review systematically, using PRISMA guidelines.

Microsampling, a reduced volume (< 50 μl) sampling method has successfully gained attention at the International Conference on Harmonization (ICH) level. It has been reflected in a few guidelines like ICH SA3, S11 and M10. The established benefits of microsampling support its use in Toxicokinetic (TK) and Pharmacokinetic (PK) studies, clinical studies, neonate sampling and remote sampling. When designing the TK component of a juvenile animal study, microsampling and sparse sampling (if justified) are strongly encouraged from the view of 3Rs (Replace, Refine, and Reduce). The novel sampling techniques arose with benefits over conventional sampling in terms of ease of sampling, storage, and shipment. These improved sampling techniques are less invasive and preferred by patients and trial participants. For the acceptance of these techniques in regulated bioanalysis, it is essential to prove its suitability with a robust and reliable method. Though there are many opportunities for the newer and smarter microsampling devices, the major obstacles are hematocrit influence, homogeneity of samples, repeats, incurred samples reanalysis and regulatory acceptance. With the advancement in techniques, opportunities are marching ahead of obstacles. The two microsampling techniques Dried Blood Spot (DBS) and Volumetric Absorption Microsampling (VAMS) are studied and elaborated in this article with respect to bioanalytical consideration, method validation and regulatory perspectives on its acceptance in regulated bioanalysis.

Dissolution testing was performed to evaluate the drug release from tablets. To mimic actual in vivo conditions, various foods and beverages were added to the dissolution media, and the release profiles were investigated. Indian people tend to have milk, curds, or eggs during their meals and then take their medications immediately after meals, whereas Americans tend to take medications with beverages. To evaluate drug release profiles in the presence and absence of these foods and beverages, in vitro dissolution testing was conducted using three different Indian quetiapine fumarate tablet brands. The effect on drug release was evaluated by adding 100 mL milk (3.1% protein), 100 g curd (4.1% protein), and 50 g raw and boiled egg white individually to 0.1 N HCl, and the release was compared with that in only 0.1 N HCl as per the Indian Pharmacopeia (IP) (1). The study was conducted for 3 h in triplicate, and the results show a significant difference among the brands in each medium with food. The maximum release obtained for each brand in 0.1 N HCl was 90%; in the presence of milk, curd, raw egg, and boiled egg it was approximately 7.06%, 2.42%, 29.56%, 24.08%, respectively, indicating that the drug was unavailable. Studies were also conducted with beverages and antacids; 200 mL of Thums Up, Sprite, and ENO were added individually to 0.1 N HCl and the release results compared. Results indicate a decrease of around 15% in availability in the presence of beverages and a 37% decrease in the presence of antacids. The results were statistically compared using one-way ANOVA at its Q value (45 min).

The present study was aimed to improve aqueous solubility and dissolution behavior of a poorly water-soluble antipsychotic drug, Paliperidone (PLDN), through the formation of inclusion complexes with beta-cyclodextrin (β-CD). The effect of water soluble polymer on the complexation efficiency and solubilizing ability of β-CD was investigated using Kollidon-30 (KDN) as a ternary component. The binary complex of PLDN: β-CD was prepared by co-precipitation method in 1:1 molar ratio and ternary complex was prepared analogously to the binary complex containing 0.3% of KDN. The solid state characterization of the complexes was carried out using DSC, FTIR, XRPD, and SEM studies. The phase solubility study carried out according to the Higuchi and Connors method revealed an increase in complexation efficiency of β-CD due to addition of KDN. Saturation solubility and in vitro dissolution studies of complexes showed that the aqueous solubility and dissolution rate of drug were improved substantially compared to drug alone. The ternary complex resulted more solubility enhancement and drug release compared to binary complexes. In conclusion, the addition of KDN to the binary system of PLDN:β-CD has a synergistic effect on the solubility enhancement ability of β-CD. Hence, ternary complexation can be used as a novel approach for solubility enhancement of PLDN.

The purpose of this study was to develop herbosomes, a novel formulation of standardized pomegranate extract (30% [w/w] punicalagins) (SPE) to overcome the limitation of poor bioavailability of punicalagins. The pharmacokinetic parameters of punicalagins from SPE and herbosomes of SPE were compared and their protective effects were studied on carbon tetrachloride (CCl4) induced acute liver damage in rats. Herbosomes of SPE were prepared by a spray drying method. The pharmacokinetic studies demonstrated that the herbosomes (equivalent to 500 mg/kg of SPE) enhanced the serum concentration of punicalagins (Cmax 466.3 ng/ml) approximately 2.5 times higher than the conventional extract (Cmax 192.5 ng/ml). Further, the antioxidant activity of SPE and herbosomes of SPE was evaluated at two doses of 100 and 200 mg/kg by measuring the levels of various liver enzymes under oxidative stress conditions. In comparison with conventional SPE, herbosomes significantly protected the liver by preventing the levels of various enzymes of liver glutathione system, superoxide dismutase (SOD), catalase (CAT) from decline and thiobarbituric acid reactive substances (TBARS) to rise with respect to CCl4 treated group. These results were substantiated by histopathological examination of liver. The results clearly elucidated that the developed herbosomes improved the antioxidant property and the hepatoprotective activity of SPE.

Punicalagins, a pair of anomeric ellagitannins, present in Punica granatum (Pomegranates) are known to possess excellent antioxidant activity in vitro, but poor oral bioavailability. The reasons cited for poor bioavailability are their large molecular size, poor lipophilicity, and degradation by colonic microflora into less active metabolites. The objective of the present research work was to complex the standardized pomegranate extract (SPE) with phospholipid to formulate standardized pomegranate extract-phospholipid complex (SPEPC), characterize it and check its permeability through an ex vivo everted gut sac experiment. SPEPC was prepared by mixing SPE (30% punicalagins) and soya phosphatidylcholine (PC) in 1:1 v/v mixture of methanol and dioxane and spray-drying the mixture. The complex was characterized by infrared spectroscopy, differential scanning calorimetry, X-ray diffraction, and scanning electron microscopy. It was evaluated for its octanol solubility, dissolution, and permeability by everted the gut sac technique. The characterization methods confirmed the formation of complex. Increased n-octanol solubility of the complex proved its increased lipophilicity. Dissolution studies revealed that the phospholipid covering may prevent the punicalagins to be released in gastro-intestinal tract, thus preventing their colonic microbial degradation. SPEPC showed better apparent permeability than SPE in an everted gut sac technique. Hence, it could be concluded that phospholipid complex of SPE may be of potential use in increasing the permeability and hence the bioavailability of punicalagins.

The objective of present study is development and evaluation of solid lipid nanoparticles SLNs of Zaltoprofen ZLT for topical delivery to formulate topical formulation with prolonged effects ZLT loaded SLNs ZLT SLN were formulated using Taguchi design of Experiment and the effect of lipid ratio surfactant ratio stirring time and concentration of surfactant was studied on entrapment efficiency The optimized formulation was spherical in shape with mean particle size distribution of nm and zeta potential of mV They were characterized for structural changes using Differential Scanning Colorimetry and Fourier Transform Infrared Spectroscopy Optimized nanoparticles were further incorporated in carbopol hydrogel and characterized for pH homogeneity viscosity and spreadability In vitro and Ex vivo studies were carried out for ZLT SLN loaded carbopol gel and compared against ZLT SLN suspension ZLT SLN suspension followed Higuchi cube root model whereas ZLT SLN loaded gel followed Korsemeyer Peppas model in in vitro as well as ex vivo studies which may be due to increase in viscosity SLN loaded gel showed sustained release as compared to plain drug loaded hydrogel confirming that SLN are efficient to encapsulate ZLT and effective for sustained release of drug

Iloperidone is a second-generation antipsychotic drug which is used for the treatment of schizophrenia and has very low aqueous solubility and bioavailability. This drug also undergoes first-pass metabolism. The aim of this work is to formulate fast-dissolving sublingual films of iloperidone to improve its bioavailability. Sublingual films were prepared by solvent casting method. Hydroxypropyl methyl cellulose E5, propylene glycol 400, and transcutol HP were optimized using Box–Behnken three-level statistical design on the basis of disintegration time and folding endurance of films. Iloperidone:hydroxypropyl-β–cyclodextrin kneaded complex was used in films instead of plain drug due to its low solubility. Optimized film was further evaluated for drug content, pH, dissolution studies, ex vivo permeation studies, and pharmacokinetic studies in rats. The optimized film disintegrated within 30 s. The in vitro dissolution of the film showed 80.3 ± 3.4% drug dissolved within first 5 min. In ex vivo permeation studies using sublingual tissue, flux achieved within first 15 min by film was around 117.1 ± 0.35 (mcg/cm2/h) which was ten times more than that of plain drug. This formulation showed excellent uniformity. AUC and Cmax of film were significantly higher (p

Bauhinia acuminata commonly known as dwarf white orchid tree is traditionally used to treat acute and chronic pain, skin ailments, cancer, diabetes, throat infections and asthma. As there were no scientific reports on use of Bauhinia acuminata for anti-nociceptive activity, the present study was designed to evaluate possible effects of aqueous and alcoholic extracts in experimentally induced pain in animals. Acute toxicity was carried out as per OECD guideline 423. The anti-nociceptive activity was evaluated in Swiss albino mice by hot plate, acetic acid induced writhing and tail immersion tests at three different dose levels (250, 500 and 1000mg/kg) of aqueous and alcoholic extracts. Formalin induced nociception test was performed in Sprague Dawley rats at three dose levels. Both aqueous and alcoholic extracts were found safe at dose of 5000mg/kg. In hot plate test, both extracts showed significant (p

An efficient, cost-effective use of Raney nickel (R-Ni) a widely used industrial catalyst for N-alkylation using alcohols is highlighted here. The work describes the scope and capability of R-Ni in hydrogen autotransfer reactions enabling its widespread use in the Chemical and Pharmaceutical industry. R-Ni of W4, T4, and W7 grades were prepared and evaluated for alkylation of amines. The best activity and selectivity for mono alkylation of amines were obtained using W4 R-Ni at 1:4 moles of amine to alcohol in xylene at reflux. T4 R-Ni also showed ability to form stable imines. The prepared R-Ni was also recycled and reused for N-alkylation reaction. The optimized methodology was applied for synthesis of Active Pharmaceutical ingredients Piribedil and Mepyramine. The simplicity and wide substrate scope makes this method a preferred Hydrogen Auto-transfer protocol for the alkylation of amines.

In cloud computing, security and storage space management techniques are most important factors for improving the performance of cloud computing. Secure deduplication is a technique for eliminating duplicate copies of storage data, and provides security to them. To reduce storage space and upload bandwidth in cloud storage The basic idea in this paper is that we can eliminate duplicate copies of storage data and limit the damage of stolen data if we decrease the value of that stolen information to the attacker. Dekey new construction in which users do not need to manage any keys on their own but instead securely distribute the convergent key shares across multiple servers for insider attacker. User profiling and decoys, then, serve two purposes. First one is validating whether data access is authorized when abnormal information access is detected, and second one is that confusing the attacker with bogus information.

Topical film-forming metered dose spray formulations were designed for management of pain. Ropivacaine, a local anesthetic is explored for its topical efficacy in alleviating pain. Metered dose spray containers, organic solvents, film forming polymers and permeation enhancers were utilized to fabricate the Metered Dose topical spray. Factors like viscosity, spray pattern, spray angle, volume of actuation, droplet size distribution of the metered dose spray formulation and drying time, flexibility and wash-ability of the film formed after spraying were assessed. Permeation of the drug into the porcine skin was observed based on ex-vivo diffusion studies and confocal microscopy. The results indicated a high level of drug concentration in the skin layers. Anti-nociceptive efficacy of the formulations was assessed on Wistar rats by hot plate and tail flick tests, based on the response to pain perception. The results were comparable to the conventional lidocaine gel. Topical film forming sprays have the ability to provide an accurate, long lasting and patient compliant delivery of drugs on the skin as compared to conventional gels.

Background: The purpose of the present study is to investigate the combined influence of three independent variables on two dependent variables for the preparation of nanoparticles. The three independent variables are the chitosan/sodium tripolyphosphate ratio, pH of sodium tripolyphosphate and levamisole concentration; while particle size and percentage drug entrapment were dependent variables. Discussion: The nanoparticles were prepared by using 23 factorial design to obtain high entrapment efficiency and small size. The polynomial equation can be used to predict the responses. Conclusion: The prepared nanoparticles show busted release for the first 2 h and then show sustained release. The differential scanning calorimetry graphs indicate that drug is completely entrapped in nanoparticles and transmission electron microscopy images show that nanoparticles are spherical in shape and dense solid in nature. The mathematical model obtained by 23 factorial design shows good relationship between independent variables and dependent variables for prediction.

Sodium cromoglicate (SCG) is given by inhalation in prophylactic control of asthma. It was encapsulated in liposomes with a view to improve utilization of the drug when given via pulmonary route. The liposomes were characterized for encapsulation efficiency, shape, size and release rate. Liposomal dispersions were freeze-dried using a cryoprotectant. Freeze-dried liposomal dispersion retained 60% of drug upon reconstitution but increase in size of liposomes was noted. Liposomes exhibited good keeping properties when stored at 4 degrees C. In vivo performance of liposomal SCG was evaluated in sensitized guinea pigs. In one of the studies, differential leukocyte count and total leukocyte count in bronchoalveolar lavage fluid was measured. Liposomal dispersion showed significant inhibition of influx of neutrophils as compared with drug solution at 24 h. However, in the second study, when recovery period required by animal to revert back to normal respiratory pattern from the onset or preconvulsion time was measured, no significant difference was found between drug solution and liposomal dispersion when administered 2 h before allergen challenge.

In the present investigation, an attempt has been made to improve aqueous solubility of a BCS class II drug by making an inclusion complex with Hydroxypropyl-β-cyclodextrin (HP-β-CD). Paliperidone (PALI) was selected as a model drug for the study. It is practically insoluble in water with low oral bioavailability. It is a major active metabolite of risperidone approved for the treatment of schizophrenia in adults. The inclusion complexes were prepared in 1:1 (PALI: HP-β-CD) molar ratio. Phase solubility studies were performed according to Higuchi Connors method to determine the optimum conditions for the complexation. The prepared solid inclusion complexes were characterized by Differential Scanning Calorimetry (DSC), Fourier- Transform Infrared Spectroscopy (FT-IR), Powder X-ray Diffractometry (PXRD), Scanning Electron Microscopy (SEM) and Proton Nuclear Magnetic Resonance Spectroscopy ((1)H-NMR). Dissolution study was performed using USP apparatus II in phosphate buffer, pH 6.8 (37 ± 0.5°C). The solid state characterization studies confirmed the formation of inclusion complex between PALI and HP-β-CD. The aqueous solubility and in-vitro dissolution study showed that the solubility and dissolution rate of drug were considerably improved by complexation with HP-β-CD with respect to the drug alone. The enhanced solubility and dissolution may help to improve in-vivo performance of PALI. Thus, the binary complexation of PALI with HP-β-CD can be used as an approach for its solubility enhancement.

Tropicamide, a mydriatic, cycloplegic drug was entrapped in liposomes. Liposomes were investigated by laser counting studies, transmission electron microscopy and differential scanning calorimetry for characterization. The precorneal clearance of liposomes was compared with solution by gamma-scintigraphy in the rabbit. The neutral liposomes failed to demonstrate significant enhancement in precorneal retention in comparison with aqueous solution. The potential of liposomes as an ophthalmic drug delivery system was investigated by comparing pupil dilatory effect of tropicamide by topical instillation, in the rabbit eye, of the solution and various drug-loaded liposomal forms, i.e. neutral liposomes, positively charged liposomes and neutral liposomes dispersed in 0.25% (w/v) polycarbophil gel. The positively charged liposomal formulation and liposomes dispersed in polycarbophil gel were found to be more effective than neutral liposomal dispersion when data were statistically treated at the 5% level of significance.