People in Indian region often apply Shankhpushpi and other Sanskrit-based common name to Evolvulus alsinoides, Convolvulus pluricaulis, Canscora decussata, and Clitorea ternatea. These are pre-European names that are applied to a medicinal plant. Before the establishment of British rule, like the other books, ayurvedic treatises were also hand written. This might be one of the reasons due to which ayurveda could not stand parallel to the western medicine and an ambiguity is reflected in the interpretation of names and description of drugs found in the books like Charaka Samhita and Sushruta Samhita. The most widespread application of Shankhpushpi is for mental problems, but they have been considered for an array of other human maladies. The present investigation deals with the comparative pharmacognostical evaluation of four ethanobotanicals of Shankhpushpi. A comparative morphoanatomy of the root, stem, and leaves has been studied with the aim to aid pharmacognostic and taxonomic species identification. Various physicochemical, morphological, histological parameters, comparative high-performance thin-layer chromatography (HPTLC), and comparative high-performance liquid chromatography (HPLC), chromatogram of methanolic extract presented in this communication may serve the purpose of standard parameters to establish the authenticity of commercialized varieties and can possibly help to differentiate the drug from the other species. All the parameters were studied according to the WHO and pharmacopoeial guidelines.

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The main disadvantage of transdermal drug delivery is the poor penetration of most compounds into the human skin. The main barrier of the skin is located within its uppermost layer, the stratum corneum (SC). Several approaches have been developed to weaken this skin barrier. One of the approaches for increasing the skin penetration of drugs and many cosmetic chemicals is the use of vesicular systems, such as, liposomes and ethosomes. Ethosomes are phospholipid-based elastic nanovesicles containing a high content of ethanol (20-45%). Ethanol is known as an efficient permeation enhancer and has been added in the vesicular systems to prepare elastic nanovesicles. It can interact with the polar head group region of the lipid molecules, resulting in the reduction of the melting point of the stratum corneum lipid, thereby increasing lipid fluidity and cell membrane permeability. The high flexibility of vesicular membranes from the added ethanol permits the elastic vesicles to squeeze themselves through the pores, which are much smaller than their diameters. Ethosomal systems are much more efficient in delivering substances to the skin in the terms of quantity and depth, than either conventional liposomes or hydroalcoholic solutions. The scope of this small review is to introduce the novel concept of ethosomes and to describe some approaches and mechanisms of stimulating topical and transdermal products with ethosomes.

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Mucoadhesive drug delivery systems interact with the mucus layer covering the mucosal epithelial surface, and mucin molecules and increase the residence time of the dosage form at the site of absorption. The drugs which have local action or those which have maximum absorption in gastrointestinal tract (GIT) require increased duration of stay in GIT. Thus, mucoadhesive dosage forms are advantageous in increasing the drug plasma concentrations and also therapeutic activity. In this regard, this review covers the areas of mechanisms and theories of mucoadhesion, factors influencing the mucoadhesive devices and also various mucoadhesive dosage forms.

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Various regulatory authorities such as the International Conference on Harmonization (ICH), the United States Food and Drug administration (FDA), and the Canadian Drug and Health Agency (CDHA) are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs). The various sources of impurity in pharmaceutical products are - reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, enantiomeric impurity, and so on. The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas-liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid-liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR) spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.

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Over the past several years, treatment of infectious diseases and immunisation has undergone a revolutionary shift. With the advancement of biotechnology and genetic engineering, not only a large number of disease-specific biological have been developed, but also emphasis has been made to effectively deliver these biologicals. Niosomes are vesicles composed of non-ionic surfactants, which are biodegradable, relatively nontoxic, more stable and inexpensive, an alternative to liposomes. This article reviews the current deepening and widening of interest of niosomes in many scientific disciplines and, particularly its application in medicine. This article also presents an overview of the techniques of preparation of niosome, types of niosomes, characterisation and their applications.

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Microsponges are polymeric delivery systems composed of porous microspheres. They are tiny sponge-like spherical particles with a large porous surface. Moreover, they may enhance stability, reduce side effects and modify drug release favorably. Microsponge technology has many favorable characteristics, which make it a versatile drug delivery vehicle. Microsponge Systems are based on microscopic, polymer-based microspheres that can suspend or entrap a wide variety of substances, and can then be incorporated into a formulated product such as a gel, cream, liquid or powder. The outer surface is typically porous, allowing a sustained flow of substances out of the sphere. Microsponges are porous, polymeric microspheres that are used mostly for topical use and have recently been used for oral administration. Microsponges are designed to deliver a pharmaceutical active ingredient efficiently at the minimum dose and also to enhance stability, reduce side effects, and modify drug release.

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Cymbopogon citratus, Stapf (Lemon grass) is a widely used herb in tropical countries, especially in Southeast Asia. The essential oil of the plant is used in aromatherapy. The compounds identified in Cymbopogon citratus are mainly terpenes, alcohols, ketones, aldehyde and esters. Some of the reported phytoconstituents are essential oils that contain Citral a, Citral b, Nerol Geraniol, Citronellal, Terpinolene, Geranyl acetate, Myrecene and Terpinol Methylheptenone. The plant also contains reported phytoconstituents such as flavonoids and phenolic compounds, which consist of luteolin, isoorientin 2'-O-rhamnoside, quercetin, kaempferol and apiginin. Studies indicate that Cymbopogon citratus possesses various pharmacological activities such as anti-amoebic, antibacterial, antidiarrheal, antifilarial, antifungal and anti-inflammatory properties. Various other effects like antimalarial, antimutagenicity, antimycobacterial, antioxidants, hypoglycemic and neurobehaviorial have also been studied. These results are very encouraging and indicate that this herb should be studied more extensively to confirm these results and reveal other potential therapeutic effects.

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Management of postoperative pain relieve suffering and leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. An effective postoperative management is not a standardized regime rather is tailored to the needs of the individual patient, taking into account medical, psychological, and physical condition; age; level of fear or anxiety; surgical procedure; personal preference; and response to therapeutic agents given. The major goal in the management of postoperative pain is to minimize the dose of medications to lessen side effects & provide adequate analgesia. Postoperative pain is still under managed due to obstacles in implementation of Acute Pain Services due to insufficient education, fear of complications associated with available analgesic drugs, poor pain assessment and inadequate staff. This review reflects the clinical aspects of postoperative pain & its assessment & management with an emphasis on research for new analgesic molecules & delivery system.

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Nymphaea stellata Willd. (Syn. Nymphaea nouchali Burman f.) (Nymphaeaceae) is an important and well-known medicinal plant, widely used in the Ayurveda and Siddha systems of medicines for the treatment of diabetes, inflammation, liver disorders, urinary disorders, menorrhagia, blenorrhagia, menstruation problem, as an aphrodisiac, and as a bitter tonic. There seems to be an agreement between the traditional use and experimental observations, such as, hepatoprotective, anti-inflammatory, and particularly antidiabetic activity. Nymphayol, a steroid isolated from the flowers has been scientifically proved to be responsible for the traditionally claimed antidiabetic activity; it reverses the damaged endocrine tissue and stimulates secretion of insulin in the β-cells. However, taking into account the magnitude of its traditional uses, the studies conducted are still negligible. This review is an attempt to provide the pharmaceutical prospective of Nymphaea stellata.

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A new oil-in-water microemulsion-based (ME) gel containing 1% itraconazole (ITZ) was developed for topical delivery. The solubility of ITZ in oils and surfactants was evaluated to identify potential excipients. The microemulsion existence ranges were defined through the construction of the pseudoternary phase diagrams. The optimized microemulsion was characterized for its morphology and particle size distribution. The optimized microemulsion was incorporated into polymeric gels of Lutrol F127, Xanthan gum, and Carbopol 934 for convenient application and evaluated for pH, drug content, viscosity, and spreadability. In vitro drug permeation of ME gels was determined across excised rat skins. Furthermore, in vitro antimycotic inhibitory activity of the gels was conducted using agar-cup method and Candida albicans as a test organism. The droplet size of the optimized microemulsion was found to be <100 nm. The optimized Lutrol F 127 ME gel showed pH in the range of 5.68΁0.02 and spreadability of 5.75΁1.396 gcm/s. The viscosity of ME gel was found to be 1805.535΁542.4 mPa s. The permeation rate (flux) of ITZ from prepared ME gel was found to be 4.234 ΅g/cm/h. The release profile exhibited diffusion controlled mechanism of drug release from ME ITZ gel. The developed ME gels were nonirritant and there was no erythema or edema. The antifungal activity of ITZ showed the widest zone of inhibition with Lutrol F127 ME gel. These results indicate that the studied ME gel may be a promising vehicle for topical delivery of ITZ.

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Irbesartan (IRB) is an angiotensin II receptor blocker antihypertensive agent. The aim of the present investigation was to develop a self-nanoemulsifying drug delivery system (SNEDDS) to enhance the oral bioavailability of poorly water-soluble IRB. The solubility of IRB in various oils was determined to identify the oil phase of SNEDDS. Various surfactants and co-surfactants were screened for their ability to emulsify the selected oil. Pseudoternary phase diagrams were constructed to identify the efficient self-emulsifying region. The optimized SNEDDS formulation contained IRB (75 mg), Cremophor^® EL (43.33%), Carbitol^® (21.67%) and Capryol^® 90 (32%). SNEDDS was further evaluated for its percentage transmittance, emulsification time, drug content, phase separation, dilution, droplet size and zeta potential. The optimized formulation of IRB-loaded SNEDDS exhibited complete in vitro drug release in 15 min as compared with the plain drug, which had a limited dissolution rate. It was also compared with the pure drug solution by oral administration in male Wister rats. The in vivo study exhibited a 7.5-fold increase in the oral bioavailability of IRB from SNEDDS compared with the pure drug solution. These results suggest the potential use of SNEDDS to improve dissolution and oral bioavailability of poorly water-soluble IRB.

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One of the major problems associated with poorly soluble drugs is very low bioavailability. The problem is even more complex for drugs like itraconazole, simvastatin, and carbamazepine which are poorly soluble in both aqueous and nonaqueous media, belonging to BCS class II as classified by biopharmaceutical classification system. Formulation as nanosuspension is an attractive and promising alternative to solve these problems. Nanosuspension consists of the pure poorly water-soluble drug without any matrix material suspended in dispersion. Preparation of nanosuspension is simple and applicable to all drugs which are water insoluble. A nanosuspension not only solves the problems of poor solubility and bioavailability, but also alters the pharmacokinetics of drug and thus improves drug safety and efficacy. This review article describes the preparation methods, characterization, and applications of the nanosuspension.

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The present investigation highlights the novel trans-buccoadhesive films of Famotidine, an H2 receptor antagonist used as an anti-ulcerative agent. The buccal films were fabricated by solvent casting technique with different polymer combinations of hydroxypropyl methylcellulose, carbopol-934P and polyvinyl pyrrolidone. Drug-polymer interaction studies by Fourier transform infrared spectroscopy show that there is no significant interaction between drug and polymers. The fabricated films were evaluated for their physicochemical characters like weight, thickness, surface pH, percentage moisture absorption, percentage moisture loss, swelling percentage, folding endurance, water vapor transmission and drug content. Stability study of buccal films was performed in natural human saliva. Ex vivo permeation studies were conducted using fresh sheep buccal mucosa and buccoadhesive strength was calculated by modified balance method and showed sufficient strength in all the formulations. Good correlation was observed between the in vitro drug release and in vivo drug release, with a correlation coefficient of 0.995. Drug diffusion from buccal films showed apparently zero order kinetics and release mechanism was diffusion controlled after considerable swelling.

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The ocular insert represents a significant advancement in the therapy of eye disease. Ocular inserts are defined as sterile, thin, multilayered, drug-impregnated, solid or semisolid consistency devices placed into the cul-de-sac or conjuctival sac, whose size and shape are especially designed for ophthalmic application. They are composed of a polymeric support that may or may not contain a drug. The drug can later be incorporated as dispersion or a solution in the polymeric support. They offer several advantages as increased ocular residence and sustained release of medication into the eye. The insert includes a body portion sized to position within a lachrymal canaliculus of the eyelid. The inserts are classified according to their solubility as insoluble, soluble, or bioerodible inserts. The release of drug from the insert depends upon the diffusion, osmosis, and bioerosion of the drug, and this article is an attempt to present a brief about this newer drug delivery system.

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Packaging is the coordinated system that encloses and protects the dosage form. Counterfeit drugs are the major cause of morbidity, mortality, and failure of public interest in the healthcare system. High price and well-known brands make the pharma market most vulnerable, which accounts for top priority cardiovascular, obesity, and antihyperlipidemic drugs and drugs like sildenafil. Packaging includes overt and covert technologies like barcodes, holograms, sealing tapes, and radio frequency identification devices to preserve the integrity of the pharmaceutical product. But till date all the available techniques are synthetic and although provide considerable protection against counterfeiting, have certain limitations which can be overcome by the application of natural approaches and utilization of the principles of nanotechnology.

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Azithromycin Dihydrate (Poorly water soluble drug), when prepared as solid dispersion showed improved solubility and dissolution. So the main purpose of this investigation was to increase the solubility and dissolution rate of Azithromycin Dihydrate by the preparation of its solid dispersion with urea using solvent evaporation method. Physical mixtures and solid dispersions of Azithromycin Dihydrate were prepared by using urea as water-soluble carrier in various proportions (1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7 by weight), by employing solvent evaporation method. The drug release profile was studied and it was found that the dissolution rate and the dissolution parameters of the drug from the physical mixture as well as solid dispersion were higher than those of the intact drug. FT- IR spectra revealed no chemical incompatibility between drug and urea. Drug-polymer interactions were investigated using differential scanning calorimetry (DSC) and Powder X-Ray Diffraction (PXRD).

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In Ayurveda, various herbal preparations are clinically used to prevent or cure infectious diseases. Herbal preparations such as Triphala churna, Hareetaki churna, Dashmula churna, Manjistadi churna, Sukhsarak churna, Ajmodadi churna, Shivkshar pachan churna, Mahasudarshan churna, Swadist Virechan churna and Pipramool churna were investigated by preparing their organic solvent extract for antibacterial potential against enteric bacterial pathogens such as Escherichia coli, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, Bacillus subtilis, Klebsiella pneumoniae, Salmonella typhi, Staphylococcus epidermidis, Salmonella typhimurium and Proteus vulgaris, respectively. In the present study, Triphala churna, Hareetaki churna, Dashmula churna were potent antibacterial agents against S. epidermidis, P. vulgaris, S. aureus, E. coli, P. aeruginosa and S. typhi. The study supports the use of these herbal preparations not only as dietary supplements but also as agents to prevent or control enteric bacterial infections.

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Research is focusing on the search for new types of natural chemotherapeutic agent that is plant based medicines which are proving to be excellent sources of new compounds. In present research study, an attempt was made to prove cytotoxicity activity of various parts of medicinal plants such as Agave americana, Strychnos nux­vomica and Areca catechu using MCF-7 and Vero cell line. Various parts of the medicinal plants were extracted by soxhlet apparatus using solvents likes methanol and water. By trypan blue dye exclusion method, Viability of MCF-7 and Vero cell lines were 85.50 and 81.13%, respectively. IC ₅₀ value of methanol extract of Agave americana leaves and aqueous extract of Afeca catechu fruits were found to be 545.9 & 826.1 μg/ml by SRB assay and 775.1 & 1461pg/ml by MTT assay, respectively, against MCF­7 cell line. From cytotoxicity study data by SRB and MTT assay, it revealed that methanol extract of Agave americana and aqueous extract of Areca catechu are potent cytotoxic.

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In the present study, a series of novel Schiff bases of isatin [5a-5l] were synthesized by condensation of imesatin with different aromatic aldehydes. The imesatins were synthesized by the reaction of isatin with p-phenylenediamine. The chemical structures of the synthesized compounds were confirmed by means of Infrared (IR), Mass spectroscopy, and Elemental analysis. These compounds were screened for the analgesic activity by the tail-immersion method at a dose of 200 mg/kg body weight. Among the tested compounds 3-(4-(4-hydroxy-3-methoxylbenzylideneamino) phenylimino) indoline-2-one (5i) exhibited better analgesic activity when compared to standard pentazocine. From the above-mentioned results it may be concluded that compounds containing electron-donating groups exhibit better analgesic activity than the electron-withdrawing groups.

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The objective of the present study was to develop a tablet formulation of S-(-)­amlodipine besylate chiral separation drug and nebivolol hydrochloride for better management of hypertension, while reducing or avoiding undesirable adverse effects, which are often associated with administration of a racemic mixture of amlodipine. The composition containing the optically pure S-(-)- isomer of amlodipine 2.5 mg has calcium channel blocking activity and, nebivolol hydrochloride 5 mg has beta-receptor blocking activity. The study was also carried out to design a suitable dissolution medium for S-(-) - amlodipine besylate and nebivolol hydrochloride. Amlodipine besylate and nebivolol hydrochloride had maximum solubility in pH 1.2 and thus pH 1.2 was selected as the most suitable media for S-(-) - amlodipine besylate and nebivolol hydrochloride dissolution studies. The RSD below 2% indicated insignificant batch-to-batch variation. The accelerated stability study of the optimized formulation was performed as the ICH guidelines. The results indicated no change in optical rotation of S-(-) - amlodipine besylate. Hence, combination of two drugs can be formulated into the tablet by wet granulation technique having satisfactory release profile.

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Cassia fistula Linn. which belongs to family Leguminosae is a medium-sized tree and its different parts are used in ayurvedic medicine as well as home remedies for common ailments. Sequential extraction was carried out using solvents viz. petroleum ether, chloroform, ethanol, methanol and water from leaf of the plant were investigated for preliminary phytochemical and antibacterial property. Results of the study showed that all the extracts had good inhibitory activity against Gram-positive test organism. Although all five extracts showed promising antibacterial activity against test bacterial species, yet maximum activity was observed in ethanol extract. The minimum inhibitory concentration ranged in between 94 to 1 500 μg/ml. Evaluation of phytochemicals such as alkaloids, flavonoids, carbohydrates, glycosides, protein and amino acids, saponins, and triterpenoids revealed the presence of most of constituents in polar extracts (ethanol, methanol, and aqueous) compared with nonpolar extracts (petroleum ether and chloroform). Furthermore, the ethanol extract was subjected to TLC bioautography and time-kill study against Staphylococcus epidermidis. All the findings exhibit that the leaf extracts have broad-spectrum activity and suggest its possible use in treatment of infectious diseases.

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Cefuroxime Axetil (Poorly water soluble drug), when prepared as solid dispersion showed improved solubility and dissolution. Therefore, the main purpose of this investigation was to increase the solubility and dissolution rate of Cefuroxime Axetil by the preparation of its solid dispersion with urea, using the solvent evaporation method. Physical mixtures and solid dispersions of Cefuroxime Axetil were prepared by using urea as a water-soluble carrier in various proportions (1:1, 1:2, 1:3, 1:4, 1:5, 1:6, and 1:7 by weight), by employing the solvent evaporation method. The drug release profile was studied and it was found that the dissolution rate and the dissolution parameters of the drug from the physical mixture as well as solid dispersion were higher than those of the intact drug. The Fourier Transform Infrared (FTIR) spectra revealed no chemical incompatibility between the drug and urea. Drug-polymer interactions were investigated using differential scanning calorimetry (DSC) and Powder X-Ray Diffraction (PXRD).

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Tuberculosis has claimed its victims throughout much of known human history and is currently the most devastating human bacterial disease. The ability to infect human population on a global scale, combined with the widespread emergence of multi-drug resistant strains, has led to the placement of Mycobacterium tuberculosis on the National Institute of Allergy and Infectious Diseases (NIAID) list of Biodefence and Emerging Infectious Disease Threats Agents. The resurgence of interest in tuberculosis (TB) has stemmed because of increased evidences from developed countries. Contrary to expectations, no country has reached the phase of elimination and in no subsection of society TB has been completely eliminated. A deeper understanding of the process will assist in the identification of the host and mycobacterial efforts involved and provide targets for therapeutic strategies against tuberculosis. The article presents a view on pathogenesis of tuberculosis and its diverse manifestations, host defense evasion, mechanisms of microbial persistence, emergence of Multiple Drug Resistance and Extensive Drug Resistance, conventional therapy used and the possible novel systems which are under extensive investigation as drug carriers for improving the cytosolic concentration of the anti-tubercular agents.

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The present study was undertaken to evaluate the mucilage isolated from Spinacia oleracea L. leaves, commonly named spinach (family: Amaranthaceae) as an innovative suspending agent. Zinc oxide suspensions (20% w/v) were prepared using the mucilage of S. oleracea L. leaves as a suspending agent, and it was evaluated for its stability by using parameters like, sedimentation profile, degree of flocculation, and redispersibility. The effect of the tested mucilage on the suspension was compared with various commonly used suspending agents, such as, tragacanth, bentonite, and sodium carboxymethyl cellulose (NaCMC) at concentrations of 0.5, 1.0, and 2.0% w/v. The results obtained indicated that the mucilage of S. oleracea L. leaves could be used as a suspending agent, and the performance was found to be superior to both tragacanth and bentonite.

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Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements.

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