Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.

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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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β-Glucans are soluble fibers with physiological functions, such as, interference with absorption of sugars and reduction of serum lipid levels. β-glucans are found in different species, such as, Rhynchelytrum repens, Lentinus edodes, Grifola frondosa, Tremella mesenterica, Tremella aurantia, Zea may, Agaricus blazei, Phellinus baummi, Saccharomyces cerevisae (yeast), and Agaricus blazei murell (mushroom). Analysis of the fractions reveals the presence of arabinose, glucose, xylose, and traces of rhamnose and galactose. The presence of β-glucan in these fractions is confirmed by hydrolyzing the polymers with endo-β-glucanase from Bacillus subtilis, followed by high-performance liquid chromatography (HPLC) analysis of the characteristic oligosaccharides produced. The 4 M KOH fractions from different tissues are subjected to gel permeation chromatography on Sepharose 4B, with separation of polysaccharides, with different degrees of polymerization, the highest molecular mass (above 2000 kDa) being found in young leaves. The molecular mass of the leaf blade polymers is similar (250 kDa) to that of the maize coleoptiles β-glucan used for comparison. The 4 M KOH fraction injected into rats with streptozotocin-induced diabetes has shown hypoglycemic activity, reducing blood sugar to normal levels for approximately 24 hours. This performance is better than that obtained with pure β-glucan from barley, which decreases blood sugar levels for about four hours. These results suggest that the activity of β-glucans is responsible for the use of this plant extract as a hypoglycemic drug in folk medicine.

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Peroxisome proliferator-activated receptors (PPARs) are ligand-activated transcription factors of nuclear hormone receptor superfamily comprising of the following three subtypes: PPARα, PPARγ, and PPARβ/δ. Activation of PPAR-α reduces triglyceride level and is involved in regulation of energy homeostasis. Activation of PPAR-γ causes insulin sensitization and enhances glucose metabolism, whereas activation of PPAR- β/δ enhances fatty acids metabolism. Thus, PPAR family of nuclear receptors plays a major regulatory role in energy homeostasis and metabolic function. The present review critically analyzes the protective and detrimental effect of PPAR agonists in dyslipidemia, diabetes, adipocyte differentiation, inflammation, cancer, lung diseases, neurodegenerative disorders, fertility or reproduction, pain, and obesity.

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Now days, breast cancer is the most frequently diagnosed life-threatening cancer in women and the leading cause of cancer death among women. Since last two decades, researches related to the breast cancer has lead to extraordinary progress in our understanding of the disease, resulting in more efficient and less toxic treatments. Increased public awareness and improved screening have led to earlier diagnosis at stages amenable to complete surgical resection and curative therapies. Consequently, survival rates for breast cancer have improved significantly, particularly in younger women. This article addresses the types, causes, clinical symptoms and various approach both non- drug (such as surgery and radiation) and drug treatment (including chemotherapy, gene therapy etc.) of breast cancer.

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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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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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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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Fast disintegrating tablets (FDTs) have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Oral drug delivery remains the preferred route for administration of various drugs. Recent developments in the technology have prompted scientists to develop FDTs with improved patient compliance and convenience. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. The popularity and usefulness of the formulation resulted in development of several FDT technologies. FDTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. FDTs or orally disintegrating tablets provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. This review describes various formulations and technologies developed to achieve fast dissolution/dispersion of tablets in the oral cavity. In particular, this review describes in detail FDT technologies based on lyophilization, molding, sublimation, and compaction, as well as approaches to enhancing the FDT properties, such as spray drying and use of disintegrants. In addition, taste-masking technologies, experimental measurements of disintegration times, and dissolution are also discussed.

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Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is a recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era.

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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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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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Male hypogonadism is a condition in which the body does not produce enough of the testosterone hormone; the hormone that plays a key role in masculine growth and development during puberty. There is a clear need to increase the awareness of hypogonadism throughout the medical profession, especially in primary care physicians who are usually the first port of call for the patient. Hypogonadism can significantly reduce the quality of life and has resulted in the loss of livelihood and separation of couples, leading to divorce. It is also important for doctors to recognize that testosterone is not just a sex hormone. There is an important research being published to demonstrate that testosterone may have key actions on metabolism, on the vasculature, and on brain function, in addition to its well-known effects on bone and body composition. This article has been used as an introduction for the need to develop sensitive and reliable assays for sex hormones and for symptoms and treatment of hypogonadism.

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This study was carried out with an objective to investigate the antibacterial and antifungal potentials of leaves of Cassia fistula Linn. The aim of the study is to assess the antimicrobial activity and to determine the zone of inhibition of extracts on some bacterial and fungal strains. In the present study, the microbial activity of hydroalcohol extracts of leaves of Cassia fistula Linn. (an ethnomedicinal plant) was evaluated for potential antimicrobial activity against medically important bacterial and fungal strains. The antimicrobial activity was determined in the extracts using agar disc diffusion method. The antibacterial and antifungal activities of extracts (5, 25, 50, 100, 250 ΅g/ml) of Cassia fistula were tested against two Gram-positive--Staphylococcus aureus, Streptococcus pyogenes; two Gram-negative--Escherichia coli, Pseudomonas aeruginosa human pathogenic bacteria; and three fungal strains--Aspergillus niger, Aspergillus clavatus, Candida albicans. Zone of inhibition of extracts were compared with that of different standards like ampicillin, ciprofloxacin, norfloxacin, and chloramphenicol for antibacterial activity and nystatin and griseofulvin for antifungal activity. The results showed that the remarkable inhibition of the bacterial growth was shown against the tested organisms. The phytochemical analyses of the plants were carried out. The microbial activity of the Cassia fistula was due to the presence of various secondary metabolites. Hence, these plants can be used to discover bioactive natural products that may serve as leads in the development of new pharmaceuticals research activities.

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Nutraceuticals are food or part of food that provides medical or health benefits including the prevention and/or treatment of a disease. Nutraceutical has advantage over the medicine because they avoid side effect, have naturally dietary supplement, etc. Nutraceutical; on the basis of their natural source, chemical grouping, categories into three key terms -nutrients, herbals, dietary supplements, dietary fiber, etc. The most rapidly growing segments of the industry were dietary supplements (19.5 percent per year) and natural/herbal products (11.6 percent per year). Global nutraceutical market is estimated as USD 117 billion. FDA regulated dietary supplements as foods to ensure that they were safe. In 2006, the Indian government passed Food Safety and Standard Act to regulate the nutraceutical industry. Herbal nutraceutical is used as a powerful instrument in maintaining health and to act against nutritionally induced acute and chronic diseases, thereby promoting optimal health, longevity, and quality of life.

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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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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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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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In ethno medicinal practices, the traditional healers use the genus Curcuma for the treatment of various ailments but Curcuma caesia Roxb. is a very less known and almost untouched drug. The present work attempts to establish the necessary pharmocognostic standards for evaluating the plant material of C. caesia Roxb. Various parameters, such as morphology, microscopy, physicochemical constants, and phytochemical profiles of the entire parts of the plant were studied and the salient diagnostic features are documented. Major chemical constituents, extractive values, physicochemical constants, and other features are also been recorded.

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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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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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Pharmacology as a subject depends largely on experiments conducted in laboratory animals. Experimental animals like rat, guinea pig, rabbit, etc. are used for the biological assay. For the teaching purposes to use isolated strip preparations from various organs, the laboratory animal species has to be sacrificed just for a piece of tissue. The present study was aimed to develop ex vivo model for pharmacological experimentation, which will mimic the actual laboratory condition without sacrificing the experimental animals. Dose response curve of acetylcholine alone and in presence of different concentrations of atropine was plotted using isolated chicken ileum, chicken duodenum, rat ileum, and rat duodenum and their EC ₅₀ values were compared. The effect of atropine in terms of its type of antagonism was predicted based on Schild plot and pA ₂ values were obtained. The chicken ileum and duodenum were also evaluated for four- and three-point bioassay, respectively. The results suggested that acetylcholine produced a dose-dependent increase in contraction in both chicken and rat ileum and duodenum preparation. The concentration response curve of acetylcholine in chicken ileum shifted toward left side of rat ileum with a higher EC ₅₀ value. Atropine shifted the concentration response curve of acetylcholine toward right with a change in EC ₅₀ value. Schild plots indicated that antagonism produced by atropine was found to be competitive in nature. The pA ₂ values of atropine were found significantly high with isolated chicken ileum as compared to rat ileum preparation. It is concluded that isolated chicken ileum and duodenum preparation can be employed for routine experiments of pharmacology subject and the use of these isolated preparations is a novel approach for managing pharmacological experiments and importantly, without sacrificing the experimental animals.

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Ayurveda and other Indian system of medicine use metals, but their use is also amply described in Chinese and Egyptian civilization in 2500 B.C. Bhasma are unique ayurvedic metallic/minerals preparation, treated with herbal juice or decoction and exposed for Ayurveda, which are known in Indian subcontinent since 7 ^th century A.D. and widely recommended for treatment of a variety of chronic ailments. Animal's derivative such as horns, shells, feathers, metallic, nonmetallic and herbals are normally administered as Bhasma. A Bhasma means an ash obtained through incineration; the starter material undergoes an elaborate process of purification and this process is followed by the reaction phase, which involves incorporation of some other minerals and/or herbal extract. There are various importance of Bhasma like maintaining optimum alkalinity for optimum health, neutralizing harmful acids that lead to illness; because Bhasma do not get metabolized so they don't produce any harmful metabolite, rather it breakdowns heavy metals in the body. Methods including for Bhasma preparation are parpati, rasayoga, sindora, etc., Bhasma which contain Fe, Cu, S or other manufacturing process plays a specific role in the final product(s). Particle size (1-2 μ) reduced significantly, which may facilitate absorption and assimilation of the drug into the body system. Standardization of Bhasma is utmost necessary to confirm its identity and to determine its quality, purity safety, effectiveness and acceptability of the product. But the most important challenges faced by these formulations are the lack of complete standardization by physiochemical parameters.

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Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.

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