NOVEL TECHNOLOGY USED IN THE PREFORMULATION STUDY: A REVIEW

Preformulation is a study which deals which provides the framework for drug’s combination with pharmaceutical ingredients in the fabrication of dosage form. Preformulation study is to develop the elegant dosage form by the establishing kinetic rate profile, compatibility with the other ingredients, establish physicochemical parameter and polymorphism of the new drug. Among these properties the preformulation also provide the information regarding degradation process, adverse condition relevant to the drug, bioavailability, pharmacokinetics, toxicity, drug stability, partition coefficient, dissolution rate, and polymorphic forms. Preformulation studies strengthen the scientific foundation of the guidance, provide regulatory relief and conserve resources in the drug development and evaluation process, improve public safety standards, enhance product quality, facilitate the implementation of new technologies. According to ICH, all technical requirements for the application of drug approval were homonized in CTD format which are scientifically more elaborate by USFDA in QoS-QbR format. QbR is based on the principle of Quality by Design (QbD) which increased efficiently in the FDA review process

ETHOSOME: A NEW TECHNOLOGY USED AS TOPICAL & TRANSDERMAL DELIVERY SYSTEM

Transdermal drug delivery system was first introduced more than 20 years ago. Transdermal drug delivery system is a type of convenient drug delivery system where drug goes to the systemic circulation through the protective barrier i.e. Skin is the main target of topical and transdermal preparations. Major aim of transdermal drug delivery system is to cross the stratum corneum. Various methods have been tried to increase the permeation rate of drugs temporarily. Vesicular system is one of the most controversial methods for transdermal delivery of active substances in that ethosome are the ethanolic phospholipids vesicles which are used mainly for transdermal delivery of drugs. Ethosomes are soft, malleable vesicles tailored for enhanced delivery of active agents. Ethosomes have higher penetration rate through the skin. The increased permeation of ethosomes is probably due to its ethanolic content. Ethanol increases the cell membrane lipid fluidity which results in increased skin penetrability of the ethosomes. These ethosomes permeates inside the skin and fuse with cell membrane lipids and release the drug. Hot and cold methods are used for formulation of ethosomes. Evaluation parameters include size, shape, drug content, zeta potential etc. Ethosomes have been successfully evaluated for the delivery of many drugs for e.g. Cyclosporine A, insulin, salbutmol, trihexyphenidil, etc. Ethosomes provides a number of important benefits including improving the drug’s efficacy, enhancing patient compliance and comfort and reducing the total cost of treatment. Ethosomes can be important drug delivery tool in the future. KEYWORDS: Ethosomes, Transdermal, Vesicular carriers, Ethanol, Phospholipid

BIOAVAILABILITY ENHANCEMENT OF REPAGLINIDE USING NANO LIPID CARRIER: PREPARATION CHARACTERIZATION & IN-VIVO EVALUATION

Objective:  The aim of this study to manufacture the prolonged release lipid nanoparticle (Solid lipid nanoparticle and nanostructure lipid carrier) of repaglinide for enhance the oral bioavailability. Methods: Solid lipid nanoparticle (SLN) and  Nanostructured lipid carrier (NLC) were prepared by slight modification in solvent diffusion method. The core material used as cetyl alcohol while blend with oleic acid were used in preparation of NLC dispersion. Tween 80 were utilized as Surfactant and lecithin as cosurfactant in both type of lipid formulation. Lipid nanoparticle were characterized for size distribution, entrapment parameter, zeta potential, surface morphology, in-vitro drug release and stability study. Pharmacodynamic study were also performed to evaluate the antidiabetic activity of repaglinide loaded lipid nano dispersion. Results: It was observed that lipid matrix based SLN and NLC having significant particle size (157.8±15.8nm for NLC and 238.4± 48.2nm for SLN dispersion), entrapment efficacy 79.82±0.84% for NLC and 72.04±1.03% for SLN dispersion. Zeta potential report were also clarifying that formulation is in stable state for a prolong time. SEM study size distribution of particle as evaluated by Malvern instrument. The formulation was also confirmed to be stable after 180 days of storage, according to the data from the stability study. The in vivo antidiabetic assessment showed that Repaglinide loaded SLN and NLC dispersion were able to reduce the blood sugar level. Interestingly, in case of the RPG-SLN, RPG-NLC-I & RPG-NLC-II group, and the average blood sugar values at all time intervals were significantly less than that of the basal glucose value (p< 0.05). Conclusion: The prepared SLN and NLC dispersion having ability to control the release and make nano formulation suitable to resolve poor bioavailability of repaglinide

Hospital-Associated Transmission of Brucella melitensis outside the Laboratory

Brucella melitensis was identified in an aspirate obtained from a patient’s hip joint during a procedure at a hospital in Canada. We conducted an investigation into possible exposures among hospital workers; 1 worker who assisted with the procedure tested positive for B. melitensis. Aerosol-generating procedures performed outside the laboratory may facilitate transmission of this bacterium

Developing a comprehensive Cardio-Oncology Program at a Cancer Institute: the Moffitt Cancer Center experience

Cardio-oncology is a multidisciplinary field focusing on the management and prevention of cardiovascular complications in cancer patients and survivors. While the initial focus of this specialty was on heart failure associated with anthracycline use, novel anticancer agents are increasingly utilized and are associated with many other cardiotoxicities including hypertension, arrhythmias and vascular disease. Since its inception, the field has developed at a rapid pace with the establishment of programs at many major academic institutions and community practices. Given the complexities of this patient population, it is important for providers to possess knowledge of not only cardiovascular disease but also cancer subtypes and their specific therapeutics. Developing a cardio- oncology program at a stand-alone cancer center can present unique opportunities and challenges when compared to those affiliated with other institutions including resource allocation, cardiovascular testing availability and provider education. In this review, we present our experiences establishing the cardio-oncology program at Moffitt Cancer Center and provide guidance to those individuals interested in developing a program at a similar independent cancer institution

Methylsulfonylmethane as an antioxidant and its use in pathology

Methylsulfonylmethane (MSM) is a naturally occurring organosulfur antioxidant. Based on its small size and unique physicochemical properties, MSM exhibits broad tissue distribution and pleiotropic effects. Animal toxicity studies suggest MSM is safe and nontoxic. Though the antioxidant mechanism is presently unclear, MSM has demonstrated the ability to protect against the activities of superoxide dismutase, catalase, and myeloperoxidase while also altering glutathione levels in numerous tissues. Through the modulation of antioxidant enzyme activities and redox hub cycling, MSM impacts cellular and tissue redox status, which can metabolically reprogram cells through redox-sensitive transcription factors. Alternatively, MSM may also affect membrane properties, specifically of mitochondria, thereby affecting reactive oxygen species production. By altering antioxidant potentials in various tissues including the brain, MSM may demonstrate unique immune modulatory properties that could prove useful to various pathological states