13-06-2014 Click here to go at the topG G N N I I P P S S T T U U L L L L T T I I N N 2 2 1 1 4 4 13 th June , 2014 Volume No.: 34 Issue No.: 03 Vision TO REACH THE PINNACLE OF GLORY AS A CENTRE OF EXCELLENCE IN THE FIELD OF PHARMACEUTICAL AND BIOLOGICAL SCIENCES BY KNOWLEDGE BASED LEARNING AND PRACTICE Contents •Message from PRINCIPAL•Editorial board•Historical article •News Update•Knowledge based Article•Disease Related Breaking News•Upcoming Events •Drugs Update•Campus News•Student’s Section•Editor’s Note•ArchiveGNIPST Photo Gallery For your comments/contribution O R For ack-Issues, mailto:gnipstbulletin@gmail. comGURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY Website: http://gnipst.ac.in
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compounding of medicines was much diminished and with it the
need for the manipulative skills that were previously applied by
the pharmacist to the preparation of bougies, cachets, pills,
plasters, and potions. The pharmacist continues, however, to fulfillthe prescriber’s intentions by providing advice and information; by
formulating, storing, and providing correct dosage forms; and by
assuring the efficacy and quality of the dispensed or supplied
medicinal product.
The first college of pharmacy was founded in the United States in
1821 and is now known as the Philadelphia College of Pharmacy
and Science. Other institutes and colleges were established soon
after in the United States, Great Britain, and continental Europe.Colleges of pharmacy as independent organizations or as schools
of universities now operate in most developed countries of the
world.
NEWS UPDATE
'Tomato pill' improves function of blood vesselsin patients with cardiovascular disease:
(9th June, 2014)A daily supplement of an extract found in tomatoes may improvethe function of blood vessels in patients with cardiovasculardisease, according to new research. The incidence ofcardiovascular is notably where a 'Mediterranean diet' consistingof a larger consumption of fruit, vegetables and olive oil
predominates. Recent dietary studies suggest that this dietreduces the incidence of events related to the disease, includingheart attack and stroke, in patients at high cardiovascular risk, orthose who have previously had the disease. One component of theMediterranean diet thought to play a role in reducing this risk islycopene, a powerful antioxidant which is ten times more potent
than vitamin E. Lycopene is found in tomatoes and other fruits,and its potency appears to be enhanced when it is consumedpureed, in ketchup or in the presence of olive oil. Whilst there isstrong epidemiological evidence to support the role of lycopene in
reducing cardiovascular risk, the mechanism by which it does so isunclear.
Human stem cells used to create light-sensitive
retina:(10th June,2014)
Like many processes in the body, vision depends on many different
types of cells working in concert, in this case to turn light intosomething that can be recognized by the brain as an image.
Photoreceptors are only part of the story in the complex eye-brain
process of vision. Using a type of human stem cell, researchers say
they have created a three-dimensional complement of human
retinal tissue in the laboratory, which notably includes
functioning photoreceptor cells capable of responding to light, the
first step in the process of converting it into visual images.
'Onion' vesicles for drug deliver developed:
(10th June, 2014)One of the defining features of cells is their membranes. Each cell'srepository of DNA and protein-making machinery must be keptstable and secure from invaders and toxins. Scientists haveattempted to replicate these properties, but, despite decades of
research, even the most basic membrane structures, known asvesicles, still face many problems when made in the lab. They aredifficult to make at consistent sizes and lack the stability of theirbiological counterparts.A certain kind of dendrimer, a moleculethat features tree-like branches, offers a simple way of creatingvesicles and tailoring their diameter and thickness, researchers
report. Moreover, these dendrimer-based vesicles self-assemblewith concentric layers of membranes, much like an onion.
Malaria-carrying mosquitoes wiped out in lab
with genetic method that creates male-only
offspring: (10th June, 2014)Since 2000, increased prevention and control measures havereduced global malaria mortality rates by 42 per cent, but thedisease remains a prevalent killer especially in vulnerable sub-Saharan African regions. Malaria control has also been threatenedby the spread of insecticide resistant mosquitoes and malaria
parasites resistant to drugs. Scientists have modified mosquitoesto produce sperm that will only create males, pioneering a freshapproach to eradicating malaria. Since 2000, increased preventionand control measures have reduced global malaria mortality ratesby 42 per cent, but the disease remains a prevalent killer especiallyin vulnerable sub-Saharan African regions. Malaria control hasalso been threatened by the spread of insecticide resistantmosquitoes and malaria parasites resistant to drugs.
Limiting carbohydrates could reduce breastcancer recurrence in women with positive IGF1
receptor:(10th June, 2014)Receptors for IGF1 have been found in breast tumor tissue, andexpression of those receptors may contribute to treatmentresistance among breast cancer survivors. Since diet can influenceinsulin activation, the researchers wondered whether diet couldimpact breast cancer prognosis based on expression of the IGF1
receptor in the primary breast tumor tissue. Using an unusualapproach, this study assessed the combined association of twofactors implicated in tumor growth -- carbohydrate intake andIGF1 receptor status -- to test whether activating theinsulin/insulin-like growth-factor axis can impact breast cancer.Since carbohydrates stimulate the biological pathway that can
increase concentrations of IGF1, the researchers focused oncarbohydrate intake.
'All systems go' for a paralyzed person to kick
off the World Cup: (10th June, 2014)All systems are go for a bold demonstration of neuroscience andcognitive technology in action: on June 12, during the opening ofthe FIFA 2014 World Cup in Brazil, a paralyzed person wearing abrain-controlled robotic exoskeleton is expected to make the firstkick. The system records electrical activity in the patient's brainand translates that to action. It also gives the patient tactilefeedback using sensitive artificial skin.
MRI shows brain abnormalities in late preterm
infants: (10th June, 2014)Babies born 32 to 36 weeks into gestation may have smaller brainsand other brain abnormalities that could lead to long-termdevelopmental problems, according to a new study. Researchersfocused on moderate and late preterm (MLPT) babies -- those
born between 32 weeks, zero days, and 36 weeks, six days, intogestation. MLPT babies account for approximately 80 percent ofall preterm births and are responsible for much of the rise in therates of preterm birth over the last 20 years.
Infection prevention implanted directly into
bones: (11th June,2014)
Hospital germs can be fatal, since they are resistant to antibiotics.As a result, alternative methods of defense against bacteria are in
demand. A research team has been able to develop bone implants
that keep the germs at bay. At first glance, the fine-grained
implant looks like flour. Only under the microscope can one see
what is inside: The individual grains of the granules consist of
apatite crystals. These are similar in composition and structure to
natural bone material, which is formed of the same chemical
elements-calcium and phosphorus. The granules make it an ideal
material for implants. To prevent complications, some
manufacturers coat their bone substitute material with
antibiotics.
Mechanism explains complex brain wiring:
(11th June, 2014)It is estimated that a person has 100 billion neurons, or nerve cells.
These neurons have thin, elongated, highly branched offshootscalled dendrites and axons. They are the body's information andsignal processors. The dendrites receive electrical impulses fromthe other neurons and conduct these to the cell body. The cellbody then decides whether stimuli will or will not be transferredto other cells via the axon. A researcher unravels a part of themystery by describing a mechanism that explains novel aspects ofhow the wiring of highly branched neurons in the brain works.
These new insights into how complex neural networks are formedare very important for understanding and treating neurologicaldiseases.
For detail mail to editor
KNOWLEDGE BASED ARTICLE
PHARMACEUTICAL WATER:
Water is the most widely used substance, raw material or startingmaterial in the production, processing and formulation ofpharmaceutical products. It has unique chemical properties due toits polarity and hydrogen bonds. This means it is able to dissolve,
absorb, adsorb or suspend many different compounds. Theseinclude contaminants that may represent hazards in themselves orthat may be able to react with intended product substances,resulting in hazards to health. Control of the quality of water
throughout the production, storage and distribution processes,including microbiological and chemical quality, is a major concern.Unlike other product and process ingredients, water is usuallydrawn from a system on demand, and is not subject to testing andbatch or lot release before use. Assurance of quality to meet theon-demand expectation is, therefore, essential. Additionally,certain microbiological tests may require periods of incubationand, therefore, the results are likely to lag behind the water use.
Different grades of water quality are required depending on theroute of administration of the pharmaceutical products. Othersources of guidance about different grades of water can be found inpharmacopoeias and related documents.
Drinking water:
Drinking-water should be supplied under continuous positivepressure in a plumbing system free of any defects that could lead
to contamination of any product. If drinking-water is used directlyin certain stages of pharmaceutical manufacture or is the feed-water for the production of higher qualities of WPU, then testingshould be carried out periodically by the water user’s site to con-firm that the quality meets the standards required for drinking-water.
Bulk Purified water:
Bulk purified water (BPW) should be prepared from a drinking-water source as a minimum-quality feed-water. It should meet therelevant pharmacopoeial specifications for chemical andmicrobiological purity with appropriate action and alert limits. Itshould also be protected from recontamination and microbial
proliferation. BPW may be prepared by a combination of reverseosmosis (RO) RO/electro-deionization (EDI) and vapourcompression (VC). Alert levels for the water system should bedetermined from knowledge of the system and are not specified in
the pharmacopoeias.
Bulk Highly Purified water:Bulk highly purified water (BHPW) should be prepared fromdrinking water as a minimum-quality feed-water. BHPW is aunique specification for water found only in the EuropeanPharmacopoeia. This grade of water must meet the same qualitystandard as water for injections (WFI), including the limit for
endotoxins, but the water-treatment process used may bedifferent. Current production methods include, for example,double-pass RO coupled with othersuitable techniques such as ultrafiltration and deionization.BHPW may be prepared by a combination of different methodssuch as RO, ultrafiltration and deionization.
Bulk water for Injections:Bulk water for injections (BWFI) should be prepared from
drinking-water (usually with further treatment) or purified wateras a minimum-quality feedwater. BWFI is not sterile water and isnot a final dosage form. It is an intermediate bulk product andsuitable to be used as an ingredient during formulation. BWFI isthe highest quality of pharmacopoeial WPU. Certainpharmacopoeias place constraints upon the permitted puri-fication techniques as part of the specification of the BWFI. TheInternational Pharmacopoeia and the European Pharmacopoeia,
for example, allow only distillation as the final purification step.BWFI should meet the relevant pharmacopoeial specifications forchemical and microbiological purity (including endotoxin) withappropriate action andalert limits. BWFI should also be protected from recontaminationand microbial proliferation.
Other Grades of water:When a specific process requires a special non-pharmacopoeialgrade of water, its specification must be documented within thecompany quality system. As a minimum it must meet the
pharmacopoeial requirements relating to the grade of WPUrequired for the type of dosage form or process step.
Maintenance of water systems:Water for Pharmaceutical Use or WPU systems should bemaintained in accordance with a controlled,documented maintenance programme that takes into account thefollowing:
– de"ned frequency for system elements;– the calibration programme;– SOPs for speci"c tasks;– control of approved spares;– issue of a clear maintenance plan and instructions;– review and approval of systems for use upon completion of work;– record and review of problems and faults during maintenance.Inspection of water system:WPU (BPW, BHPW and BWFI) systems are likely to be the
subject of regulatory inspection from time to time. Users shouldconsider conducting routine audit and self-inspection ofestablished water systems.This GMP guidance can be used as the basis of inspection. A tourof the water generation plant and visible pipework (including userpoints) should be performed to ensure that the system isappropriately designed, installed and maintained (e.g. that thereare no leaks and that the system matches the piping and
instrumentation diagram or drawing (P&ID).The following list identifies items and a logical sequence for aWPUsystem inspection or audit:– a current drawing of the water system showing all equipment inthe system from the inlet to the points of use along with sampling
points and their designations;– approved piping drawings (e.g. orthographic and/or isometric);– a sampling and monitoring plan with a drawing of all samplepoints;
– training programme for sample collection and testing;– the setting of monitoring alert and action levels;– monitoring results and evaluation of trends;– inspection of the last annual system review;– review of any changes made to the system since the last auditanda check that the change control has been implemented;– review of deviations recorded and their investigation;
– general inspection of system for status and condition;– review of maintenance, failure and repair logs;– checking calibration and standardization of critical instruments.
DISEASE RELATED BREAKING NEWS
Middle East respiratory syndrome
coronavirus (11th
June, 2014)WHO encourages all Member States to continue theirsurveillance for acute respiratory infections. Infectionprevention and control measures are critical to prevent thepossible spread of MERS-CoV in health care facilities. It is notalways possible to identify patients with MERS-CoV earlybecause like other respiratory infections, the early symptoms ofMERS-CoV are non-specific. Therefore, health-care workers
should always apply standard precautions consistently with allpatients, regardless of their diagnosis. Droplet precautionsshould be added to the standard precautions when providingcare to patients with symptoms of acute respiratory infection;contact precautions and eye protection should be added whencaring for probable or confirmed cases of MERS-CoV infection;
airborne precautions should be applied when performingaerosol generating procedures.Read more
UPCOMING EVENTS5th International Conference on Stem Cells and Cancer 2014, JNU
Convention Centre, New Delhi,India from 8-10 November.2014
DRUGS UPDATES
FDA Approves Bunavail Buccal Film for the
Maintenance Treatment of Opioid Dependence: (9th
June, 2014)
BUNAVAIL is the first and only formulation of buprenorphine andnaloxone for buccal (inside of the cheek) administration. Theability of BUNAVAIL to stick on the inside of the cheek, unlikesublingual products that need to be kept in place under the tongueuntil they dissolve, allows patients to talk, swallow and go about
normal daily activities while the medication is being consistentlyabsorbed. BioDelivery Sciences International, Inc. (BDSI)(NASDAQ: BDSI) received approval of the New Drug Application(NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccalfilm (CIII) from the U.S. Food and Drug Administration (FDA).BUNAVAIL is indicated for the maintenance treatment of opioiddependence and should be used as part of a complete treatmentplan to include counseling and psychosocial support. BDSI
expects to launch BUNAVAIL late in the third quarter of 2014. Read more