GPAT mock test
12 for Pharmaceutics
13 for Pharmacology
14 for Pharmacognosy
Saturday, May 05, 2012
GPAT mock test
Sunday, September 11, 2011
SPX-106T Treatment Yields Significant Reductions in Serum VLDL and LDL Cholesterol in Mice
Spherix Incorporated (NASDAQ: SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies – today announced that its drug candidate, SPX-106, achieved statistically significant reductions in VLDL and LDL cholesterol when administered in combination with Dtagatose (SPX-106T) for nine weeks to genetically engineered mice prone to dyslipidemia. The aortas of these mice also showed reductions in the extent of atherosclerotic lesions as measured by lesion area in response to treatment. These lipoprotein analysis and lesion measurement results represent the final data from the study whose earlier triglycerides outcome was first announced on June 2, 2011.
Treatment of animals using a range of low doses of SPX-106T twice-daily significantly reduced VLDL by 35% (from 127 mg/dl to 82 mg/dl) and LDL by 18% (from 141 to 116 mg/dl) (p=0.05). Importantly, the same therapy also reduced atherosclerotic lesion area in the aortic arch to less than one-half the value of the untreated group (graphic available at http://www.spherix.com/pdf/press/PRgraphic9-12-11.pdf). The aortic arch is generally the region where vessel disease first develops. In longer studies and in models in which high serum triglycerides fully develops, disease spreads in the vessel from the aortic arch to include the thoracic aorta. The study was not powered for an atherosclerosis endpoint and the aortas were obtained for post hoc analysis when the effectiveness of SPX-106T in lowering triglycerides and cholesterol became apparent.
Earlier this year Spherix initiated the preclinical development of SPX-106T as a treatment for hypertriglyceridemia in one arm of a study designed to evaluate both D-tagatose alone and the combination. The first studies designed specifically to test SPX-106T are nearing completion and results will be announced this fall. The Company plans to start an initial human efficacy study in the first quarter of 2012. Rapid progression to the clinic is made possible by the experienced team in place at the Company.
"Having just successfully completed two global clinical trials for a diabetes indication, Spherix has the personnel to design and execute new dyslipidemia trials much faster than other companies of a similar size," notes Dr. Claire Kruger, Chief Executive Officer of Spherix. "The preclinical pipeline of our Biospherics subsidiary can be advanced to the clinical stage rapidly because the Company is able to successfully execute multiple studies simultaneously."
Spherix Incorporated was launched in 1967 as a scientific research company under the name Biospherics Research. The Company now leverages its scientific and technical expertise and experience through its two subsidiaries – Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is dedicated to developing and licensing/marketing proprietary therapeutic products for treatment of diabetes, metabolic syndrome and atherosclerosis. Biospherics is actively seeking a pharmaceutical partner to continue the development of its Phase 3 compound for the treatment of diabetes, D-tagatose, while exploring new drugs and combinations for treatment of high triglycerides, a risk factor for atherosclerosis, myocardial infarction and stroke. Spherix's Consulting subsidiary provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products and industrial chemicals and pesticides. For more information, please visit www.spherix.com.
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of D-tagatose, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop D-tagatose may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
SOURCE Spherix Incorporated
Web Site: http://www.spherix.co
Sunday, September 04, 2011
Wednesday, August 31, 2011
Possible Trigger Point of Epileptic Seizures IdentifiedResearchers at the Stanford University School of Medicine have identified a brain-circuit defect that triggers absence seizures, the most common form of childhood epilepsy.
In a study to be published online Aug. 21 in Nature Neuroscience, the investigators showed for the first time how defective signaling between two key brain areas -- the cerebral cortex and the thalamus -- can produce, in experimental mice, both the intermittent, brief loss of consciousness and the roughly three-times-per-second brain oscillations that characterize absence seizures in children. Young patients may spontaneously experience these seizures up to hundreds of times per day, under quite ordinary circumstances.
The new findings may lead to a better understanding of how ordinary, waking, sensory experiences can ignite seizures, said John Huguenard, PhD, the study's senior author.
Epilepsy, a pattern of recurrent seizures, will affect about one in 26 people over their lifetime. Absence, or petit-mal, seizures -- the form that epilepsy usually takes among children ages 6-15 -- feature a sudden loss of consciousness lasting 15 seconds or less. These seizures can be so subtle that they aren't noticed, or are mistaken for lack of attention. The patient remains still for several seconds, as if frozen in place. Usually, a person who experiences an absence seizure has no memory of the episode.
"It's like pushing a pause button," said Huguenard, professor of neurology and neurological sciences and of molecular and cellular physiology.
Inside the brain, however, things more resemble an electrical storm than a freeze-frame.
The brain is, in essence, a complicated electrochemical calculating machine employing circuits that process information and share it with other, often-remote circuits, resulting in networks of sometimes staggering complexity. A nerve cell can be thought of as a long, branching wire that can transmit electrical signals along its length and then relay these signals to up to thousands of other nerve cells by secreting specialized chemicals at points of contact with other "wires." Depending on the nature of the signaling interaction, the result can be either excitatory (increasing the likelihood that the next nerve cell in the relay will fire its own electrical impulse) or inhibitory (decreasing that likelihood).
During an absence seizure, the brain's electrical signals spontaneously coalesce into rhythmic oscillations, beginning in the neighborhood of two important brain areas, the cortex and the thalamus. Exactly where or how this pattern is initiated has been a source of controversy, said the study's lead author, Jeanne Paz, PhD, a postdoctoral researcher in Huguenard's lab.
"In order to develop better therapies, it is important to understand where and how the oscillations originate," Paz said.
The cortex and thalamus share an intimate relationship. The cortex, like a busy executive, assesses sensory information, draws conclusions, makes decisions and directs action.
To keep from being constantly bombarded by distracting sensory information from other parts of the body and from the outside world, the cortex flags its activity level by sending a steady stream of signals down to the thalamus, where nearly all sensory signals related to the outside world are processed for the last time before heading up to the cortex. In turn, the thalamus acts like an executive assistant, sifting through sensory inputs from the eyes, ears and skin, and translating their insistent patter into messages relayed up to the cortex. The thalamus carefully manages those messages in response to signals from the cortex.
These upward- and downward-bound signals are conveyed through two separate nerve tracts that each stimulate activity in the other tract. In a vacuum, this would soon lead to out-of-control mutual excitement, similar to a microphone being placed too close to a P.A. speaker. But there is a third component to the circuit: an inhibitory nerve tract that brain scientists refer to as the nRT. This tract monitors signals from both of the other two, and responds by damping activity. The overall result is a stable, self-modulating system that reliably delivers precise packets of relevant sensory information but neither veers into a chaotic state nor completely shuts itself down.
In bioengineered mice that the Stanford team studied with Wayne Frankel, PhD, of the Jackson Laboratory in Bar Harbor, Maine, this circuit is broken because the GluA4 receptor, a protein component of cells critical to the stimulation of nRT cells, is missing. Notably, these mice are prone to intermittent absence seizures. The researchers aimed to find out why, by separately studying the mouse's key corticothalamic-circuit components. Using a technique called optogenetics, they were able to selectively switch each of the two stimulatory tracts' signal transmissions on or off at will.
The researchers observed that, as expected, signals from one of the two tracts failed to excite the receptor-deficient mice's inhibitory nRT cells. Oddly, though, signals from the other tract continued to get through to the nRT tract just fine -- "a paradoxical and totally surprising result," said Huguenard.
This leaves nRT receiving signals from one tract, but not the other, which upsets the equilibrium usually maintained by the circuit. As a result, one of its components -- the thalamocortical tract -- is thrown into overdrive. Its constituent nerve cells begin firing en masse, rather than faithfully obeying the carefully orchestrated signals from the cortex. This in turn activates the nRT to an extraordinary degree, because its contact with the thalamocortical tract is not affected in these mice.
Huguenard estimates that, typically, only a very small percentage of nRT cells are firing at a given time. In the face of over-amped signaling from the thalamocortical tract, however, the fraction of excited nRT nerve cells rose much higher, perhaps as much as 50 percent -- enough to effectively silence all signaling from the thalamus to the cortex -- a key first step in a seizure.
But the shutdown was transitory. A property of thalamic cells (like other nerve cells) is that when they've been inhibited they tend to overreact and respond even more strongly than if they had been left alone. After a burst of nRT firing, this tract's overall inhibition of the thalamocortical tract all but halted activity there for about one-third of a second. Like boisterous schoolchildren who can shut up only until the librarian leaves the room, the thalamocortical cells resumed shouting in unison as soon as the inhibition stopped, and a strong volley of signaling activity headed for the cortex. Then the nRT's inhibitory signaling recommenced, and the stream of signals from the thalamus to the cortex ceased once again.
This three-Hertz cycle of oscillations consisting of alternating quiet and exuberant periods repeated over the course of 10 or 15 seconds was the electrophysiology of a seizure.
Whether the specific nRT defect in the bioengineered mice is important in human absence seizures is not yet known, Huguenard cautioned. Most individuals who suffer from these seizures appear to have "normal" nerve cells (individually indistinguishable from those of non-epileptics) and normally formed circuits as well. But now his group has a model experimental system with which they can try to determine why ordinary experiences can trigger these seizures in everyday life. Behavioral experiments are under way in his lab to see what kinds of common sensory exposures can trip off a similar circuit malfunction in normal mice. The resulting observations may someday help patients control their own exposures to minimize seizures, Huguenard said.
Tuesday, August 23, 2011
What is Sjogren's Syndrome?Sjogren's syndrome is a chronic, slowly progressive, inflammatory autoimmune disorder characterized by the infiltration of specialized cells of the immune system called lymphocytes (T-cells in the majority of cases), monocytes, and plasma cells into the parotid (salivary) glands and lacrimal (tear) glands. These glands are part of a group of exocrine glands whose secretions pass into a system of ducts that lead ultimately to the exterior of the body. This chronic lymphocytic...
Monday, August 15, 2011
Monday, July 25, 2011
Important topics for Drug delivery
1. Fast Dissolving Drug Delivery Systems : A Review Of The Literature L. H Reddy, Bijaya Ghosh
2. Topical Ocular Drug Delivery- A Review Shyamala Bhaskaran, P. K Lakshmi, C. G Harish
3. Nanoparticles As Drug Delivery Systems Shobha Rani R Hiremath, A Hota
4..Multiple Emulsions : An Overview Of Formulation, Characterization, Stability And Applications V. R Sinha, A Kumar http://www.ijpsonline.com/temp/IndianJPharmSci643191-4343144_120351.pdf
5. Poloxamers : Promising Block Co-Polymers in Drug Delivery D. S Singhare, Shagufta Khan, P. G Yeole http://www.ijpsonline.com/temp/IndianJPharmSci675523-4347218_120432.pdf
6.Mucoadhesive drug delivery system: An overview Bindu M Boddupalli, Zulkar N.K Mohammed, Ravinder A Nath, David Banji http://www.japtr.org/temp/JAdvPharmTechRes14381-4352382_120523.pdf
7. Pectin-based colon-specific drug delivery Shailendra Shukla, Deepak Jain, Kavita Verma, Shiddarth Verma http://www.cysonline.org/temp/ChronYoungSci2283-4371243_120832.pdf
8. Novel drug delivery systems in topical treatment of psoriasis: Rigors and vigors Om Prakash Katare, Kaisar Raza, Bhupinder Singh, Sunil Dogra http://www.ijdvl.com/temp/ijdvl766612-4375785_120917.pdf
Wednesday, July 20, 2011
Friday, June 03, 2011
Lupin has entered into a strategic licensing agreement with Sydney based private specialty life science company NeuClone Pty Ltd for their cell line technology. Under the terms of the agreement, NeuClone will provide an exclusive proprietary mammalian CHO cell line which will express a specific recombinant protein of interest in oncology to its partner.
The agreement will also entail the Lupin Biological Research Programme scientific research staff working with NeuClone teams at their facility as a part of the overall technology transfer arrangements as specified within the agreement. NeuClone is an Australian biotech company specializing in cell line engineering for the biopharmaceutical and biomanufacturing industries. It has developed technology in recombinant protein production.
Dr Cyrus Karkaria, president, Lupin and Head of the Lupin Biological Research Programme said, “the multi-billion dollar opportunity with blockbuster biologics going off patent in the next 5-8 years is something that Lupin is pursuing aggressively. This exclusive licensing arrangement with NeuClone is a part of that strategy and would enable us to capitalize on cutting edge technology to address the biologicals market. This agreement and such similar agreements, coupled with our own pipeline will go a long way in helping us address the impending opportunity and develop a substantial differentiated biological pipeline.”
Dr Noelle Sunstrom, CEO of NeuClone, said, “This is an exciting time for NeuClone and our stakeholders as our investment in mammalian CHO cell lines is commercialized. In particular, we are enthusiastic about further developing the relationship with Lupin, an important global generic manufacturer.”
Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, announced that the US Food and Drug Administration (FDA) has approved Solesta as a treatment for fecal (bowel) incontinence in adult patients who have failed conservative therapy such as dietary control.
“This is a pivotal development, one that advances Oceana Therapeutics to an exciting new growth stage,” said John T Spitznagel, chairman & CEO, Oceana. “Moreover, Solesta epitomizes our corporate mission to commercialize specialty therapeutics for unmet medical needs and to achieve optimal outcomes and enhanced patient quality of life” he added.
David S Tierney, president & COO, Oceana said “Solesta was developed in collaboration with Q-Med AB* as a minimally invasive injectable gel that can be administered, relatively quickly, in an outpatient setting without the need for anaesthesia. This is a significant new treatment option for the many underserved patients who fail conservative therapy and face a life of potential social humiliation and the possibility of severe invasive treatment such as surgery.”
“I also want to commend everyone involved in the speedy responses to the items raised about a month ago in the FDA’s approvable letter for Solesta,” said Tierney. “The turnaround time between the FDA’s approvable letter and today’s announced marketing approval of Solesta has been, in our view, remarkably fast.”
Oceana intends to focus Solesta marketing and medical educational support on colorectal surgeons, specialists in treating bowel incontinence. The company is also moving expeditiously to put in place marketing materials, build product inventory, and be prepared to ship and launch Solesta during the second half of 2011. “The sooner we get Solesta into the hands of the physicians, the sooner it will be available to patients who can benefit from the product,” said Tierney. “So, we intend to push hard for a 3rd quarter US launch, although we realize that is an aggressive target.”
Solesta is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta has been developed as a minimally invasive treatment for fecal incontinence. It is the only injectable gel to be administered in an outpatient setting without the need for anaesthesia. Solesta is injected in the deep submucosal layer in the proximal part of the anal canal. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal and allowing for better sphincter control.
The Solesta PMA was submitted to the FDA in April 2010 for the treatment of fecal incontinence in adult patients who have failed conservative therapy (i.e., diet, fibre therapy, anti-motility medications). The PMA was reviewed by the FDA’s Gastroenterology and Urology Devices Advisory Panel which met on December 2, 2010 and which voted that Solesta was safe and effective, and that its benefits outweighed its risks.
The main body of clinical evidence in the Solesta PMA submission involved a multi-centre, prospective, randomized, Sham (placebo) controlled study of the product’s effectiveness and safety. The study included 206 patients (136 Solesta, 70 Sham) and consisted of a 6-month double-blinded phase followed by an open label phase in which patients originally randomized to Sham treatment were offered Solesta. The primary efficacy objective of the study required: demonstrating a statistically significant Solesta effect after 6 months of treatment; meeting a pre-defined threshold for clinical significance; and showing durability of the Solesta benefit up to 12 months after treatment. All three of these endpoints were met.
Results from this clinical trial of Solesta as a treatment for fecal incontinence were published in The Lancet (March 19, 2011; 377: 997-1003). In general, the authors of the article noted that the treatment not only met its safety and efficacy endpoints, but also was easily administered.
Oceana Therapeutics is committed to commercializing best-in-class therapeutics to address unmet and under-satisfied medical needs with a focus on colorectal, gastroenterology and urological diseases.
Himalaya partners with Karnataka govt to rehabilitate prisoners by roping them into herbal cultivation
Himalaya Herbal Healthcare signed an agreement with the Department of Prison Rehabilitation, Government of Karnataka, to create employment opportunities for prisoners, with the objective of rehabilitating them.
According to the agreement, the prisoners will cultivate medicinal herbs for Himalaya. This will help in skill-building and employment generation. The program will target prisoners charged with minor offences, who have shown good behaviour and a desire to rebuild their lives.
In phase I of the project, the herb cultivation will be undertaken at the Open Air Prison at Avathi village in Devanhalli Taluk. Initially, cultivation will be carried out on a small plot of land, approximately one to two acres. While the open air prison has a large tract of land available for cultivation, the first phase of the project will start small, in order to strengthen logistics.
Inmates of the open air prison will participate in the herb cultivation project, earning a regular monthly income and acquiring essential skills. Himalaya will provide seeds and technical assistance along with training to the prisoners. Once the system begins to operate smoothly and efficiently, Himalaya will explore the possibility of scaling up the project and expanding scope to other prisons across the state.
According to Dr Babu, Head – Agrotech Department, The Himalaya Drug Company, said “Society can be very unforgiving to prisoners. We stereotype them as criminals and never really give them a chance to rehabilitate themselves. Himalaya’s corporate social responsibility program focuses on reaching out to underprivileged sections of society through livelihood development. That is why when the Government of Karnataka approached us with this proposal, we were very excited. With the right support and encouragement, some of these prisoners can be effectively rehabilitated. This project will give prisoners an opportunity to earn a decent income and acquire new skills. In a small way, our efforts will help them rebuild their lives by giving them a fair chance.”
Prison reform is essential. Equipping prisoners with basic skills through such initiatives will help them in future employment, build their self-esteem and assist their re-integration into society.
Orthocon Inc., a privately-held therapeutic device company, announced that the Food and Drug Administration cleared Hemasorb Apply for clinical use and sale in the United States.
Hemasorb Apply is a proprietary, custom-designed applicator preloaded with Hemasorb Absorbable Bone Haemostat Matrix. The product is provided ready-to-use and enables precise application of Hemasorb to stop bone bleeding during surgical procedures and in treating traumatic injuries. Currently marketed bone haemostat products require surgeons to use their fingers or surgical instruments for application. Unlike bone waxes, Hemasorb is putty-like in consistency, does not require preparation, and is now provided in a syringe-like applicator. Furthermore, Hemasorb is absorbable, biocompatible, and water resistant.
Commenting on the significance of the Hemasorb Apply clearance, John J Pacifico, president and chief executive officer, Orthocon said the following: “This regulatory clearance is an important achievement for Orthocon. There has been very little innovation in the bone haemostat field since bone wax was first introduced in the late 1800s. We believe that the widespread adoption of flowable surgical haemostats has created new opportunities for advanced surgical products that more efficiently and effectively control bone bleeding, and we are confident that Hemasorb Apply will help secure Orthocon’s leadership position in this therapeutic category. Both Hemasorb and Hemasorb Apply are clearly differentiated from wax-like haemostats, and they are changing the way surgeons think about surgical haemostasis.”
Since its initial market introduction in 2010, Hemasorb has been approved for sale at leading hospitals throughout the United States and has been used successfully by hundreds of surgeons. Orthocon is confident Hemasorb Apply will provide surgeons with an innovative and cost effective tool to assist in their management of intra-operative bone bleeding, and the company fully expects Hemasorb to become the standard of care for bone haemostasis.
Control of bleeding from cut bone is a problem in many operative procedures including spine, orthopaedic, craniomaxillofacial, and cardiac surgeries. Excessive bleeding during surgery may impair the surgeon’s view of the operative field, may result in the need for blood transfusions, and may be associated with postoperative complications. Orthocon estimates that over 3.5 million patients undergoing surgeries in the United States, Europe, and Canada each year could benefit from the intra-operative use of Hemasorb.
Orthocon develops, manufactures, markets, and sells implantable products that stop bone bleeding.