A REVIEW ARTICLE ON SYNRIAM™ INDIA’S FIRST ANTI-MALARIAL DRUG
M.pharm (Quality Assurance), Sagar Institute of Research and Technology-Pharmacy
Synriam™ is new drugs combination in India Market and its Generic name is Arterolane Maleate and Piperaquine Phosphate. It was launched by Ranbaxy Laboratories Limited on 25 April, 2012 and approved in 2011 by Drug Controller General of India. Synriam is a fixed dose combination of two antimalarial active ingredients. Each film coated tablet contains Arterolane maleate 150 mg. and Piperaquine phosphate 750 mg, developed as simplified once-a-day therapy for three days for the treatment of acute, uncomplicated P. falciparum malaria in adult. Arterolane a synthetic trioxalane rapidly kills the malaria parasite in blood, providing fast relief from symptoms of malaria. Piperaquine on the other hand has a longer lasting effect than arterolane and kills the residual parasites, preventing the recurrence of malaria. SYNRIAM has been effective in geographical regions where resistance to chloroquine has been reported. The fever clearance time for SYNRIAM is shorter than that of arthemeter-lumefantrine. This is an added benefit over arthemeter-lumefantrine regimen, which has to be taken with high fat meals twice a day. This food independent dosing will improve patient convenience and compliance. The efficacy of Synriam has been confirmed in comparative study conduct in India, Thailand and Bangladesh.
REFERENCE ID: PHARMATUTOR-ART-1877
Malaria: The Disease
Malaria is a mosquito-borne infectious disease of humans and other animals caused by protists (a type of microorganism) of the genus Plasmodium. It begins with a bite from an infected female Anopheles mosquito, which introduces the protists through saliva into the circulatory system. In the blood, the protists travel to the liver to mature and reproduce. The disease is widespread in tropical and subtropical regions in a broad band around the equator, including much of Sub-Saharan Africa, Asia, and the Americas.
Causes of malaria
Malaria is caused by a type of parasite known as Plasmodium. This is a microscopic parasite that is transmitted by certain species of mosquitoes. Although there are numerous types of Plasmodia parasites, only four cause malaria in humans. These include:
There is a fifth species causing malaria in humans. It is called Plasmodium knowlesi. It is distributed across South East Asia and is often misdiagnosed as P. Malariae. The infection has a potentially more serious and even life-threatening course.
The Plasmodium parasite is mainly spread by female Anopheles mosquitoes, which are night-biting mosquitos.
A Plasmodium in the form that enters humans and other vertebrates from the saliva of female mosquitoes (a sporozoite) traverses the cytoplasm of a mosquito midgut epithelial cell.
Malaria is typically diagnosed by the microscopic examination of blood using blood films, or with antigen-based rapid diagnostic tests. Modern techniques that use the polymerase chain reaction to detect the parasite's DNA have also been developed, but these are not widely used in malaria-endemic areas due to their cost and complexity. The World Health Organization has estimated that in 2010, there were 219 million documented cases of malaria. That year, between 660,000 and 1.2 million people died from the disease, many of whom were children in Africa. The actual number of deaths is not known with certainty, as accurate data is unavailable in many rural areas, and many cases are undocumented. Malaria is commonly associated with poverty and may also be a major hindrance to economic development.
Despite a need, no effective vaccine currently exists, although efforts to develop one are ongoing. Several medications are available to prevent malaria in travelers to malaria-endemic countries (prophylaxis). A variety of antimalarial medications are available. Severe malaria is treated with intravenous or intramuscular quinine or, since the mid-2000s, the artemisinin derivative arterolane, which is superior to quinine in both children and adults and is given in combination with a second anti-malarial such as Piperaquine.
The life cycle of malaria parasites: A mosquito causes infection by taking a blood meal. First, sporozoites enter the bloodstream, and migrate to the liver. They infect liver cells, where they multiply into merozoites, rupture the liver cells, and return to the bloodstream. Then, the merozoites infect red blood cells, where they develop into ring forms, trophozoites and schizonts that in turn produce further merozoites. Sexual forms are also produced, which, if taken up by a mosquito, will infect the insect and continue the life cycle.
In the life cycle of Plasmodium, a female Anopheles mosquito (the definitive host) transmits a motile infective form (called the sporozoite) to a vertebrate host such as a human (the secondary host), thus acting as a transmission vector. A sporozoite travels through the blood vessels to liver cells (hepatocytes), where it reproduces asexually (tissue schizogony), producing thousands of merozoites. These infect new red blood cells and initiate a series of asexual multiplication cycles (blood schizogony) that produce 8 to 24 new infective merozoites, at which point the cells burst and the infective cycle begins anew. Other merozoites develop into immature gametes, or gametocytes. When a fertilised mosquito bites an infected person, gametocytes are taken up with the blood and mature in the mosquito gut. The male and female gametocytes fuse and form zygotes (ookinetes), which develop into new sporozoites. The sporozoites migrate to the insect's salivary glands, ready to infect a new vertebrate host. The sporozoites are injected into the skin, alongside saliva, when the mosquito takes a subsequent blood meal.
Signs and symptoms
Features of malaria include high fever over 38C (100.4F) along with chills and sweating. There is intense muscle pain, headache, blurring of vision and dizziness. Some patients may develop diarrhoea and vomiting as well. Symptoms develop within seven days after being bitten or may take between 10 to 15 days to appear.
Main symptoms of malaria
The typical fever patterns of the different types of malaria
The signs and symptoms of malaria typically begin 8–25 days following infection; however, symptoms may occur later in those who have taken antimalarial medications as prevention. Initial manifestations of the disease—common to all malaria species—are similar to flu-like symptoms and can resemble other conditions such as septicemia, gastroenteritis, and viral diseases. The presentation may include headache, fever, shivering, joint pain, vomiting, hemolytic anemia, jaundice, hemoglobin in the urine, retinal damage, and convulsions.
The classic symptom of malaria is paroxysm—a cyclical occurrence of sudden coldness followed by rigor and then fever and sweating, occurring every two days (tertian fever) in P. vivax and P. ovale infections, and every three days (quartan fever) for P. malariae. P. falciparum infection can cause recurrent fever every 36–48 hours or a less pronounced and almost continuous fever.
Severe malaria is usually caused by P. falciparum (often referred to as falciparum malaria). Symptoms of falciparium malaria arise 9–30 days after infection. Individuals with cerebral malaria frequently exhibit neurological symptoms, including abnormal posturing, nystagmus, conjugate gaze palsy (failure of the eyes to turn together in the same direction), opisthotonus, seizures, or coma.
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