Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2000-12-12
2003-07-08
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S773000, C424S774000, C424S776000, C424S779000
Reexamination Certificate
active
06589570
ABSTRACT:
TECHNICAL FIELD
This invention relates to a pharmaceutical formulation useful for the treatment of Hepatitis B and Hepatitis C and other viral infections of liver. This invention particularly relates to a pharmaceutical formulation useful for the treatment of acute and chronic Hepatitis B & C virus infections prepared from the Indian biotyped medicinal plant,
Phyllanthus amarus.
This invention also relates to a process for the preparation of the pharmaceutical formulation useful for the treatment of acute and chronic Hepatitis B and Hepatitis C and other viral infections of the liver from the medicinal plant
Phyllanthus amarus.
It is needless to stress the need for a s drug that would keep the liver functioning at its optimum or the one that would be selectively active against the currently known etiological agents of acute and chronic viral diseases of the liver. This is important because the disease of the liver throw the entire human body out of gear. The exciting alphabet of viral Hepatitis includes a wide range of totally unrelated often highly unusual pathogenic human viruses like Hepatitis A virus (HAV), Hepatitis B virus (HSV), Hepatitis C virus (HCV), Hepatitis D virus (HDV), Hepatits E virus (HEV) etc. Of the viruses it has been clearly established that HBV, HCV and HDV are the ones that are associated with the development of chronic persistent/active hepatitis, cirrhosis of the liver and even hepatocellular carcinoma besides being associated with fulminant hepatitis and sub acute hepatic failure.
BACKGROUND ART
Acute and Chronic Hepatitis-B
The natural disease course in HBV is being summarized to understand the need for the effective management and treatment of Hepatitis B in a country. For normal adults with low viral production and an early immune response, the disease course is self limiting and usually asymptomatic (60-80% of all HBV infections). Individuals who replicate the virus in larger quantities, with a relatively late immune response have a self-limiting symptomatic acute hepatitis. Irrespective of whether initially symptomatic or asymptomatic, the infection becomes chronic in 5-10% of the individuals, 20-30% of them developing clinical sequelae such as chronic hepatitis, cirrhosis or hepatoma within years or decades. In neonates, however, the immune defence is still lacking (induction of tolerance), so that infected individuals do not develop acute hepatitis, but more of them become chronic camers (80-90%). Such carriers also progress frequently to chronic clinical sequelae faster. Between these two extremes are immunocompromised individuals, such as intravenous drug users, haemodialysis patients or transplant recipients, who are more likely to become chronic carriers than are healthy adults (10-60%). (WHO Tech. Report Series 1987;754:18).
Based on substantial body of data, HBV has been proved as a major pathogen producing chronic liver diseases. It has also been proved that there are over 400 million healthy carriers of HBV all over the world and one tenth of these carriers (40 millions) being in India alone. These carriers besides acting as human reservoirs of HBV infection also act as primary source of spread of HBV infection to the community and was also shown to have 200 times increased risk of developing chronic liver diseases and/or hepatocellular carcinoma.
With the above documented international HBV scenario, the HBV epidemiology in India is to be considered as alarming since there are definite data on prevalence pattern of HBV in asymptomatic population (4%) high risk groups (13%), significant involvement of HBV in Indian acute and sub-acute liver failure cases (42 & 45%). 70% of the chronic hepatitis cases, 40-80% of cirrhosis cases and over 60% of primary liver cancer cases.
Although effective vaccines have been developed against HBV and successfully adopted, the need for effective treatment of acute and chronic Hepatitis B has become universal public health emergency since vaccines as on date are neither capable of inducing immunity in a carrier nor able to eliminate HBV carrier status. Research conducted from the mid 70s have delineated several agents to have treatment potential in chronic HBV infections which has been illustrated in the Table 1 given below.
TABLE 1
Agents that have been studied in the treatment of HBV infection
(Lau et al., Gut. Suppl. 1991;547-562)
Anti-virals
Immunosuppressive
Immunostimulators
Interferons
Corticosteroids
BCG vaccination
Alpha interferon
Levamisole
Beta interferon
Interleukin-2
Gamma interferon
Interferon gamma
Tumour necrosis factor
Thymosin
Adenine arabinoside (Ara-A)
Tumor necrosis
Acyclovir, deoxyacyclovir
factor
Zidovudine
Suramin
Ribavirin
Phosphonoformate
Quinacrine
(+) -cyanidanol-3
Lamuvidine
Phyllanthus amarus
However, except the interferons, Lamuvidine and the latest entry
Phyllanthus amarus,
the others seem to be far from successful. The limited success rate, prohibitive cost, profound side effects and the non-accessibility of interferons and Lamuvidine in developing and underdeveloped counties have necessitated further search for newer antihepatitis B agents.
Acute and Chronic Hepatitis-C
1. Acute HCV Infection
Persons with acute HCV infection typically are either asymptomatic or have a mild clinical illness; 60%-70% have no discernible symptoms; 20%-30% might have jaundice; and 10%-20% might have nonspecific symptoms (e.g. anorexia, malaise or abdominal pain). Clinical illness in patients with acute hepatitis C who seek medical care is similar to that of other types of viral hepatitis, and serologic testing is necessary to determine the etiology of hepatitis in an individual patient. In ≧20% of these patients, onset of symptoms might precede anti-HCV seroconversion. Average time period from exposure to symptom onset is 6-7 weeks, whereas average time period from exposure to seroconversion is 8-9 weeks. Anti-HCV can be detected in 80% of patients within 15 weeks after exposure, in ≧90% within 5 months after exposure, and in ≧97% by 6 months after exposure. Rarely, seroconversion might be delayed until 9 months after exposure.
The course of acute hepatitis C is variable, although elevations in serum ALT levels often in a fluctuating pattern, are its most characteristic feature. Normalization of ALT levels might occur and suggests full recovery, but this is frequently followed by ALT elevations that indicate progression to chronic disease. Fulminant hepatic failure following acute hepatitis C is rare. However, in developing country especially India, HCV in FHF was reported significantly.
2. Chronic HCV Infection
After acute infection, 15%-25% of persons appear to resolve their infection without sequelae as defined by substained absence of HCV RNA in serum and normalization of ALT levels. Chronic HCV infection develops in most persons (75%-85%), with persistent or fluctuating ALT elevations indicating active liver disease developing in 60%-70% of chronically infected persons. In the remaining 30%-40% of chronically infected persons, ALT levels are normal. No clinical or epidemiologic features among patients with acute infection have been found to be predictive of either persistent infection or chronic liver disease. Moreover, various ALT patterns have been observed in these patients during follow-up, and patients might have prolonged periods (≧12 months) of normal ALT activity even though they have histologically confirmed chronic hepatitis. Thus a single ALT determination cannot be used to exclude ongoing hepatic injury, and long term follow-up of patients with HCV infection is required to determine their clinical outcome or prognosis.
The course of chronic liver disease is usually insidious, progressing at a slow rate without symptoms or physical signs in the majority of patients during the first two or more decades after infection. Frequently, chronic hepatitis C is not recognised until asymptomatic persons are identified as HCV positive during blood donor screening or elevated ALT levels are detected during routine physical examinations. Most studies have reported t
Coe Susan D.
Ladas & Parry
Lankford , Jr. Leon B.
University of Madras
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