Title of Invention

MEDICINAL COMPOSITION FOR THE TREATMENT FOR HEPATITIS C

Abstract

A composition for the treatment of Hepatitis C is disclosed. The composition comprises a homogenized mixture of at least one serially diluted and potentized substance, as herein described, selected from: Hepatitis C Genotype 1, Hepatitis C Genotype 2, Hepatitis C Genotype 3, Hepatitis C Genotype 4, Hepatitis C Genotype 5 and Hepatitis C Genotype 6 along with a vehicle selected from a group consisting of normal saline, distilled water and ethyl alcohol(90 to 100%). A process for making the composition is also disclosed.

Full Text

FORM-2 THE PATENT ACT, 1970 (39 of 1970) & THE PATENT RULES, 2003 PROVISIONAL SPECIFICATION (See section 10 and Rule 13) MEDICIANL FORMULATIONS DR. RAJESH SHAH An Indian National of Life Force Centre, 415, Krushal Commercial Complex. Above Shoper's Stop, M.G. Road, Chembur, Mumbai-400 089, Maharashtra, India. THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION Field of invention This invention relates to medicinal formulations. SUMMARY OF INVENTION Envisaged in accordance with this invention is a medicinal formulation for inducing specific immune response in patients with Hepatitis C. In particular, this invention envisages a novel medicinal formulation for control of viral multiplication, in turn reducing the viral load in the body and hence controlling the pathogenesis and various symptoms associated with Hepatitis C disease. In accordance with another aspect of the invention there is provided a medicinal formulation which can be adapted for use as a vaccine against Hepatitis C virus. Definitions: As used in the present specification, the following words and phrases are generally intended to have the meanings as set forth below, except to the extent that the context in which they are used indicates otherwise. Hepatitis C is an infection caused by the hepatotropic virus called Hepatitis C virus, which is blood bourn and it can lead to chronic inflammatory liver disease (Hepatitis), desctrution of liver cells (Cirrhoiss of liver) and liver cancer. Estimated 170 million people in the world are suffering with Hepatitis 2 C infection. Most of those infected may remain asymptomatic for 15 to 25 years. The conventional treatment for Hepatitis C comprises the use of interferon and some antiviral agents, which are found effective in most cases. However, the adverse effects and to high cost are prohibitive factors. There are no vaccines yet available to combat Hepatitis C infections. For over two decades, homeopathic practitioners have suggested that serially agitated dilutions of infectious agents (called "nosodes") are effective in the prevention of infectious disease. A 'nosode' is a homeopathic remedy prepared from a pathological specimen. The starting material for preparation of a nosode can be blood, pus, any other body secretion or excretion, or even a diseased fragment of tissue, such as a growth. Rabies nosode, for example, starts with the saliva of a rabid dog and is then "potentized". The prepration of nosodes derives from homotoxicology, a type of homeopathic therapy created by Hans-Heinrich Reckeweg in Germany in the first part of 18th century. Homeopathic medicine, since its inception under Hahneman at the beginning of the 19th century, follows the principle of "infinitesimals." From this notion, the dosages of nosodes are in very minute and diluted forms. Thus, nosodes are not nearly as harmful as the untreated pathological product. 3 A 'nosode' is similar to an "oral vaccine" in the sense that its purpose is to "immunize" the body against a specific disease. The major difference between a nosode and a vaccine is of course the extremely small quantity of antigenic material in a nosode. In the case of nosodes from bacteria and viruses, the preparation introduces the molecular imprints of possible antigens and other constituents of the pathological agent to the immune system. The working of the nosode is based on the fact that the immune system is induced to develop a defence mechanism which is effective against variety of antigens with this kind of molecular imprint, without being exposed to the virulence of the living agent. Nosodes are also used as inter-current remedies in the treatment of chronic diseases. This is the most common use of nosodes in Homeopathic practice. Therefore, there is a need for a formulation that can induce protective immunity against broad spectrum of antigens related to tuberculosis and other chronic infections associated with tuberculosis, with better safety profile than vaccines. Summary It is an object of this invention to provide a novel, specific immunity enhancing medicinal formulation, so as to control and reduce Hepatitis C virus activities. This invention is aimed at reducing the viral load and in turn arresting the disease process. 4 The formulation is also useful in accordance with another aspect for the treatment of cirrhosis of liver and liver cancer. This preparation is also aimed to be a potential vaccine against Hepatitis C. Comparing with the conventional antiviral substances against Hepatitis C, the formulation in accordance with this invention is not only significantly cost-effective but is also free from adverse effects. Another object of the present invention is to provide a multi-antigen formulation with a mixture of antigens from all major known genotypes of Hepatitis C such as which are indicated numerically as Genotype 1, Genotype 2, Genotype 3, Genotype 4, Genotype 5, and Genotype 6. Yet another object of this invention is to provide a safe medicinal formulation containing serially agitated dilutions of mixture of antigens from aforementioned strains of Hepatitis C. Yet another object of this invention is to provide a method for preparation of a novel formulation, potentiated by means of a mathematico-mechanical process for maximal therapeutic benefits. Yet another object of this invention is to provide a novel medicinal formulation offering better patient compliance and thereby minimizing the risk of multidrug-resistant type of infections. Description: Hepatitis C multiple Genotype virus complex includes a wide range of Hepatitis C virus, inclusive of common and rare variants. 5 The Hepatitis C virus are known to cause serious diseases in humans such as Acute and Chronic Hepatitis C, Cirrhosi of liver and Liver cancer. The currently known strains of Hepatitis C virus are classified as: 1. Genotype 1 2. Genotype 2 3. Genotype 3 4. Genotype 4 5. Genotype 5 6. Genotype 6 Six samples of patients, each of them qualitatively tested positive for Hepatitis C, each with one of the Genotypes as indicated above. Each of them were confirmed negative from other known viral infections such as Hepatitis B and HIV, in particular. One ml serum of each of the above patient was separated from blood samples and mixed in a vial containing 10 ml distilled water. (It is known that the virus are found in the serum.), and thoroughly mixed by stirring for five minutes. About 2 ml of the above mixed serum was then mixed with 10 ml of distilled water and carefully preserved for further processing. Serial Dilution And Potentiation : Potentiation is a mathematico-mechanical process for rendering inert or poisonous antigen containing pathological residues, to a state of physical solubility, physiological assimilability so as to enhance their therapeutic activity and harmlessness, for use as a healing remedy. 6 The primary object of potentiation is to reduce all substances designed for therapeutic use to "a state of approximately perfect solution or complete ionization, which is fully accomplished only by infinite dilution." (Arrhenius.) Each resulting diluted culture is typically stroked by holding the bottle in a closed fist and striking the fist on a hard surface repeatedly at a regular frequency or by exercising similar powerful stroke using a mechanical device which can strike a bottle on a hard surface. Such strokes are given 10 times. This preparation is labeled as Strain l c potency. Thus 5 different preparations of l c are obtained and labeled as A-l c, B-l c, C-l c, D-l c and E-l c. In accordance with the preferred embodiment of this invention, the bottle containing the preparation for stroking is a securely stoppered glass bottle and a mechanical device is adopted to exert a force of at least 6 dynes rhythmically at a frequency of 10 strokes per minute . This procedure of serial dilution followed by stroking is repeated 10 times with each l c potency preparations to obtain respective 5c preparations for each strain. These are thus labeled as A-5c, B-5c, C-5c, D-5c and E-5c. Preparation of Hepatitis C multiple Genotype virus complex (HCMGV): At this point, about 2ml liquid + 10 ml of distilled water as prepared above, which is a mix consisting of all the above stated genotypes of Hepatitis C virus is now subjected to serial dilutions and potentiation to obtain preparations like with higher potencies like HCMGV l c, HCMGV 2c, HCMGV 3c, HCMGV 4c HCMGV 1000c, HCMGV 50000 and above. 7 A vehicle is selected from a group of vehicles consisting of normal saline, distilled water and ethyl alcohol. Preferably ethyl alcohol (90 to 100%) is used as a vehicle. While considerable emphasis has been placed herein on the specific steps of the preferred process, it will be appreciated that many steps can be made and that many changes can be made in the preferred steps without departing from the principles of the invention. These and other changes in the preferred steps of the invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation. Advantage and Application of the new preparation HCMGV 3c, 6c to 50000c (and above): These preparations are prepared from the bacterial strains but they lack the viral toxicity. Preliminary clinical investigations have shown that the formulations prepared according to the above process help to retain the capacity to induce immune response in the body, which may helps prevention and treatment of Hepatitis C disease syndrome. Dated this day of December 2006 Mohan Dewan Of R. K. Dewan &Co Applicant's Patent Attorneys 8

Documents:

2113-MUM-2006-ABSTRACT(26-6-2007).pdf

2113-mum-2006-abstract(granted)-(19-5-2010).pdf

2113-MUM-2006-ANNEXURE TO FORM 3(6-1-2010).pdf

2113-MUM-2006-CANCELLED PAGES(1-7-2009).pdf

2113-mum-2006-cancelled pages(2-3-2010).pdf

2113-MUM-2006-CLAIMS(1-7-2009).pdf

2113-MUM-2006-CLAIMS(AMENDED)-(2-3-2010).pdf

2113-MUM-2006-CLAIMS(AMENDED)-(6-1-2010).pdf

2113-mum-2006-claims(granted)-(19-5-2010).pdf

2113-MUM-2006-CLAIMS(MARKED COPY)-(2-3-2010).pdf

2113-MUM-2006-CLAIMS(MARKED COPY)-(6-1-2010).pdf

2113-MUM-2006-CORRESPONDENCE(1-7-2009).pdf

2113-mum-2006-correspondence(2-3-2010).pdf

2113-MUM-2006-CORRESPONDENCE(24-3-2009).pdf

2113-mum-2006-correspondence(ipo)-(20-5-2010).pdf

2113-mum-2006-correspondence-received.pdf

2113-mum-2006-description (provisional).pdf

2113-MUM-2006-DESCRIPTION(COMPLETE)-(1-7-2009).pdf

2113-mum-2006-description(granted)-(19-5-2010).pdf

2113-MUM-2006-FORM 1(2-3-2010).pdf

2113-MUM-2006-FORM 1(22-12-2006).pdf

2113-MUM-2006-FORM 1(6-1-2010).pdf

2113-mum-2006-form 18(26-6-2007).pdf

2113-mum-2006-form 18(28-6-2007).pdf

2113-mum-2006-form 2(1-7-2009).pdf

2113-mum-2006-form 2(granted)-(19-5-2010).pdf

2113-MUM-2006-FORM 2(TITLE PAGE)-(1-7-2009).pdf

2113-MUM-2006-FORM 2(TITLE PAGE)-(2-3-2010).pdf

2113-mum-2006-form 2(title page)-(granted)-(19-5-2010).pdf

2113-MUM-2006-FORM 3(1-7-2009).pdf

2113-MUM-2006-FORM 3(24-3-2009).pdf

2113-mum-2006-form 5(26-6-2007).pdf

2113-mum-2006-form-1.pdf

2113-mum-2006-form-2.doc

2113-mum-2006-form-2.pdf

2113-mum-2006-form-26.pdf

2113-mum-2006-form-3.pdf

2113-MUM-2006-PETITION UNDER RULE 137(6-1-2010).pdf

2113-MUM-2006-REPLY TO EXAMINATION REPORT(2-3-2010).pdf

2113-MUM-2006-REPLY TO EXAMINATION REPORT(6-1-2010).pdf

2113-mum-2006-specification(amended)-(2-3-2010).pdf