Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from piper
Reexamination Certificate
2001-08-10
2002-07-02
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from piper
C424S725000
Reexamination Certificate
active
06413553
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an herbal formulation useful for blocking of 5 lipoxygenase activity leading to the inhibition of leukotrine synthesis, suppression of IL4 production and enhancement of IFN gamma release. More particularly this invention describes the process for the preparation of extracts from the leaves or any other plant parts of plants
M. koenigii
and
P. betel
and their selective blending to evaluate biological response in order to establish their role for the treatment and remedy of bronchial respiratory troubles.
BACKGROUND AND PRIOR ART REFERENCES
Respiratory problems consist of mild to extremely severe trouble of breathing along with the other discomforts such as wheezing, coughing, chest tightness and the like. In spite of precautionary measure, public awareness campaign and monitoring system, population having respiratory trouble is on the rise all over the world. This is more true in western advanced countries, specially among the children. With
M. koenigii
leaf preparation, the relief and possible cure of asthma has been demonstrated in a large number of cases (Unpublished PCT Patent application PCT/IN/00102). Two-prong strategy was adapted in the present invention. The respiratory disease is the result of pathophysiological symptoms arising out of aberration of immune system. The immediate symptom includes bronchial constriction, inflammation of respiratory tract and closing of air way by mucus secretion. The symptomatic drugs provide relief by temporary relaxation of the distressed symptoms.
This is to state that the
Murrya koenigii
extract combined with extract obtained from piper betel has shown surprising results. According to the earlier filed unpublished PCT patent application, the betel leaf extract showed increase in IFN-&ggr; from Th1 type cells and decrease of IL-4 from Th2 type cells. This clearly is an effective measure in treating asthma as shifting of Th2 type response towards Th1 type will obviously reduce the release of IgE from mast cells which is a major manipulator of asthmatic condition. Hence the applicants earlier finding followed by the filing of PCT patent application PCT/INOO/00127 is in direct consonance with the present filing on combined extracts from any plant parts of
M. koenigii
and
P. betel
as a new medicine for treating atopic Asthma.
The root cause for respiratory problems is not well addressed by the developers of symptomatic drugs. With the advent of current knowledge, it is now well accepted that leukotrienes are found to be the main player in developing symptoms of respiratory problems.
The major symptoms of respiratory problem can be divided into early and late responses. The early response occurs within minutes of allergen exposure and involves primarily mediators such as histamine, leukotrienes and prostaglandin D2. The effects of these mediators result in bronchoconstriction and accumulation of mucus. The late response occurs hours later and involves additional mediators including IL-4, IL-5, IL-6, and TNF-alpha, eosinophils chemotactic factor (ECF) and platelet activating factor (PAF). The overall effect of these mediators is to recruit inflammatory cells including eosinophils and neutrophils. These cells are capable of causing significant tissue injury by releasing toxic enzymes. These events lead to occlusion of bronchial lumen with mucus protein, and cellular debris, thus thickening of basement membrane, fluid build up and hypertrophy of the bronchial smooth muscle. A mucus plug often forms and adheres to the bronchial wall. The mucus plug contains clusters of detached epithelial cells fragments, eosinophils, some neutrophils and spirals of bronchial tissue known as Curschmann's spiral (Immunology, J. Kuby; W.H. Freeman & Co., New York; 3rd edition 1997). In view of the current mechanisms regarding manifestation of bronchial asthma/ bronchial respiratory problems, modem strategy for drug development stressed the following approaches:
These include i) inhibition of leukotriene synthesis via blocking the 5-lipoxygenase-enzyme activity (Leqqis RA et al New England J. Med. 323:,645,1990). The formation of leukotrienes originates from the oxidation of arachidonic acid, hence inhibition of this reaction leads to the inhibition of leukotriene synthesis. Besides, leukotrine receptors antagonists have also been introduced as anti leukotriene therapy for asthma/respiratory problems (Tien F. C., Medical J. Aust. 171: 378,1999). Currently licensed drug zelutin, based on inhibition of arachidonic acid oxidation has already been introduced exclusively in the US market. However, its use is limited by hepatotoxicity. Children below 14 years are not recommended for this drug. Moreover patients taking other drugs need to be surveyed when taking zelutin as anti-asthma drug. More over patients taking other drugs need to be surveyed when taking zelutin, as anti-asthma drug. ii) the neutralization of IgE either by anti-IgE antibody (humanized) or by blocking the high affinity IgE receptor, Fc&egr;R-I (Heusser C, Jardiu P. Current Oppinio Immunol., 9: 805.1999). Since suppression of Th2 cytokines leads to decrease in IgE production, additional approach is based on the inhibition of these Th2 cytokine synthesis and enhancement of Th1 cytokine formation (Chung K. F.; Barens P. J. Thorax 54: 825, 1999).
In contrast,
M. koenigii
based anti asthmatic preparation has been tried on children as young as 7 years old and octogenarian as old as 80 years and above without any adverse reaction.
The extract of
M. koenigii
leaf was therefore examined for their potential to inhibit the production of leukotrienes. Additionally, the extract was also examined for shifting of Th2 response towards to Th1 type. Th1 and Th2 response were measured by 7-interferon (Th 1) and IL-4 (Th2) production respectively.
M. koenigii
extract showed inhibition of 5-lipoxygenase mediated arachidonic acid oxidation signifying blockage of leukotriene synthesis and marginal effect on &ggr;-interferon production. Importantly,
M. koenigii
extract drastically reduces IL-4 synthesis. On the other hand,
P. betel
leaf extracts resulted in facilitating of the shift from Th2 type response to Th1 type. In other words, a man having average skill in the art cannot just combine these two to produce inference of the combination of the ingredients. This combination is a novel combination and the combined effects of the combination are surprising and unexpected. Thus, a blend of extracts from these two plants,
M. koenigii
and
P. betel
predominantly inhibited leukotriene synthesis and shifted Th2 response towards Th1 type and therefore is proposed as a unique synergistic formulation for treatment, relief and remedy of bronchial respiratory problems. Thus, the two pronged strategy is the major objective of this new formulation and can be considered as the best modality of treatment for patients suffering from bronchial respiratory problems.
OBJECTS OF THE INVENTION
The main objective of the invention is to provide a new pharmaceutical formulation comprising combination of extracts derived from plant parts leaves of
Murraya koenigii
and
Piper betel
or any of the plant parts thereof.
Another object of the invention is to provide a new pharmaceutical formulation comprising combination of extracts derived from
Murraya koenigii
and
Piper betel
leaves.
Yet another objective of the present invention is to provide a process for the preparation of extract from the leaves or any other plant parts of
M. koenigii
and
P. betel
useful for relief, treatments and remedy of respiratory problem.
Yet another objective of the present invention is to provide a simplified method of extract preparation from leaves or any other plant parts of
M. koenigii
and
P. betel
possessing biological activities relevant to treatment, relief and remedy of respiratory problems.
Yet another objective of the present invention is to provide a simplified fast and inexpensive process for the preparation of combination of extracts possessing biological activities
Bandyopadhyay Santu
Bhadra Ranjan
Bhattacharaya Samir
Chandra Pal Bikash
Chandra Roy Keshab
Council of Scientific and Industrial Research
Foley & Lardner
Meller Mike
Naff David M.
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