Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from azadirechta
Reexamination Certificate
2000-09-15
2003-07-29
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from azadirechta
C424S404000, C424S774000, C424S779000, C424S775000, C424S725000
Reexamination Certificate
active
06599541
ABSTRACT:
FIELD OF INVENTION
The invention provides a synergistic novel composition which can be used against bacteria that have developed resistance to conventional antibiotics and other chemotherapuetic anti-microbial agents. Preferably, the invention provides a composition comprising of an herbal agent to re-sensitize the resistant bacterial strains and an antibiotic or a chemotherapuetic anti-bacterial drug to which, the bacterial strain was resistant. The invention also provides a process for the preparation of the composition.
BACKGROUND AND PRIOR ART REFERENCES OF THE INVENTION
Bacterial resistance to conventional antibiotics and other chemotherapuetic agents has been an area of serious concern in clinical practice. Sulfa-resistant gonococci were widespread 10 years after their introduction. Penicillin was introduced during 1940's. Although originally was highly susceptible,
Staphylococcus aureus
quickly developed &bgr;-lactamase mediated resistance and caused epidemics during 1950's. Semi-synthetic penicillins were developed for a broad-spectrum of anti bacterial activity. For a long time, the first member of this group, Ampicillin has been most widely prescribed drug. But, now 20-70% of
E. coli
strains are Ampicillin resistant (Beam Jr. TR 1992 on Principles of anti-infectives Use—chapter-47 in Text Book of Pharmacology, ed. Smith C M and Raynard A M, published by W. B. Saunders Company, 1
st
ed., p-812-814). This phenomenon has been an important factor necessitating the development of newer anti-microbial molecules.
The bacterial resistance to an antibiotic can be of two kinds (Beam Jr. T R, 1992 on Principles of Anti-infectives Use—chapter47 in Text Book of Pharmacology, ed. Smith C M and Raynard A M, published by W. B. Saunders Company, 1
st
ed., p-812-814.). The first one is called intrinsic resistance. This is a natural phenomenon and hence, all antibiotics do not exhibit activity against all sorts of bacteria but work in a selective manner. The second type is an acquired resistance. In this type, a particular bacterial species appear to be susceptible to an antibiotic initially but develops resistance over a period of time. Acquired resistance by bacteria to an antibiotic in use poses a specific problem in clinical practice, as the patients hosting such resistant organisms do not respond to the therapy.
So far, there are three well-known pathways in which, the bacteria develop resistance to any antibiotic substance. Firstly, it may produce certain enzymes, which may break down the antibiotic rendering it ineffective to work upon. For example, the penicillinase or &bgr;-lactamase produced by certain bacteria inactivates penicillin or its derivatives (Davey P G 1996 on Anti-microbial chemotherapy, chapter 7.6 in Oxford text book of medicine, vol. -I, Ed. By Weatherall D J, Ledingham J G G & Warell D A, published by Oxford University Press, 3
rd
edition). Similarly, Enterobacter species work to inactivate Erythromycin by producing an esterase. In the second case, the bacteria may alter the target site. For example, Erythromycin normally latches to 50s ribosomal sub-units and inhibits the synthesis of proteins and thereby kills the bacteria. To prevent such anchoring by Erythromycin, certain bacteria are now known to modify the target site. In the last pathway, the bacteria may work to reduce the permeability of antibiotic substance by altering the structure of its own cell wall. This phenomenon can be best illustrated by
Staphylococcus epidermidis,
which inhibit the entry of erythromycin (Kapusnik-Uner J E, Sande M A & Mandell G L, 1996 on Antimicrobial agents; Tetracyclines, Chloramphenicol, Erythromycin & Miscellaneous antibacterial agents the chapter-47 in Goodman & Gilman's The Pharmacological Basis of Therapeutics, ed. By Hardman J G, Limbird E, Molinoff P B & Ruddon R W & cons. Editor Goodman Gilman A, pub. By McGraw-Hill, Health Professions Division, 9
th
International edition, p-1136,1137).
Practically speaking, there can be two approaches to overcome the issue. Firstly, newer antibiotics may be developed. Alternatively, certain therapeutic additives which, can work to sensitize the bacterial species to particular antibiotic/s and render them susceptible to the present generation of antibiotics. The present invention chooses the later approach to address the problem.
In modem medicine also, there have been efforts to go by the second alternative. Development of a combination containing Amoxycillin and Clavulanic acid is the best example to illustrate such efforts. Amoxycillin is an amino-penicillin and is degraded by &bgr;-lactamase producing bacteria. Clavulanic acid was discovered to inhibit the activity of &bgr;-lactamase but is devoid of antibacterial activity of its own (Reading C & Cole M,
—
1977 A beta lactamase inhibiting beta lactam from
Streptomyces clavuligenus;
Antimicrob Agnets Chemother, 11, p-852-857, Reading C, Farmer T & Cole, M 1983,_The Beta lactamase stability of Amoxycillin with beta lactamase inhibiting Clavulanic acid, J. Antimicrob Chemother., 11, p-27-32 & Todd P A & Benfield P 1990Amoxycillin/Clavulanic acid, an up-date of its antibacterial activity, pharmacokinetic properties & Therapeutic use, Drugs 39, p-264-307).
When Clavulanic acid was combined with amoxycillin, the antibacterial spectrum of the later was found to widen and as such, the combination is now, available for clinical applications.
On the other hand, India has one of richest heritage of traditional systems of medicine. Use of herbs in preventive and therapeutic health care has been an ageless tradition in India. Various investigators with a view to develop newer drug molecules are exploring many of these medicinal plants. Similarly, identification and development of anti-microbial molecules from medicinal plants has a long history in Indian Medicine. The earliest reports on anti-microbial activity of medicinal plants appeared way back in 1930's (Chopra RN, 1994 rpt. on therapeutic and other uses of Indian Medicinal Plants in Indigenous Drugs of India Ed. By Chopra R N, Chopra I C, Handa, K L and Kapoor L D, pub. By Academic Publishers, Calcutta, p-594-606). Since then, screening of anti-microbial compounds has continued. Many of these subjects have shown promising anti microbial activity against test strains “in-vitro” (Dhar M L, Dhar M M, Dhawan B N, Bhakuni D S, Mehrotra B N et. al. 1968-'74, Screening of Indian Plants for Biological Activity, part-I to part-V, published as series of reports in Ind. Jour. Exp. Biol., between 1968-1974). But none of these observations could ever lead to an effective development of drugs or therapeutic modalities to counter bacterial infections.
Nonetheless, synergistic effect or potentiating effect of herbs is a promising field in Ayurveda. Certain investigations on medicinal plants provide a cue that herbal drugs can be effectively utilized for identifying their additive or potentiating effects in appropriate areas. The present invention goes by this approach and seeks to explore the synergistic/potentiating or additive effects of medicinal plants to address the issue of bacterial resistance.
The neem tree, also referred as
Azadirachta indica
A. juss has been used and is known since ages for its healthcare benefits. The tree has been attributed with many therapeutic effects in various Ayurvedic texts and even the common-folk appear to have a fair understanding about its medicinal uses and therefore, they use it often, for such benefits. Mostly, the leaves, the seeds and their fixed oil portion and bark of neem are used for their medicinal activities. However, the leaves and bark are preferred for oral use in humans.
One of the common beliefs is that, various parts of neem are effective against infectious conditions. Based on these perceptions, various parts of neem have been investigated and the observations have been classified commonly as observations for antibacterial, anti-fungal and anti-viral conditions.
Similarly, neem seeds and seed oils have been examined in depth for their effect on agricul
Brindavanam Narasimha Baba
Katiyar Chandra Kant
Narayana Dasalukunte Bhimrao Ananta
Dabur Research Foundation
Patten Patricia A.
Tate Christopher R.
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