Formulation comprising thymol useful in the treatment of...

Details Formulation comprising thymol useful in the treatment of... Formulation comprising thymol useful in the treatment of...

2002-12-19

2004-11-30

Flood, Michele (Department: 1654)

Drug, bio-affecting and body treating compositions

Plant material or plant extract of undetermined constitution...

Containing or obtained from mentha

C424S725000, C424S404000

Reexamination Certificate

active

06824795

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a novel synergistic composition useful in the treatment of drug resistant bacterial infections. The composition comprises an effective amount of thymol, a mixture of the essential oils of
Mentha arvensis
and
Mentha spicata
or their monoterpene components in appropriate ratio and conventional additives. The composition is useful in the treatment of drug resistant enteric and systemic infections. The formulation with enhanced activity of thymol action comprises thymol in combination with the oil which is a combination containing the rare mixture of carvone, limonene and menthol. The invention also provides methods of producing the composition and a method of using thymol obtained from the seeds of the plant
Trachyspermum ammi
(Ajwain) as a fourth generation antibiotic formulation for control of drug resistant bacteria. More particularly, the invention relate to the use of a compound ‘Thymol’ isolated from the oil distilled from the seeds of the plant
Trachyspermum ammi
(Ajwain) to kill the bacteria resistant to even prevalent third generation antibiotics and multi-drug resistant (mdr) microbial pathogens and thus useful as a plant based fourth generation herbal antibiotic formulation.
BACKGROUND OF THE INVENTION
Microbial infections are a major cause of human health hazards and misery leading to sizeable number of human deaths globally. In addition, the infections drastically affect human efficiency by incapacitating various metabolic functions and systems like digestive, respiratory, urinary, circulatory, nervous systems and skin. This then leads to continuous human suffering till the patient is completely cured of the causative microbes. Bacterial infections present a serious threat to the health and well being of people of all ages Antibiotics and antimicrobial drugs ever since the discovery of Penicillin by Alexander Fleming in the 1940s have been used by the medical practitioners to eliminate infective agents and curing the diseases. However, the infective microbes have always been able to fight back every new drug through development of resistance against the drug/antibiotic in use. Emergence of multiple drug resistant strains has appeared as a real problem in the field of medical science. The primary cause of the development of resistance is occurrence of random mutations. Mutations may occur in genes responsible for conferring sensitivity against a drug. With a relative dearth of new antibiotics with novel mode of action we may find ourselves on the verge of a medical disaster. It is high time to revive the hidden wonders of plant molecules with the modern tools of target based screening to develop newer advanced generation drugs and antibiotics with novel modes of actions.
Newer antimicrobials have been arising through structural modifications of existing agents leading to the development of higher generation drugs with wider spectrum of activity and enhanced potency. Well-exemplified cases for evolution of higher generation families of antimicrobial agents are penicillins and cephalosporins. These are evolved by the chemical modification of the basic &bgr;-lactam ring. Cephalosporin represents great-grand daughter-drug of cephalothin. Similarly, since the development of nalidixic acid as the first generation antimicrobial quinolone drug in 1962 by Lesher and colleagues, members of quinolone family have also evolved upto third generation. In fact, nalidixic acid found limited utility in treating systemic infections and subsequently marginally improved quinolones like oxolinic acid, pipemidic acid and cinoxacin were released in 1970's. Then came a breakthrough in early 1980's with the beginning of evolution of fluorinated quinolones. First to come up was norfloxacin, a second-generation quinolone having 6-fluorine and 7-piperazine substituents developed by Wolfson and Hooper. It had enhanced activity against both gram-negative and gram-positive bacteria like
Pseudomonas aeruginosa
and
Staphylococcus aureus
, respectively. This followed the development of sister drug molecules like ciprofloxacin, enoxacin, ofloxacin and pefloxacin etc. Almost concurrent has been the development of third generation agents such as lomefloxacin, fleroxacin, temafloxacin, tosufloxacin possessing one or more additional fluorine substituents as compared to second generation quinolones having a fluorine on position-
6
on the basic quinolones.
Continuous and indiscriminate use of these quinolone/floroquinolone drugs is resulted into gradual insensitivity of the bacteria against whom these are used and thereby the pathogens requires more and more amount of these compounds as doses. Being synthetic, the use of these drugs results into forced side effects. Further, the pathogens are becoming resistant to even higher doses of these compounds to make the matter worse. To counter this problem, the applicants have developed a novel method of using the known plant based compound thymol in isolation to kill the drug resistant bacteria and also in combination with other available antibiotics to check the resistance development in the bacteria.
Considering the deadliest bacterial infections, tuberculosis is world's leading killer claiming more than three million lives world-wide every year. More appalling is the increased incidence of this disease and mortality among HIV positive individuals. The resurgence of tuberculosis and its incidence in human immuno-deficiency virus-positive populations in both developing and industrialized countries has focussed attention on the urgent need for development of new advanced generation drugs.
Current scenario of global awareness repeatedly flashes the ineffectiveness of the normally used antibiotics used for the cure of diseases like Tuberculosis. These problems are now assuming epidemic proportion even in the developing countries. New drug combinations using active molecules from natural sources like plants need to be systematically explored failing which the consequences are destined to be devastating and out of control for the human race in the new millennium. Among the most promising advances in the field of drug development is discovering new molecules or novel uses of the already available compounds with known safety and without any side effects. Such active biomolecules combined with other antibiotics can kill the drug resistant bacteria and simultaneously check further development of resistance in the infectious microbes.
Use of thymol in various herbal preparations ranging from mouthwashes and enteric disorders to skin infections is common. The parent oil and thymol itself as component of grandma's household recipes to treat a range of common ailments has found resident place because of being equally effective for children and adults. These uses have been exploited in the Indian subcontinent and also across the continents through formal and informal dissemination of traditional and herbal medicine knowledge.
Some of the related or prior art that need to be specifically cited here for establishing the uniqueness of our invention include the following different uses.
1. Composition for the treatment of viral infections including HIV (Pruthi et al. 1999; U.S. Pat. No. 5,980,903; Nov. 9, 1999) and its related arts (Badaway 1998; U.S. Pat. No. 5,801,153; September, 1998; Rohatgi 1996; U.S. Pat. No. 5,529,778; June, 1996; Hozumi et al. 1995; U.S. Pat. No. 5,411,733; May, 1995).
2. Analgesic composition useful in providing a temporary relief from symptoms of arthritis (Beck 1991; U.S. Pat. No. 5,073,366; Dec. 17, 1991) and its related arts (Arbir et al. 1981; U.S. Pat. No. 4,307,109; December, 1981; Dubash et al. 1983; U.S. Pat. No. 4,383,986; May, 1983; Seth 1985; U.S. Pat. No. 4,540,572; September, 1985; Geria 1987; U.S. Pat. No. 4,702,916; October, 1987; Grohe 1989; U.S. Pat. No. 4,844,902; July, 1989; Bisset et al. 1989; U.S. Pat. No. 4,847,071; July, 1989; Deckner et al. 1989; U.S. Pat. No. 4,863,725; July, 1989).
3. Powder composition for forming a mouthwash (Smigel et al. 19

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