Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1994-07-20
1997-08-19
Peselev, Elli
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514 81, A61K 3170
Patent
active
056588879
DESCRIPTION:
BRIEF SUMMARY
This invention relates to pharmaceutical formulations, in particular to novel uses of formulations in connection with the treatment of infection by intracellular pathogens, in particular microorganisms of the genus Legionella, particularly L. pneumophila.
Intracellular pathogens include microorganisms of the genus Legionella, Chlamydia (e.g. C. trachomatis and C. pneumoniae) and Mycobacterium (e.g M. avium, M. fortuitum and M. tuberculosis). Legionella spp. are known to infect the respiratory tract of humans and animals, causing acute and sometimes fatal symptoms. It is known to treat Legionella infection with antibiotics, for example erythromycin. It is an object of this invention to provide alternative and improved pharmaceutical treatments for Legionella infection.
The invention provides a pharmaceutical formulation which comprises a pharmaceutically acceptable salt of clavulanic acid, in combination with erythromycin or a derivative thereof, and optionally one or more other antimicrobial agents.
The formulation of the invention is suitable for use in the treatment of infection by intracellular pathogens, e.g. microorganisms of the genus Legionella, in humans or animals.
The present invention also provides a method of use of a pharmaceutically acceptable salt of clavulanic acid and erythromycin or a derivative thereof, and optionally one or more other antimicrobial agents, together in combination in the manufacture of a medicament formulation, particularly a formulation for the treatment of infection of humans or animals by intracellular pathogens such as microorganisms of the genus Legionella.
The present invention further provides a method for the preparation of a pharmaceutical formulation as defined above, which method comprises admixing the combination of a pharmaceutically acceptable salt of clavulanic acid, and erythromycin or a derivative thereof and optionally one or more other antimicrobial agents.
As salts of clavulanic acid are extremely hygroscopic such formulations must be prepared in dry conditions, typically at a relative humidity of 30% or less. All constituents of the formulation should be predried.
The present invention further provides a pharmaceutical formulation as defined above for use as an active therapeutic substance, particularly in the treatment of infection of humans or animals by intracellular pathogens, such as microorganisms of the genus Legionella.
Further the invention provides a method for the treatment of an infection by intracellular pathogens, such as microorganisms of the genus Legionella in humans or animals, which comprises administering thereto, simultaneously or successively in any order, a pharmaceutically acceptable salt of clavulanic acid and erythromycin or a derivative thereof, and optionally one or more other antimicrobial agents. Typically the clavulanic acid and erythromycin may be co-administered together, e.g as a composition, optionally also together with one or more other antimicrobial agents.
Although this invention is not limited to any particular mode of operation, there appears to be an in-vivo synergistic interaction between the clavulanic acid and the erythromycin against Legionella, and the combination appears to be capable of penetrating mammalian cells.
Typical microorganisms of the genus Legionella are L. pneumophila. L. micdadei and L. bozemanii are also important pathogens.
The most pharmaceutically stable salt of clavulanic acid is the potassium salt, ie potassium clavulanate.
Suitable derivatives of erythromycin include the ethylsuccinate, acistrate, estolate, glucoheptonate, propionate, stearate and the lactobionate.
Suitable optional other antimicrobial agents which may be included in the formulations and methods of this invention as described herein include antibiotics, e.g .beta.-lactam antibiotics such as penicillins and cephalosporins. Suitable antibiotics include those for example listed in GB 1578739, e.g on page 3 line 25 to 36 thereof. Preferred .beta.-lactam antibiotics are amoxycillin and ticarcillin, especially amoxycillin
REFERENCES:
patent: 4299826 (1981-11-01), Luedders
patent: 4935247 (1990-06-01), Marttila et al.
patent: 5114929 (1992-05-01), Vardan
Dustman Wayne
Kinzig Charles M.
Lentz Edward T.
Peselev Elli
SmithKline Beecham p.l.c.
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