Description:FIELD OF INVENTION
The present invention relates to the field of pharmaceuticals and relates more specifically to a fixed dose combination comprising an antimicrobial drug and Montelukast for overcoming antimicrobial Resistance in microbes. The current invention more specifically relates to methods and compositions for treating microbial infections more effectively by using fixed dose combination comprising a cephalosporin antibiotic and Montelukast.
BACKGROUND
Antimicrobial resistance is the ability of microorganisms to survive and grow despite being subjected to concertation of antimicrobial substances under a treatment regimen that is designed to kill them. Antimicrobial resistance (AMR) is an increasingly urgent and extremely complex global health challenge that restricts the ability to control and treat life-threatening bacterial, viral or parasitic infections. Due to development of AMR in the currently used antimicrobials, treatment regimens can be adversely affected or, in some cases rendered ineffec , Claims:We Claim:

1. A fixed dose combination (FDC) pharmaceutical formulation for treating antimicrobial resistant (AMR) microbial infections comprising:
(a) 100-400mg of a cephalosporin class antibiotic, and
(b) 5-10 mg of montelukast;
wherein Montelukast acts as a AcrAB-TolC multidrug efflux pump inhibitor.
2. The FDC formulation of claim 1, wherein it comprises the antibiotic and montelukast in 80:1 to 10:1 w/w ratio.
3. The FDC formulation of claim 1, wherein the cephalosporin class antibiotic is Cefpodoxime.
4. The formulation of claim 1, wherein the antibiotic has the structure given in formula 1, and Montelukast has the formula given in formula 2.

formula 1

formula 2

5. The FDC formulation of claim 2, wherein the cefpodoxime is in prodrug ester form (cefpodoxime proxetil).
6. The FDC formulation of claim 1. wherein montelukast is in pegylated form.
7. The FDC formulation of claim 1, wherein the antibiotic is in the form of a pharmaceutically acceptable s