Novel Anti-tuberculosis compositions and anti-infectives:

Synergistic formulation of antioxidant-antimicrobials and antimycobacterial agents.

 

            Pulmonary tuberculosis (PTB) is a most common, deadly infectious disease worldwide. The current antituberculosis treatment is directed against mycobacteria and no agent is used to prevent lung alveolar injury which may be permanent. During clinical studies, inventors found that in PTB patients there is significant persistent rise in levels of lipid peroxidation (LPO) even at the end of successful completion of chemotherapy. This protected invention found out novel compositions, and process for producing them. Compositions of this invention have been seen to be capable of converting a sputum positive patient into sputum negative state very fast accompanied with sharp reduction in lipid peroxidation levels too. This, is not possible with the presently available compositions of anti-tuberculosis compositions in the market, and is obviously commercially very valuable invention for the pharma industry engaged in anti-tuberculosis compositions manufacture. The invention is protected by patent application. 

 

The inventors shall be happy to license this invention to parties capable of global commercialization. The inventors are looking forward to finalize an agreement with a suitable party by March, 2006. Interested parties may contact (info@iprmanagement.com) immediately so that IPR evaluation and other evaluation process can be expedited fast.

 

            A randomized controlled clinical trial of the composition of this invention was conducted on newly diagnosed cases of pulmonary tuberculosis by simultaneous administration of antioxidants like tocopheryl acetate and ascorbic acid to first line antimycobacterial agents(2EHRZ).for intensive phase of therapy lasting for two months.

 

Results:

1.      50 % sputum conversion as compared to 14% with 2EHRZ alone within 15 days with improvement in lung X-ray, reduction in Lipid peroxidation levels in contrast to continuous rise in control group indicating reduced lung damage due to free radicals.

2.      Better absorption of Rifampicin as determined by HPLC.

3.      Further studies showed that Tocopheryl acetate alone is bactericidal against Mycobacterium tubercle bacilli, pseudomonas, salmonella, staphylococci and  E.coli..

4.      Based on above findings it is possible to prepare single dose formulation for oral administration, incorporating

         Rifampicin + tocopheryl acetate + Ascorbic acid

         INH + tocopheryl acetate + Ascorbic acid

         Pyrazinamide + tocopheryl acetate + Ascorbic acid

         Ethambutal + tocopheryl acetate + Ascorbic acid INH + Rifampicin + tocopheryl acetate + Ascorbic acid

         Pyrazinamide + INH + Rifampicin + tocopheryl acetate + Ascorbic acid

         Ethambutal + Pyrazinamide + INH + Rifampicin + tocopheryl acetate + Ascorbic acid

         Tocopheryl acetate + Ascorbic acid + other second line agents

         Tocopheryl acetate + Ascorbic acid + other antimicrobial agents

 

These compositions are obviously commercially very valuable and protected market shall be available to the parties who shall license this invention.