R&D Highlights

Itraconazole:

• Developed the first formulation of Itraconazole using an aqueous based technology.
• Advantages of the technology is in maintaining the crystalline integrity of the product which retains its hydrophobic character and ensures that the bio transportation takes place through the lipoprotein layer.
• This ensures that the molecule is able to penetrate through the hydrophobic cell wall of the fungus.

Tacrolimus:

• Development of first pellet based formulation of Tacrolimus.
• Development conducted using an aqueous based matrix.
• Pilot bio study indicates that the intra volunteer variation is less than the innovator’s formulation.
• The platform technology developed for Tacrolimus can be applied to similar chemistries like Rapamycin (Sirolimus), Pimecrolimus and Mycophenolate Mofetil.
• Can be considered for 505 B II filing.

Clarithromycin:

• First to develop a total pellet based formulation of Clarithromycin.
• The technique involves use of ion exchange resins and a polymer which ensures that the bitter taste is masked completely.
• The pellets remain tasteless for 25 seconds when placed on tongue sans suspension mixture.
• The enteric coating ensures that the release profile matches with the innovator (Abbott Laboratories) release profile.

Orlistat:

• Development of first aqueous based pelletization technique for the manufacture of Orlistat.
• The shape of the pellets is in form of a perfect sphere as opposed to the innovator whose formulation is in form of extrudates.
• The pellets have a fine particle size which assures consistent release of the drug for systemic action.

Nano-encapsulation:

• First to have developed an aqueous based matrix for nano encapsulation of Paclitaxel.
• The skeletal matrix for nano encapsulation is ready. Trials need to be conducted in a dedicated Sterile facility
• The technology is applicable to Docetaxel, Topothecan and Irinothecan.
• Can be considered for 505 B II filing.