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.

Future plans:

  • To focus on developing semi finished formulation in form of nano particles for pulmonary release, buccal release and for orally dissolved tablets.
  • To develop solid dosage forms for products like HGHF and similar products.
  • To Develop nano particles for therapeutic peptides and monoclonal antibodies.