New Drug Development Process

New Drug Development Process

New Drug Development

Tou Pharma Bio Pvt. Ltd develops formulations for new chemical entities, OTC products, generic products, and 505(b)(2) product candidates.  The company has also evolved the following dosage forms.

• 1.Tablets
• 2.Capsules, powder-filled
• 3.Capsules, liquid-filled
• 4.Oral solutions and suspensions
• 5.Injectables
• 6.Pellets
• 7.Microspheres
• 8.Controlled release products
• 9.Sustained release products
• 10.Topical products
• 11.Lyophilized products
• 12.New Drug Development Process

Preformulation development studies were conducted to determine the physical and chemical characteristics of the compound of interest be it a small organic molecule, peptide or protein.  The data of these studies generated were a prerequisite to dosage form development and also the data required for submission of the Chemistry, Manufacturing and Control (CMC) section of the Investigational New Drug application (IND).  Tou Pharma Bio provides the following general Preformulation development studies.

Pka and or pI,2. pH-solubility profile 3.pH-stability profile at accelerated temperatures,4. Partition coefficient and distribution coefficient as a function of pH.  5.  Salt formation characteristics., 6. Dissociation constants,7.Disintegration studies,8.Dissolution studies. 9.Hygroscopicity analysis. 10. Lipophilicity analysis.11. Moisture analysis 12. Excipient compatibility studies.13. Determination of Accelerated stability studies.14. Accelerated stability studies with controlled storage at 40º C/75% RH, 60º C.15. Viscosity analysis. 16.Intrinsic solubility. 17, Preparation and writing of the CMC for the IND