Defination, objective, Goal and Area of Pre-formulation study of Tablet

Definition 

Investigation of physico chemical properties of the new drug compound that could affect drug performance and development of an efficacious dosage form.

Objective 

  • To establish its compatibility with common excipients.
  • To determine its kinetics and stability.
  • To establish the physico chemical parameters of a new entity.
  • To increase drug stability 
  • To improve drug bioavailabilty.

Goal

  1. To establish physical characteristics.
  2. To determine kinetic rate profile.
  3. Develop a stability indicating assay.
  4. Establish drug compatibility with common excepients.

Area of preformulation 

  1. Organoleptic Characters
  2. Bulk Characters
  • Crystallinty and polymorphism
  • Hygroscopicity
  • Fine particle characterization
  • Powder flow properties
      3. Solubility Analysis
  • Ionization constant PKa
  • pH solubility profile
  • Common ion effect Ksp
  • Thermal effects    
  • Solubilization
  • partition co - efficient
  • Dissolution 
     4.Stability Analysis
  • Stability in toxicology formulations
  • Solution Stability
  • pH rate profile
  • Solid state stability
  • Bulk stability
  • Compatibility       

Comments

Popular posts from this blog

TONGUE BASE STRENGTHENING EXERCISE

६ TIPS जसले हामीलाई दाँत स्वस्थ राख्न मद्दत गर्दछ |

के हो होलबडी( Holebody) चेक अप(Check up) ?