Optimization of Ingredients API Formulation by Mixture DOE 

Mixture design, DOE, API 

 

 

In pharmaceuitcal industry, active components (API) of formulations are optimized to minimize the cost. 

 - A, B and C actives are proven, patented and licensed inhibiting the same protein 

– A is the most expensive one following by B and C 

 

Objective of the experiment are
- Check and assure A, B & C are compatible

- Minimize cost (minimize A, maximize B & C) 

- Sustain effectiveness of recent formulation  

 

Any physical or chemical interaction between drug and excipient affect bioavailability and stability of formulation

- It is compulsory for FDA certification 

 

A mixture experiment is a special type of response surface experiment in which the factors are the ingredients or components of a mixture, and the response is a function of the proportions of each ingredient. 

 

Conclusion 

A, B and C are compatible 

- Various ratios for ABC mixtures might meet expectations 

 - 40%A, 60% B 

 - 75%A, 25 % C 

 - ABC mixtures might meet expectations close to A region