Pharmaceutical Formulations and API

All pharmaceutical products are formulated to specific dosage forms for drugs to be effectively delivered to patients. Typical pharmaceutical dosage forms include oral tablets, capsules, solutions, suspensions, topical ointments, gels, and solutions, and injections for intravenous (IV), intramuscular (IM), or subcutaneous (SC) administration. In addition, various drug delivery systems have been developed for transdermal, intranasal, and pulmonary deliveries. Different dosage forms require different pharmaceutical technologies and usually present different technical challenges for formulation development.

Because of the complex technical challenges scientists encounter during formulation development, it is important to use an effective methodology. Design of experiments and statistical analysis have been applied widely to formulation development, and are useful in process optimization and process validation. The major advantage of using Design of experiments to develop formulations for pharmaceutical products is that it allows all potential factors to be evaluated simultaneously, systematically, and quickly.