No doubt, preformulation studies investigate the physical, chemical, and mechanical properties of the drug substance and provide important information to formulate a safe and effective dosage form of the drug.
But, do the formulation scientists immediately jump to carry out the preformulation studies of the drug substance the moment it’s discovered?
NO! Certain preliminary and essential steps form an integral part of the drug development process; even before the preformulation studies.
Before a formulation scientist begins with a preformulation study, he must consider:
- The available physicochemical data of the drug substance which includes its chemical structure, different salts, potency relative to the competitive products and the dosage form.
- Literature providing information on the stability and decay process of the drug.
- What are the anticipated dose of the drug substance and its proposed route of administration?
- What are the different approaches to formulate the given drug and its bioavailability?
- Pharmacokinetics or the study of bodily absorption, distribution, metabolism, and excretion of chemically related drugs.
Thus, before embarking on a preformulation study, a formulation scientist has to spend considerable time in investigating and collecting the above information. This will ensure to propel his preformulation studies in the right direction.