What are pre-formulation studies? Why is there a need to perform this?
It is a series of test procedures that deals with identifying intrinsic physical,
chemical, analytical, and pharmaceutical properties related to molecule and
provides idea about suitable modification in molecule to show a better
performance.
There is a need to perform pre-formulation studies because pre-formulation
studies provide a framework for the drug’s combination with pharmaceutical
ingredients in the fabrication of a dosage form.
Preformulation studies are performed to identify the physical and chemical
properties of a drug molecule, and if needed we can modify it so that we can
produce an effective, safe, stable, and reliable drug product. It is important to
conduct pre-formulation studies because not all drug molecules are compatible
with the existing ingredients, it is significant to figure out to find which of the
excipients is compatible with the existing molecules which can produce an
effective, safer, stable, and reliable pharmaceutical formulation.
What is determined in stability studies? Identify ways to package and store drug
products easily destroyed by hydrolysis and light.
Stability studies determines if the quality of a drug substance or drug product is
altered over time by various environmental factors such as light, temperature,
humidity, pH levels, particle size, etc. Products that are easily destroyed by
hydrolysis must be protected from moisture by adding a desiccant namely silica
gel, and products that are easily destroyed by light the solution would be using
amber container or bottles so that the light would not destroy the products.