The discovery of new drugs will be one of the huge milestones in science and it becomes even more important to pass the toxicity screening and it should give potential benefits to the users than their side effects. Pre-formulation studies are very important when you have initiated new studies. The studies deal with the physical, chemical, analytical, pharmacokinetic, pharmacodynamic and also pharmaceutical properties that are related to the research molecule and they provide the idea about the suitable modifications in the molecule to show better performance.
The development of an efficient dosage is a complex and long process to carry out by the researcher. It requires teamwork it cannot be handled by a single person. Before dosage development, the researcher should have an idea about the candidate.
It is a challenge to make successful pharmaceutical products with low side effects and it all depends on their bioavailability. The preformulation studies usually carried out on candidate drug molecules that show a sufficient amount of the pharmacological promise, in general, the animal model is used for these studies.
Objectives of preformulation studies
The main objectives of the preformulation studies are as follows;
- To generate valuable data that is needed in developing stable and safe dosage forms for manufacturing on a commercial scale.
- They help generate useful information on steps to design the drug delivery system along with good bioavailability.
- They will also help the researcher to build in-depth knowledge and understanding about the physical characteristics of the candidate drug molecule before dosage development.
Goals of developing products
These are the ultimate goals that are involved in the preformulation studies;
- To provide the physiochemical parameters of the candidate’s drug molecule.
- To provide the compatibility drug molecule of the candidate.
- To find the kinetic rate profile of the drug substances.
Classes of preformulation studies
There are two classes in the preformulation studies, they are explained through the below content;
Fundamental preformulation studies
This type of preformulation studies are very specific to the candidate drug molecules and they also include the solubility analysis (partition coefficient, solubilization, ionization constant, dissolution, etc.), solid-state properties(like polymorphism, amorphous form and the solvated forms), stability analysis(like solid-state stability and the solution state stability) along with the permeability studies. All these studies will depend on the candidate drug molecule chemical structure.
Derived performulation studies
These studies usually include the properties of the particle (like the particle size and the shape of the particle), powder flow properties, bulk density, compaction behavior, etc. they are carried out based on the intended dosage of pharma solutions.
Things to consider
Before starting the studies you have to consider these things;
- The anticipated pharma solutions dose and the proposed route of drug administration.
- Situations to supply and the development schedule.
- Take a look at the available physiochemical data including the different salts, chemical structure, and the dosage form.
Final thoughts
Before initiating the preformulations studies try to understand all the essential factors and the proper understanding helps you in developing a successful dosage with fewer side effects in the users.
