Question

We presume the following; It is understood that a new chemical material that is synthesized is possibly used in Corona Virus (Covid-19) treatment, for its experimentation in living organisms (in-vivo) to be done, tablets of this material must be made.

Explain and show information about all the pre-formulation studies and research that has to be performed for this formulation to be made.

In other words, a new substance is being made to be used as a cure for Covid19, in order for it to be used in living beings/ in-vivo testing, we need to have this substance made into a tablet form so that it can be ingested.

In order to make these tablets, there are formulation procedures and pre-formulation procedures, What are the stages and procedures that are made in the pre-formulation stage of the formation of this tablet?

Answer 1

Formulation development is depends upon certain fundamental, physical and chemical properties of the drug and other properties of drug powder. The investigation of physical and chemical properties of drug substance alone or in combined form is called preformulation stage of formation of tablet. The main aim for this phase is to generate informations useful to produce stable and safe dosage tablets with good bioavailability. Datas collected about these drug development during the early stage is called preformulation data.

Preformulation data contains particle size, melting point, infrared analysis, Thin layer chromatographic purity etc about that new substance ( here it is new chemical material found for the treatment of Covid 19)

Main stages of preformulation phase.

1. Stability :- Identified from two factors ie, a) Solid state - it includes temperature, humidity and light. b) Solution - it includes Solvent, pH, light.
2. Physico-chemical properties : It is based on molecular structure, weight, colour, odour, size and shape of particle, melting point, thermal analysis profile, absorbance spectra, solubility, partition coefficient, etc. of the newly founded chemical substance for tablet formation.
3. Physico-mechanical properties : It includes bulk and tapped density and compressibility of the new substance.
4. In vitro availability properties and other studies are the other steps present in the preformulation stage.

Formulation is the process of forming a drug mixture by combining several chemical substances with the active drug to form a final product. Tablets are one of the solid formulation. Preformulation studies helps a drug to formulate as a tablet or any kind of formulation.