The preformulation studies play a paramount role in drug development, which will provide a great strength to steerage, give restrictive relief, and enhance product quality, evaluation process, and public safety standards. Before going to process your preformulation studies, you must have a basic knowledge about the drug and its relative products.
The preformulation studies have been established to achieve the main goal such as determine physiochemical properties, select the right physical form of a drug molecule and examine the stability of drug and excipients under certain conditions. The preformulation studies are filled with the physiochemical properties that are established and characterized. Now you are going to see some effective information drug excipients compatibility studies in preformulation.
Drug-Excipient Compatibility:
The drug-excipient studies are considered as a significant phase in drug development. The drug substances are integrated with the excipients for obtaining the specialized purpose. Now you are going to see some of the importance included in the preformulation studies.
- Wide range of problems have been avoided during the formulation processes
- The stability of a dosage form has been enhanced
- Establish a connection between drug discovery and development
- It is highly necessary for investigational new drug submission (IND)
Intention Of Drug-Excipient Compatibility Studies:
- To find out, how much an excipient is well suited with candidate drug molecules or Active Pharmaceutical Ingredient (API).
- For governing the impurities, design a stable and selective indicating analytical methods.
- Identify the excipient, which has the capability to stabilizes an unstable API (Active Pharmaceutical Ingredient)
- Risk level should be assigned to each excipient
Implementation Of Drug-Excipient Interactions:
Even though, you have a wide range of experience in this field, understanding the mechanism of drug-excipient is somewhat difficult.
Chemical Drug-Excipient Interactions:
By using the chemical degradation pathway, the process involved in the interaction of excipient and drug substances can be preceded. The chemical interactions can take place in the form of photolysis, hydrolysis, Maillard reactions, racemization, oxidation, polymerization, etc.
Physical Drug-Excipient Interactions:
The peoples must have great knowledge of preformulation studies for handling the physical drug-excipient interactions. The physical interactions may alter the dosage odor, uniformity, sedimentation rate, flow properties, solubility, dissolution rate, color, etc.
Let see some of the benefits included in changing the drug stability in a dosage form.
Enhance Surface Area Of Drugs:
The preformulation studies are needed for improving the surface area of drugs. In general, the surface area of the drugs can be increased due to the adsorption of drugs on excipient surface. Consequently, the bioavailability of drug substance can be increased.
Increase Bioavailability Of Water-Soluble Drugs:
With the help of the complexing agents, the bioavailability of sparing water-soluble drugs can be increased.
Increase Bioavailability Of Hydrophobic Drugs And Dissolution Rate:
In this case, the dissolution rate and bioavailability of hydrophobic rate can be enhanced due to the physical interactions of drugs with an excipient.
Final Thoughts:
Thus, these are all the important things included in the preformulation studies. Make use of this information, if you want to know about the drug-excipient interactions.
