Pre formulation factors Flashcards
what are pre formulation studies and its benefits
Pre-formulation studies are a series of experiments and tests performed before the formulation of a drug or a product to determine its physicochemical properties, stability, and compatibility with other ingredients. The objective of these studies is to ensure that the product will be safe, effective, and stable throughout its shelf life.
Some of the benefits of pre-formulation studies are:
Optimization of drug delivery: Pre-formulation studies can help in the optimization of drug delivery by selecting the appropriate drug delivery system and formulation.
Identification of stability issues: Pre-formulation studies can help identify potential stability issues such as chemical degradation, oxidation, or hydrolysis of the drug or its active ingredients.
Selection of appropriate excipients: Pre-formulation studies can help in the selection of appropriate excipients that are compatible with the drug and its active ingredients, as well as enhance its efficacy and stability.
Cost-effective: Pre-formulation studies can save time and money in the long run by identifying potential issues before the formulation process begins, reducing the risk of product failure or recalls.
Regulatory compliance: Pre-formulation studies are essential for ensuring regulatory compliance with the relevant authorities, such as the FDA, EMA, or other health agencies, by providing necessary data on the product’s safety, efficacy, and stability.
