Challenges and opportunities in pharma formulation company in India
To solve tough technical challenges in formulation development process, scientists in pharma formulation company in Indiaare employing effective and advanced technologies. In numerous pharma formulation processes, design of experiments (DOE) and numerical analysis are used, which are helpful in optimization process and validation process. The key benefit of using DOE to create formulations for pharma products is that it enables all major factors to be evaluated concurrently, systematically, and promptly.
The optimal formulation can be defined by using proper design of experiment to develop the stages of all important factors. When the manufacturing and formulation process of a pharma product are optimized in a systematic manner by using design of experiment, process validation can be quite effective because of the strength of the manufacturing and formulation process.
A formulation is the combination of a drug product that holds the active pharma ingredient (API) and other inactive components. In the formulation process, each inactive ingredient is used to fulfill specific purposes to guarantee product performance and compliance. The first level of formulation development process normally includes excipient compatibility research to choose possible excipients that are physically and chemically suitable with the active pharmaceutical ingredients. Advanced technologies have enabled the formulators to have a better understanding of excipients and their relations with the active ingredient and among themselves. Common inactive components in a tablet formulation contain binders, diluents, disintegrants, colorants, glidants, lubricants, and other specific ingredients that can change drug release or ease absorption.
In tablet formulations, out of these all, binders, diluents, lubricants and disintegrants are the most common ingredients and perform the functions as their names signifies. Formulation scientists find it difficult to determine the best choice in each excipient section and the best level of each excipient. A good formulation must contain the exact amount of active pharmaceutical ingredient in each dose that can be easily absorbed by the human body. Additionally, quality standards and specific requirements should be met to guarantee the efficiency and safety of the drug product.