A formulation is the composition of a drug product that includes the active pharmaceutical ingredient (API) and other inactive components. Each inactive ingredient in the formulation is used to serve particular purposes to ensure product production and conformance.
For example, common inactive components in a tablet formulation include diluents, disintegrants, binders, lubricants, colorants, glidants, and other special ingredients that can transform drug release or facilitate absorption.
Among them, diluents, disintegrants, binders, and lubricants are the most common elements in tablet formulations and serve the functions that their names show. A record of these pharmaceutical ingredients can be found in the National Formulary (NF).
This record contains 10–20 elements for each kind of excipients. The challenge for a formulation scientist is to determine the optimal selection in each excipient category and the optimal level of each excipient.
A proper formulation must be manufactured, chemically and physically stable during the manufacturing method and product shelf life, and bioavailable. Also, many quality standards and special provisions must be met to ensure the efficacy and safety of the product. Formulation development companies integrate functions and personnel into their product development cycle in many various ways.
Outsourcing drug development is a growing bias in the pharmaceutical and biotechnology industries. With the increasing demand to take potential drugs competitors from discovery to human clinical trials as quickly as possible, most pharmaceutical and biotech corporations are outsourcing at least a portion of the development of their potential new drugs.
Outsourcing reduces the timeline of product development and provides a cost-effective alternative to adding specialized resources. Changing requirements in the current accelerated development environment dictate that resources must be adapted fast to meet demands. Therefore, outsourcing allows a variable cost structure, improving resources and spending when needed and decreasing when demand subsides.
Formulation development is a crucial area of outcome development that can define patentability, lifecycle and, ultimately, the success of a pharmaceutical product. Companies combine formulation development functions and personnel into their product development cycle in many various ways.
In completely combined large pharmaceutical corporations, specific departments may exist to deal with such areas as the physical characterization of drug materials and formulation problems. In many cases, other departments, often in several buildings or places, may handle preclinical functions, such as animal testing. These activities must work closely to gain a full understanding of their unique drug substance.
For smaller, developing companies, as well as many biotechnology businesses, the function of formulation development often falls in one of many departments. Sometimes it exists within the project group useful for the overall development plan of a particular drug candidate.
These groups are led by project directors who interface with both internal and external resources. The analytical chemistry or the systematic development lab often executes the majority of the formulation tasks, as they are already the ‘experts’ in the analytical assays, most often high production liquid chromatography (HPLC) tests, which are an integral part of product development. Pharmaceutical companies in NC are not the Indian companies but also the MNCs that are developing to be a part of the race.
The state of the art foundation and diverse experience to provide pharmaceutical formulation development solutions for different dosage forms. It offers end to end pharmaceutical formulation development help ranging from early phase development to clinical stocks for new chemical entities, generics and life cycle extension products.
At Syngene, formulations are developed utilizing pre-formulation data to design prototype formulations and methods. The formulation development station also has its own validated security chambers to conduct lab stability tests to support the selection of a suitable formulation and manufacturing process.