Pharmaceutical products have long development times ranging from a few years to 10 years or more depending on the product, indication, and approval time.  Additional time for development activities that are not truly value added to the information needed for approval increases the cost of development and reduces the return on the product.

Creekmore Pharma Consulting can guide your project from preformulation and subsequent steps leading to the product launch of the commercial product.

There are number of things to consider in the formulation of a drug product.  One is the drug substance.  The physical and chemical properties and stability must be considered for the drug substance alone and in combination with the excipients that are used in the finished product.  For example, excipients can increase or decrease the stability of the drug substance, but excipients are almost always necessary to formulate a product that meets the desired product attributes.  The right combination of excipients and the understanding of excipients can be used to optimize the formulation.

Another consideration is the manufacturing process.  The manufacturing process is linked with the formulation as each affects the other.  The manufacturing process must be a scalable process as the dynamics change as the process moves from smaller batch sizes to larger batch sizes.  However, in moving to a larger scale of manufacture, the product attributes must remain the same.

Other items should be considered in the development of the drug product but are not limited to packaging, storage, countries for registration, manufacturing sites, cleaning, and climatic zones.

Near the end of the development cycle, the technology transfer of the formulation and manufacturing process to the manufacturing site(s) will be completed.  The technology transfer and subsequent validation requires proper planning and execution to be successful and efficient.  Additionally, an understanding of the requirements for the various countries for registration is important as there may be more efficient ways to complete the validation.  After validation, the monitoring of the product manufacture continues as continued process verification (CPV) which uses the data from the development and technology.

Documentation is key to successful development, registration, and life-cycle management of the product.  While reports are important in assembling the registration documents, other documents such as batch records, analytical reports, notebooks, and other records are also important.  Having these documents readily available makes the report and registration documents easier to write in less time with higher quality content.

An understanding of the development process from preformulation to life-cycle management at the beginning of the development of a product will decrease costs, reduce development time, and increase compliance which in turn leads to the product reaching patients sooner.

Creekmore Pharma Consulting provides advice on all aspects of the drug product development process that reduces time for the development activities, decreases costs, and reduces risk.