For product formulation development, it is necessary to ensure that it will remain chemically and physically stable and bioavailable throughout the manufacturing process and product shelf life. In addition, many quality standards and special requirements must be met to ensure the efficacy and safety of the product. When formulating microspheres and microneedles, some assumptions need to be made about the formulation prior to the drug loading stage, and strategies must be developed to facilitate efficient formulation development. When developing formulation strategies for drug delivery into microspheres and microneedles, the physical, chemical, and pharmacokinetic characteristics of the drug must be considered to determine the optimal technology for achieving formulation goals.
The formulation development of microspheres and microneedles usually includes the route of administration, dosage form, maximum and minimum doses, and the appearance of drug carriers. Formulation scientists at CD Formulation develop formulation strategies and keep formulation efforts focused and efficient.
Advances in product preparation technology allow formulators to better understand the interactions between carriers and drugs. For any given carrier form, there are unique technical challenges to its manufacturing process, and these technologies must be evaluated in feasibility studies. After selecting the manufacturing process using the results of the feasibility study, the next step is to select the formulation and how it will be prepared. To accomplish this task, two studies are usually performed: a formulation pilot study and a formulation optimization study. During preliminary and optimization studies, many material factors and responses must be evaluated. When dealing with multiple factors with potential interactions, an understanding of the carrier system and the most efficient and effective way to optimize carrier delivery of drugs is achieved by selecting the best combination of drugs.
After the formulation is optimized, more research must be done to optimize the manufacturing process. Each processing step involves multiple process parameters, and for a given formulation, all processing steps must be thoroughly evaluated in order to determine a robust manufacturing process. This process usually begins after selecting a recipe, which usually requires larger quantities of raw materials.
It is advantageous to plan the design of experiments process for each step of formulation development. The team should examine a number of factors including, but not limited to, formulation development goals, availability of previous theoretical and experimental results, relevant variables and responses, available resources, and costs. However, it should be noted that the process of experimental design throughout all stages of formulation development cannot be achieved overnight. Each process has its own unique challenges, and many different experimental designs and analytical techniques can be applied to address these challenges. As the process progresses, CD Formulation provides guidance on the design of experiments planned for the early stages of formulation development to alter plans developed at later stages.
The formulation development provided by CD Formulation for customers includes microspheres and microneedles. The content involved in the process covers various aspects, and can comprehensively consider the impact of various factors on the final product for customers, and provide corresponding solutions.
If your product needs to be optimized, you can choose our formulation development service, which not only customizes the exclusive formulation for you, but also provides optimization services for your formulation, which greatly saves your time.