BOC Sciences's formulation design team is led by senior scientists with years of experience in the pharmaceutical industry. We provide solutions for the development and design of a variety of molecules. We can tackle challenges from solubility issues, excipient incompatibility, vehicle stability, to controlled release and much more.
An appropriate route of administration and drug dosage form are of great importance to obtain desirable pharmacokinetics and bioavailability. The formulation development is a process that mainly depends on the needs of clinical medication and physicochemical properties, especially solubility and stability of the active pharmaceutical ingredients. Selection of suitable excipients, preparation technics, and prescriptions play a critical role in the development and optimization of the dosage form for a drug candidate.
Our formulation design (include but not limited to the following):
A comprehensive study of the physicochemical properties of drug substances and excipients, including solubility, stability, particle size, crystal form, pKa, log P/D, etc., is an essential process in the drug development. Data and parameters will be obtained first before formation design.
According to the characteristics of the determined dosage form, we select the excipients or additives that are suitable for the dosage form and examine the indicators of the formulation through various determination methods. The selection of the right and functional excipients is a prerequisite for the success of a new drug product.
Based on the chemical and physical stability of the drug and patient compliance considerations, combined with the preclinical research work, we will typically develop multiple formulation types in parallel to aid selection of the most appropriate form.
Optimization techniques can provide in-depth understanding of prescription and industrial factors and determine their optimal scope. In general, we first select appropriate excipients and preparation processes through appropriate pre-test methods, and then use optimization techniques to optimize the formulation and process design. To design a prescription, the various characteristics of the preparation are required to meet the specified control limits, so that the physical and chemical stability, bioavailability, and cost of the preparation can all meet the best design requirements.
Our Enabling Technology
BOC Sciences has extensive experience to guide your drug candidate to the next stage. We use the Design Quality (QBD) approach of Modeling and Design of Experiments (DoE) to achieve high standard products. We strictly abide by the client's confidentiality agreement for project development. In addition, we can keep development on a small scale to preserve the valuable APIs if necessary.