We are highly experienced in the development of pharmaceutical formulations for oral and injectable dosage forms. Our core technologies include lyophilization technology and sustained release technology, focusing on injectable products including peptide drug development.
Our Formulation Development Services include: ● Formulation development ● Analytical method validation ● Dossier preparation ● Trial batch production ● Media milling ● Sterile filling ● Exhibit batch production ● Stability testing
Our professional team works on sterile drug formulation studies, covering both liquid and lyophilized dosage forms. Lyophilization dosage form has the advantages of long-term stability, short reconstitution time, elegant appearance, isotonicity, and maintenance of the original dosage form upon reconstitution. Control of the three major parameters involved in freezing, primary drying, and secondary drying processes is important to define critical attributes to allow stability performance and ensure the efficacy and safety of the drug product.
For sustained release technology, we focus on the development of microspheres and nanosuspensions for injectables. In microsphere technology, suitable biodegradable polymers are screened and selected for encapsulation of the active pharmaceutical ingredient. Manufacturing processes are tested in lab scales and they are scaled up based on experimentally determined quality attributes. Long acting release technology relies on formulation product to maintain its drug concentration within the therapeutic window. The encapsulation efficiency and drug loading are critical process parameters in manufacturing. To ensure the achievement of drug efficacy, in vitro dissolution profiles and Bioequivelent (BE) study results need to demonstrate their comparability. Nanosuspension technology is especially suitable for APIs that have poor water solubility. Selection of the appropriate excipients, stabilizers as well as surfactants is important for nanocrystal formation.
The Design of Experiment (DOE) methodology will be applied during studies. All formulation development tasks are performed following QbD guidelines.