Xihua can provide the following product development services:
1. Pre-formulation Studies
——Literature Research——
Drug substance information in Pharmacopoeia in different countries
Drug substance stability, analytical method, impurities and so on in literature
Information of reference listed drug (RLD) and reference standard (RS)
Information such as formulation, manufacturing process, or stability of the marketed product in different markets
Analysis and comparison of formulations, processes, stability and so on of marketed drug products in various countries
——Evaluation of Drug Substance——
Analytical method development, optimization and confirmation, such as assay, relevant substance.
Drug substance supplier recommendation through evaluation and comparison of drug substance from different suppliers.
Evaluation of the drug substance solubility (solubility curves in various organic solvents and acid-base solvents, and solubility in simulated gastric and intestinal fluids)
Evaluation of the stability (including the stability under high temperature, high humidity, light, etc.; stability under acidification, alkalization, oxidation and in solutions with various pH)
Evaluation and analysis on gene impurities of drug substance
Evaluation and analysis on element impurities of drug substance
Analysis of crystal form of drug substance
——Reverse Engineering on Reference Listed Drug (RLD)——
Analysis on crystal form of drug substance in RLD
Analysis on types and grade of excipients in RLD
Analysis on amount of excipients in RLD
Analysis on assay and impurities of drug substance in RLD
RLD dissolution profiles in multi-medium solutions.
RLD stability studies
——Compatibility Study——
2. Formulation and Process Development and Optimization of Drug Product
Define the critical quality attributes of finished product
Develop the evaluation method of critical quality attributes (including solid dosage multi-medium dissolution profiles and discriminating dissolution method)
Selection of drug product manufacturing process
Selection of excipients grade
Development of formulation and process (including the development on lyophilized curves of lyophilized product)
Optimization of formulation and process (including optimization on lyophilized curves of lyophilized product)
Comprehensive quality comparison with RLD
Selection of packaging material (including the compatibility study of packaging material and pipe material)
Stability study of test product (including Stress testing) and comparison with RLD
Establish finished product quality specification
3. Process Scale-ups, Technique Transfer and manufacturing the Submission Batches
Validation and transfer of analytical method
Preparation and review of scale-up/submission batch protocols
Preparation and review of scale-up/submission batch manufacturing records
On site support during the scale-up/submission batch manufacturing
Preparation and review of scale-up/submission batch report
4 Stability Study
Stress testing of test product and RLD
Accelerated/long-term stability study of Test product and RLD
Compatibility study of packaging material (such as extractables, leachables )