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Formulation R&D

Xihua can provide the following product development services:


Formulation R&D


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 )