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Pharmaceutical Research

Laboratory-scale Preparation Testing

Equipped with Tofflon's freeze dryers, Thermo Fisher Scientific's hot melt extruder and Yamato's spray dryers, we are capable of laboratory-scale test for oral administration, injection, external use and various preparations.
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  • Laboratory-scale test of oral solid preparations
    Based on the concept of Quality by Design (QbD), the laboratory-scale test aims to conduct design of experiment (DOE) and research targeting at medium/high risks, after the early determination of quality target product profile (QTPP) and critical quality attributes (CQA) and preliminary risk assessment based on CQA. With understanding and control strategy based on the critical material attributes (CMA) and critical process parameters (CPP), the formulation process can be determined and the risks can be lowered.
    If the samples for laboratory-scale tests are approved for batch tests, facilities for pilot-scale tests, such as rotary tablet presses and hopper mixers, are recommended to avoid scale-up failure caused by facilities featuring different principles (such as the difference of dwell time between the single punch tablet press and the rotary tablet press).
    We verify our understanding of formulation process by preparing samples for laboratory-scale tests to determine whether the CQA of products of such formulation process can be guaranteed. During laboratory-scale tests, we not only focus on the quality of finished products, but also establish draft quality standards for intermediates. We also pay attention to the mixing uniformity, particle fluidity, and the possibility of delamination during tableting or filling. In the meantime, for 1~3 months, we will conduct influencing factor & acceleration tests based on samples for laboratory-scale tests to explore the stability of such samples, so as to provide reference for the improvement of formulation process, the development of quality standard draft and the stability of subsequent pilot-scale test samples.
Relevant laboratories
  • formulation lab
  • GC-MS
  • process
  • LC-MS
  • Stainless Steel Reactor
  • Liquid analysis laboratory
  • production workshop
  • HPLC
  • formulation workshop
  • Hot melt extruder
Relevant articles