Technology

Dissolution testing technology

We develop evaluation methods for the drug release functions of formulations, such as rapid release tablets, combination tablets, orally disintegrating tablets, and sustained release formulations using various dissolution test apparatus, various artificial gastric juices and intestinal fluids, to support the prediction of drug absorption in the body.

Apparatus / Method

  • USP apparatus 1, 2 (peak vessel, stationary basket etc.)
  • USP Apparatus 3 (reciprocating cylinder)
  • USP Apparatus 4 (flow-through cell)
  • Disintegration tester (JP / USP / EP, for OD tablets)
  • Biorelevant media (FaSSIF, FeSSIF, FaSSGF, FeSSGF etc …)
  • Combination of two dissolution media (eg. acid stage to buffer stage)

Application

  • Test method development / validation, release test
  • Evaluation of special formulations (MR, OD, ER etc …)
  • Support for formulation design (IVIVC/R, BE)
Flow cell dissolution test apparatus

Flow-through cell dissolution test apparatus

Inquiries About Service

SPERA provides CMC solutions from early-stage through new drug application.

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