In vitro performance testing scientifically verify that the product performs effectively, safely and consistently as designed.
In recent years, regulatory authorities, particularly the EMA and FDA, have published guidelines and established regulatory expectations supporting the reduction of clinical studies, where scientifically justified, and the use of in vitro approaches to demonstrate product performance.
In this context, reliable, reproducible, and validated in vitro studies are playing an increasingly important role in:
- Product development
- Quality assessment
- Comparative studies
- Regulatory submissions
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At WMINOLAB Innovation Laboratory, in vitro performance testing of pharmaceutical products is comprehensively conducted using advanced analytical systems, with high precision and in alignment with international regulatory requirements.
INHALATION PRODUCTS
NASAL PRODUCTS
CUTANEOUS PRODUCTS
- SAC Through Container Life
- DSD by Laser Diffraction
- PSD/DSD by Cascade Impactor
- PSD by Microscopy
- Spray Pattern
- Plume Geometry
- Priming and Repriming
In Vitro
Release Testing
In Vitro
Permeation Testing
NASAL & INHALATION PRODUCTS
In vitro performance characterization to assess,
- Dose Delivery
- Spray Characteristics
- Particle/Droplet Behavior
- 2D/3D Visualization of Droplet Size Distribution
- Spray Pattern and Plume Geometry
- Comparative and Equivalence Studies
LOCALLY APPLIED, LOCALLY
ACTING CUTANEOUS PRODUCTS
In vitro performance testing to assess,
- In Vitro Release Testing (IVRT)
- In Vitro Permeation Testing (IVPT)
- Synthetic Membrane Studies
- Human Skin Permeation Studies
- Drug Release and Skin Permeation
- Supporting Product Development
- Comparative and Equivalence Studies
In Vitro Dissolution Rate Analysis
In addition to specialized dosage forms, such as nasal sprays, inhalation products, and locally acting products, and in line with current regulatory requirements, conventional in vitro testing for solid dosage forms is also performed, including dissolution rate and dissolution profile studies.
To support product development, formulation comparison, quality control, and bioequivalence studies, appropriate dissolution conditions and analytical methods are established to ensure reliable, reproducible, and scientifically robust results.
In Vitro Dissolution Rate Process
Sample Preparing
Solid oral dosage form samples are prepared.
Dissolution Test
Analysis is performed using a dissolution device compliant with USP/EP standards.
Sampling
Samples are taken at specific time intervals.
Analysis
The quantity of samples is determined by analytical methods.
Reporting
The results are evaluated and a comprehensive report is prepared.