Abstract

Rheometry deals with the measurement of deformation and flow behavior of materials. This document establishes a method for characterizing the rheological properties of semi-solid preparations. Oscillatory rheometry is used for this purpose. Oscillatory measurements can also be used, e.g. by means of amplitude tests, to describe the viscoelastic behavior of the respective test sample and to differentiate between the elastic and viscous material properties. Rotational measurements can be used to determine the shear viscosity. This document applies to semi-solid preparations, which include ointments, creams, gels as well as pastes. Regulatory aspects are of secondary importance in the product categorization, i.e. both medicinal products and medical devices as well as cosmetics are considered. Semi-solid preparations within the meaning of this standard are stable when at rest. Stability is understood to mean the presence of a yield point. While these preparations exhibit the properties of a viscoelastic solid at rest, they behave like a liquid above the yield point. This document cannot be applied to preparations that are liquid at rest and do not exhibit stability.

Begin

2023-03-09

Planned document number

DIN 53010-1

Project number

06236368

Responsible national committee

NA 062-08-31 AA - Viscometry and Rheometry  

draft standard

Rheometry and Viscometry - Pharmaceutical, cosmetic and medical products/devices - Testing the rheological properties - Part 1: Determination of the viscoelastic behavior of semisolid preparations using an oscillatory rheometer by amplitude sweep
2024-01
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