COMPATIBILITY STUDY

API INTERACTION, EXCIPIENT, FINISHED PRODUCT and PACKAGING MATERIAL

The compatibility study in a pharmaceutical formulation aims to analyze the stability of the active pharmaceutical ingredient (API) drug against the other components of the formulation, based on the observation of possible interactions between the components in different test environments.

NanoBusiness offers the following options:

Following the convenient methods.

ACTIVE PHARMACEUTICAL INGREDIENT x EXCIPIENTS

Analyzing the compatibility between an excipient and the API is essential to develop a drug formulation. Although pharmacologically inert, excipients can physically and chemically interact with it, causing a variation in their aimed function.

Chemical reactions such as decomposition, oxidation, permeation and displacement may occur, changing the drug structure and physiological properties. Therefore, analysis of binary mixtures is mandatory by the Brazilian Health Surveillance Agency (ANVISA).[top]

FINISHED PRODUCT x PACKAGING

Physical and chemical changes in the packaging material can cause an improper interaction between its components and API, promoting product instability. Therefore, to maintain its stability, it is essential to choose a packaging container compatible with the active substance and/or excipients, and that is suitable for the pharmaceutical form.

Moreover, the packaging material must protect the pharmaceutical product from environmental factors, as high humidity, for example, is also a major risk factor and can compromise the drug quality.[top]

COMPLETE OR PRELIMINARY STUDY

The complete compatibility study includes the analysis of all the interactions existing in the final product, with Active Pharmaceutical Ingredients, excipients, coating (if applicable) and packaging material, promoting tests with samples both in stability time (tn) (tn) and initial time only (t0).

For the preliminary study, only samples with a t0 t0 stability time.[top]

TECHNIQUES USED

To prove the drug efficacy and stability, tests must be carried out in conditions of temperature and humidity that accurately simulate those to which the finished product will be exposed throughout its shelf life.[top]

Techniques usually used:

  • Differential Scanning Calorimetry (DSC);
  • Thermogravimetric Analysis (TGA);
  • X-Ray Diffraction by Polycrystalline Materials (XRDp).

Depending on the need for each substance, the protocol may undergo changes leading to the study's optimization.

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