Drug Excipient Compatibility Study
The product development success depends on compatibility of API and Excipient and clear understanding on their physiochemical characteristics. A rationale method needs to make to identify the Excipient selection to avoid late stage formulation issues.
Incompatibilities are generally referred to as changes in the physical, chemical and/or therapeutic properties of a dosage form resulting from the interaction of the API with excipients, Excipient to Excipient and with other components of the API components or excipient components or any other metals interactions with API & Excipients. This will cause changes in molecular structure of API which in turn can lead to API degradation. These chemical incompatibilities are very sensitive for formulations and key influencing factors are Physicochemical properties, relative ratios & proximity of these components in the formulations, and processing & environmental factors.
Solvent Selection (Solubility Determination)
Solubility is an important property in the design of many unit operations within the development of synthetic pharmaceutical processes. Solubility contacts drug development at several critical points with different needs. “Solubility modeling” however is not a well-defined term and consequently is fragmented
- Which solvent (organic, bio-relevant, polymer),
- Which solute (API, intermediate, impurity)
- Why (crystallization process, polymorph screening, absorption, enabling formulations, impurity rejection)?
Solubility Modeling by PharmaDEMis aimed apply the right model, in the right place, and at the right time to result in outcome at highest accuracy
Raw Material Homogeneity a Critical Factor
The critical factor in any powder based manufacturing system is, raw material blend homogeneity. The blend between potent active pharmaceutical ingredients (API) and excipient types & properties yet play key role in efficient blending process and final product quality.
Therefore advanced blend techniques with required properties of raw materials used for blending and processing time on content uniformity needs investigation and insights needs to be derived as a preproduction check, to prevent the unnecessary manufacturing overheads.
Final Powder Flowability
Final product of Powder Flowability is directly related to particle size and shape, while surface topography also affects the superior uniformity of the content and thus reveals that the relationship between surface roughness and Excipient ability for a fine blending and powder discharge.
