Confarma

Amorphous dispersions

If the solubility of a drug is insufficient and suitable salts or co-crystals cannot be produced, you may need to formulate a drug in its amorphous state, since the solubility will be higher than that of the crystalline substance. A way to kinetically stabilize the amorphous state is to form so-called amorphous dispersions, where the active ingredient is molecularly dispersed in a glassy polymer matrix. Key to successfully forming such an amorphous dispersion is to identify the optimal polymer for a particular drug substance. Solvias has developed appropriate methods to quickly identify such polymers so test samples can be produced and assessed for their stability.

Intellectual Property and Consulting

Given our vast range of methods (e.g. Raman microscopy) and experience we can generate evidence which helps to protect clients’ intellectual property. Independent and neutral reproduction of published patented examples or analyses of marketed drugs for polymorph composition result in testimonials to be used for litigation. Our experts provide an independent evaluation of studies or individual data, complemented by comprehensive reports.

QUALITY CONTROL

All solid-state techniques are available for quality control under CGMP.