| abstract |
The present invention relates to processes for producing a stable amorphous dispersion of a pharmaceutically active substance having low water solubility by applying low frequency acoustic energy to a mixture comprising the active substance and at least one polymer and heating the mixture until a stable amorphous dispersion is formed. The methods of the invention are an effective means of converting a crystalline active pharmaceutical ingredient into a substantially amorphous and stable form, i.e., the crystallinity being less than about 5%. The methods of the invention result in more complete amorphization, increased solubility, loading, and drug stability over typical amorphization and prior art processes. |