| abstract |
STABILIZED COMPOSITIONS CONTAINING LABEL ALKALINE DRUGS. The present invention relates to stabilized bioadhesive compositions, which contain a labile alkaline drug, and a method for its preparation. In one feature, the composition is extruded by hot melt (HME), comprising a pre-formed mixture of excipients, including an acid component and a thermoplastic alkaline matrix forming material, for example, polymer. The mixture of excipients is formed before being combined with the labile alkaline drug. The resulting mixture is then extruded by hot melting to form the HME composition. In doing so, the acidic component is capable of neutralizing or making the mixture of excipients moderately acidic. This particular process has been shown to substantially reduce the degradation of labile alkaline drugs during the hot melt extrusion process. The mixture of excipients softens or melts during this process. It may or may not dissolve particles containing drugs. Various functional excipients can be included in the transport system to improve process performance and / or improve the chemical or physical properties of the HME composition. |