Characterization of solid-state degradation behaviour of Acebrophylline under accelerated thermal and non-thermal conditions

Abstract

Proper formulation is an important aspect of any dosage form design. A drug-excipient compatibility screening model was developed by which potential stability problems due to interactions of drug substances with excipients in solid dosage forms can be predicted. The techniques of thermal and isothermal stress testing (IST) were used to assess the compatibility of Acebrophylline with selected excipients. Initially, differential scanning calorimeter (DSC) was used to evaluate the compatibility. IR spectrum of drug–excipient mixture was also compared with that of pure drug and excipient. Compatibility of excipients defined in the prototype formula was tested using IST.Based on the DSC and FT-IR results, lactose monohydrate, Mannitol, croscarmellose sodium, talc, sod benzoate, silicon dioxide, calcium hydrogen phosphate, eudragit, polyvinylpyrollidone, sodium alginate and starch when added alone or in combination were found to be compatible with Acebrophylline.