A moisture sensitive drug can be very challenging to formulators because of its tendency to hydrolyze when exposed to humidity and/or elevated temperatures. The development of a tablet containing a moisture sensitive drug is subject to those high temperatures and high humidity during the film coating process. Therefore, it is important that the core formulation be composed of excipients that will help prevent the drug from decomposing.
The selection of excipients within the dosage form can be optimized in order to reduce the hydroscopicity and to reduce the activity of water within the product. Starch 1500® Partially Pregelatinized Maize Starch, due to its low water-activity compared to other commonly used excipients, can aid in the formulation of moisture sensitive drugs providing robust and stable tablets, as well as in substantial savings in total process time and cost.
Moisture sensitive drugs can be protected from the environment by specialized packaging; however this can be very expensive. A more cost effective option is to choose a film coating with a polymer system proven to reduce moisture transmission rates through the film. Opadry® AMB Aqueous Moisture Barrier Film Coating System gives the protection needed for moisture sensitive cores.
