Development and evaluation of pseudoephedrine hydrochloride abuse-deterrent formulations using thermal modified rice starch.

There is a continued global effort to prevent the spread of prescription drug abuse. In particular, chemical structure of pseudoephedrine hydrochloride (PSE), an over-the-counter medication, is very similar to that of methamphetamine (MET). The aim of this study was to develop abuse-deterrent formulations (ADF) of PSE by using thermal modified starch (TMR). PSE is a water-soluble drug, but it is intended to inhibit extraction from the extraction medium in excess tablets. Starch-based formulations were successfully developed using cross-linking agent and lipid. The extraction (%) of PSE from TMR7-L5 formulation (equivalent to 5 tablets) were 75.3% in DW, 2.7% in ethyl alcohol, and 63.0% in 40% ethyl alcohol (v/v) at 60 °C for 30 min. Moreover, TMR7-L5 formulation delayed drug release compared to the commercial product in in vitro release. In conclusion, the development of ADFs using a starch-based formulation shows novelty and has potential to prevent drug abuse.