Design of Abuse-Deterrent Formulations Using Various Types of Thermal Deformed Starch (TDS)

Purpose In recent years, the problem of drug abuse has emerged and is becoming more serious. Drug abuse can be secretly and illegally perpetuated by drug dealers and the general public. Therefore, a method to address this is required. The purpose of the study is to design the abuse deterrent formulations (ADFs) using various types of thermally deformed starch (TDS) for pseudoephedrine hydrochloride (PSE), a psychotropic drug. Methods ADFs were developed using a thermal denaturation method for four types of starch with crosslinker and lipid. The extraction of PSE was evaluated in ethyl alcohol (100% and 40% [v/v]), and performed the dissolution and in vitro release tests. Results A comparative experiment using four types of starch showed that PSE extraction was successfully suppressed. The extraction (%) of PSE from TDS-L2-ADFs (5 tablets (T) dose) showed the higher inhibition of extraction ( 71.1 +/- 5.9%/2. 8 +/- 0.7%/54.0 +/- 2.3%) than compared to those of -SUDAFED((R)) (99.5 +/- 0.6%/99.1 +/- 1.3%/99.0 +/- 1.4%) in DW, ethyl alcohol (100% and 40% [v/v]), respectively, in stress condition (at 60 degrees C). Extraction (%) of PSE was significantly suppressed in ethyl alcohol (100% and 40% [v/v]). The in vitro PSE release profile of the TDS- L2 formulation (1 T and 5 T dose) showed sustain delayed release patterns compared to the -SUDAFED((R)) in the pH-shifting method. Conclusion Four types of starch-based formulations have been developed, and among them, thermal deformed natural starch formulations (TDS-L2-ADFs) have the highest drug abuse prevention ability and are expected to serve as the basis for future ADF development.