Development of Abuse-Deterrent Formulations Using Sucrose Acetate Isobutyrate

AAPS PharmSciTech
Sogra F Barakh AliZiyaur Rahman

Abstract

The objective of the present investigation was to understand the effect of sucrose acetate isobutyrate (SAIB) on abuse-deterrent properties (ADPs) of abuse-deterrent formulations (ADFs) based on Polyox™. SAIB would enhance ADPs of Polyox™-based formulations due to its glassy liquid and hydrophobic properties. Formulations were prepared by granulation followed by compression and heat curing at 90°C. The formulations were evaluated for surface morphology, hardness, manipulation in coffee grinder, particle size distribution, drug (pseudoephedrine hydrochloride) extraction in water, alcohol, 0.1 N HCl, 0.1 N NaOH at room temperature and elevated temperature using microwave and oven, syringeability and injectability, and dissolution. The heat curing of formulations significantly increased the hardness (> 490 N). Addition of SAIB imparted elasticity to formulations and decreased brittleness as indicated by lower values of work done and gradient compared to control formulations. After grinding, about 7.7-25.6% of the powder remained on the sieve (1 mm pore opening), D90 was 53.1-136.7 μm more, and Q (fraction < 500 μm) was 17.8-40.7% less in SAIB-based formulations compared to control formulations. Drug extraction between control and ...Continue Reading

References

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Methods Mentioned

BETA
scanning electron microscopy
X-Ray

Software Mentioned

. EVA Suite
lab
Diffrac
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