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Effect of polymer types on the abuse deterrent narcotic formulation

초록/요약

Pharmaceutical strategies to design abuse-deterrent formulations (ADFs) should be considered by preventing the modification of physical and chemical properties of opioid dosage forms. Among these, four major properties such as particle size by physical modification, swellability, dissolution test and solvent extraction were mainly characterized for evaluating abuse deterrence. In this study, the frequently used eight polymers in the formulation of abuse-deterrent dosage forms such as polyvinyl alcohol (PVA), HPMC 90SH 4,000, HPMC 90SH 100,000, xanthan gum (XG), cellulose acetate (CA), polyethylene oxide (PEO), carbomer 940 and Compritol 888 ATO were chosen to evaluate their potential to prevent abuse of narcotic-loaded tablet. Tramadol (TM) was chosen as a model drug. A new abuse deterrent index (ADI) of TM-loaded compressed tablet was then defined on the assumption that it was proportional to particle size and swellability and inversely proportional to dissolution and solvent extraction rates. The chosen polymers could vary these physicochemical properties, giving ADI in a decreasing order: HPMC 90SH 4,000, Carbomer 940, Compritol, XG, PVA, HPMC 90SH 100,000, PEO and cellulose acetate. This study could provide a way to utilize different polymers for the prevention of drug abuse.

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목차

1. Introduction 1
2. Materials and Methods 5
2.1. Materials 5
2.2. Preparation of abuse-deterrent narcotic tablet 5
2.3. Physical manipulation study 7
2.4. Swellability study 7
2.5. Solvent extraction study 8
2.6. In vitro dissolution study in pH 1.2 8
2.7. HPLC analysis of Tramadol hydrochloride (TM) 8
2.8. Abuse-deterrent index (ADI) for abuse-deterrent polymers 9
3. Results and discussions 11
3.1. Physical manipulation study 11
3.2. Swellablility study 14
3.3. Solvent extraction study 17
3.4. In vitro dissolution study 21
3.5. Comparison of ADI among polymer types 24
4. Conclusions 26
5. References 27
국문초록 30

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