Evaluation of commercially available meth-deterrent pseudoephedrine hydrochloride products

Ziyaur Rahman; Mohammad S Aqueel; Maxwell Korang-Yeboah; Ahmed S Zidan; Jia Chen; Alaadin Y Alayoubi; Celia N Cruz; Muhammad Ashraf

doi:10.1016/j.ijpharm.2019.118909

Evaluation of commercially available meth-deterrent pseudoephedrine hydrochloride products

Int J Pharm. 2020 Feb 15:575:118909. doi: 10.1016/j.ijpharm.2019.118909. Epub 2019 Dec 4.

Authors

Ziyaur Rahman¹, Mohammad S Aqueel², Maxwell Korang-Yeboah², Ahmed S Zidan², Jia Chen², Alaadin Y Alayoubi², Celia N Cruz², Muhammad Ashraf³

Affiliations

¹ Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, United States; Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD 20993-002, United States.
² Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD 20993-002, United States.
³ Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD 20993-002, United States. Electronic address: celia.cruz@fda.hhs.gov.

PMID: 31811923
DOI: 10.1016/j.ijpharm.2019.118909

Abstract

Pseudoephedrine (PSE) extracted from its dosage forms can be used as the starting material to prepare methamphetamine by drug abusers. Recently, some pseudoephedrine drug products marketed under the over the counter (OTC) monograph have been promoted as 'meth-deterrent'. The goal of this investigation was to evaluate the extraction and dissolution of these product against controls of non-meth-deterrent products of pseudoephedrine. Immediate release (IR) PSE OTC Product-C, Product-D and Product-E with meth-deterrent claim on their packaging were selected for this study. Accordingly, OTC IR PSE tablet Product-A and OTC extended release (ER) PSE tablet Product-B, with no meth-deterrent claims, were used as controls. The extraction studies were performed on intact tablets or capsules and on manipulated products employing water, ethanol and 0.l N HCl as solvents. The extraction studies were also performed in water at elevated temperatures by heating the water in an oven and in a microwave. The dissolution studies were performed in water and 0.1 N HCl. The amount of PSE extracted from Product-C was found similar to the amount extracted from the non-meth-deterrent control Product-A. The amount of PSE extracted from Product-D and Product-E was found lower than the amount extracted from control Product-A under the conditions studied. Product-A, Product-B, and Product-C met their respective dissolution acceptance criteria. The IR Products D and E released less than 50% drug in 12 h and did not meet either IR or ER PSE tablet USP dissolution acceptance criteria. In summary, the extraction of Product-C was found to be high (approximately 85% in 30 min) and was similar in extraction to the control Product-A. The extraction of Product-D and Product-E was found less than the extraction of control Product-A. Also, Product-D and Product-E did not exhibit complete drug release. This study showed that PSE can be extracted from Product D and Product E.

Keywords: Dissolution; Extraction; Meth-deterrent; Pseudoephedrine; Viscosity.

Published by Elsevier B.V.

MeSH terms

Capsules
Cellulose / analogs & derivatives
Cellulose / chemistry
Delayed-Action Preparations / chemistry
Drug Liberation
Galactans / chemistry
Mannans / chemistry
Methamphetamine*
Nonprescription Drugs / chemistry*
Particle Size
Plant Gums / chemistry
Plant Oils / chemistry
Polyethylene Glycols / chemistry
Polysaccharides, Bacterial / chemistry
Pseudoephedrine / chemistry*
Substance-Related Disorders / prevention & control*
Tablets
Viscosity

Substances

Capsules
Delayed-Action Preparations
Galactans
Mannans
Nonprescription Drugs
Plant Gums
Plant Oils
Polysaccharides, Bacterial
Tablets
Polyethylene Glycols
Methamphetamine
Pseudoephedrine
Cellulose
hydroxypropylcellulose
guar gum
xanthan gum