TY - JOUR
T1 - Anti-counterfeiting DNA molecular tagging of pharmaceutical excipients
T2 - An evaluation of lactose containing tablets
AU - Altamimi, Mohamad Jamal
AU - Greenwood, Joanna C.
AU - Wolff, Kim
AU - Hogan, Michael E.
AU - Lakhani, Ahuti
AU - Martin, Gary P.
AU - Royall, Paul G.
PY - 2019/11/25
Y1 - 2019/11/25
N2 - The licensed pharmaceutical industry and regulators use many approaches to control counterfeiting, but it remains a very difficult task to differentiate between counterfeit and real products. Moreover, there is a lack of techniques available for providing a batch specific molecular bar code for tablets that has the required traceability, specificity and sensitivity to be fit for purpose. The aim of this study was to evaluate DNA molecular tags as a potential anti-counterfeiting technology in tablets. Lactose tablets (400 mg) were used as a model to investigate incorporation DNA molecular tag into a solid dosage form: DNA authentication was carried out on an Applied DNA SigNify® qPCR instrument. Tablet batches were subjected to accelerated stability conditions (40 °C and 75% RH) for up to 6 months. All batches passed the monograph specifications of the British Pharmacopoeia (hardness, friability and mass uniformity) throughout the storage period. In all of recovery plots, the number of cycles required for DNA detection (Cq values) increased as a function of storage time, which indicated a reduction in tag levels, but it should be noted for all storage experiments the tag was clearly detected. It would appear that DNA molecular tags could feasibly be applied within the pharmaceutical development cycle when a new solid dosage form is brought to the market so as to mitigate the risk and dangers of counterfeiting.
AB - The licensed pharmaceutical industry and regulators use many approaches to control counterfeiting, but it remains a very difficult task to differentiate between counterfeit and real products. Moreover, there is a lack of techniques available for providing a batch specific molecular bar code for tablets that has the required traceability, specificity and sensitivity to be fit for purpose. The aim of this study was to evaluate DNA molecular tags as a potential anti-counterfeiting technology in tablets. Lactose tablets (400 mg) were used as a model to investigate incorporation DNA molecular tag into a solid dosage form: DNA authentication was carried out on an Applied DNA SigNify® qPCR instrument. Tablet batches were subjected to accelerated stability conditions (40 °C and 75% RH) for up to 6 months. All batches passed the monograph specifications of the British Pharmacopoeia (hardness, friability and mass uniformity) throughout the storage period. In all of recovery plots, the number of cycles required for DNA detection (Cq values) increased as a function of storage time, which indicated a reduction in tag levels, but it should be noted for all storage experiments the tag was clearly detected. It would appear that DNA molecular tags could feasibly be applied within the pharmaceutical development cycle when a new solid dosage form is brought to the market so as to mitigate the risk and dangers of counterfeiting.
KW - Anti-counterfeiting
KW - DNA amplification
KW - DNA molecular tag
KW - Lactose
KW - Medicine authentication
KW - Solid dosage form
KW - Tableting
UR - http://www.scopus.com/inward/record.url?scp=85072559040&partnerID=8YFLogxK
U2 - 10.1016/j.ijpharm.2019.118656
DO - 10.1016/j.ijpharm.2019.118656
M3 - Article
C2 - 31499233
AN - SCOPUS:85072559040
SN - 0378-5173
VL - 571
JO - INTERNATIONAL JOURNAL OF PHARMACEUTICS
JF - INTERNATIONAL JOURNAL OF PHARMACEUTICS
M1 - 118656
ER -