Identifying Counterfeit Medicines Using near Infrared Spectroscopy

Abstract

all rights reserved the World Health organisation (WHo) defines a counterfeit medicine as "a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source. counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging". 1 By this definition, a medicine that is knowingly substandard and deliberately and fraudulently mislabelled by the manufacturer to mislead a patient as to its content would be a counterfeit product. However, a product that is substandard because of a failure of Good Manufacturing practice would not be counterfeit. the world trade in these counterfeit medicines is very big business with a real threat both to public health and to the finances of the pharmaceutical industry. also, organised crime

Near Infrared Spectroscopy in Drug Discovery and Development Processes

“…NIRS is besides a suitable method for the fast detection of counterfeit medicines [60][61][62][63][64][65][66]. In Figure 9.11 a discriminant analysis model is presented that was computed on NIR spectra of authentic and suspect capsules.…”

On-spot quantification of modafinil in generic medicines purchased from the Internet using handheld Fourier transform-infrared, near-infrared and Raman spectroscopy

“…The literature reported conventional methods for quantification of the API in modafinil, which range from simple spectrophotometric to chromatographic methods. A spectrophotometric method was reported for the quantification of modafinil in solid dosage forms and underlined measurement of the absorbance of modafinil at its maximum wavelength (236 nm) (Moffat et al 2009). Chromatographic methods utilised mainly reverse phase high performance liquid chromatography (RP-HPLC) (Moffat et al 2009;Venkatesh et al 2011;Nageswara Rao et al 2007;Cass et al 2001), and thin layer chromatography (TLC) (Xu et al 2002).…”

“…A spectrophotometric method was reported for the quantification of modafinil in solid dosage forms and underlined measurement of the absorbance of modafinil at its maximum wavelength (236 nm) (Moffat et al 2009). Chromatographic methods utilised mainly reverse phase high performance liquid chromatography (RP-HPLC) (Moffat et al 2009;Venkatesh et al 2011;Nageswara Rao et al 2007;Cass et al 2001), and thin layer chromatography (TLC) (Xu et al 2002). The aforementioned techniques offered sensitivity, selectivity and precision yet they were time-consuming, destructive and required extensive sample preparation.…”

Влияние Оболочки На Результаты Анализа При Идентификации Твердых Дозированных Лекарственных Форм Методом Спектроскопии В Ближней Ик-Области

“…Ïðåäñòàâëÿÿ ðåàëüíóþ óãðîçó îáùåñòâåííîìó çäîðîâüþ, ôàëüñèôèêàöèÿ ëåêàðñòâåííûõ ñðåäñòâ (ËÑ) ïî-ïðåaeíåìó îñòàåòñÿ ïðîáëåìîé ìèðîâîãî ìàñøòàáà [1].  ÐÔ îäíèì èç íàïðàâëåíèé ñîâåðøåíñòâîâàíèÿ ñèñòåìû ãîñóäàðñòâåííîãî êîíòðîëÿ êà÷åñòâà ëåêàðñòâåííûõ ñðåäñòâ ÿâëÿåòñÿ ðàçâèòèå è âíåäðåíèå íåðàçðóøàþùèõ ìåòîäîâ èññëåäîâàíèÿ, â ÷àñòíîñòè ñïåêòðîìåòðèè â áëèaeíåì èíôðàêðàñíîì äèàïàçîíå (ÁÈÊ).…”

“…È åñëè ìíîãèå ìåòîäè÷åñêèå âîïðîñû, êàñàþùèåñÿ ïðîâåäåíèÿ ÁÈÊ-ñïåêòðàëüíîãî àíàëèçà òàáëåòèðîâàííûõ ôîðì, óaeå íå ðàç îáñóaeäàëèñü â íàó÷íîé ïåðèîäèêå è èìåþò îáùèå ïîäõîäû [3,4], òî â îòíîøåíèè àíàëèçà òâåðäûõ aeåëàòèíîâûõ êàïñóë îäíîçíà÷íîãî ìíåíèÿ î íåîáõîäèìîñòè ïðîâåäåíèÿ äîïîëíèòåëüíîé ïðîáîïîäãîòîâêè ñðåäè àíàëèòèêîâ íåò. Âñòðå-÷àþùèåñÿ â ëèòåðàòóðå ïðàêòè÷åñêèå ðåêîìåíäàöèè ïî çàïèñè ÁÈÊ-ñïåêòðîâ òâåðäûõ êàïñóë äèàìåòðàëüíî ïðîòèâîïîëîaeíû: îäíè àâòîðû ãîâîðÿò îá îòñóòñòâèè âëèÿíèÿ îáîëî÷êè è âîçìîaeíîñòè ðàáîòû áåç íàðóøåíèÿ öåëîñòíîñòè êàïñóë [5], äðóãèå, íàîáîðîò, ïðåäïîëàãàþò ðàáîòó èñêëþ÷èòåëüíî ñ ñîäåðaeèìûì ïîñëå óäàëåíèÿ îáîëî÷êè [1,6].…”