caa a22 4500 477127681 CHVBK 20180405111654.0 cr unu---uuuuu 170330e19970801xx s 000 0 eng 10.1023/A:1012105412735 doi (NATIONALLICENCE)springer-10.1023/A:1012105412735 Determination of Extent of Formaldehyde-Induced Crosslinking in Hard Gelatin Capsules by Near-Infrared Spectrophotometry [Elektronische Daten] [Thomas Gold, Robert Buice Jr, Robert Lodder, George Digenis] Purpose. To predict the degree of crosslinking from formaldehyde-stressed hard gelatin capsules (HGCs) using near-infrared spectrophotometry (NIR). Methods. HGCs were exposed to a 150 ppb atmosphere of formaldehyde for 2.25,4.60,9.42, 16.0 and 24.0 hours. The capsules were filled with fresh amoxicillin, placed in a 90° conical reflector cone, and scanned in a NIR spectrophotometer. Principal component regression (PCR) was employed to analyze the spectra of the intact capsules. Dissolution profiles were then obtained for each experimental group. Results. The dissolution of amoxicillin from the capsules at pH 1.2 was found to decrease with increasing time of exposure to the formaldehyde atmosphere. A set of principal components (PCs) was formed by a linear combination of the absorbance values at each wavelength scanned. A good correlation was established (r2 = 0.963) when PC values from the NIR spectra of the HGCs were regressed against percentage of amoxicillin dissolved at 45 minutes, at pH 1.2. Water content of the capsules was found to be the largest determinant in the variation between HGC spectra at each exposure time. Conclusions. NIR spectrophotometry, combined with PCR, was successful at not only predicting dissolution of HGCs exposed to formaldehyde, but also at determining which wavelengths contributed most to spectral variation of these stressed HGCs. Plenum Publishing Corporation, 1997 gelatin nationallicence crosslinking nationallicence formaldehyde nationallicence dissolution nationallicence near-infrared spectrophotometry nationallicence Gold Thomas Division of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Kentucky, 40536-0082, Lexington, KY aut Buice Jr Robert Division of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Kentucky, 40536-0082, Lexington, KY aut Lodder Robert Division of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Kentucky, 40536-0082, Lexington, KY aut Digenis George Division of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Kentucky, 40536-0082, Lexington, KY aut Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/8(1997-08-01), 1046-1050 0724-8741 14:8<1046 1997 14 11095 https://doi.org/10.1023/A:1012105412735 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1023/A:1012105412735 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Gold Thomas Division of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Kentucky, 40536-0082, Lexington, KY aut NATIONALLICENCE 700 1- Buice Jr Robert Division of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Kentucky, 40536-0082, Lexington, KY aut NATIONALLICENCE 700 1- Lodder Robert Division of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Kentucky, 40536-0082, Lexington, KY aut NATIONALLICENCE 700 1- Digenis George Division of Medicinal Chemistry and Pharmaceutics, College of Pharmacy, University of Kentucky, 40536-0082, Lexington, KY aut NATIONALLICENCE 773 0- Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/8(1997-08-01), 1046-1050 0724-8741 14:8<1046 1997 14 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer