Tablets & Capsules


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Tablet dissolution. NIR spectroscopy can also predict the dissolution rates of tablets, as demonstrated in a study of intact carbamazepine tablets [8]. Moreover, the authors showed that branded and generic carbamazepine tablets reacted differently when exposed to high humidity. In an earlier study, Lodder et al. showed how forensic chemistry might benefit from non-invasive NIR spec- troscopy to detect adulteration in both prescription and over-the-counter drug products [4]. Although it is impos- sible to predict what contaminant might be placed in a particular product, the authors argued that with a well constructed training/calibration set for each brand and SKU of product, a multivariate analysis technique could mathematically distinguish an outlier dosage form from a good one. In other words, the study's NIR method could be used to qualitatively determine whether a finished product was genuine or adulterated. Future uses NIR spectroscopy is a powerful tool that has just begun to be used in pharmaceutical development and manufacturing settings. Several manufacturers of NIR instruments have made implementation of raw-material identity testing very accessible. Yet the quantitative aspects of NIR spectroscopy have not been fully realized. For example, less conventional dosage forms, as well as single-unit operations, should benefit from in-process testing that can determine the amount of drug or other analyte present. Roller compaction is a good example. It would benefit from NIR's ability to rapidly and non-inva- sively determine drug content and ribbon density. NIR could also supplement diffusion/erosion modeling of drug release from matrix tablets. It may also emerge as a means of determining the effectiveness of drug layering on pel- lets, sugar spheres, and tablets. Finally, NIR's contribution to identifying counterfeit and adulterated drug products should not be underestimated. T&C References 1. R.G. Buice Jr., T.B. Gold, R.A. Lodder, and G.A. Digenis. Determination of moisture in intact gelatin cap- sules by near-infrared spectrophotometry. Pharm. Res. 12, 161-163 (1995). 2. United States Pharmacopeia and National Formulary, (USP 37-NF 25) Second supplement. Rockville, MD: United States Pharmacopeia Convention; 2013:953-959. 3. R.P. Cogdill, C.A. Anderson, and J.K. Drennen, III. Using NIR spectroscopy as an integrated PAT tool. Spectroscopy 19 (12), 104-109 (2004). 4. R.A. Lodder, M. Selby, and G.M. Hieftje. Detection of capsule tampering by near-infrared reflectance analy- sis. Anal. Chem. 59 (1987), 1921-1930. 5. B.E. Jones. The history of the gelatin capsule, in Hard Capsulesā€”Development and Technology, K. Ridgway, Ed.; The Pharmaceutical Press: London, UK, (1987), pp. 1-12. 6. T.B. Gold, R.G. Buice Jr., R.A. Lodder, and G.A. Digenis. Determination of extent of formaldehyde-induced crosslinking in hard gelatin capsules by near-infrared spec- trophotometry. Pharm. Res. 14, 1046-1050 (1997). 7. T.B. Gold, R.G. Buice Jr., R.A. Lodder, and G.A. Digenis. Detection of formaldehyde-induced crosslinking in soft elastic gelatin capsules using near-infrared spec- trophotometry. Pharm. Dev. Technol. 3, 209-214 (1998). 8. P.N. Zannikos, W.-I. Li, J.K. Drennen, and R.A. Lod - der. Spectrophotometric prediction of the dissolution rate of carbamazepine tablets. Pharm. Res. 8 (1991), 974-978. Thomas B. "Brad" Gold, Ph.D., is vice president of pharma- ceutical development at Metrics Contract Services, 1240 Sugg Parkway, Greenville, NC 27834. Tel. 252 752 3800. Website: Gold is responsible for all personnel, facil- ities, and services related to the formulation development of potent and cytotoxic products and fast-track development. He has worked in contract pharmaceutical product development for 19 years, the last 11 of them at Metrics. Prior to joining Metrics, Gold held scientific roles at DSM Pharmaceuticals as group leader and at Banner Pharmacaps (now part of Patheon) as a scientist and pilot plant manager. He earned his master's of sci- ence degree in chemistry and a Ph.D. in pharmaceutics from the University of Kentucky. 14 March 2015 Tablets & Capsules Write an article for Tablets & Capsules Our articles are written by technical professionals for technical professionals. Ask about the types of articles we're looking for, as well as tips on preparing an article for consideration. Contact: Matthew Knopp, Editor Tablets & Capsules Tel. +1 651 287 5618 Fax +1 651 287 5650 E-mail:

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