Abstract A method and system for determining the homogeneity of one or more components of a mixture of ingredients, especially, is presented. Most importantly, it can be used to determine homogeneity of a tabletted mixture of the produced pharmaceuticals, including active and inactive ingredients. The method and system monitor the pharmaceutical material during tablet manufacture as a powder mix, granular mix and compressed tablets. This system uses near infrared technology for analyzing the uniformity and mass balance of the pharmaceutical mixture to control the tablet manufacturing process. As part of the system and method, a NIR spectral library, consisting of a pharmaceutical materials spanning the normal process range for is developed. Assessment of uniformity is accomplished by comparison of future production with the library of acceptable material.
A process for measuring the uniformity of a pharmaceutical tableting process, comprising the steps of: selecting representative samples of tablets during the tableting process; placing each tablet within a tablet position die; removing the tablet position die; determining the near infrared spectrum of each tablet; and comparing the near infrared spectrum of each tablet to a previously generated "Recognition Index," of acceptable tabletted material; and determining which of the tablets are acceptable based on agreement with the "Recognition Index".
Claim 2
Dependent Claim
79 words
A process for measuring the uniformity of a pharmaceutical tableting process, comprising the steps of: selecting representative samples of tablets during the tableting process; placing each tablet within a tablet position die; removing the tablet position die; determining the near infrared spectrum of each tablet; and comparing the near infrared spectrum of each tablet to a previously generated "Recognition Index," of acceptable tabletted material; and determining which of the tablets are acceptable based on agreement with the "Recognition Index".