Method and system for determining the homogeneity of tablets

• US 5,504,332 A
• Filed: 08/26/1994
• Issued: 04/02/1996
• Est. Priority Date: 08/26/1994
• Status: Expired due to Fees

• Current Assignee: Merck & Co., Inc.
• Original Assignee: Merck & Co., Inc.
• Inventors: Buchanan, Bruce R., Richmond, Eric W., Baxter, Mark A., Duff, Andy, Thornton, Samuel A., Tully, Oksana M.
• Primary Examiner(s): Fields, Carolyn E.
• Assistant Examiner(s): Glick, Edward J.
• Application Number:
  US08/296,833
• Time in Patent Office: 585 Days
• Field of Search: 250/339.11, 250/339.12, 250/341.8, 250/340
• US Class Current: 250/339.12
• CPC Class Codes: B01F 35/213 of the properties of the mixtures, e.g. temperature, density or colour
• CPC Class Codes: B30B 11/005 Control arrangements
• CPC Class Codes: G01N 21/3563 for analysing solids; Preparation of samples therefor
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility

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.

Claims

1. 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".