[ii]
"Although nature commences with reason and ends in experience it is necessary for us to do the opposite, that is to commence with experience and from this to proceed to investigate the reason."-Leonardo da Vinci [iii]
Abstract
Attenuated Total Reflection Infrared Spectroscopy (ATR-IR) as an in situ Technique for
Dissolution StudiesDissolution studies are critical tests for measuring the performance, or rate of release, of a drug product. There are many variables that affect the dissolution rate of the drug. Such variables may include characteristics of the active pharmaceutical ingredient (API) (e.g., particle size, crystal form, and bulk density), drug product composition (e.g., drug loading, and the identity, type, and levels of excipients), the drug product manufacturing process (e.g., compreSSIon forces, equipment), and the effects of stability storage conditions (e.g., temperature, humidity). Since dissolution has the ability to detect these variables, the regulatory agencies (i.e. FDA and EMEA) have placed great emphasis on the test. Moreover, the regulatory agencies have increased the monitoring and auditing of the dissolution test.A novel technique using in situ attenuated total reflection-infrared spectroscopy (ATR-IR) to monitor dissolutions of pharmaceutical drug products was developed. The accuracy of this technique is ±3% relative to HPLC. Salicylic acid calibrator tablets were studied and two over-the-counter (OTe) formulations containing acetaminophen, and/or acetylsalicylic acid were tested during the research. This novel approach was also used to analyze multiple components in a single tablet. For example, dissolution of the individual components of caffeine-free version of Excedrin® tablets, acetaminophen and acetylsalicylic acid were easily distinguished.[iv]