processanalyticaltechnology

Drug product manufacturing in pharmaceutical industries is generally controlled by testing products resulting from a process - finished product testing. Another innovative approach is process analytical technology (PAT) analytical testing is performed during the process. This approach allows adjusting product quality in time and final product testing can be avoided. Process understanding is the basis for this innovative process control system.

The principle of PAT is to control the quality of a drug product based on process understanding by in/on/at line process control. US FDA describes the term "Process Analytical Technologies (PAT)" has been used to describe "a system for designing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes for raw and in-process materials and also processes with the goal of ensuring final product quality".

In recent years, near-infrared spectroscopy has gained growing interest within the pharmaceutical industry for both quality control and process monitoring. Extending with the diffuse reflectance option, pharmaceutical applications of near-infrared spectroscopy offers the nondestructive instrumental analysis even for intact solid samples (for in-process and end-product control) and gives both chemical and physical information in development or production. Nowadays NIR is used in both off-line and on-line applications in different pharmaceutical industrial process control applications. This paper reviews the application of near infrared (NIR) spectroscopy mainly from a pharmaceutical point of view.

The Near-Infrared Region

The electromagnetic (EM) spectrum covers the range from corpuscular gamma rays to radio radiation. Near infrared (NIR), as defined by the International Union of Pure and Applied Chemistry (IUPAC) is the radiation range of the electromagnetic spectrum, extending from 780 – 2500 nm (12800–4000 cm-1). The absorption in the NIR region arises from overtones and combinations of the fundamental mid-infrared bands. Thus in a wider sense, NIR specroscopy deals including wavelengths between 700 - 3000 nm, near the red of the visible spectrum and near the beginning of fundamental infrared stretches of organic compounds.

NIR- PAT Applications

• Raw material analysis

• API Applications

    * Identification
    * Moisture content determination
    * Characterization of polymorphism
    * Quantitative assay

• Drying

• Granulation

• Blend Uniformity

• Content Uniformity

Drawbacks of conventional tests like HPLC:

They require slow sample preparation, slow analysis and are destructive in nature.

What ifs:

1. What if there was a faster method?

2. What if the method was non destructive?

3. What if tablets could be measured in the native solid state?

4. What if this technique could be moved out of QC and be at-line in production environment?

Better yet, why not On-line?

The method is NIR!

Benefits of NIR On-line Tablet Analysis

    * Fast (5 - 10 sec. Typical)
    * Little or no sample preparation
    * No solvent usage so highly economic
    * Simple to operate
    * No waste, no pollution
    * Multi-component analysis
    * Acceptable accuracy and precision
    * Non-destructive and non-invasive measurement
    * Measures both chemical and physical properties
    * Transferable Methods
    * Remote monitoring for Process.