The Advanced Modular Platform (AMP) is the first tool that combines an adequate and customized simulation of in-vivo conditions which take into account the specific requirements of the dosage form and the experimental setup dictated by the gastrointestinal environment of healthy and diseased subjects.

The AMP consists of a universal basic device and interchangeable modules for specific tests. It realistically simulates the dynamics of the mechanical and physicochemical conditions of the GI transit, allows the use of bio-relevant liquids and dynamic fluctuations of the physicochemical conditions, simulates the bio-relevant temperature gradients and is suitable for bio-predictive and compendial dissolution testing.

The basic specifications of the AMP include:

• continuous monitoring and dynamic adjustment of the pH in the range between 1 and 9
• using liquid and gaseous titrants
  simulation of mechanical pressure in the range of 50 – 500 mbar
• simulation of vertical movement of the dosage form with basket velocity range: 0.1 – 20 cm/s
• adjustment of the frequency and position of the sampling
  compatibility with online UV-VIS spectroscopy and offline sampling
• suitability for compendial and bio-predictive dissolution testing
• customized and flexible adjustment of the test programs, including realization of single or two test programs within one experiment (one program per triplet)
• digital monitoring of the experimental parameters with output of a log file

The basic functions of the AMP are:

• standard dissolution testing in the USP Apparatus I and II, including mini-vessels
• dissolution testing combined with dynamic pH control unit (pHysio-grad®) and dynamic adjustment of the pH by gasses (CO2, N2, compressed air) and/or liquids (NaOH, NaHCO3, Na2CO3, HCl)
• stress test with simulation of the GI motility forces of physiological intensity
• simulation of the dynamic digestion and processing of the dissolution media
• a transfer model combined with each of configurations specified above
• bio-predictive dissolution tests using a combination of the functions mentioned above

Owing to the unique features the AMP effectively supports the rational, physiology-oriented development of oral medicines. The use of the AMP in the development cycle of oral medicines allows to improve the biopharmaceutical quality, reduce the risk of clinical trials and consequently reduce the cost of the development and shorten the time to market.