Technological solution

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Characteristics

The AGS technology brings to market an entirely new and original process of dry granulation thanks to innovative concepts that, thanks to a custom-made plant, allows the processing of a broad range of substances.

Main features:

  • An innovative principle based on tribo-electric activity
  • Worldwide process patent protection (Patent N. WO 2010/052748 A2)
  • Closed circuit process providing very high yields
  • Continuous cycle requiring less in-process controls
  • Reduced manpower requirements
  • Flexibility allowing for successful treatment of a broad range of APIs
  • Proven track record with a large number of substances
  • Easy scale-up to industrial phase
  • Limited requirements of plant surface
  • Low-capital intensity
  • The main technical innovations of AGS:
    1. A gas flow that carries the particles of the substance through each phase of the process and allows a clear cut separation of granules from the finer fraction.
    2. A magnetic field that allows the tribo-electric effects generated during the process to be set and controlled.
    3. The use of a closed system that defines the quantity and direction of the gas flow.

    AGS is a continuous and closed-circuit process that allows the use of either air or inert gases. The plant is eventually cleaned with the use of the same gas that was employed in the manufacturing process.

Technical advantages over traditional granulation processes

The AGS technology offers pharmaceutical manufacturers an effective solution for appropriate formulations:

  1. Versatility: it enables the dry-granulation of a broad range of active ingredients with virtually any excipient; a large number of positive tests on many APIs is available in our files.
  2. Reduction of processing times: the production of granules requires much shorter times thanks to a rather easy process of balance between API and excipients. Developments are possible with a very few tests requiring days if not hours, as opposed to present market standards that need to conduct a number of trial/error attempts. Additionally, no scale-up is in practice required as the quantity of processed material is not a binding factor.
  3. Reproducibility: the AGS system is very consistent as far as the characteristics of the resulting granules are concerned, just based on the preset parameters of the plant.
  4. Flexibility: AGS allows the production of formulations of existing drugs with improved characteristics of solubility, so avoiding sub-optimal performances (Product Cycle Management). AGS is especially suited for special formulations such as ODT (Orally Disintegrating Tablets) or modified release dosages.
  5. Eco-sustainability: the plant operates as closed circuit and does neither use water nor chemical solvents, with a very limited use of excipients.
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Benefit for our licensees

    1. Relatively low capital investment
    2. Reduced working area required as opposed to conventional systems
    3. Considerable reduction in production costs thanks to:
      1. Higher process yields because of the continuous process in closed circuit
      2. Contained processing times
      3. Limited requirements of energies
    4. Versatility, with broad field of applications on a large variety of APIs with different physical characteristics
    5. Unique generalized approach to drug formulation development with limited or no use of excipients and/or liquids (water or solvents)

AGS pilot plant