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Precipitation Processes01:12

Precipitation Processes

434
The experimental conditions in a gravimetric analysis should be optimized to maximize the particle size and purity of the obtained precipitate. Ideally, the concentration of the precipitating reagent should be low with effective stirring to maintain low relative supersaturation for the growth of large crystals. In homogeneous precipitation, the precipitant is slowly generated by a chemical reaction in the solution to avoid local reagent excesses. For example, urea decomposes gradually to...
434

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Material-sparing method development for liquid-to-solid ratio determination for wet granulation process development.

Catarina Luz1, Ricardo Sousa2, João F Pinto3

  • 1Oral Drug Product Development, Hovione Farmaciência S.A., Lisbon, Portugal; Research Institute for Medicines (iMed.Ulisboa), Faculty of Pharmacy, Universidade de Lisboa 1649-003 Lisboa, Portugal.

International Journal of Pharmaceutics
|June 8, 2025
PubMed
Summary
This summary is machine-generated.

This study evaluated IKA and FT4 rheometers as alternatives to Mixer Torque Rheometers (MTR) for determining the liquid-to-solid (L/S) ratio in wet granulation. Both instruments showed promise, with FT4 proving most reliable for both high-shear and twin-screw wet granulation processes.

Keywords:
FT4 rheometerHigh-shear wet granulationIKA magic plantLiquid-to-solid ratioMixer torque rheometerTwin-screw wet granulation

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Area of Science:

  • Pharmaceutical Technology
  • Powder Rheology
  • Granulation Science

Background:

  • The liquid-to-solid (L/S) ratio is critical for granule quality in wet granulation.
  • Mixer Torque Rheometer (MTR) is the standard for L/S ratio determination.
  • Material-sparing methods are needed for efficient granulation development.

Purpose of the Study:

  • To evaluate IKA Magic Plant and Freeman FT4 powder rheometers as MTR alternatives.
  • To develop a material-sparing method for L/S ratio determination.
  • To compare rheometer performance in high-shear wet granulation (HSWG) and twin-screw wet granulation (TSWG) processes.

Main Methods:

  • Tested three formulations with varying excipient ratios and water as granulation liquid.
  • Compared torque data from IKA and FT4 rheometers against MTR data.
  • Analyzed "Total Energy" data from FT4 and torque profiles from IKA.

Main Results:

  • Both IKA and FT4 correlated well with MTR for HSWG L/S ratio determination.
  • FT4 and MTR showed similar L/S ratios for TSWG processes.
  • FT4 demonstrated high reliability for predicting optimal L/S ratios in both HSWG and TSWG using small sample sizes (4g).

Conclusions:

  • IKA and FT4 are viable alternatives to MTR for L/S ratio determination in HSWG.
  • FT4 is the preferred alternative for TSWG L/S ratio determination.
  • FT4 rheometer is the most reliable tool for optimizing L/S ratios in both HSWG and TSWG with minimal material.
  • IKA offers production-scale capabilities despite requiring more material.