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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

208
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
208

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Using a Model-based Material Sparing Approach for Formulation and Process Development of a Roller Compacted Drug

Kalyan V Vasudevan1, Yu Elaine Pu2, Hossein Amini3

  • 1Drug Product Development, Pharmaceutical Science & Technology, Bristol Myers Squibb, Summit, NJ, USA. kalyan.vasudevan@bms.com.

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|February 26, 2022
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Summary

This study presents a material-sparing method for developing roller-compacted drug products. It uses material profiling and a mathematical model to efficiently guide formulation and process development, saving valuable drug substance.

Keywords:
Dry granulationEncapsulationFormulation developmentMaterial sparingRC-model

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Developing roller-compacted drug products often requires significant material quantities and extensive batch testing.
  • Early-stage drug development faces challenges with limited drug substance availability and aggressive timelines.

Purpose of the Study:

  • To introduce a material-sparing approach for roller compaction (RC) formulation and process development.
  • To demonstrate the efficacy of combining material profiling with a predictive RC mathematical model.
  • To reduce material consumption and batch numbers in drug product development.

Main Methods:

  • Material profiling (true density, compression, friction) and a predictive RC mathematical model were employed.
  • Pre-blend powder properties and RC granule characteristics guided formulation and process parameters.
  • Less than 10g of model drug compound was used for initial material profiling.

Main Results:

  • Successful development of roller-compacted capsule formulations at 1.4% and 14.4% drug loadings.
  • Scale-up batches were manufactured using parameters derived from the predictive model.
  • Measured ribbon solid fractions closely matched the model's target solid fraction.

Conclusions:

  • The material-sparing approach significantly reduces material usage and batch requirements for RC drug product development.
  • This method is particularly advantageous for early-stage development with limited drug substance.
  • Predictive modeling integrated with material profiling streamlines formulation and process optimization.