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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

121
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...
121
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
289

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Material-Sparing Approach to Predict Tablet Capping Under Processing Compression Conditions Based on Mechanical and

Pratap Basim1,2,3, Harsh S Shah1,4, Robert Sedlock2,5

  • 1Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Division of Pharmaceutical Sciences, Long Island University, 75 DeKalb Avenue, Brooklyn, New York, 11201, USA.

AAPS Pharmscitech
|October 10, 2024
PubMed
Summary
This summary is machine-generated.

Compaction simulation models accurately predict tablet capping risk for Acetaminophen (APAP) and Ibuprofen (IBU) by analyzing mechanical properties and molecular behavior under compression. This material-sparing approach identifies threshold compression pressures (TCP) to prevent capping.

Keywords:
Compaction simulation and emulationMechanical propertiesMultivariate analysisTablet capping

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Tablet capping is a critical manufacturing defect affecting drug product quality.
  • Traditional methods for assessing capping risk are material-intensive and time-consuming.
  • Predictive modeling offers a potential material-sparing alternative for process optimization.

Purpose of the Study:

  • To evaluate the efficacy of compaction simulation-based mechanical models for predicting tablet capping.
  • To establish material-sparing methods for determining threshold compression pressures (TCP) for Acetaminophen (APAP) and Ibuprofen (IBU).
  • To validate predictive models using molecular simulations and X-ray powder diffraction (XRPD).

Main Methods:

  • Mechanical properties of APAP and IBU formulations were measured and analyzed using Principal Component Analysis (PCA) and Principal Component Regression (PCR).
  • PCR models predicted capping scores (CS) based on compression pressure (CP).
  • Molecular models, incorporating XRPD data, calculated slip plane properties to predict TCP and validate mechanical model predictions.

Main Results:

  • APAP formulations showed a quadratic relationship between CS and CP, with a TCP between 200-300 MPa.
  • IBU formulations exhibited a linear relationship between CS and CP, with a TCP between 100-200 MPa.
  • Mechanical and molecular models accurately predicted TCP values (245 MPa for APAP, 175 MPa for IBU), aligning with observed capping behavior.

Conclusions:

  • Compaction simulation-based mechanical models are effective, rapid, and accurate tools for predicting tablet capping risk.
  • These models serve as a valuable material-sparing approach for pharmaceutical process development and optimization.
  • Understanding the relationship between compression pressure, material properties, and molecular behavior is key to preventing tablet capping defects.