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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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

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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...
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Downstream Processing of Amorphous and Co-Amorphous Olanzapine Powder Blends.

Nuno F da Costa1, Rolf Daniels2, Ana I Fernandes3

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Summary

Amorphous olanzapine (OLZ) and co-amorphous OLZ with saccharin (SAC) show stability during direct compression tableting. While flowability decreased, the process offers an expedited amorphization technique for enhanced drug solubility.

Keywords:
(co-)amorphouscohesivenesscompressibilityflowabilityolanzapinetablet

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Direct compression is a preferred tableting method for its efficiency.
  • Amorphous solid forms can offer improved drug solubility but often present stability and processing challenges.

Purpose of the Study:

  • To evaluate the stability and processability of amorphous olanzapine (OLZ) and its co-amorphous form with saccharin (SAC) during direct compression tableting.
  • To compare the properties of tablets containing amorphous/co-amorphous OLZ with those containing crystalline OLZ.

Main Methods:

  • Characterization of powder flowability and compressibility.
  • Tablet manufacturing via direct compression.
  • Stability assessment using X-ray powder diffraction (XRPD), Fourier-transform infrared (FTIR), and near-infrared (NIR) spectroscopies.
  • Drug release studies.

Main Results:

  • Amorphous and co-amorphous OLZ powders exhibited reduced flowability due to increased cohesiveness compared to crystalline OLZ.
  • Tablets maintained long-lasting amorphous OLZ with enhanced water solubility.
  • Drug release rate from amorphous/co-amorphous OLZ tablets was slower than from crystalline OLZ tablets.
  • High compaction pressure (155 MPa) and dwell time (5 min) facilitated significant amorphization (approx. 20%) in physical mixtures.

Conclusions:

  • Amorphous and co-amorphous OLZ demonstrate good stability during direct compression tableting.
  • Compaction pressure positively influences the formation of co-amorphous OLZ, presenting a potential expedited amorphization technique.
  • Process development challenges need to be addressed for practical implementation.