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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).
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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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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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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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High-Throughput Microarray Approaches for Predicting the Stability of Drug-Polymer Solid Dispersions.

Noha F Ghazi1,2, Jonathan C Burley1, Ian L Dryden3

  • 1School of Pharmacy, University of Nottingham, University Park, Nottingham NG7 2RD, United Kingdom.

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|December 21, 2024
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Summary
This summary is machine-generated.

This study developed stable amorphous solid dispersions (ASDs) for poorly soluble drugs using inkjet printing. Key drug properties like fewer hydrogen bond acceptors and lower melting points enhance ASD physical stability.

Keywords:
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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Amorphous solid dispersions (ASDs) are crucial for enhancing the bioavailability of poorly soluble drugs.
  • Developing stable ASDs requires understanding drug-polymer interactions and API physicochemical properties.

Purpose of the Study:

  • To create and screen a library of ASD formulations using diverse drugs and polyvinylpyrrolidone vinyl acetate (PVPVA).
  • To identify physicochemical properties of Active Pharmaceutical Ingredients (APIs) that correlate with ASD physical stability.

Main Methods:

  • Utilized high-throughput 2D inkjet printing to create microarrays of ASDs with nanogram material amounts.
  • Conducted a six-month accelerated stability study (40 °C, 75% RH) on the ASD library.
  • Developed multiple linear regression models to correlate API properties with ASD stability, validated by Leave-One-Out Cross-Validation.

Main Results:

  • ASD physical stability varied significantly based on drug-polymer combinations, with some crystallizing rapidly and others remaining stable for days.
  • Increased ASD stability correlated with APIs having fewer hydrogen bond acceptors, a higher count of heteroatoms and oxygen, and lower melting points.
  • The developed regression models demonstrated good predictability of ASD stability trends.

Conclusions:

  • High-throughput inkjet printing is an efficient method for screening ASD physical stability and predicting crystallization risks.
  • Minimizing repulsive drug-polymer interactions and considering specific API physicochemical properties are key for developing stable ASDs.
  • This study provides valuable insights into ASD formulation development, enhancing efficiency and material usage.