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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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Solids in which the atoms, ions, or molecules are arranged in a definite repeating pattern are known as crystalline solids. Metals and ionic compounds typically form ordered, crystalline solids. A crystalline solid has a precise melting temperature because each atom or molecule of the same type is held in place with the same forces or energy. Amorphous solids or non-crystalline solids (or, sometimes, glasses) which lack an ordered internal structure and are randomly arranged. Substances that...
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Crystalline solids are divided into four types: molecular, ionic, metallic, and covalent network based on the type of constituent units and their interparticle interactions.
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There is no one solvent that can dissolve every type of solute. Some substances that readily dissolve in a certain solvent might be insoluble in a different solvent. A simple way to predict which substances dissolve in which solvent is the phrase "like dissolves like". This means that polar substances, such as salt and sugar, dissolve in a polar substance like water. In contrast, non-polar substances are more soluble in non-polar solvents such as carbon tetrachloride.
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Metallic solids such as crystals of copper, aluminum, and iron are formed by metal atoms. The structure of metallic crystals is often described as a uniform distribution of atomic nuclei within a “sea” of delocalized electrons. The atoms within such a metallic solid are held together by a unique force known as metallic bonding that gives rise to many useful and varied bulk properties.
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Microstructure Formation for Improved Dissolution Performance of Lopinavir Amorphous Solid Dispersions.

Na Li1, Lynne S Taylor1

  • 1Department of Industrial and Physical Pharmacy , Purdue University , 575 Stadium Mall Drive , West Lafayette , Indiana 47907 , United States.

Molecular Pharmaceutics
|February 28, 2019
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Summary
This summary is machine-generated.

Amorphous solid dispersions (ASDs) can improve drug solubility but may undergo phase separation. This study reveals that specific microstructural changes in lopinavir-HPMC ASDs enhance drug release, offering insights for better formulation design.

Keywords:
amorphous solid dispersionsdissolutiondrug-loadingmiscibilitynanoTAphase-separation

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Amorphous solid dispersions (ASDs) are crucial for enhancing the oral bioavailability of poorly soluble drugs.
  • Amorphous-amorphous phase separation in ASDs can lead to drug crystallization and altered release profiles.
  • Understanding ASD microstructure is vital for optimizing drug release performance.

Purpose of the Study:

  • To investigate the microstructure evolution in lopinavir-hydroxypropylmethylcellulose (HPMC) ASDs prepared via a solvent-based process.
  • To elucidate the relationship between ASD microstructure, phase separation, and in vitro drug release kinetics.
  • To identify critical microstructural factors influencing the performance of lopinavir ASDs.

Main Methods:

  • Preparation of lopinavir-HPMC amorphous solid dispersions using a solvent-based method.
  • Characterization of local composition at the submicron scale using Atomic Force Microscopy (AFM)-based nanoscale thermal analysis (nanoTA).
  • Evaluation of in vitro drug release profiles of the prepared ASDs.

Main Results:

  • Heterogeneous domain formation was observed in lopinavir-HPMC ASDs.
  • Improved in vitro release of lopinavir was achieved for drug loadings above 33% w/w due to these heterogeneous domains.
  • The composition, amount, size, and location of drug-rich phases were identified as critical factors affecting release kinetics.

Conclusions:

  • ASD microstructure significantly impacts drug release performance.
  • Controlled phase separation and resulting heterogeneous domains can enhance the release of poorly soluble drugs like lopinavir from ASDs.
  • This study provides a deeper understanding of ASD release mechanisms, aiding in the rational design of optimized formulations.