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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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Network covalent solids contain a three-dimensional network of covalently bonded atoms as found in the crystal structures of nonmetals like diamond, graphite, silicon, and some covalent compounds, such as silicon dioxide (sand) and silicon carbide (carborundum, the abrasive on sandpaper). Many minerals have networks of covalent bonds.
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Heating a crystalline solid increases the average energy of its atoms, molecules, or ions, and the solid gets hotter. At some point, the added energy becomes large enough to partially overcome the forces holding the molecules or ions of the solid in their fixed positions, and the solid begins the process of transitioning to the liquid state or melting. At this point, the temperature of the solid stops rising, despite the continual input of heat, and it remains constant until all of the solid is...
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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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The word polymer is derived from the Greek words “poly” which means “many” and “mer” which means “parts”. Polymers are long chains of molecules composed of repeating units of smaller molecules, known as monomers. They either occur naturally, such as DNA and proteins, or can be constructed synthetically, like plastics. They have varied structural characteristics, such as linear chains, branched chains, or complex networks, that contribute to the...
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Melt-based screening method with improved predictability regarding polymer selection for amorphous solid dispersions.

Carolin Auch1, Meike Harms2, Karsten Mäder3

  • 1Institute of Pharmacy, Faculty I of Natural Sciences, Martin Luther University Halle-Wittenberg, 06120, Halle/Saale, Germany; Department of Pharmaceutical Technologies, Merck KGaA, 64293 Darmstadt, Germany.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|September 3, 2018
PubMed
Summary
This summary is machine-generated.

A new melt-based screening method improves polymer selection for amorphous solid dispersions (ASD), enhancing drug supersaturation and precipitation prediction over traditional solvent-based methods. This approach minimizes time and material costs for better formulation development.

Keywords:
Amorphous solid dispersionsManufacturingPolymer selectionPreformulationScreening

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Amorphous solid dispersions (ASD) are crucial for enhancing the solubility and bioavailability of poorly soluble drugs.
  • Predicting polymer performance in ASDs is challenging, often leading to discrepancies between screening methods and final product performance.

Purpose of the Study:

  • To systematically evaluate the predictability of preformulation screening tools for polymer selection in ASDs.
  • To develop and validate a new, improved screening method for more accurate ASD formulation development.

Main Methods:

  • Comparison of a traditional solvent-based screening method (film casting) with a novel melt-based screening approach.
  • Scale-up of selected API-polymer combinations using hot-melt extrusion and spray-drying to verify screening predictions.
  • Testing of four polymers with two model active pharmaceutical ingredients (APIs) under non-sink dissolution conditions.

Main Results:

  • The traditional solvent-based screening showed discrepancies with actual ASD performance, particularly for certain polymers like polyvinylpyrrolidone (PVP) and cellulose derivatives (HPMCAS, CAP).
  • The novel melt-based screening method demonstrated improved correlation with ASD prototypes, successfully avoiding false negative results for polymers like PVP-co-vinyl acetate (PVP-VA64).
  • The study identified specific polymer behaviors, with PVP-based polymers showing good supersaturation in ASDs despite initial screening limitations, and cellulose derivatives performing well in spray-dried dispersions (SDD).

Conclusions:

  • The developed melt-based screening tool offers enhanced predictability for polymer selection in ASDs compared to conventional solvent-based methods.
  • This refined screening approach minimizes resource investment while improving the accuracy of predicting drug supersaturation and precipitation.
  • Comparing results from both screening methods allows for informed prediction of extrudate versus spray-dried dispersion performance with specific polymeric excipients.