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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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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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Ternary solid dispersions: classification and formulation considerations.

Shambhavi Borde1, Sagar Kumar Paul1, Harsh Chauhan1

  • 1School of Pharmacy and Health Professions, Creighton University, Omaha, NE, USA.

Drug Development and Industrial Pharmacy
|April 5, 2021
PubMed
Summary
This summary is machine-generated.

Ternary solid dispersions (TSD) enhance the solubility and bioavailability of poorly water-soluble drugs. This advanced formulation approach improves drug performance for oral dosage forms.

Keywords:
Ternary solid dispersionamorphouscrystallizationmiscibilitypreparation and characterizationsolubilitystability

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Increasing number of Biopharmaceutical Classification System (BCS) Class II and IV compounds with poor aqueous solubility.
  • These poorly soluble drugs possess high therapeutic potential but face formulation challenges for oral delivery.
  • Traditional formulation approaches like amorphous solid dispersions (ASD) have shown success.

Purpose of the Study:

  • To review the advancements in ternary solid dispersions (TSD) for improving drug solubility and bioavailability.
  • To discuss the classification, mechanisms, preparation, and characterization of TSD.
  • To highlight TSD as a promising formulation strategy for poorly water-soluble drugs.

Main Methods:

  • Literature review on ternary solid dispersions (TSD).
  • Discussion of formulation strategies including amorphous solid dispersions (ASD) and TSD.
  • Analysis of preparation techniques and characterization methods for TSD.

Main Results:

  • TSD, an advancement of ASD, incorporates an additional component to enhance solubility, stability, and processability.
  • Various formulation approaches are discussed for improving the performance of poorly water-soluble compounds.
  • TSD offers improved solubility and bioavailability compared to conventional methods.

Conclusions:

  • Ternary solid dispersions represent a significant advancement in formulating poorly water-soluble drugs.
  • TSD formulations can overcome the challenges associated with BCS Class II and IV compounds.
  • Further research and application of TSD are crucial for developing effective oral dosage forms.