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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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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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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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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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Initial Drug Dissolution from Amorphous Solid Dispersions Controlled by Polymer Dissolution and Drug-Polymer

Yuejie Chen1, Shujing Wang1, Shan Wang1

  • 1School of Pharmaceutical Sciences and Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Tsinghua University, Beijing, China.

Pharmaceutical Research
|June 11, 2016
PubMed
Summary
This summary is machine-generated.

The initial drug release from amorphous solid dispersions (ASDs) depends on polymer dissolution, drug-polymer interaction strength, and mixing homogeneity. Understanding these factors is crucial for optimizing ASD formulation and drug delivery.

Keywords:
Flory-Huggins interactionamorphous solid dispersiondissolution mechanismdrug-polymer interactionketoconazole

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) are crucial for enhancing the solubility and bioavailability of poorly soluble drugs.
  • Controlling drug and polymer dissolution rates from ASDs is essential for predictable drug release and therapeutic efficacy.

Purpose of the Study:

  • To elucidate the key formulation factors governing the initial drug and polymer dissolution rates from amorphous solid dispersions (ASDs).
  • To investigate the influence of drug-polymer miscibility, interaction strength, and mixing homogeneity on dissolution profiles.

Main Methods:

  • Preparation of ketoconazole (KTZ) ASDs with various polymers (PVP, PVP-VA, HPMC, HPMC-AS) using spray-dried dispersion (SDD) and physical blend (SDD-PB) methods.
  • Characterization of drug-polymer interactions using Flory-Huggins parameters (χ), solution (13)C NMR, and FT-IR spectroscopy.
  • Assessment of intrinsic dissolution rates of both drug and polymer from ASDs using a Higuchi-style apparatus; confirmed absence of crystallinity via PXRD and confocal Raman microscopy.

Main Results:

  • Ketoconazole (KTZ) exhibited varying miscibility with polymers, with negative χ values indicating good miscibility (PVP, PVP-VA, HPMC-AS) and a positive χ value indicating poor miscibility (HPMC).
  • Stronger drug-polymer interactions (e.g., KTZ/HPMC-AS) correlated with drug release matching polymer release in SDD systems, while weaker interactions or absence of interaction (KTZ/HPMC) led to independent release rates.
  • Mixing homogeneity significantly impacted release rates: intimate mixing (SDD) ensured synchronized drug-polymer release when interactions were present, whereas physical blends (SDD-PB) showed slower drug release when molecular-level mixing or interaction was lacking.

Conclusions:

  • Initial drug release from ASDs is dictated by polymer dissolution rate, drug-polymer interaction strength (intrinsic and apparent), and mixing homogeneity.
  • The choice of polymer, drug-polymer ratio, and processing conditions profoundly influence the dissolution behavior of ASDs.
  • Optimizing ASD formulation requires careful consideration of these interconnected factors to achieve desired drug release profiles.