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Related Concept Videos

In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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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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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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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In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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Synthesis of Phase-shift Nanoemulsions with Narrow Size Distributions for Acoustic Droplet Vaporization and Bubble-enhanced Ultrasound-mediated Ablation
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A novel method for preparing stabilized amorphous solid dispersion drug formulations using acoustic fusion.

Zack Guo1, Christopher Boyce1, Timothy Rhodes2

  • 1Discovery Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ, USA.

International Journal of Pharmaceutics
|November 2, 2020
PubMed
Summary

Acoustic fusion is a novel method for creating amorphous solid dispersions (ASD) of poorly soluble drugs, significantly improving their solubility and in vivo performance.

Keywords:
Acoustic fusionAmorphous solid dispersionFormulationMiniaturizationSolubility enhancement

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Materials Science

Background:

  • Amorphous solid dispersions (ASD) are crucial for enhancing the solubility and bioavailability of poorly soluble drugs.
  • Traditional methods like spray drying and hot melt extrusion have limitations in scale-up and material compatibility.
  • Developing novel, scalable methods for ASD formation is essential for drug formulation.

Purpose of the Study:

  • To introduce and evaluate a new method, acoustic fusion, for generating amorphous solid dispersions (ASD) on a milligram scale.
  • To demonstrate the versatility of acoustic fusion across various drug candidates (BCS Class 2 and 4) and polymer excipients.
  • To assess the in vitro and in vivo performance of ASDs prepared by acoustic fusion.

Main Methods:

  • Utilized acoustic fusion to prepare ASDs with diverse drug-polymer combinations, including torcetrapib, itraconazole, and lopinavir with polymers like HPMCAS, copovidone, and Soluplus®.
  • Evaluated solubility enhancement of ASDs compared to crystalline drugs in aqueous buffers.
  • Conducted in vivo pharmacokinetic studies in rats to assess the bioperformance of acoustic fusion-prepared ASDs.

Main Results:

  • Acoustic fusion successfully formed ASDs for multiple drug-polymer combinations, indicating its general applicability.
  • ASDs prepared via acoustic fusion exhibited significantly enhanced solubility and supersaturation compared to crystalline drugs.
  • Rat pharmacokinetic studies showed an approximately 8-fold increase in drug exposure (AUC(0-24)) for acoustic fusion products versus crystalline suspensions.

Conclusions:

  • Acoustic fusion is a viable and generalizable method for producing amorphous solid dispersions (ASD) at the milligram scale.
  • The method effectively enhances drug solubility and in vivo bioperformance, comparable to established techniques like spray drying and hot melt extrusion.
  • Acoustic fusion represents a promising novel approach for developing advanced drug formulations with improved therapeutic efficacy.