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Related Concept Videos

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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Recrystallization: Solid–Solution Equilibria

Recrystallization is a purification technique used to separate impurities from solid compounds. In this technique, no chemical reactions occur. Instead, it exploits physical properties only, specifically, the solubility differences between the desired compound and impurities, either at a single temperature or at different temperatures, and under other selected conditions. The solid-solution equilibrium (solubility equilibrium) of each component in the solution represents a binary phase...
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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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Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.
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Crystallization is a phase transformation process in which crystals are precipitated from a supersaturated solution or formed from other sources. During crystallization, atoms or molecules arrange themselves into a well-defined, rigid crystal lattice to minimize energy.
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Disposable Dosators for Pulmonary Insufflation of Therapeutic Agents to Small Animals
04:22

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Published on: March 30, 2017

Designing inhalable amorphous solid dispersions to mitigate crystallization risks in atropisomer development.

Paola Disisto1, Irene Bassanetti2, Luca Fornasari2

  • 1Dipartimento di Scienze Chimiche, della Vita e della Sostenibilità Ambientale, Università di Parma 43124 Parma, Italy; Preclinical Analytics and Early Formulations Department, Chiesi Farmaceutici S.p.A., Largo Belloli 43123 Parma, Italy.

International Journal of Pharmaceutics
|June 19, 2026
PubMed
Summary
This summary is machine-generated.

Developing inhaled drugs like CHF-6523 faces challenges from molecular shape-shifting (atropisomerism). This study created stable amorphous solid dispersions (ASDs) via spray-drying, improving drug delivery for inhalation therapies.

Keywords:
Amorphous drugAtropisomerismDissolution performancePhysical stabilityPulmonary drug delivery

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Solid-State Chemistry

Background:

  • CHF-6523, a PI3Kδ inhibitor, exhibits atropisomerism and amorphous solid formation, complicating crystalline form development for inhalation.
  • Atropisomers of CHF-6523 exist in near-equilibrium with low interconversion energy, posing challenges for isolating a single active form.

Purpose of the Study:

  • To overcome challenges in developing crystalline forms of CHF-6523 for inhalation.
  • To develop stable amorphous solid dispersions (ASDs) for improved pulmonary delivery of CHF-6523.

Main Methods:

  • Investigated atropisomer distribution and interconversion using NMR and DFT calculations.
  • Conducted salt screening to identify crystalline and amorphous salt candidates.
  • Evaluated blending, spray-drying, and freeze-drying techniques for ASD manufacturing.
  • Assessed physicochemical properties, dissolution, and aerosolization performance of formulations.

Main Results:

  • CHF-6523 monomaleate was the only crystalline diastereoisomer obtained; however, concerns existed regarding its pulmonary suitability.
  • Spray-dried amorphous solid dispersions (ASDs) of CHF-6523 xinafoate exhibited optimal particle size, low moisture, and stability.
  • Spray-dried ASDs demonstrated superior in vitro dissolution and a higher respirable fraction compared to crystalline forms and other ASD manufacturing methods.

Conclusions:

  • Atropisomerism-related conformational dynamics can impede crystalline form selection for inhaled drugs.
  • Spray-dried ASDs offer a promising strategy for developing stable and effective inhalation formulations of CHF-6523.
  • This approach enhances drug dissolution and aerosolization, crucial for pulmonary drug delivery.