Related Experiment Video
Updated: Oct 15, 2025
11:27
A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
2.2K
Amorphous Solid Dispersions (ASDs): The Influence of Material Properties, Manufacturing Processes and Analytical
Raman Iyer1, Vesna Petrovska Jovanovska2, Katja Berginc2
1Technical Research and Development, c/o Global Drug Development, Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936, USA.
Pharmaceutics
|October 23, 2021
Summary
Amorphous solid dispersions (ASDs) enhance oral drug absorption by improving solubility. This review covers ASD design, manufacturing, characterization, and the development of new polymers for improved bioavailability.
Area of Science:
- Pharmaceutical Science
- Drug Delivery
- Materials Science
Background:
- Poorly water-soluble drugs exhibit low oral absorption and bioavailability.
- Formulation strategies like amorphous solid dispersions (ASDs) enhance drug solubility and dissolution.
- ASDs are the most prevalent technology for solubility enhancement in marketed drugs (2000-2020).
Purpose of the Study:
- To review the scientific principles and influencing factors in designing amorphous solid dispersion (ASD) products.
- To discuss recent advancements in analytical techniques for ASD characterization and processability.
- To address the need for novel ASD polymers and the regulatory pathway for their development.
Main Methods:
- Review of scientific literature on amorphous solid dispersions.
- Discussion of factors influencing ASD selection and design (drug properties, materials, manufacturing).
- Overview of analytical tools for ASD stability and processability assessment.
Main Results:
- Amorphous solid dispersion technology is a key strategy for improving oral bioavailability of poorly soluble drugs.
- Successful ASD product development depends on understanding drug-excipient interactions, material properties, and manufacturing processes.
- Advanced analytical tools are crucial for characterizing ASDs and ensuring processability into patient-centric dosage forms.
Conclusions:
- Amorphous solid dispersions represent a mature and widely adopted technology for enhancing drug solubility and bioavailability.
- Further innovation in ASD polymers is needed, alongside clear regulatory guidance, to address unmet needs in drug development.
- Characterization and processability are critical for translating ASD technology into effective and patient-friendly medicines.
Related Concept Videos
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
213
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...
213
01:21Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
426
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...
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
426
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
15
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,...
15
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
28
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
28
01:20Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
287
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...
287
01:23Factors Affecting Dissolution: Particle Size and Effective Surface Area
1.1K
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...
1.1K