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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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).
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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Automated PET-RAFT Polymerization Towards Pharmaceutical Amorphous Solid Dispersion Development.

Rahul Upadhya¹, Ashish Punia², Mythili J Kanagala¹

¹Department of Biomedical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA.

ACS Applied Polymer Materials

|August 9, 2021

Summary

This summary is machine-generated.

Developing new polymers for amorphous solid dispersions (ASDs) improves oral drug bioavailability. This study used a combinatorial approach to create and screen novel polymer excipients, identifying key relationships for better drug delivery systems.

Keywords:

amorphous solid dispersions combinatorial polymer synthesis drug precipitation inhibition oral drug delivery polymer excipients

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Area of Science:

Pharmaceutical Sciences
Materials Science
Polymer Chemistry

Background:

Over 90% of pharmaceutical drugs in development exhibit poor aqueous solubility, hindering oral bioavailability.
Amorphous solid dispersions (ASDs) are a key strategy to enhance oral bioavailability of poorly soluble active pharmaceutical ingredients (APIs).
Limited regulatory-approved polymer excipients necessitate the design of novel materials for tailored ASD development.

Purpose of the Study:

To explore an automated combinatorial library approach for synthesizing and screening polymer excipients for amorphous solid dispersions (ASDs).
To investigate the relationship between polymer characteristics and the dissolution performance of a model drug, probucol.
To identify novel polymer excipients that can effectively enhance oral drug delivery.

Main Methods:

Synthesis of a 25-member random heteropolymer library with varying ratios of hydrophilic (2-hydroxypropyl acrylate) and hydrophobic monomers.
Fabrication of ASDs using a rapid film casting method.
Evaluation of ASD performance via dissolution testing with ultra-performance liquid chromatography (UPLC) analysis.

Main Results:

A clear correlation was established between polymer hydrophobicity, monomer side group geometry, and the dissolution performance of probucol.
Novel synthesized polymers demonstrated effective enhancement of drug dissolution compared to existing standards.
The most effective polymers exhibited modulated drug release kinetics, offering potential for controlled drug delivery.

Conclusions:

An automated combinatorial library approach is effective for rapid synthesis and screening of polymer excipients for ASDs.
Understanding polymer-API interactions is crucial for designing effective drug delivery systems.
This strategy enables the identification of designer polymer excipients with tunable properties for specific API functionalities and improved oral bioavailability.