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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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Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

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Published on: April 7, 2023

Process development to overcome drug substance agglomeration and restore dissolution performance.

Mayank Singhal¹, Kalyan Nidadavole¹, Dean S Murphy²

¹Early Product Development and Manufacturing, Pharmaceutical Sciences, BioPharmaceuticals R&D, AstraZeneca, Macclesfield, UK.

Journal of Pharmaceutical Sciences

|June 17, 2026

Summary

This summary is machine-generated.

Investigational drug dissolution issues were resolved by identifying and eliminating drug agglomerates through shear deagglomeration. This simple step improved drug release without altering the formulation, ensuring patient bioavailability.

Keywords:

Agglomeration Dissolution Milling Mixing Powder technology Tablet(s)

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Published on: September 20, 2017

Area of Science:

Pharmaceutical Sciences
Drug Delivery
Formulation Development

Background:

Dissolution testing is critical for predicting in vivo drug bioavailability.
An investigational BCS Class II compound showed poor dissolution at relevant physiological pH.
This posed a risk of reduced drug exposure in patients with altered gastric pH.

Purpose of the Study:

To diagnose the cause of slow and incomplete drug dissolution.
To identify formulation or processing strategies to enhance drug release.
To maintain the original clinical formulation composition.

Main Methods:

Evaluated drug substance particle size (milled vs. unmilled).
Assessed formulation wettability with surfactants and different fillers.
Investigated the impact of shear mixing on powder blends.
Utilized dissolution testing to assess drug release profiles.

Main Results:

Particle size and surfactant addition did not significantly improve dissolution.
Drug agglomerates were identified as the primary cause of poor dissolution.
A pre-blend shear deagglomeration step markedly enhanced drug dissolution rates.

Conclusions:

Drug agglomeration, not particle size or wettability, caused dissolution issues.
Shear deagglomeration is an effective strategy to improve dissolution of agglomerated compounds.
The clinical formulation was retained by implementing a simple processing modification.