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Research Literature

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Formulation Development & Manufacturing 5

Duplicate DOIs are merged. This is a selected collection, not an exhaustive bibliography.

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Reviews & perspectives
Frontiers in Chemistry

Review examines cocrystal performance and barriers to clinical translation

Muhammad Inam; Muhammad Hayat; Abuzar Osman

A Frontiers in Chemistry review examines pharmaceutical cocrystals as a way to modify dissolution and related biopharmaceutical properties without changing an API's chemical identity. The abstract distinguishes solubility-limited BCS II drugs from permeability-limited BCS IV drugs. It highlights gastrointestinal instability, manufacturing reproducibility, coformer selection, and limited pharmacokinetic evidence. Much of the reported performance evidence remains preclinical.

Pharmaceutical solid stateFormulation Development & Manufacturing
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DOI: 10.3389/fchem.2026.1965408

Methods
AAPS Open

Compaction density reveals reversible urea polymorph changes under pressure

Gerrit Vreeman; Changquan Calvin Sun

An AAPS Open study used a compaction simulator to track reversible density changes in urea between 600 and 900 MPa, consistent with its known form I-to-III transformation. The original abstract proposes in-die density monitoring as a material-sparing screen for pressure-induced phase changes. Applicability depends on a sufficiently large density difference; urea is the demonstrated model compound.

Pharmaceutical solid stateFormulation Development & Manufacturing
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DOI: 10.1186/s41120-026-00206-x

Original research
Molecular Pharmaceutics

Formulations at the Nanoscale: Multi-dimensional Electron Diffraction of Long-Acting Injectable, Cabotegravir

Helen W. Leung; Royston C. B. Copley; Stephanie Lam; Luca Russo; Simon Fairclough; Duncan N. Johnstone; Paul A. Midgley

This study applied multidimensional electron diffraction to cabotegravir nanocrystals within a long-acting injectable formulation. 3D electron diffraction confirmed a structure consistent with the known X-ray model, while imaging and diffraction linked particle shape to crystal structure and revealed dislocations. The results describe nanoscale structural features that may guide formulation work; improved product performance was not demonstrated.

MicroED structure determinationFormulation Development & Manufacturing
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DOI: 10.1021/acs.molpharmaceut.6c00365

Original research
Molecular Pharmaceutics

Structural Analysis of Active Pharmaceutical Ingredients in Tablets Using 3D ED/MicroED

Keiyo Nakai; Takashi Kikuchi; Kuniyoshi Miki; Akito Sasaki; Mitsuhisa Yamano

The study examined API crystals directly in Allegra, Clarith, and Ibrance tablets using selected-area 3D ED/MicroED. Fexofenadine hydrochloride Form I and clarithromycin Form II retained their polymorphs, while palbociclib Form A showed slight lattice shrinkage. The results demonstrate formulation-level structural analysis and emphasize that a lattice change and a new polymorph are different findings.

MicroED structure determinationPharmaceutical solid stateFormulation Development & Manufacturing
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DOI: 10.1021/acs.molpharmaceut.5c00028

Original research
IUCrJ

From formulation to structure: 3D electron diffraction for the structure solution of a new indomethacin polymorph from an amorphous solid dispersion

Helen W. Leung; Royston C. B. Copley; Giulio I. Lampronti; Sarah J. Day; Lucy K. Saunders; Duncan N. Johnstone; Paul A. Midgley

3D electron diffraction resolved the structure of the ninth reported indomethacin polymorph, designated sigma, from crystals found within an amorphous solid dispersion. Subsequent experiments produced the same form by solvent evaporation. The work demonstrates structure determination directly from a formulation-related sample containing an excipient; it does not establish improved dissolution or clinical performance for the new form.

MicroED structure determinationPharmaceutical solid stateFormulation Development & Manufacturing
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DOI: 10.1107/s2052252524008121

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