Evidence map›Paper›PMID 41625778›Full record

ArticleInternational journal of pharmaceutics: X2026

Double action of HPMCAS as a dry binder and precipitation inhibitor in ASD tablet formulations of nifedipine prepared by hot-melt extrusion.

David S Nakhla, Saurabh M Mishra, Christian Lübbert, Luis Mejia, Kess Agatovure, Andreas Sauer

Abstract read
In one paragraph

Article in International journal of pharmaceutics: X, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

David S NakhlaSE Tylose USA Inc., Pharmaceutical Application Laboratory, Totowa, NJ 07512, USA.
Saurabh M MishraSE Tylose USA Inc., Pharmaceutical Application Laboratory, Totowa, NJ 07512, USA.
Christian LübbertAmofor GmbH, Otto-Hahn-Str. 15, Dortmund D-44227, Germany.
Luis MejiaSE Tylose USA Inc., Pharmaceutical Application Laboratory, Totowa, NJ 07512, USA.
Kess AgatovureSE Tylose USA Inc., Pharmaceutical Application Laboratory, Totowa, NJ 07512, USA.
Andreas SauerSE Tylose GmbH & Co. KG, Kasteler Str. 45, 65203 Wiesbaden, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Poor tablet hardness and drug re-crystallization are two common challenges of amorphous solid dispersion (ASD) formulations prepared with hot-melt extrusion (HME). In the present study, we investigated the double action of hypromellose acetate succinate (HPMCAS) as a dry binder and precipitation inhibitor when externally added to high ASD load (65 %) tablets of nifedipine (NIF). Binary ASDs of NIF were prepared using either HPMCAS or copovidone (Kollidon® VA 64, PVP-VA64) as carrier polymers. Pre-dissolving HPMCAS (AS-HF) in the dissolution medium inhibited the drug precipitation and prolonged its supersaturation state at 12.5 wt % or 100 wt % relative to NIF content in ASDs prepared with either HPMCAS (1: 2, drug: polymer), or PVP-VA64 (1: 6, drug: polymer), respectively. In contrast, pre-dissolving hydroxypropyl cellulose (Klucel™, HPC-EXF) or PVP-VA64, did not prevent the drug re-crystallization. The external addition of AS-HF (5 %

Indexed as

Amorphous solid dispersionsDry binderHot-melt-extrusionHPMCASPrecipitation inhibitionSupersaturation

Identifiers

PMID41625778
PMCPMC12856634

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.