Evidence map›Paper›PMID 42525646›Full record

ArticlePloS one2026

Formulation development of a biphasic release tablet-in-tablet system containing ketorolac tromethamine.

Ping Zou, Yuan Zeng, Xiang-Ru Liao, Xiang-Yang Xie, Yin-Ke Li, Yi-Hui Ma, Hui Liu

Abstract read
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

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

7 authors.

Ping ZouDepartment of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Yuan ZengDepartment of Pharmacy, General Hospital of Central Theater Command, Wuhan, China.
Xiang-Ru LiaoDepartment of Pharmacy, General Hospital of Central Theater Command, Wuhan, China.
Xiang-Yang XieCollege of Nursing and Health Management & College of Life Science and Chemistry, Wuhan Donghu University, Wuhan, China.ORCID https://orcid.org/0000-0001-8260-3988
Yin-Ke LiDepartment of Pharmacy, General Hospital of Central Theater Command, Wuhan, China.
Yi-Hui MaDepartment of Stomatology, General Hospital of Central Theater Command, Wuhan, China.
Hui LiuDepartment of Clinical Pharmacy, General Hospital of Central Theater Command, Wuhan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ketorolac tromethamine (KT) is a potent nonsteroidal anti-inflammatory drug (NSAID) used for moderate to severe pain management. Its short elimination half-life necessitates frequent dosing, which can reduce patient compliance. The objective of this study was to formulate, develop, and optimize a novel biphasic-release tablet-in-tablet (TIT) system for KT to provide immediate pain relief followed by extended drug release. A TIT system was designed, comprising an immediate-release (IR) outer layer and an extended-release (ER) core matrix. The ER core was optimized using a 32 full factorial design, with the amounts of HPMC K100M and HPMC K4M as independent variables. Formulations were evaluated for pre- and post-compression parameters, drug-excipient compatibility, and in vitro drug release. The drug release kinetics and mechanism were analyzed using various mathematical models. The optimal ER core formulation (F1) exhibited a drug release of 4.6% at 0.5 h and 66.1% at 12 h, closely matching the theoretical profile (similarity factor f2 = 51). Release kinetics followed the first-order model and the Korsmeyer-Peppas model indicated an anomalous (non-Fickian) release mechanism (n = 0.831). The corresponding TIT formulation (F11) demonstrated desired physicochemical properties: hardness of 75 N, friability of 0.59%, and rapid outer layer disintegration (<50 s). The TIT provided an initial burst release (~30%) within 30 minutes, followed by sustained release exceeding 90% over 24 hours. This TIT system represents a promising alternative to conventional KT tablets for effective pain management.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalKetorolac TromethamineTabletsChemistry, PharmaceuticalDelayed-Action PreparationsDrug LiberationExcipientsKineticsAnti-Inflammatory Agents, Non-SteroidalDelayed-Action PreparationsExcipientsKetorolac TromethamineTablets

Identifiers

PMID42525646
PMCPMC13421754

What Socratic holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.