Evidence map›Paper›PMID 33417081›Full record

ArticleAAPS PharmSciTech2021

Development of a Pediatric Mini-Tablet Formulation for Expedited Preclinical Studies.

Monika Lavan, Xueqi Wang, Robyn McCain, Amber Jannasch, Bruce Cooper, Scott Hostetler, Stephen Byrn, Gregory Knipp

Abstract read
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In one paragraph

Article in AAPS PharmSciTech, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Review
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

8 authors.

Monika LavanDepartment of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907-2091, USA.
Xueqi WangDepartment of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907-2091, USA.
Robyn McCainBindley Bioscience Center, Purdue University, West Lafayette, Indiana, USA.
Amber JannaschPurdue Translational Pharmacology CTSI Core Facility, Purdue University, West Lafayette, Indiana, USA.
Bruce CooperPurdue Translational Pharmacology CTSI Core Facility, Purdue University, West Lafayette, Indiana, USA.
Scott HostetlerElanco, 2500 Innovation Way, Greenfield, Indiana, USA.
Stephen ByrnDepartment of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907-2091, USA.
Gregory KnippDepartment of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907-2091, USA. gknipp@purdue.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Multiple considerations are essential to address the main challenges of dose flexibility and patient adherence in pediatric drug development, particularly for oncology. Mini-tablets, 2 mm in diameter, were manufactured using a rotary tablet press at a set weight and compression force level. The physical characteristics were consistent for mini-tablets throughout multiple batches. Polymeric amorphous solid dispersion (ASD) was used as a solubility enhancing technique to increase solubility and exposure of lapatinib. The effects of the polymeric excipient and disintegrant on drug release properties were investigated. While having a lower apparent solubility and shorter storage stability, hydroxypropyl methylcellulose E3 (HPMCE3) formulation provided a higher percentage of drug release compared to hydroxypropyl methylcellulose phthalate (HPMCP). The intermolecular interaction within the ASD system plays a role in the level of apparent solubility, physical stability, and concentration of free drug available in an aqueous environment. Juvenile porcine models at two different weight groups (10 and 20 kg) were used to obtain the pharmacokinetic parameters of lapatinib. While the dose-normalized exposure of drug was found to be lower in the pig study, the dose flexibility of mini-tablets enabled a constant dose level to be administered to achieve equivalent plasma concentration-time profiles between the two groups. This linear scaling in the amount of drug in pediatric and adult population has also been observed in human clinical studies.

Indexed as

AnimalsChildDrug CompoundingDrug DevelopmentDrug LiberationHumansLapatinibSolubilitySwineTabletsLapatinibTabletsAmorphous dispersionJuvenile porcine modelMini-tabletsPediatric drug deliveryPharmacokinetics

Identifiers

PMID33417081

What OpenQuestion holds

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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.