ArticlePharmaceutical medicine2026
Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation.
Article in Pharmaceutical medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Not yet cited in PubMed.
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.
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.
A Phase 1/2 Study of Crizotinib, an Oral Small Molecule Inhibitor of Anaplastic Lymphoma Kinase (ALK) and C-Met, in Children With Relapsed/Refractory Solid Tumors and Anaplastic Large Cell Lymphoma
A Phase 1 Study of Crizotinib in Combination With Conventional Chemotherapy for Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
A Phase 1, Open-label, Crossover Taste And Pharmacokinetic Study In Healthy Adult Volunteers To Evaluate The Palatability And Estimate The Bioavailability Of Three Prototype Formulations Of Crizotinib
A Phase 1, Open-label, Single Dose Study To Evaluate The Effects Of Food And The Proton Pump Inhibitor, Esomeprazole, On The Pharmacokinetics Of Crizotinib In A Coated Microsphere Formulation In Adult Healthy Volunteers
A phase 1, open label, crossover study to evaluate palatability and relative bioavailability of two pediatric microsphere formulations of crizotinib in healthy participants
A PHASE 1, OPEN-LABEL, CROSSOVER STUDY TO ESTABLISH BIOEQUIVALENCE OF AN ENCAPSULATED MICROSPHERE FORMULATION (eMS) TO THE FORMULATED CAPSULE (FC) OF CRIZOTINIB IN HEALTHY ADULT PARTICIPANTS
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDeveloping pediatric dosage forms remains challenging, particularly for poorly palatable drugs, which can limit tolerability and adherence. Crizotinib, an anaplastic lymphoma kinase inhibitor used to treat rare pediatric cancers, was initially available only as an oral solution or capsules, with the solution demonstrating unacceptable taste in pediatric patients.
objectivesThe objectives of this work were to outline results from clinical studies supporting the crizotinib pediatric formulation development and commercialization process, summarize key clinical and formulation challenges encountered, and present lessons learned from an over-a-decade-long development process.
methodsSix clinical studies conducted in pediatric patients and healthy adult participants were collectively used to evaluate palatability, tolerability, pharmacokinetics, and bioequivalence of multiple crizotinib formulations. These studies assessed an oral solution and taste-masked microsphere formulations under fasted, fed, and proton pump inhibitor coadministration conditions, using validated palatability assessments and pharmacokinetic endpoints.
resultsEarly oral solution formulations showed poor palatability, contributing to reduced tolerability and discontinuation in some pediatric patients. Taste-masked microsphere formulations improved palatability but initially showed reduced drug absorption under elevated gastric pH conditions. Reformulation with a pH-independent Opadry SGR coating resulted in a microsphere formulation that achieved acceptable palatability and consistent pharmacokinetic performance and demonstrated bioequivalence to the commercial adult capsule.
conclusionsThis over-a-decade-long clinical development program led to the commercialization of a palatable, dose-flexible, oral solid multiparticulate pediatric formulation of crizotinib for patients with anaplastic large cell lymphoma or inflammatory myofibroblastic tumors. The clinical outcomes and development strategy described herein provide a practical framework to support future pediatric formulation development programs. CLINICALTRIALS: gov trial registration number (date of registration): NCT00939770 (15 Jul 2009), NCT01606878 (28 May 2012), NCT02006277 (10 Dec 2013), NCT03137134 (02 May 2017), NCT03978143 (06 Jun 2019), NCT04856293 (23 Apr 2021, retrospectively registered).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.