Preferential Oxycodone Loss of Physically Manipulated Abuse Deterrent Oxycodone HCl Extended Release Tablets Prepared for Nasal Insufflation Studies.

Zhengjie Meng, Heather J Boyce, Dajun Sun, Minori Kinjo, Saeid Raofi, Tonglei Li

Abstract read

In one paragraph

Article in Pharmaceutical research, 2021. 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

0.4field-weighted citation impact, top 35% of its field

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, 3 citations in OpenAlex.

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 at 3 institutions in 2 countries.

Zhengjie MengDepartment of Industrial and Physical Pharmacy, Purdue University, RHPH Building, RM 124, 575 Stadium Mall Dr, West Lafayette, Indiana, 47907, USA.

Heather J BoyceOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Building 75, RM 4692, 10903 New Hampshire Ave, Silver Spring, MD, 21231, USA. heather.boyce@fda.hhs.gov.ORCID http://orcid.org/0000-0001-9817-7784

Dajun SunOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Building 75, RM 4692, 10903 New Hampshire Ave, Silver Spring, MD, 21231, USA.

Minori KinjoOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Building 75, RM 4692, 10903 New Hampshire Ave, Silver Spring, MD, 21231, USA.

Saeid RaofiOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Building 75, RM 4692, 10903 New Hampshire Ave, Silver Spring, MD, 21231, USA.

Tonglei LiDepartment of Industrial and Physical Pharmacy, Purdue University, RHPH Building, RM 124, 575 Stadium Mall Dr, West Lafayette, Indiana, 47907, USA. tonglei@purdue.edu.

United States Food and Drug Administration · USNanjing Tech University · CNPurdue University West Lafayette · US

Funding

FDA HHS HHSF223201510138C

6 · The paper itself

Abstract

A method to reproducibly mill abuse deterrent oxycodone hydrochloride (HCl) extended release (ER) tablets was developed for a nasal insufflation pharmacokinetic (PK) study. Several comminution methods were explored before determining that a conical mill resulted in controlled milling of tablets to a size range equal to or below 1000 μm. However, milling resulted in significant loss of oxycodone from abuse deterrent oxycodone HCl ER tablets compared to minimal oxycodone loss from oxycodone HCl immediate release (IR) tablets. Characterization of milled tablet powder showed that loss of oxycodone was not attributed to analytical procedures or oxycodone phase change during high intensity milling processes. The content uniformity of oxycodone in the milled tablet powder varied when ER and IR tablets were milled to a particle size distribution equal to or below 500 μm but did not vary when particles were sized above 500 µm to equal to or below 1000 μm. In addition, the initial excipient weight to drug substance weight ratio impacted the amount of oxycodone lost from the respective formulation. However, dissolution demonstrated that when oxycodone HCl ER tablets are milled, differences in excipient weight to drug substance weight ratio and particle size distribution of milled tablets did not result in significantly different release of oxycodone.

Indexed as

Abuse-Deterrent FormulationsAnalgesics, OpioidChemistry, PharmaceuticalDelayed-Action PreparationsDrug CompoundingDrug LiberationInsufflationMorphine DependenceOxycodonePowdersSingle Molecule ImagingTabletsAbuse-Deterrent FormulationsAnalgesics, OpioidDelayed-Action PreparationsOxycodonePowdersTabletsdissolutiondrug lossmillingopioidspolyethylene oxide (PEO)

Identifiers

PMID34128146

DOI10.1007/s11095-021-03066-0

OpenAlexW3171594258

What OpenQuestion holds

Textmetadata

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 OpenQuestion graph.