Evidence map›Paper›PMID 34378150›Full record

ArticlePharmaceutical research2021

Lipid Based Formulations in Hard Gelatin and HPMC Capsules: a Physical Compatibility Study.

Niklas J Koehl, Sanket Shah, Ingrid Djouka Tenekam, Tatsiana Khamiakova, Nicolas Sauwen, Sien Vingerhoets, Hans Coppenolle, René Holm

Abstract read
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Article in Pharmaceutical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 38% 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

5 citing papers in PubMed, 10 citations in OpenAlex.

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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 at 2 institutions in 3 countries.

Niklas J Koehl *Drug Product Development, Janssen Research and Development, Johnson & Johnson, Turnhoutseweg 30, 2340, Beerse, Belgium.
Sanket Shah *Drug Product Development, Janssen Research and Development, Johnson & Johnson, Turnhoutseweg 30, 2340, Beerse, Belgium.
Ingrid Djouka TenekamDrug Product Development, Janssen Research and Development, Johnson & Johnson, Turnhoutseweg 30, 2340, Beerse, Belgium.
Tatsiana KhamiakovaQuantitative Sciences, Janssen Research and Development, Johnson and Johnson, Turnhoutseweg 30, 2340, Beerse, Belgium.
Nicolas SauwenOpen Analytics NV, Jupiterstraat 20, 2600, Antwerp, Belgium.
Sien VingerhoetsDrug Product Development, Janssen Research and Development, Johnson & Johnson, Turnhoutseweg 30, 2340, Beerse, Belgium.
Hans CoppenolleQuantitative Sciences, Janssen Research and Development, Johnson and Johnson, Turnhoutseweg 30, 2340, Beerse, Belgium.
René HolmDrug Product Development, Janssen Research and Development, Johnson & Johnson, Turnhoutseweg 30, 2340, Beerse, Belgium. reho@sdu.dk.ORCID http://orcid.org/0000-0003-4894-7765
Janssen (Belgium) · BEJohnson & Johnson (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the compatibility between hard gelatin and HPMC capsules with a range of different isotropic lipid based formulations containing multiple excipients.

methodsThe miscibility was investigated for 350 systems applying five different oils (Labrafac ™ lipophile WL1349, Maisine® CC, Captex 300 EP/NF, olive oil, and Capmul MCM EP/NF), five different surfactans (Labrasol ® ALF, Labrafil M 2125 CS, Kolliphor ® ELP, Kolliphor ® HS 15, Tween 80) and three different cosolvents (propylene glycol, polyethylene glycol 400, and Transcutol ® HP). For the isotropic systems capsule compatibility was investigated in both gelatin and HPMC capsules at 25°C at 40% and 60% relative humidity by examining physical damages to the capsules and weight changes after storage.

resultsThe miscibility of lipid based vehicles was best when the formulation contained monoglycerides and surfactants with a hydrophilic-lipophilic balance value <12. Gelatin capsules in general resulted in a better compatibility when compared to HPMC capsules for the evaluated formulations. Addition of water to the formulation improved the capsule compatibility for both capsule types. The expected capsule mass change could partly be predicted in binary systems using the provided data of the single excipients weighted for its formulation proportion.

conclusionsThe capsule compatibility was driven by the components incorporated into the formulations, where more was compatible with gelatin than HPMC capsules. Prediction of the mass change from individual excipient contributions can provide a good first estimate if a vehicle is compatible with a capsule, however, this needs to be proved experimentally.

Indexed as

CapsulesDrug CompoundingExcipientsGelatinHypromellose DerivativesLipidsSolubilityCapsulesExcipientsGelatinHypromellose DerivativesLipidscapsule compatibilityhard gelatin capsulesHPMC capsuleslipid based formulationlipid excipientsliquid filled capsuleSNEDDSsoft gel capsules

Identifiers

PMID34378150
OpenAlexW3192216516

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.