Evidence map›Paper›PMID 28924630›Full record

ReviewThe AAPS journal2017

Role of In Vitro Release Methods in Liposomal Formulation Development: Challenges and Regulatory Perspective.

Deepak Solomon, Nilesh Gupta, Nihal S Mulla, Snehal Shukla, Yadir A Guerrero, Vivek Gupta

Abstract readReview
PubMed Publisher
In one paragraph

Review in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing 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

33 citing papers in PubMed.

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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

6 authors.

Deepak SolomonResearch and Development, Neofluidics LLC, 6650 Lusk Blvd, Suite B102, San Diego, California, 92121, USA.
Nilesh GuptaResearch and Development, Neofluidics LLC, 6650 Lusk Blvd, Suite B102, San Diego, California, 92121, USA.
Nihal S MullaDepartment of Pharmaceutical and Administrative Sciences, College of Pharmacy and Health Sciences, Drake University, 2507 University Ave, Des Moines, Iowa, 50311, USA.
Snehal ShuklaDepartment of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, St. Albert Hall, B14, Queens, New York, 11439, USA.
Yadir A GuerreroResearch and Development, Neofluidics LLC, 6650 Lusk Blvd, Suite B102, San Diego, California, 92121, USA.
Vivek GuptaDepartment of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, St. Albert Hall, B14, Queens, New York, 11439, USA. guptav@stjohns.edu.ORCID 0000-0002-3618-8178

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the past few years, measurement of drug release from pharmaceutical dosage forms has been a focus of extensive research because the release profile obtained in vitro can give an indication of the drug's performance in vivo. Currently, there are no compendial in vitro release methods designed for liposomes owing to a range of experimental challenges, which has created a major hurdle for both development and regulatory acceptance of liposome-based drug products. In this paper, we review the current techniques that are most often used to assess in vitro drug release from liposomal products; these include the membrane diffusion techniques (dialysis, reverse dialysis, fractional dialysis, and microdialysis), the sample-and-separate approach, the in situ method, the continuous flow, and the modified United States Pharmacopeia methods (USP I and USP IV). We discuss the principles behind each of the methods and the criteria that assist in choosing the most appropriate method for studying drug release from a liposomal formulation. Also, we have included information concerning the current regulatory requirements for liposomal drug products in the United States and in Europe. In light of increasing costs of preclinical and clinical trials, applying a reliable in vitro release method could serve as a proxy to expensive in vivo bioavailability studies. Graphical Abstract Appropriate in-vitro drug release test from liposomal products is important to predict the in-vivo performance.

Indexed as

Drug LiberationLiposomesChemistry, PharmaceuticalChromatography, GelMicrodialysisUltracentrifugationLiposomesdialysisin vitro releaseliposomesregulatoryUSP apparatus

Identifiers

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.