Evidence map›Paper›PMID 33447869›Full record

ArticleAAPS PharmSciTech2021

Novel Application of Hot Melt Extrusion Technology for Preparation and Evaluation of Valacyclovir Hydrochloride Ocular Inserts.

Gauri Shadambikar, Sushrut Marathe, Akash Patil, Rohit Joshi, Suresh Bandari, Soumyajit Majumdar, Michael Repka

Abstract read
PubMed Full text at PMC Publisher
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 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
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  5. 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

7 authors.

Gauri ShadambikarDepartment of Pharmaceutics and Drug Delivery, Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, Mississippi, 38677, USA.
Sushrut MaratheDepartment of Pharmaceutics and Drug Delivery, Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, Mississippi, 38677, USA.
Akash PatilDepartment of Pharmaceutics and Drug Delivery, Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, Mississippi, 38677, USA.
Rohit JoshiDepartment of Pharmaceutics and Drug Delivery, Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, Mississippi, 38677, USA.
Suresh BandariDepartment of Pharmaceutics and Drug Delivery, Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, Mississippi, 38677, USA.
Soumyajit MajumdarDepartment of Pharmaceutics and Drug Delivery, Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, Mississippi, 38677, USA.
Michael RepkaDepartment of Pharmaceutics and Drug Delivery, Pii Center for Pharmaceutical Technology, School of Pharmacy, University of Mississippi, University, Mississippi, 38677, USA. marepka@olemiss.edu.

Funding

Center of Research Excellence in Natural Products Neuroscience (CORE-NPN)P20GM104932 · NIGMS · UNIVERSITY OF MISSISSIPPI · PI MAJUMDAR, SOUMYAJIT · 2012 to 2016
$10.0M
NIGMS NIH HHS P20 GM104932
6 · The paper itself

Abstract

The objective of this study was to investigate the processability of hot-melt extrusion (HME) to formulate ocular inserts of valacyclovir hydrochloride and evaluate the in vivo bioavailability of the formulation. To optimize the formulation of this drug, different physical mixtures of the polymers and plasticizer were prepared. The physical mixture was extruded through a co-rotating twin-screw extruder, and the obtained ocular inserts were cut with dimensions of 4 mm × 2 mm × 1 mm to enhance the formulation instillation in the eye. Ocular inserts were evaluated for drug content, weight variation, uniformity of thickness, in vitro drug release, and in vivo drug bioavailability. The ocular inserts were thermally characterized using differential scanning calorimetry (DSC). The attributes observed for the ocular inserts were within the target specifications. The ocular inserts of valacyclovir hydrochloride were successfully prepared using the HME. They provided sustained drug release along with enhanced drug permeation when compared with the eyedrop solution and dissolve completely in 8 h. Additionally, the obtained results demonstrated that the formulation of ocular inserts of valacyclovir hydrochloride using HME was reproducible, robust, and effective method.

Indexed as

Drug ImplantsHot Melt Extrusion TechnologyAdministration, OphthalmicAntiviral AgentsBiological AvailabilityCalorimetry, Differential ScanningDrug CompoundingDrug LiberationKeratitis, HerpeticPolymersValacyclovirAntiviral AgentsDrug ImplantsPolymersValacycloviracyclovirantiviralhot-melt extrusionocular drug deliveryocular inserts

Identifiers

PMID33447869
PMCPMC7886274

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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.