Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Blinding controlled-release tablets for clinical trials.

Linda A Felton1, Cody J Wiley

  • 1College of Pharmacy, University of New Mexico, Albuquerque, New Mexico 87131, USA. lfelton@unm.edu

Drug Development and Industrial Pharmacy
|February 27, 2003
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Spray drying Eudragit® E-PO with acetaminophen using 2- and 3-fluid nozzles for taste masking.

International journal of pharmaceutics·2024
Same author

Readers' Comments An Explanation for the Effect of Different Storage Conditions on Sublingual Nitroglycerin Tablet Stability.

The American journal of cardiology·2019
Same author

Open-Label Study of the Stability of Sublingual Nitroglycerin Tablets in Simulated Real-Life Conditions.

The American journal of cardiology·2018
Same author

Use of polymers for taste-masking pediatric drug products.

Drug development and industrial pharmacy·2018
Same author

Influence of relative humidity during coating on polymer deposition and film formation.

International journal of pharmaceutics·2016
Same author

Influence of temperature and relative humidity conditions on the pan coating of hydroxypropyl cellulose molded capsules.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2015
Same journal

Preparation and Characterisation of Pre-Nanoemulsions Encapsulating Multiple Oil-Soluble Active Substances.

Drug development and industrial pharmacy·2026
Same journal

Synergistic anticancer potential of andrographolide and paclitaxel: a dose-reduction strategy to minimize toxicity and enhance therapeutic efficacy.

Drug development and industrial pharmacy·2026
Same journal

Sustainable nanomaterial production from fruit waste: green synthesis of ZnO nanoparticles for antioxidant, antimicrobial, and therapeutic applications in wound healing and cancer therapy.

Drug development and industrial pharmacy·2026
Same journal

Biocompatible and bio-orthogonal surface engineering of inorganic self-assembled nanocrystals for precision drug targeting: a review.

Drug development and industrial pharmacy·2026
Same journal

Next-generation drug delivery for age-related macular degeneration: promise of controlled release formulations.

Drug development and industrial pharmacy·2026
Same journal

Design, optimization, and evaluation of ferulic acid-loaded cubosomal cream for enhanced topical delivery and anti-hyperpigmentation efficacy.

Drug development and industrial pharmacy·2026
See all related articles

Overcoating Wellbutrin SR tablets with hydroxypropyl methylcellulose effectively blinded them without affecting drug release. However, this method failed for other controlled-release products due to tablet design and mechanical integrity issues.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Clinical Trial Methodology

Background:

  • Blinding is crucial for clinical trials to prevent bias.
  • Controlled-release formulations present unique challenges for blinding due to their complex designs.

Purpose of the Study:

  • To develop and evaluate an overcoating method for blinding Wellbutrin SR 150 mg tablets.
  • To assess the applicability of this overcoating technique for other controlled-release products (Glucotrol XL, Theo-Dur).

Main Methods:

  • Overcoating Wellbutrin SR tablets with hydroxypropyl methylcellulose (Opadry II) at varying weight gains.
  • Comparative dissolution testing of coated and uncoated Wellbutrin SR tablets.
  • Application of the overcoating technique to Glucotrol XL and Theo-Dur tablets, followed by evaluation.

Related Experiment Videos

Main Results:

  • Overcoating successfully blinded Wellbutrin SR tablets with no significant impact on drug release over 8 hours.
  • The overcoating method was unsuccessful for Glucotrol XL and Theo-Dur due to tablet features (debossing, laser-drilled hole) and mechanical weakness.
  • Dissolution testing showed significantly higher drug release from blinded Glucotrol XL tablets compared to unblinded ones at 12 hours.

Conclusions:

  • Hydroxypropyl methylcellulose overcoating is a viable blinding method for certain sustained-release tablets like Wellbutrin SR.
  • This technique may not be universally applicable to all controlled-release formulations, particularly those with intricate designs or structural vulnerabilities.
  • Further research is needed to adapt blinding strategies for diverse controlled-release drug products.