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Related Experiment Videos

Effect on dissolution from halving methylphenidate extended-release tablets

J Erramouspe1, E J Jarvi

  • 1Department of Pharmacy Practice and Administrative Sciences, College of Pharmacy, Idaho State University, Pocatello 83209, USA.

The Annals of Pharmacotherapy
|October 24, 1997
PubMed
Summary
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Cutting methylphenidate extended-release tablets in half significantly increased in vitro dissolution, particularly within the first two hours. However, the overall differences were not substantial, suggesting it may be a viable method for dose adjustment.

Area of Science:

  • Pharmacology
  • Pharmaceutical Sciences
  • Drug Delivery

Background:

  • Methylphenidate is a central nervous system stimulant used to treat ADHD.
  • Extended-release formulations are designed for sustained drug delivery.
  • Dosage adjustments are common in clinical practice.

Purpose of the Study:

  • To evaluate the impact of halving methylphenidate extended-release tablets on their in vitro dissolution profile.
  • To compare the dissolution of whole versus halved tablets for both branded and generic formulations.

Main Methods:

  • Utilized US Pharmacopeia dissolution methods for Ritalin-SR and generic methylphenidate extended-release tablets.
  • Tested tablets in both whole and halved conditions.
  • Analyzed methylphenidate content using High-Performance Liquid Chromatography (HPLC) at various time points.

Related Experiment Videos

Main Results:

  • Halving tablets led to a statistically significant increase in cumulative dissolution starting at 15 minutes.
  • Maximum dissolution differences between whole and halved tablets were observed at 2 hours (e.g., 57% vs. 74% for Ritalin-SR).
  • Dissolution profiles became parallel after 2 hours, with no significant difference by 7 hours.

Conclusions:

  • Statistically significant differences in in vitro dissolution exist when methylphenidate extended-release tablets are halved.
  • The absolute differences in dissolution are relatively small.
  • Halving these tablets could be a clinically acceptable method for minor dose adjustments.