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Related Experiment Videos

Tablet dissolution affected by a moisture mediated solid-state interaction between drug and disintegrant.

B R Rohrs1, T J Thamann, P Gao

  • 1Pharmaceutical Development, Pharmacia & Upjohn, Kalamazoo, Michigan 49001, USA. brian.r.rohrs@am.pnu.com

Pharmaceutical Research
|January 22, 2000
PubMed
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High humidity decreases delavirdine mesylate tablet dissolution by converting the salt to its free base. This solid-state reaction, facilitated by water, reduces drug solubility and tablet deaggregation.

Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry
  • Drug Formulation

Background:

  • Delavirdine mesylate tablets are susceptible to changes in dissolution profiles.
  • High humidity can significantly impact tablet performance and drug release.

Purpose of the Study:

  • To determine the cause of reduced delavirdine mesylate 200 mg tablet dissolution after high humidity exposure.
  • To investigate the chemical and physical changes occurring within the tablets.

Main Methods:

  • Dissolution testing using USP 2 apparatus.
  • Karl Fischer titration for water content.
  • Solid-state analysis using 13C CP/MAS NMR and FT-IR spectroscopy.

Main Results:

  • Exposure to high humidity led to a substantial decrease in delavirdine mesylate tablet dissolution.

Related Experiment Videos

  • Approximately 30% conversion of delavirdine mesylate to its free base was observed.
  • A solid-state reaction between methanesulfonic acid and croscarmellose sodium was identified.

    • Conclusions:

    • Water acts as a reaction medium and plasticizer, facilitating the conversion of delavirdine mesylate to its free base.
    • The reduced solubility of the delavirdine free base significantly lowers dissolution extent.
    • Altered inter-particle bonding contributes to decreased tablet deaggregation during dissolution.