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Uneven Distribution of Microgranules in Divided Lansoprazole Tablets

Gillian A Teitelbaum1, Jonathan E Teitelbaum

  • 1*Biotechnology High School, Freehold †Department of Pediatric Gastroenterology and Nutrition, Unterberg Children's Hospital at Monmouth Medical Center, Long Branch, NJ.

Journal of Pediatric Gastroenterology and Nutrition
|April 18, 2015
PubMed

Insights

Dividing lansoprazole tablets for infants results in uneven microgranule distribution, impacting accurate pediatric dosing. Further clinical relevance assessment is needed for this common practice.

Area of Science:

  • Pediatric pharmacology
  • Gastroenterology
  • Pharmaceutical sciences

Background:

  • Lansoprazole, a proton pump inhibitor, is frequently prescribed for infants under 12 months.
  • There is a notable absence of efficacy and safety data for lansoprazole in this specific pediatric age group.
  • Healthcare providers often divide standard oral disintegrating tablets to achieve lower, weight-appropriate pediatric doses.

Purpose of the Study:

  • To investigate the uniformity of lansoprazole distribution within 15-mg oral disintegrating tablets.
  • To determine if dividing these tablets ensures accurate and consistent medication dosing for infants.

Main Methods:

  • Ten 15-mg lansoprazole (Prevacid SoluTabs) were bisected.
  • Each tablet half (A and B) and the residual dust (C) were dissolved independently.
  • Microgranules in each portion were counted using magnified images.

Main Results:

  • Significant differences were observed in microgranule counts between tablet halves A (2514.7 ± 130.5) and B (2342.9 ± 130.1).
  • The residual dust (C) contained a minimal number of microgranules (49.4 ± 38.8).
  • The total microgranule count per tablet averaged 4907 ± 140.5, with a statistically significant difference between halves (P = 0.0086).

Conclusions:

  • Significant variations in lansoprazole microgranule content exist between halves of divided tablets.
  • This uneven distribution raises concerns about therapeutic accuracy when dosing infants with divided lansoprazole.
  • Clinical relevance of these dosing discrepancies requires further evaluation by healthcare providers.
Abstract

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