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New Orodispersible Mini Tablets of Enalapril Maleate by Direct Compression for Pediatric Patients

Claudia A Ortega1, Laura S Favier1, Valeria A Cianchino1

  • 1Area de Tecnologia Farmaceutica, Universidad Nacional de San Luis, Ejercito de los Andes, San Luis (5700), Argentina.

Current Drug Delivery
|May 9, 2020
PubMed

Insights

This study developed orodispersible mini-tablets (ODMTs) for pediatric hypertension using enalapril maleate. Formulation A with StarLac® demonstrated optimal hardness, disintegration, and wetting times, meeting pediatric dosage requirements.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Pharmacology

Background:

  • Pediatric hypertension poses significant mortality and morbidity risks.
  • Developing specialized pharmaceutical forms for children is crucial.
  • Orodispersible mini-tablets (ODMTs) are gaining importance for pediatric drug delivery.

Purpose of the Study:

  • To design and develop orodispersible mini-tablets (ODMTs) of enalapril maleate for pediatric use.
  • To evaluate the suitability of different co-processed excipients for pediatric ODMT formulations.

Main Methods:

  • Five pharmaceutical formulations (A-E) were designed using lactose co-processed excipients (Tablettose® 80, Microce- Lac® 100, StarLac®).
  • Micromeritic properties of physical mixtures were assessed.
  • Mini tablets were produced via direct compression and quality control parameters were evaluated per US Pharmacopeia standards.

Main Results:

  • Three ODMTs utilizing StarLac® exhibited favorable hardness, flowability, and rapid disintegration.
  • Formulation A, containing 0.1 mg enalapril maleate, showed optimal hardness (4.0 kp), friability (<1%), disintegration (28s), content uniformity (103.6%), and wetting time (23s).

Conclusions:

  • Three ODMT formulations with StarLac® met official quality standards for pediatric use.
  • Formulation A demonstrated excellent wetting time and appropriate pediatric dosage, making it suitable for industrial-scale manufacturing.
Abstract

Keywords:
Co-processed excipientsDirect compressionEnalapril maleateHypertensionOrodispersible mini tabletsPediatric form

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