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Development of Losartan Orally Disintegrating Tablets by Direct Compression: a Cost-Effective Approach to Improve

Candela Juan1,2, Loreana Gallo1,3, Noelia Gonzalez Vidal4,5

  • 1Departamento de Biología, Bioquímica y Farmacia-Universidad Nacional del Sur (UNS), Bahía Blanca, Buenos Aires, Argentina.

AAPS Pharmscitech
|April 8, 2024
PubMed

Insights

This study developed orally disintegrating tablets (ODTs) for pediatric arterial hypertension treatment using losartan potassium. The ODTs demonstrated rapid drug release and stability, offering a promising new dosage form for children.

Area of Science:

  • Pharmacology
  • Pharmaceutical Technology
  • Pediatric Medicine

Background:

  • Effective pharmacological treatment in children requires suitable dosage forms.
  • Orally disintegrating tablets (ODTs) offer advantages like ease of administration and dosage accuracy, particularly for pediatric patients.
  • Arterial hypertension in children necessitates specialized and accessible treatment options.

Purpose of the Study:

  • To develop and characterize orally disintegrating tablets (ODTs) containing losartan potassium (LP) for treating arterial hypertension in children.
  • To evaluate the impact of various superdisintegrants and diluents on ODT properties.
  • To assess the in vitro performance and preliminary stability of the developed ODTs.

Main Methods:

  • Losartan potassium ODTs were formulated using direct compression with different superdisintegrants and diluents.
  • Thirty formulations were evaluated for disintegration time, hardness, and friability.
  • Drug-excipient compatibility, tabletability, flow properties, in vitro dissolution, and preliminary stability were assessed.

Main Results:

  • Two formulations met optimal criteria for disintegration time (<30 s), hardness, and friability (≤1.0%).
  • Developed ODTs exhibited favorable drug-excipient compatibility, tabletability, and flow characteristics.
  • In vitro dissolution studies showed very rapid drug release, and stability studies indicated the need for protective packaging, with retained quality after 12 months in airtight containers.

Conclusions:

  • Successfully developed and characterized losartan potassium ODTs suitable for pediatric use.
  • The ODTs represent a potential advancement in the treatment of childhood arterial hypertension.
  • Further development into a final prototype is warranted to improve pediatric hypertension management.

Keywords:
arterial hypertensionlosartan potassiumorally disintegrating tabletsorphan formulationpaediatric

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