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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Pediatric Formulation Optimization Using a Rational Design: Exploring Amorphous Solid Dispersion Technology with

Izabelle Amorim Ferreira Boza1, Stéfani Laise da Silva1, Nicolly Bittencourt Guedes2

  • 1Department of Chemistry, Center for Physical and Mathematical Sciences, Federal University of Santa Catarina, Florianópolis, SC, 88040-900, Brazil.

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Summary

Developing pediatric antifungal formulations for terbinafine hydrochloride (TER) is challenging due to its low solubility. Researchers identified Soluplus® as a promising carrier for amorphous solid dispersions, enhancing TER solubility and bioavailability in children.

Keywords:
amorphous solid dispersionoral drug administrationpediatric formulationrational designsolubilityterbinafine hydrochloride

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Pediatric Formulations

Background:

  • Pediatric formulations face unique challenges, especially for drugs like terbinafine hydrochloride (TER), an antifungal with low aqueous solubility.
  • Tinea capitis, a common pediatric fungal infection, requires effective oral treatments, but TER's poor solubility hinders oral bioavailability.

Purpose of the Study:

  • To rationally select suitable, pediatric-approved carriers for enhancing TER's apparent solubility.
  • To develop amorphous solid dispersions (ASDs) of TER using spray drying for improved oral bioavailability in pediatric patients.

Main Methods:

  • Evaluated solubility parameters, equilibrium solubility, and pediatric dose numbers for carrier selection.
  • Utilized Plasdone S-360 ULTRA®, HPMCAS L, and Soluplus® as potential carriers.
  • Characterized drug-carrier interactions and solid-state properties using various techniques.
  • Prepared ASDs of TER using spray drying with the selected carrier.

Main Results:

  • Solubility of TER was pH-dependent, with highest solubility observed in pH 6.5 buffer with 10% Soluplus®.
  • Soluplus® yielded the lowest pediatric dose number (0.23) for children over 6 years old.
  • Spray-dried ASDs significantly enhanced TER's apparent solubility and maintained prolonged supersaturation.
  • No phase transitions or significant drug-carrier interactions were observed.

Conclusions:

  • Soluplus® is a suitable carrier for developing TER amorphous solid dispersions for pediatric oral formulations.
  • Spray-dried ASDs of TER with Soluplus® offer a promising strategy to improve oral bioavailability and efficacy in children.
  • This approach addresses the challenges of developing effective oral antifungal treatments for pediatric patients.