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DoE-based Development of Transdermal Risedronate-laden Cubosomes: In Vitro Characterization, Drug Deposition, and In

Amrendra J Gautam1, Sarika Wairkar2

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This study developed a novel risedronate-loaded cubosomal gel for transdermal osteoporosis treatment. The new formulation significantly enhances drug bioavailability and skin retention, offering a patient-friendly alternative to oral medications.

Keywords:
central composite designcubosomesdrug depositionimproved skin permeationrisedronate

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Area of Science:

  • Pharmaceutical Sciences
  • Biomaterials Science
  • Drug Delivery Systems

Background:

  • Osteoporosis management is challenged by risedronate's poor oral bioavailability and gastrointestinal side effects.
  • Transdermal delivery offers a potential alternative to overcome oral limitations of bisphosphonates like risedronate.

Purpose of the Study:

  • To develop and characterize risedronate-loaded cubosomes for enhanced transdermal delivery.
  • To evaluate the efficacy and safety of the cubosomal formulation as a transdermal system for osteoporosis treatment.

Main Methods:

  • Cubosomes were fabricated using a top-down approach and optimized using Central Composite Design.
  • Formulations were characterized for particle size, PDI, zeta potential, entrapment efficiency, and in vitro drug release.
  • In vitro skin permeation, ex vivo studies, skin irritation tests, and in vivo pharmacokinetic evaluations were performed.

Main Results:

  • Optimized cubosomes showed favorable physicochemical properties: 61.45 nm size, 0.312 PDI, -24.27 mV zeta potential, and 90.65% entrapment efficiency.
  • The cubosomal gel demonstrated significantly enhanced ex vivo skin permeation (0.184 mg/cm²·h) compared to plain risedronate (0.0069 mg/cm²/h).
  • In vivo studies revealed a 1.39-fold increase in bioavailability versus plain risedronate and a 3-fold increase compared to oral tablets.

Conclusions:

  • Risedronate-loaded cubosomal gel represents a promising, patient-friendly transdermal system for osteoporosis management.
  • The developed cubosomal formulation overcomes the limitations of oral risedronate, improving therapeutic outcomes.
  • This novel delivery system warrants further investigation for clinical application in osteoporosis treatment.