Abstract
Objective: The objectives of this study were to formulate and characterize nanoparticles gel of timolol maleate (TM) by ionic gelation method using chitosan (CS) and sodium alginate (SA).
 Methods: Optimization was carried out by factorial design using Design Expert®10.0.1 software to obtain the concentration of CS, SA, and calcium chloride (CaCl2) to produce the optimum formula of TM nanoparticles. The optimum formula was characterized for particle size, polydispersity index, entrapment efficiency, Zeta potential, and molecular structure. Hydroxy Propyl Methyl Cellulose (HPMC) K15 was incorporated into optimum formula to form nanoparticles gel of TM and carried out in vivo release study using the Franz Diffusion Cell.
 Results: TM nanoparticles was successfully prepared with concentration of CS, SA, and CaCl2 of 0.01 % (w/v), 0.1 % (w/v), and 0.25 % (w/v), respectively. The particle size, polydispersity index, entrapment efficiency, and Zeta potential were found to be 200.47±4.20 nm, 0.27±0.0154, 35.23±4.55 %, and-5.68±1.80 mV, respectively. The result of FTIR spectra indicated TM-loaded in the nanoparticles system. In vitro release profile of TM-loaded nanoparticles gel showed controlled release and the Korsmeyer-Peppas model was found to be the best fit for drug release kinetics.
 Conclusion: TM-loaded CS/SA nanoparticles gel was successfully prepared and could be considered as a promising candidate for controlled TM delivery of infantile hemangioma treatment.
Highlights
Infantile hemangioma (IH) is the most prevalent vascular benign tumor in children with an incidence of about 4 to 10 % in the first year of life [1]
The Korsmeyer-Peppas model was found to be the best fit for drug release kinetics
The best formula was prepared with concentration of CS, sodium alginate (SA), and CaCl2 of 0.01 % w/v, 0.1 % w/v, and 0.25 % w/v, respectively
Summary
Infantile hemangioma (IH) is the most prevalent vascular benign tumor in children with an incidence of about 4 to 10 % in the first year of life [1]. It will improve spontaneously, about 10 to 20 % of infants who have IH require interventions to prevent and reduce complications associated with the proliferation phase [2]. Topical TM is a promising alternative treatment for IH. The use of topical TM for IH treatment was first reported in 2010. Many case reports and case series have demonstrated the efficacy of TM for the treatment of IH. TM has systemic absorption due to it is administered topically and result in unwanted effects [6]
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