A Novel Nanogel Formulation of Finasteride for Topical Treatment of Androgenetic Alopecia: Design, Characterization and In-vitro evaluation
The present paper describes the development and evaluation of a novel Finasteride (FSD) nanogel topical delivery for the treatment of Androgenetic Alopecia. Nano based topical formulation was chosen to enhance the solubility, permeability, biocompatibility of drug and to overcome the problems associated with the oral delivery of finasteride such as “gynecomastia, breast tenderness, malignant neoplasms of the male breast, decreased ejaculate volume, decrease in testicular size reduction in penile curvature, reduction in penile size, sexual disorder, male infertility” (USFDA,2017) . Glycerol monostearate (GMS), Transcutol HP and Tween 80 that showed the highest solubility and partition coefficient were selected as solid lipid, liquid lipid and surfactant respectively in the preparation of Nano structured lipid carrier (NLC). Various trails batches were prepared by using probe sonication method. Based on stability studies and particle size, NP3 trail was optimized. The optimized NP3 trail exhibited spherical shape with a mean diameter of 113.80±0.72, polydispersity of 0.28 ± 0.01, zeta potential of -25.2 mV, drug entrapment efficiency of 92.67±0.47 %, and drug loading of 6.15±0.02 %. Storage stability studies demonstrated that the particle size and entrapment efficiency of the FSD-NLCs were not changed during 3 months both at 4°C and room temperature. Finasteride NLCs were characterized for particle size by scanning electron microscope (SEM), chemical state by XRD, physical stability by centrifugation and thermodynamic stability by Freeze-thaw method. These prepared nanoparticles were transformed into topical nanogel. Different batches of NLC gel was prepared using gelling agent as Carbopol 934P (0.5, 1, 1.5%) (C1-C3) and Carbopol 974P (0.5, 1, 1.5%) (C4-C6) (USFDA). Among them, C2 trail has shown excellent gelling capacity, clear appearance, good viscosity characteristics and was selected for further studies. Batches of topical nanogel were characterized through pH, homogeneity, spreadability, viscosity, drug content and in vitro drug release study. Based on pH (6.5-6.8), drug content (91.25 ± 0.9%), spreadability (6.7 cm/sec), C2 batch was subjected to in vitro skin occlusivity study, invitro release study and invitro heamolysis study.
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