| Summary: | Periodontal disease is an inflammatory condition of the gingiva and/or
periodontium resulting in destruction of attachment apparatus and subsequently tooth
loss. This study aimed to formulate and evaluate the biological properties of a novel
nanoemulgel in-situ (NEG-IS) drug delivery system incorporating Nigella sativa
essential oil (NSEO) and carbon dots (CDs). Essential oil was extracted from Nigella
sativa (N. sativa) seeds by hydro-distillation method. CDs were green synthesized
from ginger by hydrothermal method. To obtain optimum concentration of NSEO
and CDs for nanoemulgel formulation, optimization was performed using three
different NSEO:CDs ratios; 9:1, 1:1, 1:9 and assessed for antioxidant and antiinflammatory
properties. NEG-IS gelling system was formulated by optimization
using a three level (low, medium and high) with two factors (poloxamer and
carbopol) full factorial design, that included a statistical design with nine runs. The
phytochemical constituents’ analysis for NSEO was performed using Gas
Chromatography Tandem Mass Spectrophotometry (GC-MS/MS) followed by the
analytical characterization using UV-Vis Spectrophotometry, FT-IR Spectroscopy
and Zeta Potential (ZP) measurement. CDs characterization included particle size
evaluation, fluorescence profiling, HR-TEM, SEM-EDX, AFM, XRD, UV-Vis
Spectrophotometry, FT-IR Spectroscopy and ZP measurement. Physico-chemical
characterization of NEG-IS was done to assess its pH, viscosity, gelation time,
gelation temperature, spreadability, syringeability and in-vitro gelling capacity. Other characterizations included globule size distribution, in-vitro drug release kinetics,
UV-Vis spectroscopy FTIR and ZP measurement. Further stability studies for NEGIS
were performed for a period of 1.5 months. Antioxidant, anti-inflammatory and
antimicrobial properties against selected oral, fungal and periodontal pathogens were
assessed for NSEO, CDs and NEG-IS. Cytotoxicity of NSEO, CDs and NEG-IS was
assessed over human gingival fibroblast (HGF) cell lines. Presence of 17 bioactive
compounds in NSEO was confirmed by GC-MS/MS. CDs exhibited mean particle
size of 2.9 nm and other characterization results confirm presence of CDs. NEG-IS
exhibited adequate physico-chemical characteristics and sustained release of the drug
for up to 12 hours, which followed the Korsmeyer-Peppas (K-P) model kinetics that
aligns with Fickian tendencies. NEG-IS was stable at elevated temperature and room
temperature with no significant changes in gel appearance. NSEO, CDs and NEG-IS
exhibited significant biological properties and had less cytotoxicity effects over HGF
cell lines. The developed NEG-IS formulation showed biological properties in-vitro
with the potential to be utilized as therapeutic formulation in future clinical studies
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