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Ph.D.
(Pharmacy)
DEVELOPMENT AND EVALUATION OF SOME
PHYTOPHARMACEUTICALS FOR CERTAIN
INFLAMMATORY CONDITIONS
Ph.D. Scholar : Patel Jayaben Manubhai
Research Supervisor : Dr. Nikunjanaben A. Patel

Regi. No.: 18276011006
Abstract :
Inflammation is currently treated with NSAIDs but, the risk of blood clots, incidence of
heart attacks, and strokes are increased by these synthetic medications. Therefore, the
development of potent anti-inflammatory drugs from natural sources with fewer side
effects is very essential. Medicinal plants play an important role in curing many diseases
associated with inflammation among other natural products. Hence, the current research
work was envisaged to develop a polyherbal formulation comprising of medicinal plants
claimed for anti-inflammation effect for better efficacy and fewer side effects. To achieve
these attributes, the formulation was selected based on property of extract, route of
administration, desired drug release profile and patient compliance. Hence, hydrogel was
formulated to incorporate the selected extracts.

The objectives of the present study were standardization of Berberis aristata root (Family:
Berberidaceae), Rubia cordifolia root (Family: Rubiaceae) and Boswellia serrata gum
(Family: Burseraceae), preparation and evaluation of selected crude drugs extracts and
formulation of polyherbal gel. A HPLC method was developed and validated for the
simultaneous estimation of marker compounds (Berberine, Rubiadin and 3-O- acetyl-11-
keto-β-boswellic acid (AKBA)). The 32 factorial design was used to optimize the final
formulation. Polymer (carbopol 934) and propylene glycol (as a penetration enhancer)
was selected as independent variables while viscosity (m.Pas), % in vitro release of
Berberine, Rubiadin and AKBA as dependent variables based on the preliminary studies. A
total of 9 experimental runs were formulated and evaluated. Gel formulation was
optimized by design of experiment approach using Design expert version 13. The
developed formulation was validated by graphical method and the formulation was
validated for selected criteria. The optimized formulation showed viscosity 39568 m.Pas,
content of Berberine (0.48 mg), Rubiadin (0.42 mg) & AKBA (0.51 mg). Accelerated
stability study of the developed formulation was carried out and was found to be stable
for at least 6 months. The developed formulation was found to similar in terms of
viscosity and spreadability compared to marketed formulation. The in vivo study (TPA
induced ear edema in mice model) and its histopathology studies of the gel revealed an
effective anti-inflammatory activity, almost similar to diclofenac gel (marketed).

Key words: Design of Expert (DoE), Polyherbal Gel, Anti-inflammatory, Berberis aristata
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