PHARMACEUTICO-ANALYTICAL STUDY OF PATOLADI CHURNA AND IT'S MODIFICATION INTO SCRUB FORM AND ITS CELL LINE TOXICITY STUDY

Introduction: Patoladi Churna is a classical Ayurvedic polyherbal formulation comprising Patola, Nimba, Manjishtha and Tulsi and is described in relation to Kikkisa. Although the powder dosage form is pharmaceutically simple, its topical application may be inconvenient. The present study therefore explored conversion of Patoladi Churna into a scrub formulation and evaluated its pharmaceutical, physicochemical, microbiological and chromatographic characteristics together with in vitro cell viability. Objectives: To prepare Patoladi Churna according to the classical procedure, develop a Patoladi Scrub, characterize both preparations using selected analytical parameters, and assess their in vitro cytocompatibility using the MTT assay on L929 mouse connective tissue cells. Materials and Methods: Authenticated raw materials of Patola, Nimba, Manjishtha and Tulsi were processed into Churna and subsequently incorporated into a topical scrub base. Organoleptic and physicochemical parameters, microbiological quality, heavy metals, preliminary phytochemical characteristics, HPTLC and HPLC-PDA profiles were evaluated. Cell viability was assessed in triplicate at 10, 40 and 100 μg/mL using the MTT assay. Results: The final Patoladi Churna yield was 869 g from 880 g of the four sieved ingredients. The Churna showed 8.38% loss on drying, 13.51% total ash, 2.93% acid-insoluble ash, 5.10% alcohol-soluble extractive, 9.21% water-soluble extractive and pH 6.50. The Patoladi Scrub showed pH 5.89, loss on drying 2.93% and spreadability 6.4 cm, with satisfactory homogeneity, washability, foamability and grittiness; no irritation or rancidity was observed, and no phase separation occurred after exposure at 45 ± 1°C for 48 h. Microbial counts were 38 CFU/g for total plate count and 4 CFU/g for yeast and mould. HPTLC demonstrated characteristic marker profiles, including confirmation of eugenol in Tulsi extract against the reference standard. HPLC-PDA showed three major chromatographic constituents; a predominant peak at 1.875 min with 52.50% area and UV maxima at 262 and 336 nm was putatively interpreted as a quercetin-like flavonoid. In the MTT assay, viability for Churna was 93.08%, 87.29% and 67.51% at 10, 40 and 100 μg/mL, respectively; corresponding values for Scrub were 87.97%, 84.62% and 67.51%. Conclusion: Patoladi Scrub was successfully developed from the classical Churna and demonstrated satisfactory pharmaceutical and analytical characteristics. The cell-line findings support preliminary cytocompatibility at the lower tested concentrations, while the reduction in viability at 100 μg/mL warrants cautious interpretation. Further analytical confirmation, dermal safety studies and well-designed clinical evaluation are required before conclusions regarding therapeutic efficacy or long-term topical safety can be made.