Stability studies on Ghanvati formulated from Psidium guajava Linn. leaf decoction

Area of Science:

• Pharmacognosy
• Pharmaceutical Sciences
• Phytochemistry

Background:

• Psidium guajava L. (guava) leaves are traditionally used for medicinal purposes.
• Developing stable herbal formulations is crucial for consistent therapeutic efficacy.
• Standardized stability testing ensures product quality and safety.

Purpose of the Study:

• To develop and assess the stability of a Psidium guajava L. leaf decoction tablet (Ghanvati).
• To evaluate the impact of storage conditions on the physicochemical properties and phytocompound content of the Ghanvati.
• To identify potential challenges in the long-term stability of this herbal formulation.

Main Methods:

• Organoleptic, physicochemical, and friability analyses of guava leaves and extract.
• Stability testing of Ghanvati tablets (hardness, disintegration, loss on drying) under ICH Q1(R2) guidelines (ambient, intermediate, accelerated conditions) for 12 months.
• Quantification of key phytocompounds (gallic acid, epigallocatechin gallate, ellagic acid, quercetin) using High-Performance Liquid Chromatography (HPLC).

Main Results:

• The organoleptic, physicochemical, and friability parameters were within acceptable limits.
• Stability studies revealed a significant increase in Loss on Drying (LOD), indicating hygroscopicity, which affected tablet hardness.
• Phytocompound analysis showed an increase in epigallocatechin gallate and ellagic acid, but a decrease in gallic acid and quercetin over 12 months under ambient and intermediate conditions.

Conclusions:

• The developed Psidium guajava L. Ghanvati exhibited acceptable initial quality but demonstrated instability issues related to moisture absorption and chemical variability over time.
• Despite maintaining hardness and disintegration time, the observed hygroscopicity and changes in phytocompound concentrations necessitate further research into alternative formulation strategies.
• Improved stability approaches are required to ensure the consistent quality and therapeutic potential of this herbal medicinal product.