Development And Optimization Of Picroside Ii Capsules For The Treatment Of Liver Disease Using Quality By Design Approach.
Keywords:
Picroside II, Weight variation, In-Vitro Drug Release, QbD approachAbstract
The proposed research work explores the systematic development and optimization of Picroside II capsules employing the Quality by Design (QbD) approach. Picroside II, a bioactive compound derived from Picrorhiza kurroa rhizomes, has exhibited potential therapeutic properties, making it an attractive candidate for formulation in pharmaceutical dosage forms. The study integrates the principles of QbD, a contemporary pharmaceutical quality management paradigm, to enhance the robustness and efficiency of the formulation process. This study is aimed at formulating solid oral dosage forms of picroside II for the treatment of liver disease. The flow property of the picroside II formulation was determined. The formulated capsules passed pharmacopeia tests, including evaluations of weight uniformity, disintegration, drug content, and dissolution. The formulation was excellent flow characteristics. The prepared capsules exhibited excellent in vitro release of the extract, with more than 90% released within 30 minutes. Additionally, they effectively fulfilled the requirements for uniformity of weight, disintegration, and drug content testing. The results obtained from these evaluations are examined to assess the efficacy of the QbD-driven formulation method in attaining the intended product quality.
The findings of this research contribute to the systematic understanding of the formulation process for Picroside II capsules, emphasizing the importance of QbD principles in ensuring the reproducibility and reliability of pharmaceutical formulations. The application of QbD in this study provides a valuable template for the development of other herbal-based pharmaceuticals, fostering the advancement of evidence-based traditional medicine in the modern pharmaceutical landscape. Picroside II capsules have been successfully formulated and are available to use as conventional dosage forms for the treatment of liver diseases.
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