Accelerated Stability Study of Powder Formulation Safoof Muqliyasa and Safoof Mulayyin

ABSTRACT

Background and Objectives: Evaluation of stability studies of Unani Medicine (UM) formulations determined on the basis of scientific data are the need of the time and also recommended in D and C Act. There is immense need to evaluate precise shelf life for each powder formulations.Materials and Methods: Accelerated Stability Study (ASS) of Safoof Muqliyasa(S. Muq) and Safoof Mulayyin. (S. Mul) was carried out with at elevated temperature and humidity conditions 40ºC±2ºC with Relative Humidity of 75%±5% RH according to ICH guidelines, by keeping in stability chamber in containers used by commercial UM. Pharmacy’s (i.e. sealed HDPE containers). Testing frequency of samples was 0, 3 and 6 months and was subjected to various organoleptic, physical, microbiological and chemical tests parameters with HPLC quantification of active constituents/markers (Chebulic acid in S. Muq and Gingerol in S. Mul). Results were accessed as per API guidelines and are also statistically analyzed for 10% degradation, from liner regression equation using individual slope and Intercept. Results:Both S. Muq and S. Mul were suitable at accelerated condition upto 3 month storage on selected physical, microbiological and chemical parameters as per API evaluation guidelines, and it can be extrapolated that real time shelf life period (predicted stability) according to Grimm's statement, for zone III and IV, 3.3 as 10 month at room temperature and packaging method adopted in the study and by 10% degradation in different parameters by multiplying factor of 3.3 accelerated stability of Safoof Muqliyasa can be extrapoled as 2 years and 1 month and for Safoof Mulayyin 1 year and 5 months. Conclusion:According to physical and microbiological parameters both S. Muq and S. Mulare stable for 6 months in ASS but changes in selected chemical parameters was observed for after 3rd month making it stable approximately for 1 year. Stability of salt containingS. Mulwas found to be comparatively lower than the non-salt containing S. MuqThis observation/ shelf life may be exclusive to both the powders.

KEYWORDS

• Accelerated stability
• Safoof Mulayyin
• Safoof Muqliyasa
• Unani
• Powder
• Shelf-life

Showing references and in-text citations exactly as published.

• DOI10.5530/pres.20252160Copy

RELATED ARTICLES

Matched on section and article type within this issue of Pharmacogn. Res..

• Article · VOLUME 17, ISSUE 4Comparative LC-MS Profiling of two Linderniaceae SpeciesThachan Sreelakshmi, Meethaley Valappil Jeeshna, Abhijith Sarga, Sugunan Ashitha · pp. 1187–1196Original ArticleSame type: Article
• Article · VOLUME 17, ISSUE 4Investigating the Expression of Apoptosis and Metastasis Genes in Satureja khuzistanica along with Nisin and Doxorubicin in Colorectal CancerEsmaeil Kheiri, Zahra Hojjati Bonab, Hossein Soltanzadeh · pp. 1197–1204Original ArticleSame type: Article
• Article · VOLUME 17, ISSUE 4Nephroprotective and Cytotoxic Assessment of Moringa concanensis Leaf Extract in Gentamicin-Induced Renal Injury in RatsAbhishek Raghavendra, Hariprasad Madakasira Guggilla, Diya Lakshman Shetty, Deeksha Giridhar · pp. 1205–1213Original ArticleSame type: Article
• Article · VOLUME 17, ISSUE 4Evaluation of Anti-Depressant Activity of Garcinia cambogia Fruit Using Animal ModelsJ. Priyadharisini, N. Savitha, Lydia Jeeboi Paramel · pp. 1214–1217Original ArticleSame type: Article