Abstract
Objective: Shelf life is the period during which the potency (Virya) of a drug remains unaffected due to environmental factors or from microbial contamination. Considering the growing popularity of Ayurveda products, it becomes important to maintain the quality of all such products. Shelf life is one of the essential components under quality and needs to be evaluated for all products. Dantashodhana paste (DP) is a polyherbal toothpaste containing Vyosha (Zingiber officinale Roxb., Piper nigrum Linn., and Piper longum Linn.), Trijata (Cinnamomum zeylanicum Blume., Elettaria cardamomum Maton., Cinnamomum tamala (Buch.-Ham.) T.Nees and Eberm.), Tejovati (Zanthoxylum armatum DC.), Saindhava (rock salt), and other excipients.
 Methods: DP was prepared with the following standard guidelines. The samples were subjected to accelerated stability study by maintaining temperature and humidity 40±2°C and 75±5%, respectively. Relevant analytical parameters were analyzed at an interval of 0, 1, 3, and 6 months to check the degradation levels in the formulation.
 Results: DP was found to be free from microbial contamination. Heavy metals were within the prescribed limits for toothpaste complying the official standards. There were insignificant changes in physicochemical profiles at different intervals. On extrapolation of the observations, the shelf life of DP was found to be 12.16 years.
 Conclusion: Shelf life of DP is found to be much longer than the standards specified in the D and C act. This prolonged shelf life may be contributed to care taken during drug preparation, storage, and properties of herbal drugs used in the formulation.
Highlights
One of the some misinterpretations among the common public about Ayurveda medicines is that Ayurveda medicines last lifetime and they have no expiry date; this is not always true
Dantashodhana paste (DP) was found to be free from microbial contamination
Shelf life of DP is found to be much longer than the standards specified in the D&C act
Summary
One of the some misinterpretations among the common public about Ayurveda medicines is that Ayurveda medicines last lifetime and they have no expiry date; this is not always true. Ayurveda medicines lose potency gradually with time. There are many categories of formulations, namely, Vati, Gutika, Asava-Arista, Lepa, and Avaleha which have a specific shelf-life period mentioned in Gazettes. The Gazette released in 2016 is the latest one for the shelf life of ASU medicines [1]. Shelf-life periods are mentioned in classical textbooks, it needs to be evaluated with currently available techniques and parameters, and this becomes more important when formulation or dosage form is not mentioned in classics. The shelf life of Shirishadi Avaleha was found same as mentioned in classics [2], while shelf-life period of Shirisha Ashwagandhadi Avaleha, which is an Anubhuta Yoga was found to be 8 years and 6 months that are much higher than the Avaleha [3]
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