Vol 13, Issue 4, 2020 Online - 2455-3891 Print - 0974-2441 SHELF-LIFE ASSESSMENT OF DANTASHODHANA PASTE (A POLYHERBAL TOOTHPASTE): A PRELIMINARY STUDY DHARA MAKWANA 1 *, GALIB R 2 , PARTH PRAKASHBHAI DAVE 3 , MANJUSHA RAJAGOPALA 4 , PRADEEP KUMAR PRAJAPATI 2 1 Department of Shalakya Tantra, Murlidhar Ayurveda College, Rajkot, Gujarat, India. 2 Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, India. 3 Department of Ayurveda, RRAP Central Ayurveda Research Institute for Cancer, Mumbai, India. 4 Department of Shalakyatantra, All India Institute of Ayurveda, New Delhi, India. Email: dharapatelddd@gmail.com Received: 05 August 2019, Revised and Accepted: 07 February 2020 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&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. Keywords: Ayurveda, Dantashodhana paste, Polyherbal toothpaste, Saviryata avadhi, Shelf life. INTRODUCTION 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 also 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]. Although 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. For example, 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]. Dantashodhana Choorna described in Sushruta Samhita contains seven herbal drugs and rack salt, the formulation is to be used as Pratisarana (gentle rubbing over the teeth and gums) [4]. For increased patient compliance and acceptance, this formulation was converted into Dantashodhana paste (DP) [5]. In the present study, an attempt has been made to evaluate its shelf life with the help of modern analytical techniques. METHODS All drugs were procured from the local market, Jamnagar, and authenticated in the Pharmacognosy Laboratory, Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar, and an article on pharmacognostical analysis was published [6]. Composition formulation is stated in Tables 1 and 2. Preparation of formulation As a specific method of preparation is not mentioned for the paste, the herbal part of DP was collected in Yavakuta (coarse powder) form except for Saindhava (rock salt) (Table 1); Kwatha (decoction) was prepared to add 16 times of water and reduced it to one-fourth. The contents were filtered through dry and clean cotton cloth. The filtrate was again subjected to heat to prepare Ghana (concentrated aqueous herbal extract). This Ghana and base materials for toothpaste were mixed in a proportion of 40:60, respectively (Table 2). Mixture was triturated properly in edge runner for 1 day until the formation of a homogenous paste. This paste was filled in non-rigid collapsible tube containers of 20 g each and containers were sealed carefully from both the sides (Fig. 1). Sample quantity and packing for shelf-life evaluation Samples in 25 tubes, each contains 20 g of DP. Storage conditions Temperature: 40±2°C and relative humidity: 75±5%. © 2020 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ajpcr.2020.v13i4.35243 Research Article