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

DAVE, PARTH PRAKASHBHAI

MAKWANA, DHARA

PRAJAPATI, PRADEEP KUMAR

R, GALIB

RAJAGOPALA , MANJUSHA

English

Innovare Academic Sciences: E-Journals

Vol 13, Issue 4, 2020Online - 2455-3891 Print - 0974-2441SHELF-LIFE ASSESSMENT OF DANTASHODHANA PASTE (A POLYHERBAL TOOTHPASTE): A PRELIMINARY STUDYDHARA MAKWANA1*, GALIB R2, PARTH PRAKASHBHAI DAVE3, MANJUSHA RAJAGOPALA4, PRADEEP KUMAR PRAJAPATI21Department of Shalakya Tantra, Murlidhar Ayurveda College, Rajkot, Gujarat, India. 2Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, India. 3Department of Ayurveda, RRAP Central Ayurveda Research Institute for Cancer, Mumbai, India. 4Department of Shalakyatantra, All India Institute of Ayurveda, New Delhi, India. Email: dharapatelddd@gmail.comReceived: 05 August 2019, Revised and Accepted: 07 February 2020ABSTRACTObjective: 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.INTRODUCTIONOne 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.METHODSAll 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 formulationAs 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 evaluationSamples in 25 tubes, each contains 20 g of DP.Storage conditionsTemperature: 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.v13i4.35243Research Article80Asian J Pharm Clin Res, Vol 13, Issue 4, 2020, 79-83 Makwana et al. ParametersBasic analytical parameters, including fineness [7], pH [8], foaming index [9], spreadability [10], and heavy metals [11], were evaluated at intervals as specified earlier. Test for microbial contamination was done initially and at the end of 6 months of storage [12]. Chromatographic profile (high-performance thin-layer chromatography [HPTLC]) was evaluated out under 254, 366, and 540 nm initially and after 6 months of storage.Frequency of withdrawalThe products were withdrawn from the container and analyzed initially, and at a gap of 1, 3, and 6 months.RESULTSNo changes in organoleptic characters were noted in the drug at different levels of storage (Table 3). Physicochemical characteristics of DP at initial, 1, 3, and 6 months interval are presented in Table 4. Microbial growth was found below the prescribed limits in DP initially and after 6 months (Table 5). Heavy metals, including arsenic, lead, Table 1: Drugs composition of Dantashodhana Ghana [4]S. No. Name Botanical/English name Proportion1. VyoshaShunthiMarichaPippaliZingiber officinale Rosc.Piper nigrum Linn.Piper longum Linn.1 part2. TrivargaTwakaElaTamalaCinnamomum zeylanica Bl.Elettaria cardamomum Maton.Cinnamomum tamala Nees.1 part3. Tejovati Zanthoxylum armatum DC. 1 part4. Saindhava Rock salt 1 partTable 2: Ingredients of DPNo. Name Percentage1. Dantashodhana Ghana 272. Dantashodhana Kwatha 183. Saindhava 7.204. Glycerin 12.605. Sorbitol 12.606. CMC 1.267. SLS 3.248. Calcium carbonate 189. Methylparaben 0.0210. Propylparaben 0.0211. Saccharine 0.0612. Peppermint oil 0.5SLS: Sodium lauryl sulfate, CMC: Critical micelle concentration, DP: Dantashodhana pasteFig. 2: Peak display in high-performance thin-layer chromatography, (a) peak display 254 nm, (b) peak display 366 nm, (c) peak display 540 nmabcFig. 1: (a and b) Packing of Dantashodhana paste in a non-rigid collapsible tube containeraband mercury, were found in the amount of 1.245 ppm, 2.658 ppm, and 0.657 ppm, respectively, that are within the prescribed limits (Table 6). HPTLC showed three spots at 254 nm, one spot at 366 nm, and six spots at 540 nm. Rf values recorded were the same for both samples (0 and 6 months) (Table 7 and Figs. 2 and 3). Based on the physicochemical values, intercept and slope were calculated followed by expected time for 10% degradation for individual parameters (Tables 8 and 9) (Graphs 1-3). On extrapolation of these values, the shelf life of DP was found to be 12.16 years (Table 10).81Asian J Pharm Clin Res, Vol 13, Issue 4, 2020, 79-83 Makwana et al. DISCUSSIONThe present study is a preliminary attempt toward evaluating shelf life of DP. No changes in organoleptic characters were found at different levels of storage. DP was found to be blackish-gray with characteristic odor and thick consistency. Color of the formulation can be contributed to the use of Ghana and Kwatha in the formulation. Insignificant differences were observed in basic physicochemical profiles in the drugs at different stages of analysis.Microbial count and heavy metals were within the prescribed limits as per BIS and API, indicating safety and quality of the product [13,14]. Stability study of the same drug with respect to baseline microbial count has already been published which concluded that DP does not show any microbial contamination with the change in climatic conditions [15]. Prevention of the contamination may be attributed to antimicrobial properties of formulation contents.Table 3: Organoleptic parameters DPS. No. Parameters Initial (October 1, 2016) 1st month (November 1, 2016) 3rd month (January 1, 2017) 6th month (April 1, 2017)1. Color Blackish-gray Blackish-gray Blackish-gray Blackish-gray2. Odor Characteristic Characteristic Characteristic Characteristic3. Consistency Thick paste Thick paste Thick paste Thick pasteDP: Dantashodhana pasteTable 4: Physicochemical parameters of DPS. No. Parameters Initial (October 1, 2016) 1st month (November 1, 2016) 3rd month (January 1, 2017) 6th month (April 1, 2017)1. Fineness Good Good Good Good2. pH 6.87 7.03 7.08 7.103. Spreadability 1.2 cm/10 g weight 1.25 cm/10 g weight 1.10 cm/10 g weight 1.2 cm/10 g weight4. Foaming index 175 178 175 1755. Gritty particles Not present Not present Not present Not presentDP: Dantashodhana pasteTable 5: Microbial load in DPS. No. Test Initial (October 1, 2016)6th month (April 1, 2017)1. Total plate count <10 cfu/g <34 cfu/g2. Total yeast and mold countAbsent Absent3. Escherichia coli Absent Absent4. Salmonella Absent Absent5. Staphylococcus aureusAbsent Absent6. Pseudomonas aeruginosaAbsent Absent7. Candida albicans Absent AbsentDP: Dantashodhana pasteThe changes in all these parameters (such as pH, spreadability, foaming ability, fineness, stability studies, and test for Hg, Pb, and As) were analyzed to evaluate the shelf life of the formulation that is found to be 12.16 years, indicating longer shelf life of the compound.Table 6: Heavy metal test (by AAS test)Sr. no. Test Result (ppm)Permissible limit as per API [14] (ppm)BIS standards1. Arsenic 1.245 3 2 2. Lead 2.658 10 203. Mercury 0.657 1 Not mentioned4. Cadmium 0.197 0.3 Not mentionedppm: Parts per million, AAS: Atomic absorption spectroscopy, API: Active pharmaceutical ingredients, BIS: Bureau of Indian StandardsGraph 3: Slope of spreadability of Dantashodhana pastey =-0.006x + 1.2024R² = 0.0627 00.511.520 1 2 3 4 5 6 7Y valueMonth Spreadability0 1.21 1.253 1.16 1.2Intercept 1.20Slope 0.2140246810y = 0.0319x + 6.9402R² = 0.65570 1 2 3 4 5 6 7Y valueGraph 1: Slope of pH of Dantashodhana pasteMonth pH0 6.871 7.033 7.086 7.10Intercept 6.9402Slope 0.0319Month Foaming index0 1751 1783 1756 175Intercept 176.29Slope −0.2143y =-0.2143x + 176.29R² = 0.1429 0501001502002500 2 4 6 8Y valueGraph 2: Slope of F of Dantashodhana paste82Asian J Pharm Clin Res, Vol 13, Issue 4, 2020, 79-83 Makwana et al. CONCLUSIONThe shelf life of DP was found to be 12.16 years. This higher stability is may be due to the use of Ghana preparation of herbal drugs. The present study is a preliminary study and further investigations are essential to ascertain actual cause behind the longer shelf life.AUTHORS’ CONTRIBUTIONSDhara Makwana carried out the test and collected all data. R Galib outlined the test and worked out all technical details, analytical and numerical calculations. Dhara Makwana and Parth Dave contributed to the preparation of the study drug (DP) and wrote the manuscript in consultation with R Galib. PK Prajapati and Manjusha Rajgopala were in charge of overall direction and planning.ACKNOWLEDGMENTThe author would like to thank the Institute of Postgraduate Teaching and Research in Ayurveda, Jamnagar, Gujarat, for providing all required facilities and financial support to conduct the study. The author also acknowledges Vasu Research Centre, Vadodara, Gujarat, for technical support. The author would like to thank Dr. Pankaj Goriya who helped in the preparation and packaging of the formulation.CONFLICTS OF INTERESTThe authors do not have any conflicts of interest.FINANCIAL SUPPORTNil.REFERENCES1. The Gazette of India. Extraordinary, Part-II. Section-3. New Delhi: The Gazette of India; 2009.2. Kaur H, Ruknuddin G, Prajapati PK. Shelf life evaluation of shirishavaleha: A preliminary study. BLDE Univ J Health Sci 2016;1:120-4.3. Parth PD, Vaghela DB, Galib R, Hasmukh JR. Shelf life assessment of shirisha ashwagandhadi avaleha-a preliminary assessment. J Med Pharm Allied Sci 2016;5:302-13.4. Trikamji VY, Acharya NR. Sushruta Samhita with Dalhan Tika. Varanasi: Chaukhamha Surbharati Prakashan; 2008. p. 338.Table 7: HPTLC of DPDrug Spot no. Rf at 254 nm Rf at 366 nm Rf at 540 nmTrack-2 (0 month)Track-2 (6 months)Track-2 (0 month)Track-2 (6 months)Track-2 (0 month)Track-2 (6 months)1. 0.21 0.21 0.39 0.39 0.21 0.212. 0.39 0.39 0.55 0.553. 0.89 0.89 0.90 0.90DP: Dantashodhana paste, HPTLC: High-performance thin-layer chromatographyTable 8: Intercept and slope of DPS. No. Parameters Intercept Slope1. pH (1% w/v) 6.94 0.0322. Spreadability 1.20 0.0063 Foaming index 176.29 0.214DP: Dantashodhana pasteTable 9: Approximate period for 10% degradation in DPParameters Initial 10% degradationApproximate months required for 10% degradationpH (1% w/v) 6.87 6.183 23.66Spreadability 1.2 1.08 20Foam index 175 157.5 87.80Mean month 43.22DP: Dantashodhana pasteTable 10: Extrapolation of shelf life in DPDrug Months Multiplication factor Shelf lifeMonths YearsDP 43.22 3.33 145.92 12.16DP: Dantashodhana pasteFig. 3: High-performance thin-layer chromatography (HPTLC) study of Dantashodhana paste. (a) Comparative HPTLC plate at 254 nm, (b) comparative HPTLC plate at 366 nm, (c) comparative HPTLC plate at 540 nma b c83Asian J Pharm Clin Res, Vol 13, Issue 4, 2020, 79-83 Makwana et al. 5. Makwana D, Vaghela DB, Patel KS. A comparative study of dantashodhana chroorna and dantashodhana paste after scaling in preventing the recurrence of dantasharkara (calculus). Int J Ayurvedic Med 2017;8:80-91.6. Makwana DM, Prajapati PK, Manjusha R, Harisha CR, Shukla VJ. Pharmacognostical and pharmaceutical analysis of dantashodhana choorna. Int J Ayurvedic Pharm Chem 2017;6:19-26.7. Bureau of Indian Standards, Government of India. Anonymous. Annexure B. In: Anonymous. Indian Standard Toothpaste-specification. 3rd ed. New Delhi: Bureau of Indian Standards, Government of India; 2001. p. 5.8. Bureau of Indian Standards, Government of India. Anonymous. Annexure C. In: Anonymous. Indian Standard Toothpaste-specification. 3rded. New Delhi: Bureau of Indian Standards, Government of India; 2001. p. 6.9. Bureau of Indian Standards, Government of India. Anonymous. Annexure F. In: Anonymous. Indian Standard Toothpaste-specification. 3rd ed. New Delhi: Bureau of Indian Standards, Government of India; 2001. p. 8.10. Roshan T, Deshmukh P, Gunde M. Formulation and evaluation of herbal toothpaste: Compared with marketed preparation. Int J Pharm Drug Anal 2017;5:406-10.11. Bureau of Indian Standards, Government of India. Anonymous. Annexure D. In: Anonymous. Indian Standard Toothpaste-specification. 3rd ed. New Delhi: Bureau of Indian Standards, Government of India; 2001. p. 7.12. Ministry of Health and Family Welfare, Government of India. Anonymous. Appendix-2 (2.4). In: Anonymous. The Ayurvedic Pharmacopoeia of India, Part II. 1st ed., Vol. 1. New Delhi: Ministry of Health and Family Welfare, Government of India; 2007. p. 163.13. Bureau of Indian Standards Government of India. Anonymous. Indian Standard Toothpaste-specification. 3rd ed. New Delhi: Bureau of Indian Standards Government of India; 2001.14. Ministry of Health and Family Welfare, Government of India. Anonymous. Appendix-2 (2.3.3). In: Anonymous. The Ayurvedic Pharmacopoeia of India, Part II. 1st ed., Vol. 1. New Delhi: Ministry of Health and Family Welfare, Government of India; 2007. p. 153.15. Dhara M, Meera C, Vaghela DB, Patel KS. Stability study of dantashodhana paste with respect to baseline microbial profile. Int J Ayurvedic Med 2017;3:376-83.

SHELF-LIFE ASSESSMENT OF DANTASHODHANA PASTE (A POLYHERBAL TOOTHPASTE): A PRELIMINARY STUDY

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SHELF-LIFE ASSESSMENT OF DANTASHODHANA PASTE (A POLYHERBAL TOOTHPASTE): A PRELIMINARY STUDY

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