BLDE University Journal of Health Sciences

ORIGINAL ARTICLE
Year
: 2016  |  Volume : 1  |  Issue : 2  |  Page : 120--124

Shelf life evaluation of Shirishavaleha: A preliminary study


Harmeet Kaur, Galib Ruknuddin, Pradeep Kumar Prajapati 
 Department of Rasa Shastra and Bhaishajya Kalpana including Drug Research, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India

Correspondence Address:
Dr. Harmeet Kaur
Department of Rasa Shastra and Bhaishajya Kalpana including Drug Research, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar - 361 008, Gujarat
India

Abstract

Context: Shelf life of the drug can be considered up to the period it gets deteriorated and does not get any alteration in its physicochemical state. Every product has definite shelf life, which depends on various physical, chemical, environmental, and biological factors. Ancient seers have clarified shelf life of various compound formulations. However, there is a need to revalidate and ascertain the shelf life of individual formulations by following parameters prevalent in respective scenario. Aim: To evaluate shelf life of Shirishavaleha prepared in the presence of water (SW) and Kanji (SK) as liquid media through accelerated stability study. Subjects and Methods: Physicochemical parameters were measured at 40°C ± 2°C temperature and 75% ±5% relative humidity. Analysis was repeated at intervals of 1, 3, and 6 months, and average 10% degradation of both the test drug samples was calculated and extrapolated to find the shelf life. Results: The sample prepared in the presence of Kanji (SK) showed more extractive values and sugar contents and found to have longer shelf life (2.6 years) than SW (1.4 years). Conclusion: Shirishavaleha prepared with Kanji (SK) is comparatively more stable than the sample prepared with water (SW).



How to cite this article:
Kaur H, Ruknuddin G, Prajapati PK. Shelf life evaluation of Shirishavaleha: A preliminary study.BLDE Univ J Health Sci 2016;1:120-124


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Kaur H, Ruknuddin G, Prajapati PK. Shelf life evaluation of Shirishavaleha: A preliminary study. BLDE Univ J Health Sci [serial online] 2016 [cited 2019 Sep 19 ];1:120-124
Available from: http://www.bldeujournalhs.in/text.asp?2016/1/2/120/196099


Full Text

In ayurvedic literature, "Saviryata avadhi" refers to the time period during which the drug remains potent. Although this concept was known to earlier scholars, exclusively described in later texts such as Vangasena,[1] Sharangadhara Samhita,[2] and Yogaratnakara[3] for different ayurvedic dosage forms. As per Sushruta Samhita, a drug can be utilized for various therapeutic purposes unless it remains in intact state, i.e., maintaining its appearance, taste, smell, and qualities.[4] These parameters are the quality parameters of the present era. Shelf life of the drug can be considered up to the period it gets deteriorated and does not get any alteration in its physical state. Ayurvedic Formulary of India also has given the time period from the date of manufacture within which the formulations should be consumed for best results.[5] By following prevalent guidelines, stability study of some ayurvedic formulations such as Churna (powder)[6],[7],[8] Vati (tablets),[9] supplements,[10] and Avaleha (confectionaries)[11],[12] have been attempted earlier. Shirishavaleha possesses anti-inflammatory,[8] immunomodulatory,[13] antitussive properties[14] and is a promising remedy for Tamaka Shwasa (bronchial asthma).[15] However, no stability profiles of this formulation are available till date. Considering this, it has been planned to evaluate the same through accelerated study. Besides, Jala (water), many other solvents such as Gomutra (cow-urine), Kanji (sour gruel), Ksarodaka (water-soluble extract of plant ash) are used in Ayurveda pharmaceutics. However, comparative studies emphasizing the rationale and impact of such solvents are not reported. Looking into this, it was planned to prepare Shirishavaleha with water and Kanji and evaluate comparative stability profiles.

 Subjects and Methods



Collection of raw materials

Shirishavaleha is a compound ayurvedic formulation [Table 1], which comprises dried powders of nine drugs in equal proportion and Guda (Jaggery) as sweetening substance. Stem bark of Shirisha was freshly collected from Botanical Garden, Jamnagar, while other raw materials were procured from Pharmacy, GAU, Jamnagar. Jaggery was purchased from local market of Jamnagar. All the herbal drugs were authenticated at Pharmacognosy Laboratory, IPGT and RA, Jamnagar. These drugs were cleaned and shade dried before usage. Kanji (sour gruel) was prepared by the following classical guidelines.[16]{Table 1}

Test drugs

One sample of Shirishavaleha was prepared in the presence of water (SW) and other in the presence of Kanji (SK) as liquid media by the following standard guidelines established in earlier studies.

Packing

Both the samples (SW and SK) of 100 g each were packed in airtight food grade plastic containers and stored in accelerated stability chambers.

Storage conditions

Accelerated stability study was conducted as per ICH Guidelines Q1A (R2).[17] Temperature was maintained at 40°C ± 2°C while relative humidity was maintained at 75% ±5%.

Frequency of withdrawal and analysis

Any changes in physicochemical profiles of samples at an interval of 0, 1, 3, and 6 months were observed. The parameters considered for evaluation of stability study are organoleptic characters (color, odor, and taste) and physicochemical parameters such as pH value,[18] moisture,[19] total ash,[20] acid insoluble ash,[21] water-soluble extractive value,[22] methanol-soluble extractive value,[23] total fat,[24] total solid,[25] total sugar,[26] total saponin,[27] total alkaloids,[28] and total tannins.[29] Microbial load and determination of heavy metals were also estimated in test drug samples.

Based on the analytical values obtained before and after 6 months of storage, intercept and slope were calculated. Based on these, approximate 10% degradation was calculated and extrapolated to get shelf life.

 Results



No significant change was noticed in color, odor, and taste of both samples up to storage of 6 months at accelerated conditions [Table 2] and [Table 3]. On storing for 6 months at accelerated conditions, both the formulations were found to be free from heavy metal content and the microbial growth is within the prescribed limits. This reveals safety aspects of the product [Table 4] and [Table 5]. Changes in physicochemical parameters at different intervals were found to be insignificant [Table 6] and [Table 7]. Based on these values, intercept, slope, and approximate time for 10% degradation were calculated that was 4.8 for SW and 9.3 for SK [Table 8] and [Table 9]. As India comes under climatic Zone III, multiplication factor 3.3 was used for extrapolation of shelf life [Table 10]. Thus, the shelf life of SW was found to be 1.4 years, whereas for SK, it was 2.6 years.{Table 2}{Table 3}{Table 4}{Table 5}{Table 6}{Table 7}{Table 8}{Table 9}{Table 10}

 Discussion



Results showed no significant change in color, odor, and taste of both samples of Shirishavaleha after storing for 180 days under accelerated conditions. Differences in physicochemical profiles of SW and SK were insignificant. Heavy metals and microbial count in both the samples were in prescribed limits. This reflects about quality and safety aspects of the product. It also reveals that due care has been taken during manufacturing of the formulation avoiding cross-contamination and strictly following classical guidelines. Although insignificant difference was found in the preliminary physicochemical parameters, moisture percentage of SK was less (10.43) than SW (13.47). The reason may be more solid content of Kanji and more extractions from the raw material into the formulation. Seers also expressed facilitation of more extraction in presence of Kanji as media.[30] More moisture content indicates early degradation as observed in case of SW that has comparatively lesser shelf life. Both samples were found to be acidic in nature. Tannins are weak acidic in nature,[31] thus the acidic pH of final product may be due to rich tannin content. As total tannin % was comparatively more in SK sample (3.26%) than SW (2.88%); SK was slightly more acidic than SW. Water-soluble extractive was also more in SK (75.83) than SW (74.83), thus more bioavailability of SK than SW. SK showed more percentage of sugar (66.94) than SW (59.98). Increase percentage of sugars also helps in preventing the deterioration of a formulation; this was noticed in the current study, as SK was more stable with 66.94% sugar content against SW with 59.98% sugar. Comparative analyses revealed that Shirishavaleha prepared in the presence of Kanji found to be more stable with shelf life of 2.6 years against Shirishavaleha prepared in the presence of water that has shelf life of 1.4 years.

 Conclusion



The profiles developed for the sample prepared in the presence of Kanji (SK) showed more extractive values and sugar contents and has longer shelf life (2.6 years) than Shirishavaleha prepared in the presence of water (SW) (1.4 years). Microbial count and heavy metals were within permissible limits in both samples indicating their standards and safety for therapeutic utilization. This study also provided certain leads toward using different solvents in Ayurveda pharmaceuticals. However, extensive studies focusing on the exact mechanism pharmacodynamically and pharmacokinetically be carried out and changes that take place with the change in liquid media are needed.

Acknowledgment

Authors are sincerely thankful to the management of Vasu Healthcare Pvt. Ltd., for the state of the art testing facility to carry out this work.

Financial support and sponsorship

The study was supported by Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University.

Conflicts of interest

There are no conflicts of interest.

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