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 Table of Contents  
ORIGINAL ARTICLE
Year : 2023  |  Volume : 8  |  Issue : 1  |  Page : 74-80

Shelf life computation of Bhallataka Rasayana: A preliminary disquisition


Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, India

Date of Submission05-May-2022
Date of Acceptance21-Nov-2022
Date of Web Publication30-Dec-2022

Correspondence Address:
Dr. Shivani Sharma
Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi 110076
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jdras.jdras_61_22

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  Abstract 

BACKGROUND: Bhallataka Rasayana (BR), an Ayurvedic formulation, contains Bhallataka (Semecarpus anacardium L.f.) as the main ingredient. This ingredient is well-known for its anti-oxidant, anti-atherogenic, anti-inflammatory, anti-microbial, anti-reproductive, CNS stimulant, hypoglycemic, and anti-carcinogenic activities. Although it is an effective classical formulation, yet no published data is available on its stability. Therefore, it is the need of the hour to evaluate the shelf life of each formulation following parameters predominant in the concerned scenario. Here, an attempt has been made to determine the shelf life of BR through an accelerated stability study. METHODS: Following classical reference, BR was prepared in the Pharmaceutical Laboratory, All India Institute of Ayurveda, New Delhi. The samples were subjected to an accelerated stability study maintaining temperature and humidity of 40°C ± 2°C, and 75% ± 5% respectively. Relevant analytical parameters were performed at an interval of 0, 1, 3, and 6 months to check the degradation levels in the formulation. RESULT: Insignificant changes were observed in the organoleptic parameters, while significant changes were observed in some of the physico-chemical constants at different stages of analysis. Also, microbial contamination and heavy metals examination tests were found within the permissible limits. On extrapolation of the observations, the shelf life of BR is found to be 4 years and 4 months. CONCLUSION: The shelf life of BR exceeds the classical standards for confectionary preparations. Increased shelf life may be due to minimal ingredients and strict following of standard manufacturing procedures with proper hygiene maintenance.

Keywords: Accelerated stability study, Bhallataka Rasayana, Saveeryata avadhi, Shelf life


How to cite this article:
Sharma S, Yadav P, Ruknuddin G, Prajapati Pk. Shelf life computation of Bhallataka Rasayana: A preliminary disquisition. J Drug Res Ayurvedic Sci 2023;8:74-80

How to cite this URL:
Sharma S, Yadav P, Ruknuddin G, Prajapati Pk. Shelf life computation of Bhallataka Rasayana: A preliminary disquisition. J Drug Res Ayurvedic Sci [serial online] 2023 [cited 2023 Jan 28];8:74-80. Available from: http://www.jdrasccras.com/text.asp?2023/8/1/74/366297




  Introduction Top


Shelf life is the length of time during which an active pharmaceutical ingredient (API) or finished pharmaceutical product (FPP) is expected to remain well for use within the approved stability specifications provided under the specific storage conditions.[1] In classical treatizes such as Vangasena,[2]Sharangdhara samhita,[3] and Yogaratnakar,[4] the concept of Saveeryata Avadhi has been presented, which is comparable to shelf life. It shows the duration in which any drugs remain secure and preserves their required properties under the desired storage environment. In this era of globalization, the drugs are manufactured in large quantities and commercially, considering the rising demands.[5] In 2018, Indian Ayurveda market values about 300 billion and is expected to reach about 710 billion by the year 2024.[6] The clinic’s mortar pestle has now been converted into the corporate manufacturing units of big companies. Usually, a drug has to move a lot during its transportation to hospital/pharmacy/Clinics. Before it reaches to its beneficiary, various environmental factors such as exposure to heat and light, transportation, moisture, mechanical stresses and microbial contamination etc., may cause enormous changes in the required quality of the drug. Therefore, a need arises to establish a product’s shelf life that ensures the drug’s quality. Rule 161 (B) of Drugs and Cosmetics Rules 1945 has made it a requirement to prove the expiry date on the container’s label during the packaging of all Ayurvedic, Siddha, and Unani (ASU) drugs.[7] For industrial utilization, accelerated stability tests are advisable to determine the shelf life of a drug to reduce the period to bring any drug into the market.[8] The idea behind accelerated stability testing is to put a product under stress to speed up the degradation rate. Extrapolation at the storage temperature will anticipate the material’s shelf life based on the degradation rate-temperature relationship.[9]

Bhallataka Rasayana (BR), a single drug Ayurvedic formulation, contains Bhallataka (Semecarpus anacardium L.f.) as an ingredient. This ingredient is well-known for its anti-oxidant, anti-atherogenic, anti-inflammatory, anti-microbial, anti-reproductive, CNS stimulant, hypoglycemic, and anti-carcinogenic activities.[10],[11] It is an important classical formulation, yet no data is available on its stability. The government of India has mentioned the shelf life of different Ayurvedic dosage forms in the Gazette.[12] Nevertheless, it became demanded to legitimize the shelf life of all formulations. Because of this, an attempt has been made to evaluate the shelf life of BR through the accelerated stability study.


  Materials and Methods Top


Processing (Shodhana) of bhallataka

Semecarpus anacardium L.f. nuts were procured from the local market of Jaipur, Rajasthan. Identification and authentication were made at the Pharmacognosy laboratory of AIIA, New Delhi, Voucher Specimen number RRDR/AIIA/19. As Bhallataka is a schedule E-1 drug,[13] it’s purification (Shodhana) is essential. After prashasta-aprashasta pariksha of Bhallataka, it was purified in three Batches. For shodhana of Bhallataka, the thalamus of the fruits was removed with the help of a beetle nut cutter. Simultaneously, a 4–5 mm thick layer of Ishtikachurna (brick powder) was made on a jute bag. Then, these Bhallataka fruits were inserted on that jute bag containing brick powder. It was then kept undisturbed for three days. On the 4th day, Bhallataka fruits were rubbed thoroughly to remove Ishtika churna, followed by washing with hot water and drying.[14] The average loss in Shodhana of Bhallataka was about 26% in all three batches.

Preparation of Bhallataka Rasayana

The Shodhita Bhallataka fruits were taken and crushed in the mortar and pestle to make kalka of it. Bhallataka kwatha was then prepared by adding one part of Bhallataka Kalka in four parts of potable water and reduced to 1/4th part by heating it on mild flame. Bhallataka kwatha was then filtered by using two folds of muslin cloth. Simultaneously, cow milk was taken in another clean stainless-steel vessel and placed on a heating device. Once cow milk starts boiling, filtered Bhallataka kwatha was added to it and boiled till it reduced up to 1/4th quantity. At this stage this mixture was looking like Khoya (Mawa). Thereafter, cow ghee was added to it and boiled again till it gets mixed into it. After the paka, sharkara was added to it and kept on the heating device until avaleha sidhhi lakshanas (chief desired characters) achieved. Classical guidelines were meticulously followed throughout the preparation of BR in the pharmaceutical laboratory.[15] The total time taken for the preparation of BR was about 3 hours. [Table 1] enlists the formulation composition of BR.
Table 1: Formulation composition of Bhallataka Rasayana as per A.H.U. (39/75–77)

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Shelf-life evaluation

Packing and Storage conditions

Drug samples were packed and stored in three good quality airtight glass containers of 200ml capacity. Each container carried 100 g of BR [Figure 1]. Samples were further stored in a stability chamber at a temperature of 40°C ± 2°C and relative humidity of 75% ± 5% and put through accelerated stability testing as per ICH Guidelines Q1A (R2).[1] This study was performed during April - October 2021. Samples were analyzed initially and at an interval of 1, 3 and 6 months for analytical parameters following the guidelines of official standard texts. The parameters taken are organoleptic characters (color, odor, and taste) and physico-chemical analysis such as loss on drying,[16]total ash,[17] acid insoluble ash,[18]pH value,[19] total fat,[20] rancidity,[21] total sugar, (reducing sugar, non-reducing sugar),[22] and total polyphenol content. Additionally, microbial contamination[23] has also been done at two different time intervals, i.e., at 0 and after 6 months of storage. Heavy metal estimation was carried out initially only[23]
Figure 1: Bhallataka Rasayana packed in airtight glass containers

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Evaluation of Shelf life

Calculation of shelf life is done by multiplying the mean of all months with real-time ageing factors. There are four zones in the world that are distinguished by their characteristic prevalent annual climatic conditions, that is, 5 for climatic Zone I and II countries and 3.33 for climatic Zone III and IV countries, respectively. As India is classified under climatic zone III; 3.33 was used here as multiplying factor. This is based on the concept described by W. Grimm.[24]

[Months when 10% degradation occurs = [0 month assay value – {[0 month assay value x 10/100]} – Intercept/Slope]


  Results and Discussion Top


All products deteriorate over time, resulting in the formation of by-products. These by-products could harm the health of an individual consuming this drug. As a result, it is important to set a time frame for the consumption of a therapeutic unit. This period i.e. shelf life, is established through the evaluation of the product’s overall stability statistics. In the present study, the shelf life of Avaleha, that is, BR has been evaluated through accelerated stability testing by following ICH guidelines Q1A (R2) using the relevant organoleptic and physicochemical profile, heavy metal estimation, as well as analysis for microbial growth. Each quality control parameter has its specific significance for the respective formulation, which reflects stability and various other aspects viz., safety and efficacy of the finished product. Comparative organoleptic characters and physicochemical profiles of BR at specified intervals of sample withdrawal (Initial, 1st, 3rd, and 6thmonths) have been shown in [Table 2]. BR was found to have a characteristic aroma and a dark brown appearance. Results showed no significant change in color, odor, and taste of samples of BR after storing for 180 days under accelerated conditions. An insignificant increase in the pH, loss on drying, and total fat content were noticed in the physicochemical analysis. Apart from this, total ash, and total sugar content were found to decrease insignificantly during the study period. For instance, an upturn in the amount of total fatty matter in a sample indicates hydrolysis of triglycerides by the action of lipase enzyme, which indicates inadequate or improper processing and storage conditions (high temperature and relative humidity, tissue damage).[25] In microbial limit testing, the pathogens, including yeast, mold, Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa were examined, and Microbial analysis of BR revealed zero total yeast and mold count and absence of all the aforementioned pathogens.
Table 2: Organoleptic and physicochemical parameters of BR at different intervals

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Total plate count was also found within the prescribed limits, which been shown in [Table 3]. It infers the maintenance of hygiene and the following of good manufacturing practices throughout the pharmaceutical process and during the storing period. BR was also evaluated for the presence of heavy metals that showed Samples were found free from lead and mercury, whereas levels of cadmium and arsenic were detected below permissible limits. These findings have been depicted in [Table 4]. It has also been mentioned that physico-chemical parameters shall not vary beyond 25 percent of the initial value. Failure to meet these acceptance criteria show the significant changes observed in the formulation. In BR, we have not observed any significant changes in all parameters’ initial and final values.[26] This assessment establishes its safety parameter.
Table 3: Total microbial growth in BR at different intervals

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Table 4: Heavy-metal estimation in BR

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The classical texts of Ayurveda have mentioned the shelf life of confectionary formulations (Avaleha) as 12 months[3] while the shelf life of Avaleha is laid down as 03 (three) years in rule 161-B of the Drug and Cosmetics Act 1940 and Rule 1945. Based on results acquired at different stages of analysis (0, 1, 3, and 6 months), intercept and slope [Table 5] and [Graph 1]A–H were calculated, followed by a predicted time for 10% degradation [Table 6] for each parameter. The mean months of 10% degradation were found to be 15.615, and thus, the shelf life of BR was found to be 4 years and 4 months [Table 7] i.e., more than the classical description of the shelf life of Avaleha. This finding infers that the product was prepared as per classical recommendations. Also, optimal precautions were taken from the collection of raw material to intermediate pharmaceutical procedures, packaging, and storing of the finished product. This result is observed to be perfect for the contemporary standards set for Avaleha. The formulation in the current study contains a minimal number of ingredients, which probably reduces the possibility of interaction between the functional groups of drugs. Also, Bhallataka oil is rich in PUFA (Poly Unsaturated Fatty acid) content which has high level of tocopherols and these tocopherols are believed to protect PUFA from peroxidation.[27] Hence, it may be a cause for having a higher shelf life of BR. Besides all these explanations, accelerated stability testing has its own limitations as it is always possible that the application of excessive stress may cause some reactions that would not occur under normal storage settings. When we discuss the concept of shelf life and Ayurvedic formulations, the shelf life of very few classical Avaleha have been evaluated and reported to dates such as Shirisha avaleha,[28]Trivrit avaleha,[29] and Kamsaharitaki avaleha.[30] However, it is pretty easy to determine that a single active ingredient is responsible for the shelf life of this formulation. Therefore, it is necessary to revalidate each formulation’s shelf life following parameters prevalent in the concerned scenario.
Table 5: Intercept and slope of BR for different parameters

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Graph 1: Linearity plot graph: (A) pH, (B) loss on drying, (C) total ash, (D) total fat (E) total sugar, (F) reducing sugar, (G) nonreducing sugar, and (H) total polyphenol content

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Table 6: Approximate period (in months) for 10% degradation in Bhallataka Rasayana

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Table 7: Extrapolation of shelf life of Bhallataka Rasayana

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  Conclusion Top


The shelf life of BR is found to be 4 years and 4 months, which exceeds the classical standards for confectionary preparations. Here we conclude that the shelf life of a formulation having milk as an ingredient does not create any degradation if we strictly follow the standard manufacturing procedure. Moreover, research pertaining to about the evaluation of the shelf life of many more such Avaleha (processed with various herbs and milk) are required to corroborate the findings of the present study.

Acknowledgement

The authors are truly thankful to the Vasu Healthcare Pvt. Ltd., for their support in conducting the shelf-life analysis of the product.

Financial support and sponsorship

This study was supported by the All India Institute of Ayurveda, Sarita Vihar, New Delhi.

Conflicts of interest

There are no conflicts of interest.





 
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    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]



 

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