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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 6  |  Issue : 4  |  Page : 206-217

Shelf life evaluation of Vasaharitaki Avaleha and Vasaharitaki granules: An Ayurvedic polyherbal formulation with its modified dosage form


Department of Rasashastra & Bhaishajya Kalpana, All India Institute of Ayurveda (AIIA), New Delhi, India

Date of Submission09-Oct-2021
Date of Acceptance12-Jan-2022
Date of Web Publication17-May-2022

Correspondence Address:
Neelam Matwan
Department of Rasashastra & Bhaishajya Kalpana, All India Institute of Ayurveda (AIIA), Mathura Road, Gautam Puri, Sarita Vihar, New Delhi 110076
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jdras.jdras_67_21

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  Abstract 

The stability of the product is its ability to resist deterioration due to environmental or microbial degradation, which is also called as shelf life, akaSaviryata Avadhi in Ayurveda. Vasaharitaki Avaleha (VHA) is a purely polyherbal formulation, which is mentioned for the management of various ailments of the respiratory system such as Shwasa (bronchial asthma) and Kasa (cough). There is always an issue regarding the palatability of this drug found in daily practices. Alteration or modification of the dosage form is a way to recover this problem without compromising the efficacy and stability of the drug. Therefore, this study was planned and the stability data of VHA and Vasaharitaki granules (VHG) is being presented based on primary physicochemical parameters (pH, loss on drying [LOD], extractive value, total sugar, total fat, and microbial count) and chromatographic fingerprinting as per International Council of Harmonization (ICH) Guidelines for Accelerated Study. The product withdrawn periods were 0, 1st, 3rd, and 6th months of storage in a condition of 40°C ± 2°C temperature and 75% ± 5% relative humidity. As per the current gazette notification, the shelf life of Avaleha and granules is not more than 3 years. On the basis of the accelerated stability data, 10% degradation of VHA was found in pH (3.312), LOD (11.088), total sugar (53.28), total fat (0.198), total plate count (378) parameters, and 10% degradation of VHG was found in pH (3.762), LOD (5.724), total sugar (63.702), water-soluble extractive (68.913), alcohol-soluble extractive (40.968), and total plate count (864.9). On the basis of these alterations, the stability period of VHA and VHG has been calculated to be 3.3 years and 2.8 years, respectively.

Keywords: Saviryata Avadhi, stability study, Vasaharitaki Avaleha, Vasaharitaki granules


How to cite this article:
Matwan N, Bhattacharjya N, Yadav P, Prajapati PK. Shelf life evaluation of Vasaharitaki Avaleha and Vasaharitaki granules: An Ayurvedic polyherbal formulation with its modified dosage form. J Drug Res Ayurvedic Sci 2021;6:206-17

How to cite this URL:
Matwan N, Bhattacharjya N, Yadav P, Prajapati PK. Shelf life evaluation of Vasaharitaki Avaleha and Vasaharitaki granules: An Ayurvedic polyherbal formulation with its modified dosage form. J Drug Res Ayurvedic Sci [serial online] 2021 [cited 2022 Jun 29];6:206-17. Available from: http://www.jdrasccras.com/text.asp?2021/6/4/206/345397




  Introduction Top


Preparation and dispensing of medicines to patients had remained the domain of Vaidya since ancient times. Therefore, comprehensive knowledge of pharmacodynamics of a drug was an indispensable part of teaching and learning process. However, due to changes in patient perception, economic viability, and probably due to increased demands, Vaidyas are also now dependent on the market for the supply of prepared drugs.[1] Preparation, packaging, transport, storage, and supply up to the end user takes a substantial amount of time which can alter the characteristics of a product. Such changes are required to be addressed as they can affect efficacy, safety, and lead to ethical issues.[2] Therefore, it becomes essential for anyone who are involved in manufacturing and marketing of drugs to comply with government norms and provide stability data for a product.

The stability of the product is its ability to resist deterioration is denoted as shelf life. The Ayurvedic Pharmacopoeia of India (API) provides general information on stability for Ayurvedic formulations.[3] There is no doubt that our ancients Acharyas were very well aware of shelf life period of various formulations and the concept has been elaborated in texts such as Vangasena,[4]Sharangadhara Samhita,[5] and Yogaratnakara.[6] But Acharya Sharangdhara coined the term for the first time as Saviryataavadhi and provided shelf life of various formulae generally used at that time. Saviryataavadhi can be considered as the time period for which a drug sustains its Virya (potency).[7],[8]

Vasaharitaki Avaleha (VHA) is an Avaleha dosage form prepared with Vasa, Abhaya, Vansalochana, Pippali, Chaturjataka (Twak, Ela, Twaka Patra, and Nagakshera) Karkatasringi, Sharkara, Madhu, and Sharkara (sugar) as the sweetening agent and indicated in the management of Shwasa (bronchial asthma), and Kasa (cough).[9],[10] Nowadays in the field of Ayurveda, many Churna (powder) dosage form and Avaleha dosage forms are converted into granules to increase their palatability, acceptance, patient compliance, ease for storage, transportation, and better shelf life. Therefore, in this work, VHA was also converted into granules form. The stability study data for VHA could not be traced in available online sources and search engines. Therefore, this study has been undertaken to determine the stability period of VHA and Vasaharitaki granules (VHG) as per the standard International council for harmonization (ICH) guidelines[11] for accelerated study.


  Materials and Methods Top


Procurement of raw ingredients and preparation of test drugs

VHA[10] and VHG [12] were prepared as per the standard described methods at Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi. Ingredients and their ratio were same in both dosage forms. Ingredients of VHA and VHG are given in [Table 1].[10] The raw drugs were purchased from the local market, Khari Baoli, New Delhi and verified prior to preparing the formulations by Taxonomist of Regional Raw Drug Repository(RRDR), All India Institute of Ayurveda (AIIA), New Delhi. The herbarium number of Vasa (Adhatoda vasica Nees.) is RRDR/AIIA/055, 056, 057, 058, 059, 060, 061, 062, 063 respectively.
Table 1: Formulation composition of Vasaharitaki Avaleha as per AFI part III[10]

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Freshly prepared batches of VHA and VHG were subjected for stability study. The samples for both the dosage forms were packed in an air-tight high-density polyethylene (HDPE) food-grade container (200-mL, 400-mL capacity, respectively) having aluminum foil with cardboard induction wads.

Storage condition

The standard International Council of Harmonization (ICH) guideline Q1 A (R2) was followed to determine the stability period of VHA and VHG in accelerated conditions. The relative humidity 75% ± 5% and temperature 40°C ± 2°C were undertaken for sample storage condition by using KESAR make walk in stability chamber. Samples were analyzed at different points of time, that is, 0, 1st, 3rd, and 6th months.

Parameters of evaluation

Basic analytical parameters[13],[14] comprising moisture content,[15] total ash value,[16] acid-insoluble ash value,[17] pH value,[18] extractive (water soluble and alcohol soluble),[19],[20] and total fat and total sugar contents[21] as per Ayurvedic Pharmacopeia of India were assessed. Determination of heavy metals was done through atomic absorption spectrophotometer (AAS) as per the standard guidelines.[22] Assessment of microbial overload was done as per standard method addressed in Indian Pharmacopoeia at preliminary stage and at 6 month.[23]

High-performance thin-layer chromatography

High-performance thin-layer chromatography (HPTLC) is a sophisticated instrument used for identification, purification, and quantification of various components of plant origin.[24],[25]

Preparation of sample

The samples of test drugs (initial and after sixth month) were prepared as per the standard method described in the API where ethyl acetate was used as solvent media.[26]

Chromatographic conditions for samples

After preparing the samples, 8 μL of each were applied over MERCK F254 HPTLC plate (stationary phase) by LINOMAT 5 automatic sample applicator. Toluene, ethyl acetate, formic acid, and methanol in a ratio of 6: 3: 0.1: 1 (v/v) were used as mobile phase. The plate has been developed in Twin trough TLC chamber up to 80 mm from the base. After developing the plate, it was dried on a TLC plate heater at 105°C. After that Rf values and spectra were obtained at 254, 366, and 540 nm (after derivatization by Vanillin—sulfuric acid reagent) of UV light.

Data collection and analysis

Data comprising primary physicochemical parameters were obtained at 0, 1, 3, and 6 months of interval. Microbial contamination and chromatography data were collected at 0 and 6 months of study. The prevailed data of mentioned time periods were placed mathematically to calculate intercept, slope, and 10% degradation of VHA and VHG. The derived mean value was multiplied with real-time aging factor, that is, 3.33 to determine the shelf life as India comes under climatic Zone III and IVb. The time duration (month) of 10% degradation was derived through the following mechanism:

10% degradation(month) = [Initial Intercept - {(Initial assay value10)/100}] - Intercept Slope


  Observations and Results Top


Stability study

The obtained results are stipulated in [Table 2][Table 3][Table 4][Table 5][Table 6].
Table 2: Accelerated time stability study of VHA

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Table 3: Estimation of intercept and slope for VHA according to different parameters

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Table 4: Accelerated time stability study (temp: 40oC, RH: 75%) of VHG

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Table 5: Estimation of intercept and slope for VHG according to different parameters

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Table 6: Estimated time for 10% degradation accelerated time stability study of VHA and VHG

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High-performance thin-layer chromatography analysis

HPTLC profile of VHA and VHG at 254, 366, and 540 nm of UV light are shown in [Figure 1] and [Figure 2].
Figure 1: HPTLC profile of Vasaharitaki Avaleha at 254, 366, and 540 nm

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Figure 2: HPTLC profile of Vasaharitaki granules at 254, 366, and 540 nm

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  Discussion Top


During the ancient time, as medicines were prepared for an individual and in prescribed quantities by the Vaidya himself, the concept of Saviryata avadhi or shelf life has not been elaborated upon in classical Ayurveda texts. However, the quality of the drug has been addressed many times in the classics. Starting from the characteristics of soil, cultivation procedure, seasonal changes, collection method, parts of the drug used, storage condition, and packaging all are mentioned as responsible factors for safe and effective drug. These factors have been precisely elaborated in classical texts.[27],[28],[29] However, with the advancement of pharmacy and pharmaceutics, the texts of medieval period have taken into consideration and clearly defined the stability of many classical dosage forms.

For understanding this concept and evaluation of stability of a product in terms of existing scientific parameters, ICH guidelines are widely recommended and followed. Stability testing provides establishes shelf life or expiry period of a dosage form through which its quality, efficacy, and safety can be ensured.

Stability study indicates a time duration in which the desired characteristics of a product remain same if reanalyzed in recommended storage conditions. It also establishes evidences how the principal components of a product deteriorate with time by the influence of various environmental or biological factors. Therefore, it has been included as an essential tool for assessing the quality of any formulation/dosage form.[30]

As India is present in Zone III (hot dry zone) and IVb (hot higher humidity) temperature 40°C ± 2°C and 75% ± 5% relative humidity were considered for this accelerated study. The intercept and slope [Table 3] and [Table 5] were recorded in reference to the data obtained from various analytical parameters.

Ayurvedic formulations by the method of their preparation are inherently hydrophilic in nature. They are greatly affected by changes in biosphere such as light, temperature, and humidity. Moisture % or LOD (loss on drying) indicates the amount of water molecules absorbed by the formulation during the accelerated storage conditions. Similarly, pH also changes over time and greatly affects the drug absorption on ingestion. The changes and moisture content, pH can activate series of chemical reactions in the functional groups within a product and lead to alterations in total sugar content, extractive values, and total fat contents. It also serves as a nidus for growth and multiplication of bacterial and fungal spores. Therefore, a change in all these parameters directly indicates the changes due to storage over a period of time and gives a fair assessment of shelf life. Stability of drug also largely depends upon storage conditions and packing material. In addition to that, the ingredients and prescribed pharmaceutical procedures play a major role in the stability of a formulation. High sugar content in Avaleha can render it stable for longer durations.

In the present study, no significant variations were found in both the dosage forms at any level of withdrawal. Physicochemical parameters at different time period reveal changes in both the dosage forms [Table 2] and [Table 4]. Moisture %, pH and total fat showed inclination while, total sugar is found to be decreased after 1, 3, and 6 months of withdrawal in VHA. Moisture %, water soluble extractive (% w/w), total ash value (%) and alcohol soluble extractive (% w/w) increased while total sugar and pH were decreased after 1, 3, and 6 months in VHG.

HPTLC fingerprinting of both samples was developed at initial level and after 6 months and observed at 254, 366, and 549 nm. Rf value indicates different phyto-constituents arranged according to their polarity and molecular weight. Most of the Rf values were identified in both the dosage form at preliminary and 6 months of interval with mild degradation. Botanicals owing richness in a wide array of phytomolecules show a wide array of bioactivities.[31],[32],[33] Considering this, the quantitative screening of these compounds is warranted to provide leads for future researchers.

Analysis of VHA and VHG for microbial contamination revealed the absence of yeast and mould count. The total plate count was also found to be decreased after 6 months indicating good preservation. The micro-matrix of the ingredients, high sugar concentration, and good storage condition of the test drug may be the possible reasons for growth inhibition of microorganism.

Heavy-metal content assessment indicates the presence of cadmium, mercury, and arsenic in VHA and presence of arsenic in VHG. The source of these contaminants can be raw materials or chances of cross-contamination during drug preparation. However, all the heavy metals were present within permissible limits and hence safe on internal administration.

The data related to different analytical parameters generated in accelerated conditions are placed for calculating the 10% degradation rate [Table 6] and ultimately the stability period. After mathematical determination, the life period of VHA and VHG are derived as 3 years 3 months and 2 years 8 months, respectively.

A general description regarding the stability period and determination of shelf life for classical and new Ayurvedic formulations has been mentioned in the API. The specification, frequency, conditions along with the guideline according to which real-time and accelerated data should be generated are also introduced.[26] General life span of Ayurvedic dosage forms is mentioned in gazette notification issued by Govt. of India on August 12, 2016,[34] which is a modified form of previously issued notifications.[35],[36] However, no standard data regarding the mean life of specific Ayurvedic formulations are depicted. Same gazette states shelf life of Avaleha and Khanda (granules) to be same, that is, 3 years. However, previous published literature on shelf life related to Avaleha and its modified dosage form (granules) show variation in their stability periods.[37],[38],[39] The type and concentration of sweetening agent (sharkara, khanda sharkara, guda) used were reported as the primary factors to safeguard the potency of a formulation.[39],[40] The granule dosage form of the drug is found more stable in comparison to its Avaleha form when it is formulated with guda as a sweetening agent.[12] However, in another study Avaleha is reported to have more shelf life than the granule form when both the dosage forms are prepared to form khandasharkara.[38] VHA and VHG both were prepared by using the khanda sharkara. Apart from that increased exposed surface area of the granule to environmental (moisture, temperature, light) and biological factors (microbial contamination), dissimilarities in the quality control parameters used to determine 10% degradation may be the cause of variation in the stability period. However, both are very near to the standard stability period mentioned in recent gadget notification. As this is a preliminary study, further research by eliminating the present limitation factors and data for real-time study may give perfect value.

Further, while describing the Saviryataavadhi, Acharya Sharangadhara clearly mentioned that the potency of Avaleha Kalpana remains preserved up to 1 year of time period.[41] According to classical literature, both the products are stable more than the prescribed limits. This indicates both the products are having a good shelf life.


  Conclusion Top


This study shows variation in the analytical parameters in different time periods of withdrawal. However, Rf values recorded in HPTLC fingerprinting of VHA and VHG show very minimum degradation in preliminary and after 6 months of this study. Test for microbial and heavy metals contamination indicates that both the dosage forms are safe for internal administration. After calculating data, the stability period of VHA and VHG has been found to be 3.3 years and 2.8 years, respectively.

Evaluation and degradation in respect to functional groups and marker compounds viz vasicine, chebulic acid, galic acid, etc. of Vasa and Haritaki could not be done in this study. Assessment of effectiveness of both the dosage form through comparative preclinical and clinical trials may explore more suitable justification for modification of this formulation.

Acknowledgement

The authors thank VASU pharmaceuticals for conducting the stability study; Dr. Galib, Associate Professor, for valuable inputs in designing the research protocol and helping throughout the study; and Director, All India Institute of Ayurveda (AIIA), New Delhi for providing the necessary financial support for conducting the research.

Financial support and sponsorship

All India Institute of Ayurveda (AIIA), 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]



 

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