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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 7
| Issue : 1 | Page : 38-46 |
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Shelf-life evaluation of Kasisadya Ghritam prepared by two different methods: A preliminary evaluation
Pramod R Yadav, R Galib, Pradeep Kumar Prajapati, Preeti Singh
Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda (AIIA), New Delhi, India
| Date of Submission | 18-Jul-2021 |
| Date of Decision | 01-Feb-2022 |
| Date of Acceptance | 03-Feb-2022 |
| Date of Web Publication | 07-Jul-2022 |
Correspondence Address:
Dr. Preeti Singh
Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda (AIIA), Sarita Vihar, New Delhi
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jdras.JDRAS_2_21
BACKGROUND: Kasisadya ghritam (KG) is a herbomineral formulation comprising 32 natural ingredients mentioned in Sharangadhara samhita. Different methods of preparation have been mentioned regarding the same especially in respect to the heating pattern, that is, Agnipaki and Suryatapi. As this medicine has shown promising results in various ailments since the ages, the use of this medicine has become very prevalent in recent clinical practices. The globalization and commercialization of Ayurveda sought for the stability of this medicine is unfortunately not evaluated to date. Therefore, a plan had been made to evaluate the shelf life of this formulation by following parameters prevalent in the respective scenario. The aim of this study was to evaluate the shelf life of both the samples of Kasisadya ghritam Suryatapi (KGS) and Kasisadya ghritam Agnipaki (KGA) through basic analytical parameters and chromatographic fingerprinting. MATERIALS AND METHODS: Stability period of both the samples was determined by the accelerated stability study as per International Council of Harmonization (ICH) Guidelines Q1A (R2). The test drugs were stored at 40°C ± 2°C temperature and 75 ± 5% relative humidity and withdrawn at the intervals of 0, 1st, 3rd, and 6th months of storage. Physicochemical parameters of KGS and KGA were analyzed at the intervals of 0, 1, 3, and 6 months, whereas chromatographic fingerprinting was done initially and after 6 months of the study. Based upon the observations, intercept, slope, 10% degradation of the sample, and the shelf life of both the samples were calculated. RESULTS: Basic analytical parameters showed both the samples deteriorate by time. By calculating the analytical data, 10% degradation of KGS was found in specific gravity (0.83), viscosity (194.4), acid value (6.58), peroxide value (1.97), and total fatty matter (78.83). The data of KGA revealed 10% degradation in parameters, that is, specific gravity (0.8295), viscosity (496.8), acid value (0.864), peroxide value (1.341), and total fatty matter (82.81). Rf values obtained from high-performance thin-layer chromatography (HPTLC) of both samples initially and after 6 months showed minimum deterioration of the product. Microbial count and heavy metals were below the permissible limits in both the samples. Accelerated stability study reveals the shelf life of KGS as 3.8 years, whereas that of KGA as 4.4 years. CONCLUSION: Rule 161 B of Drugs and Cosmetics Rule, 1945 mentioned the shelf life of medicated Ghrita as 2 years. This time period is general, and different formulations may have different shelf lives based upon several factors. The samples tested in the current study, that is, KGS and KGA, are found to have a shelf life of 3.8 and 4.4 years, respectively, which are more than the time specified in the guidelines. The findings suggest that the sample prepared by subjecting to heat has more shelf life than the sample prepared by subjecting to sunlight. Keywords: Accelerated stability study, Agnipaki, Kasisadi ghrita, shelf life, Suryatapi
How to cite this article:
Yadav PR, Galib R, Prajapati PK, Singh P. Shelf-life evaluation of Kasisadya Ghritam prepared by two different methods: A preliminary evaluation. J Drug Res Ayurvedic Sci 2022;7:38-46 |
How to cite this URL:
Yadav PR, Galib R, Prajapati PK, Singh P. Shelf-life evaluation of Kasisadya Ghritam prepared by two different methods: A preliminary evaluation. J Drug Res Ayurvedic Sci [serial online] 2022 [cited 2023 Sep 23];7:38-46. Available from: http://www.jdrasccras.com/text.asp?2022/7/1/38/350051 |
| Introduction | |  |
The shelf-life of a product is known as Saviryata avadhi in Ayurveda, which means the time period during which a drug remains therapeutically potent. It can also be defined as the period, after which the quality of a drug starts to deteriorate and becomes unsuitable for consumption. The concept of shelf life is exclusively described in classical texts such as Vangasena,[1]Sharangadhara Samhita,[2] and Yogaratnakara[3] for different Ayurvedic dosage forms. As per Sushruta Samhita,[4] a drug can be utilized for various therapeutic purposes unless it remains in an intact state, that is, maintaining its appearance, taste, smell, and qualities. These parameters are the quality parameters of the present era for explaining safety and efficacy of any drug. The Gazette notification on Drug and Cosmetic Act, 1940 (Part-II, Section 3) incorporates Rule no. 161-B referring to the shelf life (Saviryata Avadhi) of the Ayurveda, Siddha, and Unani medicines in which shelf life for medicated ghrita is mentioned as 2 years.[5] The main responsible factors affecting the shelf life of a drug or dosage forms are environmental factors (humidity, temperature, light), microbial contamination, storage conditions, and packaging system. Kasisadya ghritam (KG) is a herbomineral formulation, which is successfully used in different ailments, that is, Parikartika (Proctalgia), kustha (integumentary disease), and vrana (wounds) since the ages. Previously, Ayurvedic Vaidyas have prepared medicines for their patients themselves and dispensed them immediately. But, nowadays the commercialization of traditional system of medicine needs proper inventory management for dispensing of the quality drug. The stability of the drugs and their modified forms (if any) is an integral part of this and needs to be explored and established. Considering this, it was planned to prepare KG by Suryatapi (classical) and Agnipaki methods and evaluate their comparative stability profiles following accelerated stability study protocols.
| Materials and Methods | | |
Collection of raw materials
KG is a compound herbomineral Ayurvedic formulation [Table 1], which comprises 32 ingredients in equal proportion. All the ingredients were purchased from the local Khari Bauli market, New Delhi. The herbal ingredients were authenticated (Voucher Specimen no. 0401-0427) by the Botanist of Pharmacopoeia Commission of Indian System of Medicine and Homeopathy (PCIM & H), Ghaziabad, Uttar Pradesh, and samples were deposited in concern Raw Drug Repository before using in this preparation. The base of this formulation, that is, ghee, was purchased from the local market and in-house quality testing was done in the Quality Control laboratory, AIIA as per the standard protocol.[6] After meeting the standard criteria mentioned in Ayurvedic Pharmacopeia of India (API), it was taken for use in the preparation.[7]
Preparation of KG (Suryatapi and Agnipaki)
KG prepared by subjecting to sun rays is labeled as KGS, whereas ghritam prepared by boiling process is labeled as KGA.[8] For KGS, Go-Ghrita in the mentioned quantity was taken in a copper vessel and a mixing of Kalka dravyas was done by using spatula. After proper mixing, the copper vessel was subjected to heat under direct sunlight rays. The vessel was covered with cotton cloth to prevent any contamination of dust and other foreign matter from open air. The vessel was left under sunlight throughout the whole day with re-current mixing and measurement of temperature at regular intervals. At evening, the vessel was kept inside a room and undisturbed for overnight. The same procedure was repeated for total 7 days and on 8th day; the ghrita was filtered through a cotton cloth and stored in a properly labeled airtight glass container. For KGA, Go-Ghrita was heated at a temperature of 100°C for evaporation of moisture content in a copper vessel and then the bolus of Kalka was added into it. After proper frying of kalka, Drava dravya (water) was added into it and subjected to heat over mild flame (95–100°C.) Heating was continued maintaining the temperature with continuous stirring. The mixture was left undisturbed throughout the night and heating was continued for the next day. Contents were stirred continuously to avoid the possibility of settling down and charring. After obtaining chief desired characteristics (Sneha siddhi lakshana), the vessel was taken out from gas stove and filtered through clean cotton cloth. The prepared ghrita was stored in a properly labeled glass airtight container after cooling.
The organoleptic and physicochemical parameters[9],[10] were analyzed at regular intervals in order to estimate shelf life of both the samples as per ICH guidelines[11]
Packaging
KGS and KGA (150 mL each) were packed in sterilized airtight glass containers and stored in accelerated stability chambers [Figure 1]A, Suryatapi KGS] and [[Figure 1]B, Agnipaki KGA].
Storage conditions
Accelerated stability study was conducted as per ICH Guidelines Q1A (R2). Temperature was maintained at 40°C ± 2°C, whereas relative humidity was maintained at 75% ±5%.
Frequency of withdrawal and analysis
The samples were withdrawn from the stability chamber at intervals of 0, 1, 3, and 6 months and evaluated for the following parameters, viz. organoleptic characters (color, odor, and taste), proximate physicochemical characters including moisture content,[12 specific gravity[13] saponification value,[14] acid value,[15] peroxide value,[16] total fatty matter, viscosity,[17] microbial contamination,[18] and comparative high-performance thin-layer chromatography (HPTLC) fingerprinting as per the standard guidelines.[19],[20] Based on the results of analytical profiles obtained at different intervals, intercept and slope and approximate 10% degradation was calculated and extrapolated to obtain shelf life.
| Results | | |
The comparative organoleptic characters and physicochemical parameters of KGS and KGA obtained at different stages of withdrawal (0, 1, 3, and 6 months) are shown in [Table 2]. Microbial count and heavy metal contamination of both the samples were found within the permissible limit in the initial stage and after the sixth month of the study which indicates their safety for oral consumption [Table 3]. Results obtained at different stages of withdrawal (0, 1, 3, and 6 months) were slightly varied from each other which are used to calculate intercept, slope [Table 4], and 10% degradation of KGS and KGA [Table 5]. The obtained results are multiplied with the real-time aging factor, that is, 3.3 as India comes under climatic zone III countries. The shelf life of KGS and KGA was calculated to be 3 years 8 months and 4 years 4 months, respectively [Table 6]. | Table 2: Analytical profile of Kasisadya Ghritam (both samples) at different intervals
Click here to view |
The classics of Ayurveda have mentioned the shelf life of medicated fatty dosage form (Sneha kalpana) as 16 months, whereas the Gazette of India states the shelf life as 2 years for medicated ghee (Ghrita kalpana). The shelf life of both the samples is found more than the classically described value.
| Discussion | | |
Shelf life represents the nature and characteristics of ingredients, their processing, packaging, storage, distribution until its utilization by a consumer. It depends upon several factors (i.e., environmental and biological) which play a major role in the biodegradation of a product. Moisture content is one of such important factors. Subjecting the contents to heat during the pharmaceutical procedure will help in reducing the moisture content in a formulation. Thus, during Agnipaki method, the contents of KGA will lose moisture considerably, because of which, comparatively increased shelf life was noticed. Contrary to this, the sample in Surya paka, where heat was supplied in the means of sunrays, optimum quantity of heat to evaporate equal moisture content could not be achieved. There is another possibility of increase moisture content in KGS is from the atmospheric humidity as it processed in open air for 7 days. Further, there may be some environmental factors like dust particles that might enter into the formulation during Suryapaki method and affect the product adversely. The process ghrita murchana may be another factor for relatively less moisture content in KGA. The particular process increases the solubility of drug, eliminate factors responsible for the deterioration of product (Ama dosha and Gandha dosha) increasing drug absorbance and assimilation.[21] Organoleptic characters of both the samples showed significant change in their color; however, their odor and taste were similar after storing for 180 days under accelerated conditions. In reference to the analytical parameters of KGS, acid value and peroxide value have been found to be changed drastically at the initial stage to first and sixth months of interval. Acid value represents the amount of free fatty acid, which is produced by the hydrolysis process of triglycerides present in the formulation.[22] Peroxide value determines the magnitude of oxidation in the form of hydroperoxides in a substance.[23] There are two types of fatty acid, that is, short chain and long chain, which undergo oxidation by the time period. Long-chain fatty acids are reported to have a more vigorous oxidation process than the shorter ones. The method of preparation, packaging, storing condition, environmental factors, and biological factors like microorganism are the responsible factors for the above said hydrolysis and oxidation process.[24],[25] The study difference in the method of preparation may be the possible cause for drastic change in acid values and peroxide values of KGS. The saponification value is comparatively more in KGS (258.9) than KGA (238.9) which indicates a higher notion of oxidation in KGS during storage. The increased saponification value also indicates the rancidity and deterioration of KGS.[26] Viscosity is the parameters analyzed to measure the fluidity of a product. Fluidity of a product can be changed during storage due to oxidation and denature of other contents. Change in viscosity may also reflect possible chemical changes in agnipaki sample during the processing and storage.[27] Both the samples showed a higher stability period than the general time period mentioned in recent gazette notification for medicated ghee. As it is a herbomineral formulation, both the samples are comprised of minerals, that is, Kasisa, Hartala, Manahsila, Gandhaka, Tutthaka, Sindura. Metals and mineral-containing formulations are having longer stability than the pure herbal ones. The Gazette notification regarding the general shelf life of Ayurvedic dosage forms also supports this statement.[28] Presence of metals and mineral may counter the environmental and biological factors responsible for degradation of other organic components present in the formulation. The type of pot (Tamra patra) used in preparation of KGS is also a factor for increasing the stability as there is interaction of copper, ghee, and other herbal and mineral ingredients with the presence of sunlight.
| Conclusion | | |
Shelf-life defined for Ghrita in Rule 161B of Drugs and Cosmetics Act–1940 is 2 years. In the current study, KGS are found to have a shelf life of 3.8 years, whereas KGA was found to be comparatively more stable with a shelf life of 4.4 years. This observation may be specific to KGS and KGA prepared in presence of Sunlight rays and boiling method, respectively.
Assessment of stability in relation to real-time stability study, other analytical parameters (i.e., Aflatoxin Pesticide residue), and functional groups may reveal a more perfect scenario.
Acknowledgement
The authors would like to acknowledge the support extended by the Director, All India Institute of Ayurveda (AIIA), New Delhi. Also sincerely thankful to PCIM&H for helping in the authentication of herbal ingredients and the management of VASU Health Care Pvt. Ltd., for conducting the shelf-life analysis of the product.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]
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