|Year : 2020 | Volume
| Issue : 4 | Page : 304-307
Shelf-life evaluation of Marichyadi Lepa prepared with Agnipaki and Bhanupaki method: A preliminary assessment
Sandhya Barad1, Sonam Sagar Bhinde2, Prashant Bedarkar2, Galib Ruknuddin3
1 Department of RS & BK, B.G.Garaiya Ayurveda College, Rajkot, India
2 Department of Rasa Shastra and Bhaishajya Kalpana Including Drug Research, IPGT & RA, Jamnagar, India
3 Department of RS & BK, All India Institute of Ayurveda, New Delhi, India
|Date of Submission||04-Nov-2020|
|Date of Decision||01-Dec-2020|
|Date of Acceptance||10-Dec-2020|
|Date of Web Publication||11-Feb-2021|
Dr. Sandhya Barad
Department of RS & BK, B.G.Garaiya Ayurveda College, Rajkot, Gujarat.
Source of Support: None, Conflict of Interest: None
Introduction: The shelf life of a drug can be considered up to the period when it gets deteriorated and it does not experience any alteration in its physicochemical state. Every product has a shelf life, which depends on various physical, chemical, environmental, and biological factors. Ancient seers have clarified the shelf life of various compound formulations. However, there is a need to revalidate and ascertain the shelf life of individual formulations by following parameters that are prevalent in the respective scenario. Aim: To evaluate the shelf life of Marichyadi Lepa prepared by Agnipaki (heating by using fire) method (MLA) and Bhanupaki (heating by using sunlight) method (MLB) through an accelerated stability study. Subjects and Methods: Physicochemical parameters were measured at 40 ± 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: MLB and MLA showed a shelf life of 6.24 months and 5.50 months, respectively. Conclusion: MLB is comparatively more stable than the sample prepared with MLA.
Keywords: Accelerated stability study, Agnipaki, Bhanupaki, Marichyadi Lepa, shelf life
|How to cite this article:|
Barad S, Bhinde SS, Bedarkar P, Ruknuddin G. Shelf-life evaluation of Marichyadi Lepa prepared with Agnipaki and Bhanupaki method: A preliminary assessment. J Indian Sys Medicine 2020;8:304-7
|How to cite this URL:|
Barad S, Bhinde SS, Bedarkar P, Ruknuddin G. Shelf-life evaluation of Marichyadi Lepa prepared with Agnipaki and Bhanupaki method: A preliminary assessment. J Indian Sys Medicine [serial online] 2020 [cited 2021 Mar 7];8:304-7. Available from: https://www.joinsysmed.com/text.asp?2020/8/4/304/309120
| Introduction|| |
In Ayurveda literature, “Saviryata Avadhi” refers to the period during which the drug remains potent. Although this concept was known to earlier scholars, it was exclusively described in later texts such as Vangasena, Sharangadhara Samhita, and Yogaratnakara for different Ayurveda dosage forms. As per Sushruta Samhita, 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 current era. The shelf life of the drug can be considered up to the period when it gets deteriorated and there is an alteration in its physical state. The Ayurveda Formulary of India has also given the period as the time from the date of manufacture within which the formulations should be consumed for best results. By following prevalent guidelines, the stability study of some Ayurveda formulations such as powder,, pills, supplements, and confectionaries has been attempted earlier.
Marichyadi Taila is a herbomineral topical application and a promising remedy for Shvitra (Vitiligo). Classic advice is to keep the ingredients in specified quantities in a copper vessel that should be placed in the sun’s rays for seven consecutive days (Bhanupaka/Adityapaka). Heating by using sunlight is a unique Ayurveda pharmaceutical technology having wide applicability in Ayurveda pharmaceutics and it is potent to direct innovations in contemporary pharmaceutical science, too. As it is not possible to follow Bhanupaka in places at all times, an attempt is also made to prepare it by the classical process of heating by using fire. As gels (Lepa) are preferred nowadays, both these samples were converted into Lepa form and dispensed to the enrolled patients with Vitiligo for topical application during the treatment period. The modified external dosage form (Lepa) has several merits that overcome the demerits of classical oil formulations, and they are found to be efficacious in evidence-based studies.
However, no stability profiles of this modified formulation are available till date. Even comparative studies emphasizing the rationale and impact of such variations of the pharmaceutical method on its shelf life are also not reported. Looking into this, it was planned to prepare MLA and MLB, respectively, and evaluate comparative stability profiles through an accelerated study.
| Materials and Methods|| |
Collection of Raw Material
All drugs were procured from the local market, Jamnagar, and authenticated in the pharmacognosy laboratory, Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar. Formulation composition is depicted in [Table 1].
One sample of MLB was prepared as per classical references and other samples of MLA as per a modified method. Both were converted into Lepa formulation. This formulation is mentioned as Sidhmahara Lepa in Charaka Samhita, with its indication in Sidhma and Shvitra. As this is used in Shvitra and not in Sidhma, the name of this formulation is changed and is called Marichyadi Lepa. The classical reference is of Taila preparation, but to make it easy to use, it is converted into gel formulation by adding Aerosol (SiO2 = silicon dioxide, Product no. 0571901000 with LOT # S50061208 of Loba Chemie, Particle size 40-150 Mesh), 15% in MLA and 17% in MLB.
Both the samples (MLA and MLB) comprising 100 gm each were packed in airtight plastic containers and stored in accelerated stability chambers.
An 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
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 the stability study are organoleptic characters (color and odor), consistency, moisture content by KF (%), and spread ability; these were evaluated at regular intervals.
Based on the analytical values obtained before and after six 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 the color and odor of both samples up to a storage of six months at accelerated conditions [Table 2] and [Table 3]. Based on these values, intercept, slope, and approximate time for 10% degradation were calculated, which was 1.65 for MLA and 1.876 for MLB [Table 4] and [Table 5]. As India comes under climatic Zone III, multiplication factor 3.3 was used for extrapolation of shelf life [Table 6]. Thus, the shelf life of MLA was found to be 5.5 months, whereas for MLB it was 6.2 months.
|Table 2: Observations in organoleptic and physicochemical profile of MLA|
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|Table 3: Observations in organoleptic and physicochemical profile of MLB|
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| Discussion|| |
Ayurveda science has a large variety of medicines, which include medicated oil, Ghrita, confections, powder, pills, tablets etc., which contain herbal, herbomineral, animal product, metals etc. in them. In the current study, Marichyadi Lepa was prepared by two different methods (heating by using fire and heating by using sunlight) by using Manahshila, Kasisa, Tamalapatra, Kushtha, and Maricha. According to The Gazette of India, the shelf life of mineral formulations is five years and that of oil preparations is three years. Both oils were converted into ointment form. Hence, the current study was carried out to observe the microbial contamination of sample-prepared and accelerated stability in different climatic and temperature conditions.
As per [Tables 2] and , the color and odor of both the samples remain the same throughout the accelerated stability study. Phase separation was observed after one month in MLA and in MLB it was present even at baseline. Moisture content tends to decrease as time passes in both the samples, which might be because of increased temperature during this study. Spread ability remains the same in the Agnipaki sample whereas in MLB it increases after three months. This might be because of the lower viscosity of MLB compared with MLA.
Data pertaining to [Tables 4] and  show the 10% degradation of both the samples that was extrapolated and according to that, the shelf life of MLA and MLB is 5.504 months and 6.249 months, respectively. This shelf life of both the samples is very less, may be due to the quality of aerosol; the major responsible factor for change is reduction in moisture content, spread ability, and viscosity. Though Acharya has not mentioned the shelf life of Lepa, these samples were prepared from Taila and hence the shelf life of MLA and MLB could be considered as 16 months as per Sharangadhara Samhita. Ayurvedic formulations are of a complex nature and, thus, the shelf life of each formulation should be recorded for proper understanding.
As mentioned in [Table 7], it is also important to notice that there was no microbial overgrowth after 224 and 401 days in MLA and MLB samples, respectively, which are more than the obtained shelf life in this study. This indicates that shelf life obtained in this study is based on physical and chemical changes in samples and not on the bases of microbial overgrowth.
There are multiple factors responsible for product degradation, such as temperature, humidity, microbial growth (catabolism, metabolism by microorganisms, enzymatic degradation); chemical interactions involving constituents of drugs (changes in particular constituents due to the factors mentioned earlier or interaction of constituents with other chemical moieties) such as oxidation, reduction, hydrolysis, displacement reactions, new formation (complexation/formation of co-ordination compounds), degradation (volatilization, sublimation, phase conversion, transformation into different compound) etc. Hence, after this study, it is a matter of further research as to which specific factors are responsible in these samples for this shelf life.
| Conclusion|| |
After converting Taila into Lepa form, due to the addition of aerosol, when shelf life is calculated through an accelerated stability study with the 10% degradation and extrapolation method, it was found that MLB has a longer shelf life of 6.249 months than 5.504 months of MLA. However, there was no growth of microorganisms in MLA and MLB even after 224 and 401 days respectively. This study also provided certain leads toward using different methods of preparation in Ayurveda pharmaceuticals.
Financial Support and Sponsorship
Conflicts of Interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]