Development and Evaluation of Monoherbal Fast Dissolving Oral Film (FDOF) From The Root Extract of Achyranthes aspera Linn for the Treatment of Snake Bites

R. Sundhararajan, P. T. Sangeetha*, A. Akash Bernat Singh,

Ammar Jaffar Mohideen, P. Sumitha, J. Yugavarshini

Mohammed Sathak College of Pharmacy, Chennai, Tamilnadu

*Correspondence: angeethakanadasan05@gmail.com

DOI: https://doi.org/10.71431/IJRPAS.2026.5211   

INTRODUCTION

Snakebite is a serious and life-threatening medical emergency, especially in tropical and rural regions like India. According to the World Health Organization (WHO), snakebite envenomation is classified as a neglected tropical disease due to its high mortality and morbidity rates, particularly in developing countries [1]. Immediate treatment is crucial to prevent systemic complications such as

neurotoxicity, hemotoxicity, tissue necrosis, and organ failure [2]. However, access to anti-snake venom (ASV) therapy is often delayed in rural areas due to lack of healthcare facilities, transportation barriers, and cost issues [1]

Traditional medicinal plants have long been used in folklore medicine for the management of snakebite [3]. One such plant is Achyranthes aspera (Family: Amaranthaceae), commonly known as Apamarga. It is widely distributed in India and has been reported to possess anti-inflammatory, anti-toxic, antimicrobial, and wound healing properties [4]. The plant contains bioactive constituents such as alkaloids (achyranthine), saponins, flavonoids, and triterpenoids, which are believed to contribute to its anti-venom potential. [5]

Fast dissolving oral films (FDOFs) are a novel drug delivery system designed to disintegrate rapidly when placed on the tongue without the need for water. These films offer advantages such as rapid onset of action, improved bioavailability, ease of administration, and better patient compliance, especially in emergency conditions where swallowing tablets or injections may not be feasible [6,7]. The development of a monoherbal fast dissolving oral film of Achyranthes aspera aims to combine traditional herbal medicine with modern drug delivery technology. This formulation may provide a rapid, convenient, and accessible first-aid treatment option for snakebite victims, particularly in rural settings.

MATERIALS AND METHODS

Collection and Authentication Of Plant material

Fresh roots of Achyranthes aspera were collected from areas of Palayamkottai, Tamilnadu during the month of December and was authentified by a qualified botanist from the Department of Botany, Siddha Central Research Institute Arumbakkam, Chennai. A voucher specimen (A21012607A) was prepared and deposited in the department herbarium for future reference.The collected roots were washed thoroughly with distilled water to remove adhering soil and debris. The material was shade-dried at room temperature (25–30°C) for 7–10 days to prevent degradation of thermolabile phytoconstituents. The dried roots were coarsely powdered using a mechanical grinder and passed through sieve No. 40 to obtain uniform particle size [1,2]

Preparation of plant extract

The dried and powdered root material of Achyranthes aspera was subjected to Extraction by cold maceration method. Approximately 100 g of coarse powder was soaked in 500 mL of solvent mixture Ethanol and water (1:1) in a closed container and kept at room temperature for 72 hours with intermittent shaking to ensure maximum extraction of phytoconstituents. The mixture was filtered through muslin cloth followed by Whatman No.1 filter paper to obtain a clear filtrate. The filtrate was concentrated under reduced pressure using a rotary evaporator at a temperature not exceeding 45°C to prevent degradation of thermolabile constituents. The concentrated hydro alcoholic extract obtained was further dried in a desiccator until constant weight was obtained and stored in an airtight container at 4°C for further studies. Preliminary phytochemical screening was carried out to identify major secondary metabolites such as alkaloids, flavonoids, saponins, tannins, and glycosides using standard procedure [8-11].

Development of Fast Dissolving Oral Film

Fast dissolving oral films were prepared by the solvent casting method. Required quantity of polyvinyl alcohol (PVA) was dissolved in distilled water with continuous stirring and gentle heating at 60–70 °C until a clear solution was obtained. Gelatin was dissolved separately in warm distilled water and added to the PVA solution to enhance film-forming capacity [20]. Glycerine was incorporated as a plasticizer to improve flexibility and reduce brittleness of the film [21].Sodium starch glycolate (SSG) was added as a superdisintegrant to promote rapid disintegration by swelling action in the presence of saliva [22]. Sweetening agents such as sucrose and D-mannitol were incorporated to improve palatability and mouthfeel [23]. Citric acid was added as a saliva-stimulating agent to accelerate disintegration in the oral cavity [20] .Sodium benzoate was included as a preservative to enhance microbial stability of the formulation [21] .Peppermint oil was added as a flavoring agent to mask the taste and improve patient acceptability [23].Previously prepared Achyranthes aspera root extract was incorporated into the polymeric solution under continuous stirring to obtain a uniform dispersion [24]. The solution was allowed to stand to remove entrapped air bubbles (20). The homogeneous solution was poured into a leveled petri dish and dried at room temperature or in a hot air oven at 40–45 °C until a thin film was formed [22]. The dried film was carefully peeled off, cut into uniform strips of required dimensions, and stored in airtight containers for further evaluation [20]

Table 1. FDOF Formulation table

Evaluation of Fast dissolving oral film

The surface pH of the herbal formulation containing extract of Achyranthes aspera Linn. was determined to evaluate its compatibility with the skin. The formulation was allowed to swell in distilled water for 1 hour, and the pH was measured using a calibrated digital pH meter. The surface pH was found to be 6.5 ± 0.2, which is within the normal skin pH range (5.5–7.0), indicating that the formulation is non-irritant and suitable for topical application [21].The moisture content of the prepared formulation was evaluated by placing the sample in a desiccator containing activated silica for 24 hours and calculating the percentage moisture loss. The moisture content was found to be 3.8% ± 0.4%, indicating low residual moisture and good stability of the formulation [22].The thickness of the formulation was measured at three different points using a digital micrometer screw gauge to ensure uniformity. The average thickness was recorded as 0.24 ± 0.03 mm, confirming uniform distribution of the herbal extract and excipients [23].Folding endurance was determined by repeatedly folding the film at the same point until it broke. The formulation withstood more than 250 folds without breaking, demonstrating good mechanical strength and flexibility [24]. The weight uniformity test was performed by individually weighing different samples of the formulation and calculating the average weight. The percentage deviation was found to be within ±5%, complying with pharmacopoeia standards and confirming uniform drug distribution [25].

Table 2: Evaluation Parameters

Table 3: Phytochemical screening

Fig 1 Fast dissolving oral film

RESULT AND DISCUSSION

The monoherbal fast dissolving oral films containing Achyranthes aspera Linn root extract were successfully prepared by the solvent casting method. The prepared films were smooth, thin, and flexible with a slightly brown color due to the presence of the herbal extract. No cracks, bubbles, or stickiness were observed, indicating proper formulation and uniform drying of the film.The thickness and weight of all formulations were found to be uniform, showing that the extract and excipients were evenly distributed throughout the film matrix. Uniformity is important to ensure that each film delivers an accurate dose. The folding endurance test showed that the films could be folded repeatedly without breaking, which indicates good mechanical strength and flexibility. The presence of plasticizers helped in improving the elasticity of the films.The surface pH of the films was found to be close to neutral (around salivary pH), suggesting that the formulation would not cause irritation to the oral mucosa. Drug content uniformity was within acceptable limits (above 94%), confirming that the Achyranthes aspera root extract was uniformly dispersed in the polymeric base.

The disintegration study showed that all films dissolved rapidly within 30–45 seconds, while the optimized formulation disintegrated within approximately 20–25 seconds. Rapid disintegration is essential for emergency conditions such as snakebite, where quick onset of action is required. The in-vitro dissolution study revealed that nearly 85–90% of the active constituents were released within 5 minutes,and almost complete drug release occurred within 10 minutes. This rapid release indicates that the phytoconstituents such as alkaloids, saponins, and flavonoids may become quickly available for action. Stability studies conducted under accelerated conditions showed no significant change in physical appearance, drug content, or disintegration time. This indicates that the developed oral film formulation is stable and suitable for storage.

Overall, the results demonstrate that incorporation of Achyranthes aspera root extract into a fast-dissolving oral film is feasible and produces a stable, rapidly disintegrating dosage form that may act quickly in emergency situations.

CONCLUSION

The Phytochemical screening of root extract also confirms the presence of bioactive compounds like Alkaloids, Flavonoids, Glycosides, steroids and Proteins. The Evaluation study of the prepared films also showed good mechanical strength, uniform drug content, rapid disintegration, and fast drug release. The formulation was also found to be stable under accelerated storage conditions. Due to its quick dissolving nature, ease of administration, portability, and no requirement of water, the developed oral film may serve as a useful supportive first-aid measure in rural and emergency settings. Therefore it can be concluded that fast dissolving oral film containing Achyranthes aspera root extract may be used as supportive management for snake bites. However, it should not replace conventional antivenom therapy but may be used as an adjunct treatment until proper medical care is available. Further investigations have to be carried out to confirm its therapeutic effectiveness. Future studies may include In-vivo anti-venom activity using suitable animal models, Pharmacokinetic studies to determine absorption and bioavailability & Clinical trials to establish efficacy in human subjects. These studies will help to scientifically validate the use of Achyranthes aspera root extract oral film as a supportive treatment for snakebite management.

ACKNOWLEDGEMENT

The authors are grateful to the Management, The Principal of Mohamed Sathak A.J. College of Pharmacy for providing the facilities to perform the above research work.

REFERENCES

1.  World Health Organization. Snakebite environment: A strategy for prevention and control. Geneva: WHO; 2019.

2.  Warrell DA. Snake bite. Lancet. 2010;375(9708):77–88.

3.  Alam MI, Gomes A. Snake venom neutralization by Indian medicinal plants (Vitex negundo and Emblica officinalis) root extracts. J Ethnopharmacology. 2003;86(1):75–80.

4.  Kumar S, Bhowmik D, Chiranjib, Chandira RM. Medicinal uses and pharmacological properties of Achyranthes aspera: A review. Int J Pharm Sci Rev. Res. 2010;3(1):45–49.

5.  Sharma V, Chaudhary U. An overview on indigenous knowledge of Achyranthes aspera. J Pharmacognosy Phytochemical. 2015;3(5):85–89.

6.  Dixit RP, Puthli SP. Oral strip technology: Overview and future potential. J Control Release. 2009;139(2):94–107.

7.  Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: An innovative drug delivery system. Int J Chemtech Res. 2010;2(1):576–583.

8.  Harborne JB. Phytochemical Methods: A Guide to Modern Techniques of Plant Analysis. 3rd ed. Chapman & Hall; 1998.

9.  Trease GE, Evans WC. Pharmacognosy. 16th ed. Elsevier; 2009.

10.  Azwanida NN. A review on extraction methods use in medicinal plants. Int J PharmTech Res. 2015;4(3):196–201.

11.  Kokate CK. Practical Pharmacognosy. 4th ed. Vallabh Prakashan; 1994.

12.  Azwanida NN. A review on extraction methods use in medicinal plants. Med Aromat Plants. 2015; 4:196.

13.  Pandey A, Tripathi S. Concept of standardization, extraction and pre-phytochemical screening strategies. J Pharmacogn Phytochem. 2014;2(5):115-119.

14.  Harborne JB. Phytochemical Methods: A Guide to Modern Techniques of Plant Analysis. 3rd ed. Chapman & Hall; 1998.

15.  Mors WB, et al. Plant natural products active against snake bite. Phytochemistry. 2000; 55:627-642.

16.  Samy RP, et al. Snakebite management: Ethnopharmacologil approach. J Ethnopharmacol. 2008;115:1-17.

17.  Kumar A, et al. A review on pharmacological and phytochemical properties of Achyranthes aspera. Int J Pharm Sci Rev Res. 2010;3(1):45–52.

18. Sharma V, et al. Traditional and medicinal uses of Achyranthes aspera Linn: A review. Int J Res Pharm Biomed Sci. 2011;2(3):1231–1236.

19.  Singh D, et al. Anti-inflammatory activity of Achyranthes aspera Linn. J Ethnopharmacol. 2009;123(1):123–129.

20.    Dixit RP, Puthli SP. Oral strip technology: Overview and future potential. J Control Release. 2009;139(2):94-107.

21.    Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: An innovative drug delivery system and dosage form. Int J ChemTech Res. 2010;2(1):576-583.

22.    Dinge A, Nagarsenker M. Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity. AAPS PharmSciTech. 2008;9(2):349-356.

23.    Cilurzo F, Cupone IE, Minghetti P, Selmin F, Montanari L. Fast dissolving films made of maltodextrins. Eur J Pharm Biopharm. 2008;70(3):895-900.

24.    Srivastav S, Singh P, Mishra G, Jha KK, Khosa RL. Achyranthes aspera – An important medicinal plant: A review. J Nat Prod Plant Resour. 2011;1(1):1-14.