1. INTRODUCTION:

The recent trends for living a healthy and long life entirely depends on the traditional medication systems i.e., Ayurveda is one of the most favorable systems because of it possess several natural elements to eliminate the critical causes of the disease by restoring the equilibrium and preventing further reoccurrence¹. WHO estimated that around 80% of the world’s populations still trusting in traditional or Ayurvedic medicines for their healthy survival of life². The traditional Indian medicines play an important role for targeting SARS-CoV-2 and its pathway. Corona virus disease (COVID-19) has been considered as major life threatening disease and it is dangerous to the human population worldwide. This virus has a single stranded RNA as the genetic material surrounded by helical envelope resembling the shape of corona³. Since these viruses emerge periodically and unpredictably spread at a very rapid rate inducing serious infectious diseases, they have turned out to be a serious risk to mankind. The symptoms associated with the upper and lower respiratory tracts like cough, fever and headache are visualized during viral infections and finally fatal if conditions remains chronic more than 10 days⁴. The herbal medicines which make use of natural products with minimal side effects have made a comeback. They are getting recognized due to pharmacological evidence of safety and efficacy, development of standardized dosage forms and quality control measures⁵.

Siddha medicines which do not cause any adverse effects for treating several viral diseases like chicken pox, mumps, influenza, dengue and prophylaxis⁶. In various traditional systems of Indian medicine the poly herbal formulations are favored with respect to single drug therapies^7-8. The meaning of Kabasura Kudineer (KK) is kabam-cold, suram-fever, kudineer-concoction and it is a siddha formulation contains fifteen herbal ingredients compositions has major many phytoconstituents. The combination of various herbs (polyherbal) in a particular ratio will give a desirable therapeutic effect because the potent phytochemical constituents of individual plants are inadequate to achieve the beneficial effect^9-10. The polyherbal formulation contains two or more herbs with different phytoconstituents possessing similar or dissimilar therapeutic potential have been collectively producing desirable effects during the management of human ailments^11-12. The popularity of the polyherbal formulation is outstanding because of their wide therapeutic range i.e., effective at a low dose and safe at high dose. Kabasura Chooranam (KC) is indicated for use in fever (Aiya Suram) and respiratory disease (Aiya Noigal) in Siddha system of medicine. It consist of 15 herbal ingredients such as dried rhizomes of Zingiber officinale, Cypreus rotundus, entire plant of Andrographis paniculata, dried flower buds of Syzygium aromaticum, dried roots of Sida acuta, Rotheca serrate, Tragia involcurata, Anacyclus pyrethrum, Hygrophila auriculata dried fruits of Piper longum, Terminalia chebula dried leaves of Justicia adathoda, Plectranthus amboinicus, dried stem of Tinospora cordifolia, and dried tubers of Saussurea lappa are shown to possess antiviral, anti-inflammatory activity.

Basically 5gm of KC was mixed with 240ml of water, boiled and reduced to its half volume. This is recommended to take twice or thrice daily not exceeding 60ml¹³.

Oral administration of KC in the form of oral liquids is a convenient method, but in some instances, administration of the drug is not feasible like preparation of powder into liquid preparation with application of heat. Degradation of KC aqueous extract may happened on storing prolonged time may produce instability. It has higher chance of dose variability since the delivery of the dose depends upon the patient measuring the proper volume. The taste is usually unpleasant is always more prominent when in solution than in a solid form. For increasing stability time, producing fast actions, consuming required dose and masking bitter taste, an attempt of oral dispersible tablet has been developed.

Tablets and capsules are the mostly used and acceptable dosage forms. However, they face a drawback for some patients who feels difficulty in swallowing. Orodispersible tablets (ODTs) a rapidly emerging drug delivery system with better patient compliance. ODTs are used for people who have swallowing difficulties as well as for active people^14-16. ODTs disintegrate in the patient’s mouth within a few seconds and are ideal for patients having dysphasia^17-18. The advantages of mouth dissolving dosage form are increasingly being acknowledged in both industry and academia¹⁹. ODTs are commonly known as orally disintegrating tablets, mouth dissolving tablets, fast dissolving tablets, or rapid melt tablets.

The present research work was designed to formulate and evaluate a novel polyherbal oral dispersible tablet containing aqueous extracts of some selected plants possessing active phytoconstituents which were scientifically proven for the management of COVID-19. Orodispersible tablet of KC can take without need of water and also readily dissolved in mouth with producing quick actions and pleasant taste, these helps to reduce the dose related side effects, nauseatic effects and also helps in prevention and management of COVID-19.

2. MATERIALS AND METHODS:

2.1 Materials:

KC was purchased in local herbal shop at Virudhunagar District, Tamil Nadu. The other chemicals such as Croscarmellose sodium, Micro crystalline cellulose, Mannitol, Talc, Magnesium stearate and Sodium saccharine were purchased from Sigma-Aldrich. Instruments such as Freeze dryer, Monsanto hardness tester, Vernier caliper, Friabilator USP type, UV–Visible Spectrophotometer, USP dissolution, Disintegration test apparatus, High Performance Thin Layer Chromatography (HPTLC), Differential Scanning Calorimeter (DSC), Fourier Transform Infrared Spectroscopy (FT-IR) and Double punch tablet machine were used for this study.

2.2 Methods:

Evaluation of Physio-Chemical Parameter of Crude Polyherbal KC:

The physio-chemical evaluation such as the Moisture content, ash value, extractive value, Foaming index, swelling index and volatile oil content for KC were evaluated as per standard protocol for the polyherbal kabasura chooranam^20-21.

Preparation of Kabasura Kudineer (KK) Extracts:

KC of 50gm was added with 2400ml of distilled water and the extraction is done by hot maceration technique ²². The extracts were filtered by using Whatman filter paper and concentrated at an appropriate temperature (40°C) on a rotary evaporator and dried under freeze drier. The final dried powder was stored in a closed container at a cool place²³ for further usage.

Preliminary Phytochemical Screening of Aqueous Extract of KC:

The aqueous extract obtained was subjected for phytochemical screening to determine the presence of phytoconstituents such as Carbohydrates, Proteins Alkaloids, Flavonoids, Glycosides, Sterols, Terpenoids, and Tannins present in the extract followedas of standard procedure²⁴.

Characterization of Freeze dried Polyherbal Aqueous Extract of Kabasura Chooranam (PHAE-KC):

The freeze dried PHAE-KC was evaluated for various flow properties such as angle of repose, bulk density, tapped density, Hausner’s ratio, and Carr’s index.

Angle of repose:

The flow properties of freeze dried polyherbal extract powder were determined for the angle of repose by the fixed height method. A funnel with 10mm in diameter of the bottom was fixed at the height of 2cm over the plain and smooth surface. About 5gm of a thoroughly mixed sample was slowly passed beside the wall of the funnel until the tip of the pile formed and touches the bottom of the funnel. A rough circle drowned around the pile base, and the radius of the powder cone was measured²⁵. The angle of repose was calculated by the average radius using the following formula.

Tan σ = h/r

Where h and r are the height and radius of the powder cone respectively.

Bulk Density:

The bulk density (BD) of polyherbal powder mixture were determined by pouring gently 5gm of sample mixture through a glass funnel into a 10ml graduated cylinder. The initial volume occupied by the sample was recorded. The bulk density was calculated from the below formula.

BD = Weight of the powder/Volume of the packing

Tapped Density:

The tapped density (TD) of freeze dried polyherbal extract powder were determined by pouring gently 5gm of sample mixture through a glass funnel into a 10ml graduated cylinder. The cylinder was tapped from the height of 2 inches until a constant volume obtained and then the average value of all formulation reported. The final volume occupied by the sample after tapping were recorded²⁶ and tapped density calculated from the below formula.

TD = Weight of the powder/Tapped volume of the packing

Compressibility:

The Carr's compressibility gives a useful empirical guide. The compressibility of the polyherbal powder mixture was calculated by comparing the bulk density and tapped density. The percentage compressibility of all formulation was calculated.

Carr’s compressibility index (Carr’s index) = [(TD − BD) × 100]/TD

Hausner’s ratio:

It also shows densification of polyherbal powder mixture which may result from the vibration of the feed hopper, which was calculated by using the formula. Lower Hausner’s ratio-better flow ability, Higher Hausner’s ratio- Poor flow ability^27-28.

Hausner’s ratio = Tapped density/Bulk density

High Performance Thin Layer Chromatography^:

CAMAG Linomat was used for the detection and Linomat 5 sample applicator was used for the application of the track. Twin trough plate development chamber was used for the development of chromatogram. Mobile phase used are Toluene: Ethyl acetate: Formic acid: Methanol (3:6:1.6:0.4) was. The developed plates were examined at wavelength 200-400nm²⁹. The Retention factor values and area under curve for aqueous extract of Kabasura Chooranam was examined.

Orodispersible Tablets Preparation:

The freeze dried PHAE-KC was added with other excipients in a geometrical dilution method to maintain uniformity. The excipients were selected depending on preformulation studies, and their concentrations were established on the basis of an extensive literature survey. Microcrystalline cellulose was selected as a directly compressible diluent³⁰, Sodium saccharine was selected as a sweetening agent³¹. Magnesium stearate was chosen as the lubricant to improve the flow properties of the blend³². The ingredients such as 5% Croscarmellose sodium, 55% Micro crystalline cellulose, 15% Mannitol, 1% Talc, Magnesium Stearate, and 3% Sodium saccharine was added. The Orodispersible tablet was formulated by adding the required amount of above mentioned excipients and compressed by direct compression method technique^33-34. The compressed tablet has been evaluated for its preformulation and stability studies such as tablet hardness, thickness, weight variation, friability, drug content, disintegration time, dissolution time³⁵ and drug-excipient interaction study using FT-IR and DSC analysis were carried out.

Preformulation studies of Freeze dried PHAE-KC Orodispersible tablet:

Tablet Hardness:

Hardness is a vital parameter that prevents breakage of tablets during transportation, handling, and storage. The hardness of tablet was measured with the Monsanto hardness tester and was expressed in terms of kg/cm².

Tablet Thickness:

A single tablet was placed between the two arms of the Vernier caliper, and thickness was determined.

Weight Variation:

Five tablets was selected and weighed individually using a digital balance. The individual weights were noted and compared with the average weight for the weight variation.

Friability:

Five tablets was weighed and then placed in a plastic chambered Friabilator USP type Roche Friabilator attached to a motor revolving at a speed of 25rpm for 4 minutes. The tablets were reweighed, and the percentage weight loss (friability) was calculated using the following formula:

Friability = [(Initial weight – Final weight) / (Initial weight)] × 100%.

Drug content

Five tablets were weighed and crushed to a fine powder, and introduced into a 100mL volumetric flask and extracted using pH 6.8 phosphate buffer. The solution obtained was filtered, and the filtrate was suitably diluted with pH 6.8 phosphate buffer. The drug content was determined by measuring the absorbance at 250nm using a UV–Visible Spectrophotometer. The drug content was determined using the standard calibration curve.

Wetting time and water absorption ratio (R)

A tissue paper was taken and folded twice and placed in a Petri dish (with an internal diameter of 5cm) containing 6mL of water. A tablet was cautiously placed on the top of the tissue paper in the Petri dish. Wetting time was noted as the time required for water to reach the upper surface of the tablet and to completely wet it. Water absorption ratio (R) was then determined according to the following equation:

R = 100 × (wa − wb)/wb

Where wb and wa denote the tablet weights before and after water absorption, respectively.

In-vitro Disintegration Time:

Six tablets were placed individually in each tube of disintegration test apparatus. The medium was maintained at a temperature of 37±2^◦C, and the time was noted for the entire tablet to disintegrate completely.

Drug-Excipient Interaction Study:

The crude polyherbal KC, freeze dried PHAE-KC with various excipients used in the preparation of ODT formulation were characterized by FR-IT and DSC to determine the compatibility. The scanning range was 500-4000cm^-1 and the FT-IR spectra of samples was obtained using the KBr disk method^36-37.

Stability Studies:

The stability study of the prepared Orodispersible tablets was carried out by keeping the samples in the stability chamber at 40±20 ^◦C/75±5% RH for 3 months as per the ICH guidelines³⁸. The optimized batch was selected for stability studies. The tablets were evaluated for hardness, friability, drug content, and disintegration time.

3. RESULTS AND DISCUSSIONS:

The physio-chemical property of crude polyherbal KC such as moisture content, ash value, extractive values, foaming index, swelling index and volatile oil content were determined (Table 1).

Table 1 Physiochemical parameters of crude polyherbal KC

S. No	Physiochemical parameters	Results (%)
1	Moisture content	2.076±0.0023
2	Ash values
	Total ash	7.2±0.016
	Acid insoluble ash	4.7±0.004
	Water soluble ash	1.3±0.002
	Sulphated Ash	1.7±0.052
3	Extractive value
	Aqueous	3.4±0.052
	Pet Ether	1.6±0.009
	Ethanol	2.8±0.041
4	Foaming index	Less than 100
5	Swelling index
i)	Initial volume	2.7±0.14
ii)	Final volume	4.9±0.152
6	Volatile oil content	Nil

Based on the extractive value yield in aqueous solvent, water was selected for the extraction of KC were prepared by maceration technique, subjected to freeze drying and stored for further usage. The yield of aqueous extract obtained was 12.34gm.

The presence of phytoconstituents in aqueous Kabasura Chooranam Extract was evaluated by preliminary phytochemical screening of which showed the presence of Carbohydrates, Proteins, Alkaloids, Flavonoids, Sterols, Terpenoids, and Tannins (Table 2).

Table 2 Preliminary Phytochemical Screening of Aqueous extracts of KC

S. No	Phytoconstituents	Indications
1	Carbohydrates	+
2	Proteins	+
3	Alkaloids	+
4	Flavonoids	+
5	Sterols	+
6	Terpenoids	+
7	Tannis	+
8	Glycosides	-

Note: (+) -Presence (-) -Absence

The freeze dried PHAE-KC was evaluated for tablet Precompression studies (Table 3).

Table 3 Precompression parameters of Freeze dried PHAE-KC

S. No	Precompression parameters	Results
1	Angle of repose	26.24° ± 1.32
2	Bulk density	0.58 ± 0.06g/cm³
3	Tapped density	0.51 ± 0.08g/cm³
4	Carr’s index	17.16 ± 0.39 %
5	Hausner’s ratio	1.20 ± 0.10 cm³

By HPTLC finger print analysis at 254 nm the aqueous extract of KC showed 10 peaks with varying peak heights. The standard quercetin is compared with aqueous extract of KC. The peak 8 coincides with the standard quercetin at a R_f of 0.68. The Max R_f, area and chromatograms of the KC aqueous extract, standard Quercetin were determined (Table 4 and figure 1).

Table 4 HPTLC of aqueous extract of KC

S. No	Start Position (R_f)	Start Height (AU)	Max Position (R_f)	Max Height (AU)	Max %	End Position (R_f)	End Height (AU)	Area (AU)	Area %	Assigned Substances
1	-0.03	0.3	0.02	351.1	17.95	0.06	66.3	10677.0	14.76	Unknown
2	0.06	166.5	0.07	172.8	8.84	0.09	44.0	4176.3	5.74	Unknown
3	0.10	143.6	0.11	168.1	8.60	0.14	15.3	4781.6	6.61	Unknown
4	0.14	115.3	0.17	136.3	6.97	0.23	39.6	6095.3	8.42	Unknown
5	0.23	39.6	0.26	51.8	2.65	0.30	37.2	2212.7	3.06	Unknown
6	0.31	38.8	0.33	43.5	2.23	0.36	32.1	1520.3	2.10	Unknown
7	0.47	47.8	0.58	318.9	16.31	0.62	00.9	14140.9	19.54	Unknown
8	0.62	101.5	0.68	310.1	15.86	0.72	70.5	11351.8	15.69	Quercetin
9	0.74	172.7	0.79	195.6	10.00	0.81	90.4	8995.5	12.43	Unknown
10	0.82	191.9	0.85	207.3	10.60	0.92	0.3	8399.4	11.61	Unknown

Orodispersible tablet was prepared by adding the required quantities of additives and evaluated for its characterization studies (Figure 2 and Table 5).

Figure 2 Compressed ODT of freeze dried PHAE-KC

Table 5 Precompression parameters of Freeze-dried powder of aqueous KC extract

S. No	Post compression parameters	Results
1	Tablet hardness	2.4 ± 0.1kg/cm²
2	Tablet thickness	3.83 ±0.014 mm
3	Friability	0.08%
4	Drug content	98.96%
5	Wetting time	37.76 ± 2.41 sec
6	Water absorption ratio	133.55 ± 0.28
7	Invitro disintegration time	46± 2.51 sec

The hardness of PHAE-KC was found to be 2.4± 0.1kg/cm² which possessed a good mechanical strength with sufficient hardness. The thickness of the formulated Orodispersible tablet was 3.83±0.014mm. Friability test values of our prepared Orodispersible tablet showed less than 1% weight loss that is highly within the acceptable limit. Hence all tablets passes in friability test. The percentage drug content for the formulated tablet was found to be between 98.96% w/w. The wetting and water absorption time is important for the solid dosage form which determines the capacity of a disintegrant used in the formulation to swell in the presence of a small amount of water. The wetting time of formulated Orodispersible tablet was found to be 37.76±2.41 sec. In-vitro disintegration time of our prepared Orodispersible tablet were 46±2.51 sec, these show least disintegration time (46sec). From the FT-IR graphical image, the freeze-dried powder of KC aqueous extract followed by addition of excipients one by one and at last all the ingredients were added and checked for compatibility interactions. By FT-IR and DSC graphical image analysis for Drug excipient interaction revealed that, there were no appreciable physicochemical interaction between the aqueous extract of KC and other excipients used for tablet formulation (Figures 3 and 4)

Figure 3 FTIR graphical images of KC and excipients

A -Crude Aqueous extract of KC.

B- Freeze dried PHAE-KC.

C- Freeze dried PHAE-KC and other tablet excipients.

Figure 4 DSC graphical image of freeze dried PHAE-KC (A) and all excipients added together (B)

The stability study results indicated that there was no significant change in the physical and chemical characteristics of the formulated tablet and it was stable at 40^◦C/75% RH for 3 months. (Table 6).

Table 6 Stability studies parameters for formulated Orodispersible tablet

S. No	Parameters	Month 1	Month 2	Month 3
1	Hardness (kg/cm²)	2.4 ± 0.1	2.3 ± 0.7	2.48 ± 0.5
2	Friability (%)	0.08	0.07	0.08
3	Drug content (%)	98.96	98.01	98.19
4	Disintegration time(s)	46± 2.51	45± 1.31	46± 2.32

4. CONCLUSION:

The results from the angle of repose, Carr's index and Hausner’s ratio showed that the freeze dried PHAE-KC possess good flow properties. The physical properties of formulated tablets were determined for the uniformity in weight, hardness, drug content and friability which have complied with the official requirements, and comply with the official limits mentioned in IP 2010. The formulated Orodispersible tablets showed good disintegration property and invitro dispersion time. The FT-IR spectroscopy suggests that there was no chemical interaction between the polyherbal extract and the excipients used in the formulation of dispersible tablet. The formulation was kept for stability studies and observed that it was reproducible even on stored for three months. So further investigations are needed for the comparative in-vivo pharmacological activity screening.

In conclusion, the present work revealed that, KC Orodispersible tablet (solid dosage form) was successfully formulated and it will be very useful for patients having COVID-19 infection especially for pediatrics, in which its bitter taste has been masked, nontoxic, patient compliance, quick onset of action, high bioavailability, consuming required dose and increasing stability time, all of which make these tablets a better dosage form for the management, treatment and to boost immune response against COVID-19 virus.

5. CONFLICTS OF INTEREST:

The authors declare that there is no conflict of interests regarding the publication of this article.

6. AUTHORS CONTRIBUTIONS:

The entire authors have contributed equally

7. ACKNOWLEDGEMENT:

We acknowledge our gratitude to thank Tamil Nadu State Council for Science and Technology for providing the grant Lr. No. TNSCST/SPS/2021-2022/ dated 11.03.2022, Project Code MS-211. Also Thankful to SB College of Pharmacy, Sivakasi for giving permission to carry out this research work.

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Received on 11.06.2025 Revised on 08.08.2025

Accepted on 16.09.2025 Published on 18.10.2025

Available online from November 03, 2025

Res. J. Pharma. Dosage Forms and Tech.2025; 17(4):231-238.

DOI: 10.52711/0975-4377.2025.00032

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