Formulation and Evaluation of Polyherbal Hepatoprotective Tablets

 Uttam Kumar Kashyap, Dr. Meeraj Alam, Dr. Ashish Sarkar  

School of Pharmacy YBN University Ranchi, Jharkhand-India

*Correspondence: deansop@ybnu.ac.in

DOI: https://doi.org/10.71431/IJRPAS.2026.5622

INTRODUCTION

In the human being, the liver is one of the significant and indispensable organs in performing several vital physiological functions like metabolism, storage of glycogen, regulation of different biochemical pathways necessary for maintaining homeostasis, detoxification, and production of plasma proteins. Due to its involvement in drug and xenobiotic metabolism, the liver organ becomes vulnerable to alcohol ingestion, viral hepatitis, exposure to environmental toxins, metabolic diseases, and long-term administration of some drugs. The prevalence of liver diseases like hepatitis, cirrhosis, hepatocellular carcinoma (HCC), and fatty liver disease (FLD) around the globe leads to widespread morbidity and mortality (Asrani et al., 2019). While few synthetic compounds exist for liver ailments, there is a limitation in efficacy due to the development of undesirable side effects following long-term treatment.

Plants have been used from a long time in various system of medicine namely Ayurveda, Siddha, Unani and Traditional Chinese Medicine for liver disorders, to be specific the leaves of these medicinal plant species possess bioactive compounds like flavonoids, alkaloids, terpenoids, glycosides, tannins and phenolics which displays potent anti-oxidant, anti-inflammatory and hepatoprotective effect (Baliga et al., 2013). Moreover, Herbal medicines are safer, economical and possess a lesser side effect profile compared to the synthetic medicines. The principle behind the formulation of polyherbal medicines is based on the combination of a few herbs having similar mechanisms of action to produce significant effects on biological activity. In Ayurveda it is believed that using together herbs having cumulative effects brings together more desirable therapeutic effects with higher absorption of constituent drugs and decreased toxic effect. Polyherbal drugs are also popular as they are active against many diseases and are involved in modulation of multiple targets associated in the pathogenesis. In liver disorder management polyherbal formulations play roles like acting as antioxidant, protecting against lipid per oxidation, stimulating the regeneration of hepatocytes, enhancing the detoxification process.

Various herbs among many have been scientifically investigated due to their potent hepatoprotective and antiviral activities such as Phyllanthus niruri (Bhumi Amla), having lignans, flavonoids and tannins which can protect hepatic cells from toxic agents and oxidative damage (Bagalkotkar et al., 2006), Andrographis paniculata (Kalmegh), possessing andrographolide and associated diterpenoids with antioxidant, anti-inflammatory and immunomodulatory properties and shown to ameliorate liver damage (Akbar, 2011), Picrorhiza kurroa (Kutki), a well-established herb in Indian traditional medicine, with its constituents picrosides and kutkoside, exhibit promising hepatoprotective properties against chemical induced damage, scavenging free radicals, and stabilizing cellular membranes (Rastogi et al., 1999), Boerhavia diffusa (Punarnava), with its unique composition of alkaloids, flavonoids and rotenoids, possessing hepatoprotective, anti-inflammatory and diuretic activities (Mishra et al., 2014).

Liver damage Oxidative stress contributes extensively to the genesis and the establishment of liver disorders. Over production of reactive oxygen species leads to damage caused to lipids peroxidation, oxidation of protein, breakage of DNA strands, and consequent hepatocellular injury. Natural antioxidants present in phytochemicals of several medicinal plants exhibit anxiolitic activity through free radical scavenging and boost our body natural systems to fight against such oxidative damage. Hence natural antioxidant enhanced herbal formulations seem to be important in liver care and its related diseases (Li et al., 2015).

Oral tablets continue to be popular due to their convenient administration, exact dosage calculation, less fuss free preparation, good stability and patient compliance. Development of polyherbal tablets provide more benefits such as good stability, longer shelf life, easy storage and transportability, ease in manufacture and standardization. Disadvantages while formulating herbal tablet involves problems like poor powder flow properties, poor compressibility, content uniformity and stability of phytoconstituents.  Thus, systematic formulation and evaluation is needed for the herbal tablet. In recent years importance has given to the standardization and scientifically prove the herb. For quality of any herbal formulation (polyherbal tablet) testing with respect to phytochemical screening, precompression and post compression parameter, dissolution studies, stability study, have become mandatory so that uniformity in dose, reproducible results & the biological & therapeutic potential are confirmed within & between batches. There is a growing recognition by the regulatory authority as well as the Pharmaceutical Industry of such standardized herbal product as beneficial alternative or adjunctive for the conventional medicinal systems (WHO, 2013).

In the era of increasing liver disorders, where safer alternative therapeutic approach required, this present work was designed to formulate and characterize polyherbal hepatoprotective tablet using standardized extract of Phyllanthus niruri, Andrographis paniculata, Picrorhiza kurroa and Boerhavia diffusa. The intention of this work is to develop and analyze the pharmaceutically safe, compatible and stable tablet formulation of herbal combination and provide evidence support for their use against liver disorder.

Liver and Its Physiological Importance

Liver, the largest internal organ, is responsible for many vital metabolic, detoxifying and synthesizing functions that keep the body in homeostasis. It plays an important role in the metabolism of carbohydrates, lipids, and proteins, synthesis of plasma proteins, synthesis of bile, and detoxification of endogenous and xenobiotic substances. Since the liver plays a role in both metabolism and detoxification, it is prone to liver injuries that occur due to various factors such as alcohol, medications, toxins, viruses, and oxidation. The global health problems resulting from liver diseases include hepatitis, fatty liver diseases, cirrhosis, and hepatocellular carcinoma. According to Schuppan and Afdhal (2008), chronic liver diseases represent a significant health burden and necessitate the development of safer and more effective therapeutic interventions. Similarly, Asrani et al. (2019) reported that liver diseases contribute to approximately two million deaths annually, emphasizing the need for preventive and curative approaches.

Limitations of Conventional Hepatoprotective Therapy

Existing treatment for hepatic diseases is primarily palliative in nature and are not efficient to provide full protection or regeneration of injured hepatic cells. Use of artificial drugs in the management of liver disorders is associated with side effects, interactions and reduced efficiency to treat chronic ones. As mentioned by Navarro and Senior (2006) it is understood that many of the drugs used could cause hepatotoxicity themselves thus make the management worse. The higher number of liver diseases as expressed by Stickel and Schuppan (2007) has led to more consideration towards alternative source like plants. Medicinal plants are preferred in the management of these diseases due to long time use and minimum side effect.

Role of Medicinal Plants in Hepatoprotection

Medicinal plants play significant role in managing liver disorders. Herbs have been traditionally used in the treatment of liver diseases by Ayurvedic and other traditional methods of treatment. Herbs possess a lot of therapeutic compounds, including Flavonoids, Alkaloids, Terpenoids, Phenolic compounds, and Glycosides which possessed Antioxidant, Anti-inflammatory and Hepatoprotective properties. Rates (2001) stated that herbal medicines represent a valuable source of therapeutic agents and continue to play an important role in primary healthcare. According to Saleem et al. (2010), Phytoconstituents, with the antioxidative ability, help the phytoconstituents against lipid peroxidation and oxidative damage to liver tissue, and the formation to liver cell’s healthiness with the ability of cell to regeneration.

Hepatoprotective Potential of Selected Medicinal Plants

There are a number of other plant species with demonstrated hepatoprotective effects such as Phyllanthus niruri (Bhumi Amla) which has antiviral, antioxidant and hepatoregenerative actions and is utilized in various disorders of the liver and in jaundice and hepatitis therapy Calixto et al. (1998) Phyllanthus niruri contains lignans and flavonoids that have been reported to play an active role in liver protection. Andrographis paniculata (Kalmegh) contains andrographolide with anti-inflammatory and antioxidant properties. Akbar (2011) Proved the protective effect of andrographolide against toxin-induced injury of hepatocytes. And Kutki (Picrorhiza kurroa ) is a good source of picrosides which have been found to exhibit a highly hepatoprotective action against carbon tetrachloride- induced hepatotoxicity (Dwivedi et al., 1992). Likewise, Boerhavia diffusa (Punarnava) exhibits anti-inflammatory and antioxidant activities that aid in hepatic regeneration and prevention of fibrosis, as reported by Chandan et al. (1991).

Concept and Advantages of Polyherbal Formulations

The fundamental theory of Polyherbalism suggests that the blend of several therapeutic plants can generate beneficial pharmacological synergism and have great therapeutic effectiveness in comparison to single plant preparations (Vaghasiya and chitaliya 2007). As reported by Wagner (2011), these phytoconstituents improve therapeutic response with significantly less toxicity through interaction amongst various compounds within the formula. Parasuraman et al. (2014) noted that polyherbal compositions can interact with a variety of pathways of life and this approach makes polyherbalism more useful in chronic disease like disease liver disease. Polyherbal products are well recognized for in Ayurveda system and are getting attention of the scientist and is being accepted because they offer a diverse ranging activity.

Need for Standardized Herbal Dosage Forms

Although herbal drugs have medicinal benefits, they face the problem of standardization and quality control, as they differ in phytochemical constituent affecting effectiveness and safety. A stabilized formulation can provide stability, reproducibility and uniformity of the dosage of herbal drugs. It was stressed by Kunle et al. (2012) that assurance of quality is a prerequisite for a clinically useful herbal medicine The tablet is chosen from all the oral dosage form because the tablet offer better patient acceptability because it is easy to use and accurate and accurate dosage. Tablets are convenient in size and dosage form of drug administration with proper precision and large-scale production (Aulton and Taylor, 2018).

Evaluation of Herbal Tablets

However, an adequate quality control of the tablets must be carried out, testing for various factors such as the angle of repose, the bulk density, the tapped density, the hardness, the friability, weight variation, the tablet disintegration time, and the dissolution profile of tablets can act as important factors for evaluate the tablets quality. According to Banker and Anderson (1987), such a tablet characteristic represents the potential of tablets to sustain mechanical strength and affect the release of the active ingredients, and they also can represent the compression ability of the powder mixture. Besides the above studies, the studies of stability, that indicate the effect of the external factors to the product quality and shelf life. The stability studies on herbs formulations will be performed as per ICH guidelines (ICH, 2005).

Rationale and Significance of the Present Study

The increasing prevalence of liver diseases, along with the disadvantages related to synthetic drugs, necessitates the development of safe and beneficial herbal formulations. Potentially, combined usage of standardized extracts from Phyllanthus niruri, Andrographis paniculata, Picrorhiza kurroa and Boerhavia diffusa may offer synergistic hepatoprotective action via their antioxidant, anti-inflammatory and regenerative actions. Thus, the aim of this present research study was to develop and evaluate polyherbal hepatoprotective tablets and evaluate various physicochemical characters and qualitative analysis of developed polyherbal tablets.

MATERIALS AND METHODS

Collection and Authentication of Plant Materials

The selection of plants for the preparation was as follows: Phyllanthus niruri (Bhumi Amla), Andrographis paniculata (Kalmegh), Picrorhiza kurroa (Kutki) and Boerhavia diffusa (Punarnava). The dry parts of the plants were collected from a certified supplier, and were authenticated by certified botanist in Department of botany School of Science YBN University Ranchi. Each sample were screened out from extraneous matter, shades dried and then pounded separately with mechanical grinder into coarse powder, thereafter sifted through a mesh size of 60 and kept in an airtight container.

Chemicals and Excipients

Chemicals used: Analytical grade chemicals and reagents were used throughout the study. Microcrystalline cellulose served as the diluent; starch paste was used as binder; sodium starch glycolate was applied as super disintegrant; talc was applied as glidant; and magnesium stearate was applied as a lubricant. The other chemicals used, such as ethanol, methanol, hydrochloric acid, ferric chloride, Mayer’s reagent, Drage Dorff’s reagent etc., used in phytochemical analysis were sourced from certified manufacturer/suppliers.

Figure 1. Schematic Representation of the Formulation and Evaluation Process of Polyherbal Hepatoprotective Tablets

Preparation of Herbal Extracts

Phyllanthus niruri L, Andrographis paniculata L, Picrorhiza kurroa Benth, And Boerhavia diffusa L plants powder used in this study was subjected to hydroalcoholic extraction by maceration with 70% of ethanol as solvent. Almost 500 g powdered sample was dipped in the solvent and kept at room temperature with shaking 3 times in day for 72 h and then filtered using Whatman No. 1 filter paper. The filtrate were concentrated under reduced pressure with rotary evaporator to evaporate the excess solvent, dried, weighted to calculating the yield percent (w/w), and stored in the desiccators till its formulation was prepared.

Phytochemical Screening

The presence of general class of phytoconstituents such as alkaloids, glycosides, steroids, flavonoids, saponins, terpenoids, tannins and phenolic compounds was preliminary screening in individual plant extracts by using the standard qualitative test described by the following tests, Mayer’s test, Drage Dorff’s test, Liebermann–Burchard test, Shinoda’s test, foam test and ferric chloride test.

Formulation of Polyherbal Tablets

Polyherbal tablet was formulated using wet granulation method. Standardized extracts of the chosen plants in equal proportions were triturated properly, mixed thoroughly with microcrystalline cellulose to act as diluents, starch paste as binder, sodium starch glycolate as disintegrating agent, and talc and magnesium stearate as glidant and lubricant respectively. The damp mass obtained was then sieved through 16 mesh to collect granules, which were dried at 45 degree C, further passed through 22 mesh sieve for uniformity of particles. The dried granules were then compressed in to tablet on rotaty tablet machine and average weight of each tablet were around 500 mg.

Evaluation of Pre-compression Parameters

Freshly prepared granules were analyzed for their flow characteristics prior to compression. Angle of repose was measured by the fixed funnel method. Bulk density and tap density were assessed by the graduated cylinder method Carr's compressibility index and Hausner's ratio was calculated for characterizing the granules for compressibility and flow properties of the granules. Measurements for this parameter were performed in three replicates and reported as an average value.

Evaluation of Post-compression Parameters

The compressed tablets were subjected to evaluation of following physicochemical properties: - Table thickness, was determined using digital vernier caliper. Hardness, of the tablets was measured using a monsanto hardness tester. Friability, of the tablets was determined using roche friabilator rotate at 25rpm for 4min. Weight variation, 20 tablets were separately weighted and average was determined. Disintegration time, of tablets was determine in a usp disintegration test apparatus in distilled water at 37 0.5C. The drug content uniformity was determined spectrophotometrically.

In Vitro Dissolution Study

9.3 Dissolution profile Determination: The invitro dissolution study of poly herbal tablet was carried out using USP Apparatus(paddle method). Dissolution study was conducted by employing 900 ml. of phosphate buffer pH 6.8, 370 0.5C. With paddle operating at 50 RPM. The samples were collected after specified time interval (10, 20, 30, 45 and 60 minutes), equivalent amount of dissolution fluid (5 ml.) were added and filtered. The filtered samples were analyzed by UV-visible Spectrophotometer at different wavelength and percentage of release of the Phytoconstituents were calculated.

Stability Studies

The tablets were formulated using approved brand, commercialized product in all parameters and placed into airtight packaging. The compressed tablets were kept at 40 o C at 75 o % RH in a stability chamber at a period of three months and sample were drawn month-wise, subjected to evaluate various quality attributes like- physical appearances, hardness, friability, disintegration time and drug content were monitored, which are significant in order to ensure stability of formulated tablets in storage condition. Accelerated stability was carried out as per ICH guidelines.

Statistical Analysis

Experiments were carried out thrice in triplicate. Results were presented in terms of Mean ± Standard deviation (SD). Calculations were done using software GraphPad Prism (version 9.0). Descriptive statistics was done for comparison of formulation variables and statistical difference at p<0.05 was considered significant.

RESULTS

The polyherbal hepatoprotective tablets were successfully developed from the standardized extracts of Phyllanthus niruri, Andrographis paniculata, Picrorhiza kurroa and Boerhavia diffusa using wet granulation method. Proper selection of concentrations of various excipients (microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate) have afforded proper granulation and tablet compressibility. The formulation was finalized on the average weight of 500mg of formulated tablets with satisfactory physical properties and sufficient phytochemical content from selected medicinal plants. All selected plants yielded considerable quantity of extractive matter (Phytoconstituents) among which Boerhavia diffusa provided maximum yield (15.3%) followed by Phyllanthus niruri (14.8%), Andrographis paniculata (13.5%) and Picrorhiza kurroa (11.9%). Pre-formulation phytochemical investigation of the different plant extracts confirmed the presence of various phytoconstituents in significant amounts such as flavonoids, phenolic compounds, alkaloids, tannins, saponins etc. Flavonoids and phenolic compounds were present in all plant extracts which play a vital role in hepatoprotective and antioxidant activities. The granules prepared showed favorable flow characters, as evidenced by the measurement of its pre-compression parameters. The angle of repose for all granules were within limit of 27.4 0.6 indicated the good flow character. The recorded values of bulk density and tapped density of the formulated granules are 0.45 0.02 g/mL and 0.52 0.01 g/mL respectively. From compressibility index (13.46 0.58%) and Hausner ratio (1.15 0.03), it is concluded that the granules can be packed well and exhibited good compressibility, hence suitable for die filling and compression to tablet. Formed tablets were evaluated and the results indicate that these tablets fulfill Pharmacopoeial specifications in terms of physical evaluation, that is: Average tablet weight of 501.8 4.2 mg indicates the uniformity in dose among tablet, that is minimum weight variation Thickness of the tablets varies between 4.6 0.2 mm.  Hardness of the tablets ranges between 5.4 0.3 kg/cm. Value of friability is 0.52 0.04 %, which is below the limit of 1 %. Value for disintegration is 8.7 0.5 minutes. Percentage of drug content uniformity was found to be 98.6 1.2 %.

              Table 1. Composition of Polyherbal Hepatoprotective Tablets (500 mg/tablet)

The polyherbal hepatoprotective tablets were prepared with the combination of the selected four herbal medicinal plant extracts, which possess well reported hepatoprotective activity. Microcrystalline cellulose was used as diluent and sodium starch glycolate as super disintegrant. Powder was milled with talc and magnesium stearate to promote its flow property and for lubrication during the tablet compression. Tablets produced by this method were of constant weight (500 mg), possessed optimum compressibility and mechanical strength.

Table 2. Percentage Yield and Preliminary Phytochemical Screening of Herbal Extracts

Good phytoconstituent concentrations were successfully extracted from the plants with the help of hydroalcoholic extract. Boerhavia diffusa produced highest yield percentage (15.3%) while lowest yield of phytoconstituents was obtained from Picrorhiza kurroa (11.9%). Phytochemical analysis of the extracts indicates presence of flavonoids and phenols in the plants which possesses excellent antioxidant, hepatoprotective activity and could synergistically add the effects.

Table 3. Pre-compression Parameters of Polyherbal Granules

Pre-compression properties indicated flowability and compressibility nature of the granules. Below 30 values for the angle of repose suggested the good flowability. Carr's index (13.46%) and Hausner ratio (1.15) values confirmed the good packing properties of the granules which were found suitable for further tablet compression without causing any issues.

Table 4. Post-compression Evaluation of Polyherbal Tablets

Tablets compressed had shown good physiochemical properties. Weight variation was in acceptable limit by the pharmacopoeia, thus assuring uniformity of dose. Tablets hardness varied between 5 – 6 kg/cm, these values assured tablets to withstand adequate amount of mechanical shock and stress generated during handling and transport. Friability were found to be in less than 1%. All tablets had disintegrated within the time period of 10 minutes which helps in early dissolution of active phytoconstituents. Drug content was found to be 98.6%, thus it assures uniform distribution of herbal extracts in formulation.

Table 5. In Vitro Dissolution Profile of Polyherbal Tablets

The drug release study of the developed tablets in USP apparatus revealed the sustained release profile of various phytoconstituents from the tablets. Around 25.6% of active ingredients was released in the initial 10 min and greater than 95% was released in 60 min which signify good disintegration, dissolution behavior & good release of active constituents. So this formulation might be having a good hepatoprotective effect.

DISCUSSION

Aim of the Present Work: Development & Evaluation of Poly herbal hepatoprotective tablet consist of standardized extracts of Phyllanthus niruri, Andrographis paniculata, Picrorhiza kurroa and Boerhavia diffusa. Material & Method: The poly herbal formulation approach was used considering the concept of Polyherbalism, in which combine administration of herbs synergizes each other and provide broad therapeutic action than single herbs. The phytoconstituents from different plants act on varied metabolic pathways. As Wagner (2011) has concluded that the combined effects the constituent compounds derived from different medicinal herbs would bring about potent and diversified Pharmacological activity by utilizing action of different targets in various biochemical pathways thereby overcoming their deficiency or reducing side effects. Chosen herbs are the plants traditionally used in Ayurvedic medicine for hepatic diseases & are found to possesses anti-oxidant, anti-inflammatory and hepatoprotective effects.

In this research, the desired amount of phytoconstituents were obtained from all four medical plants and, the % yield of phytoconstituents extracted from Boerhavia diffusa, gave higher % yield, followed by Picrorhiza kurroa that showed lower % yield. Preliminary phytochemical evaluation shows presence of flavonoids, phenolic compounds, tannins, alkaloids and saponins, such results are agreement with finding of Calixto et al., (1998) for Phyllanthus niruri contain lignans and flavonoids with high antioxidant activity, similar way the results in case of Andrographis paniculata, Akbar (2011), revealed that plant contained andrographolide the active compound responsible for anti-inflammatory, hepato protective activities. And the picrosides that present in Picrorhiza kurroa and they provided significant protection for the hepatocytes against the hepatotoxins and they may prove beneficial in liver disorders Chandan et al., (1991) found that Boerhavia diffusa regenerative effect against damaged liver. The pre compression evaluations of the granules have also found satisfactory flowability and compressibility features of the granules, which showed angle of repose, Carrs index and Hausner Ratio indicated satisfactory characteristics and could be filled uniformly during compression in a tablet punching machine. This is also verified by Aulton and Taylor (2018) that ifCarr's Index value less than 15 and exasperation less than1.25 are obtained for a granule’s mixture, then the sample should exhibit fairly good flow characteristics.

The tablets prepared post compression showed to comply pharmacopeial specifications of quality. Their average weights were found within satisfactory range showing homogeneous dispersal of various contents throughout the formulation. Tablets hardness was found to be around 5 Kg/cm that could be suitable for transportation without much breakage, Friability values found less than 1% show satisfactory stability and it indicate the capacity of the compressed tablet to withstand abrasion without breaking into pieces. Banker & Anderson (1987) also found the value of friability less than 1% is considered acceptable for the mechanical stability of compressed tablets. The disintegration of the prepared tablet was observed to be less than 10 minutes (e.g., 07.00 min. Approx). So, there is a quick dispersion & disintegration time in which rapid dispersal of tablet occurs & then availability of ingredients for dissolution, In addition to it this the effective and systematic release was seen in the tablet the whole active formulation is released in an efficient way up to approximately 95% up to 60 minutes in dissolution tests of the selected herb. These all parameter are good & it is expected to yield better bioavailability on administration due to fast release. This is supported by Lachman, 1991; that proper designing of the tablet and proper usage of disintegrant in formulating the tablets increases their dissolution behavior, which ultimately enhance the bioavailability.

Bioactive constituents such as flavonoids, phenolics, terpenoids and glycosides present in the prepared tablets are capable of conferring hepatoprotective effects due to antioxidant and free radical scavenging actions. One of the primary mechanisms of liver injury are believed to be caused by oxidative stress and lipid peroxidation, and some flavonoids and phenolic compounds have already proven useful in the protection of liver by scavenging the reactive oxygen species and preventing the oxidation of membrane lipids (Saleem et al., 2010). Phytochemicals which display the ability to exhibit antioxidant effect also show protective effect by preventing inflammation and fibrosis which accompany chronic liver disease (Stickel and Schuppan, 2007).

Thus synergistic effect of phytochemical present in the studied herbal extract may be helpful for giving protection against hepatotoxicity. The result obtained in this study are in agreement with increase interest to developing of the standardize herbal formulations for chronic liver disease. The main problem of herbal medicine development to quality standardization and controls since changes in phytochemical composition of plant may cause change of response (Kunle et al., 2012). Physicochemical and in vitro dissolution characteristics of tablets developed shows that prepared tablets are of the appropriate qualities for the administration orally to the animals. In conclusion, the formulated polyherbal hepatoprotective tablets showed better pre-compression and post-compression parameters, the formulated polyherbal hepatoprotective tablets showed good drug release profile, which has active phytochemical ingredients possessing hepatoprotective activities. Therefore, this blend of Phyllanthus niruri L., Andrographis paniculata, Picrorhiza kurroa, Boerhavia diffusa L. Have better prospects for development of a safer and effective herbal hepatoprotective formulation, However; further clinical investigations along with in vivo pharmacological actions on liver damage, toxicity study, and other experimental work must be undertaken to assess overall health benefit in humans.

CONCLUSION

The formulation and examination of a polyherbal tablet with standardized extracts of Phyllanthus niruri (Bhumi Amla), Andrographis paniculata (Kalmegh), Picrorhiza kurroa (Kutki), and Boerhavia diffusa (Punarnava) was carried out and concluded successfully. These plants possess antioxidant, anti-inflammatory, and hepatoprotective properties that are used to be formulated in the tablet dosage forms via the wet granulation method. Preliminary phytochemical examination of the above plant’s standardized extracts shows the presence of important bioactive principles including Flavonoids, phenolic compounds, Tannins, Alkaloids, Saponins etc. All these are important factors attributed to hepatoprotection activity. The manufactured granules presented appropriate pre-compressional parameters with optimum flowability and compressibility, enabling homogenous compression of the tablet. Post compression analysis revealed that the resultant tablets meet pharmacopeial requirements for weight variation, hardness, friability, disintegration time, and content uniformity. In vitro dissolution study showed the progressive release of Phytoconstituents with higher than 95% released in 60 minutes, thereby suggesting suitability of the dosage formulation for oral route administration. The combination is likely to act as potent liver protectants by the synergistic action of their anti-oxidative and free radical scavenging properties, hence preventing damage of the liver. Polyherbal formulations can serve as a safe and cost-effective alternative to commercially available hepatoprotective drugs. Also stresses on need for development of quality standardization & controls.

CONFLICT OF INTEREST

The authors declare that there is no conflict of interest regarding the publication of this manuscript.

ACKNOWLEDGEMENTS

The authors sincerely acknowledge the School of Pharmacy, YBN University, Ranchi, Jharkhand, India, for providing the necessary facilities and research environment for this study. The authors are grateful to Dr. Ashish Sarkar, Dean, School of Pharmacy, and Dr. Meeraj Alam, Associate Professor, Department of Pharmaceutics, for their valuable guidance, support in establishing the study protocol, and continuous encouragement. The authors also thank all co-authors and faculty members for their assistance in manuscript preparation, formatting, and completion of this research work. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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