Herbal Medicine represents the oldest known healthcare system to humanity, having been utilized by diverse cultures throughout history. It played a crucial role in the development of modern civilization, as early humans recognized and utilized the vast array of plants available to them for sustenance, clothing, shelter, and healing purposes. The medicinal use of plants evolved through careful observations of wildlife and through experimental trial and error. Over time, each community contributed to a collective knowledge of herbal remedies, documenting their findings in detailed herbal pharmacopoeias. This traditional knowledge profoundly influenced scientific medicine well into the 20th century, with many contemporary drugs having origins in herbal sources. Approximately 25 percent of prescription drugs in the United States today include active ingredients derived from plants, either directly extracted or synthesized to replicate natural plant compounds. Herbal medicinal products are specifically defined as those containing one or more active substances for medicinal use.[1] Traditional herbal medicine refers to the practice of using plants or plant materials, whether in their natural or processed forms, to treat injuries or illnesses. Currently, medicinal plants valued for their ethnomedicinal properties are undergoing evaluation to assess their potential therapeutic benefits.[2] The ethnopharmacological approach to studying traditional and herbal medicines integrates social and natural sciences. Observations in anthropology fields that detail the local use of natural medicines form the foundation of ethnopharmacological research inquiries. [3] Herbal products have been widely employed for treating numerous diseases over time. The vast diversity of biologically active secondary metabolites from microbial and plant species makes natural products and their structures crucial sources for developing new pharmaceuticals.[4] Administering medications orally is the most frequently recommended method for achieving a systemic effect. Tablets, being the most common form of oral medication available to consumers, are widely used by both individuals and healthcare providers.[5] Physicians recommend the parenteral route only in specific, limited situations. The topical method has constraints in effectively absorbing drugs for systemic pharmacological action. The oral route is predominantly chosen for achieving systemic effects and is also preferred for administering polyherbal formulations. It is widely recognized that herbal remedies tend to have fewer adverse effects compared to allopathic medicines.[6]

Clove:

Eugenia caryophyllus, a tree from the Myrtaceae family, produces fragrant flower buds known as cloves. These cloves, commonly used as spices, originate from Indonesia's Maluku Islands. Major producers of cloves include Tanzania, Madagascar, Sri Lanka, Indonesia, India, and Pakistan, with Madagascar and Indonesia leading in clove oil production. Clove oil is available in three forms: bud oil, leaf oil, and stem oil. Bud oil, derived from the flower buds of Eugenia caryophyllus, primarily contains 60–90% eugenol, along with caryophyllene, eugenyl acetate, and other minor components. Leaf oil, extracted from the leaves, comprises about 82–88% eugenol, with eugenyl acetate and other traces. Stem oil, obtained from the twigs, consists of 90–95% eugenol and some additional trace elements. Eugenol is a key component in the distinctive flavor and fragrance of cloves, making up 72–90% of clove essential oil. Herbal treatments remain integral to traditional medicine due to their natural origin, fewer side effects, and higher efficacy compared to synthetic alternatives. [9,10]. Around 80% of the global population currently relies on traditional medicine for most of their primary healthcare needs. [11]. Numerous herbal plants possess pharmacological properties that make them valuable for food preservation, embalming, and various other applications. Additionally, they exhibit anti-inflammatory, antibacterial, spasmolytic, analgesic, and local anesthetic effects. [12,13].

Collection of Clove powders from local market.

Fig.1: Clove buds:

Preformulation studies:

Organoleptic properties :

Recording organoleptic characteristics such as color, taste, and odor is crucial, with color documentation being vital for identifying appropriate batches.

Determination of melting point :

The capillary method is employed to identify herbs. First, seal one end of a capillary tube and fill it with finely powdered herbs. Secure the capillary tube to a thermometer using a rubber band. Place both the thermometer and capillary tube into the sample holder of a melting point apparatus. Heat the sample until it reaches its melting point, and record the temperature at which the powder melts.

Selection of excipients:

Clove is collected from local market. The raw materials and chemicals were taken from Ashokrao mane institute of pharmacy, ambap, kolhapur.

Method Of Prepration:

• 20 gm of clove powder is taken for each batch  to prepare tablets
• After weighing, the clove powder were pulverized properly using mortor pestle.
• After uniform mixing of all the particles, sieving was performed by using sieve No. 66.
• After sieving all the ingredients the required excipients were added to it in required quantity  and was further taken to wet granulation.
• For wet granulation the starch slurry was added to it.
• After adding slurry the uniform granules were formed.
• This granules were taken to the hot air oven for drying / moisture removal for at approx. 10 mins at 38oC.
• Magnesiun Stearate was added to the formed granules in specific amount for lubrication.
• This dried granules ware taken for compression in tablet punching machine and tablets were formed.
• The formed tablets then taken for the Evalution.

Evaluation of Herbal Tablet:

Pre-Evaluation Test:

1. Bulk density:

The bulk density of the powder is determined by measuring the volume of known mass of powdered sample in graduated cylinder (100 ml).                            

2. Tapped density:

The tapped density is determined by mechanically tapping (100 times) a graduated cylinder (100 ml) containing the powdered sample.

3. Carr’s index:

Carr Index of any powder is calculated for compressibility of a powder which is based on tapped density and bulk density. [14]

Tapped density                

4. Hausner ratio:

Hausner ratio is the ratio of a powder's tapped density to its poured (loose) bulk density.

5. Angle of repose:.

The fixed funnel method was used for determination. A specified quantity of the powdered drug was transferred into the funnel, with the funnel's opening initially blocked by a thumb. After the powder was released from the funnel, the angle of repose was measured and recorded in degrees (?). [15]                    

Angle of Repose = tan-1h/r

Post-Evaluation Test:

Colour and appearances:

The compressed tablets were examined for the colour and appearance.

Thickness:

The dimensions of the tablets are measured using a calibrated dial caliper. Five tablets are randomly selected from the sample formulation, and their thickness is measured individually. The average thickness is then calculated.

Weight variation:

The weight variation test involves weighing 20 individual tablets, calculating their average weight, and then comparing the weight of each tablet to this average. This method is considered effective for assessing the uniformity of drug content in tablets.

Hardness:

Hardness, also known as tablet crushing strength, was assessed using a Monsanto hardness tester. The tablet was positioned lengthwise between upper and lower plungers, and a threaded bolt was turned to apply force until the tablet fractured. The tablet's hardness was then measured in Kg/cm2. [15]

Disintegration Time:

Disintegration time refers to the duration required for a tablet to break down into small grains or pieces. This test is conducted using a device equipped with a basket rack assembly containing six glass tubes, each measuring 7.75 cm long and 2.15 mm in diameter, fitted with a 10-mesh sieve at the bottom. The assembly moves up and down 28 to 32 times per minute in 900 cc of medium maintained at a constant 37 °C. Each tube accommodates six tablets, and the disintegration time is determined by measuring how long it takes for all tablet fragments to completely pass through the sieve.

Friability:

The friability of tablets is assessed using a Roche friabilator, where tablets are placed in a rotating plastic chamber at 25 rpm. Tablets are dropped from a specified height for 100 revolutions. After dusting and reweighing pre-measured tablets, the friability is evaluated, aiming to meet the standard limit of less than 1%. [16]

% Friability = (Initial weight – Final weight) / Initial weight X 100

Content uniformity test:

Drug content analysis was conducted three times for each formulation of ranolazine tablets. A quantity of powder equivalent to 500 mg of ranolazine was weighed and transferred into a 50 ml volumetric flask. The drug was dissolved in methanol and pH 6.8 phosphate buffer solution using sonication for 15 minutes. The resulting samples were filtered through a membrane with a diameter of 0.45 ?m. After filtration, the solutions were appropriately diluted with pH 6.8 phosphate buffer solution, and the drug content in the diluted solutions was measured using a UV spectrometer at a wavelength of 224.2 nm.

The drug content was calculated as: 

% Drug Content = (Analysed value / Theorotical Value) × 100

RESULT :-

Optimization of Batch:

We are focused on achieving the optimal balance of tablet properties—weight, hardness, disintegration time, and content uniformity—for the chewable tablet containing clove powder in our detailed batch formulation optimization.

Pre-Evaluation Test:

Bulk Density:

The bulk density of the tablets of batches formulated A1, A2, A3 was found to be 0.45 g/ml.

Tapped Density:

The Bulk Density of the batches was found to be 0.55 g/ml.

Hausner’s Ratio:

The Hausner’s Ratio of the following formulated batches A1, A2, A3 is 1.22

Cars Index:

The Cars index of the batches was found to be 18.18%.

Angle of Repose:

The Angle of Repose of the formulated batches A1, A2, A3 was found to be 35oC.

Post-Evaluation Test:

Colour and Appearance test:

The colour of the tablets formulated is Brown and the shape was Round.

Weight Variation:

The Weight Variation of the tablets is 290 ± 5%.

Thickness:

The thickness of the formulated tablet is 4mm.

Hardness:

Hardness of formulated is 4-6 kg/cm2

Friability:

The friability of the tablet batches is <1>

Disintegration Time:

The Disintegration time of tablets is <15>

Content uniformity test:

The content uniformity is 95-105