Formulation and Evaluation of a Tablet by Using Nyctanthes Arbor-tristis Leaves

Due to their cultural acceptance, low side effects, and therapeutic effectiveness, herbal medicines have garnered considerable attention worldwide. Traditional medicinal plants must be included into contemporary pharmaceutical dosage forms in order to increase shelf life, ensure dosage accuracy, and promote patient compliance. Commonly referred to as Night Jasmine or Parijatak, Nyctanthes arbor-tristis Linn.  is a plant with a long history of use in Ayurvedic and traditional Indian medicine. Many parts of the plant, particularly the leaves, are said to have anthelmintic, hepato-protective, antioxidant, antipyretic, and anti-inflammatory qualities ^[1].

Its extensive phytochemical composition, which includes flavonoids, iridoid glycosides, tannins, and alkaloids, is responsible for the pharmacological actions of N. arbor-tristis. Even though its leaf extract has several medical uses, there hasn't been much progress in creating standardized, scientifically tested dosage forms. Herbal actives can be delivered precisely and efficiently with tablet formulation, which is both handy and effective.^[2]

Techniques for extraction, excipient selection, formulation, and conventional assessment tests, such as physicochemical characterisation and in vitro drug release studies, are emphasized. By providing a scientific foundation for the integration of Nyctanthes arbor-tristis into contemporary phytopharmaceutical formulations, the goal is to advance the plant's medicinal potency through standardized dose forms. ^[3]

Plant Description:-      

Fig. No. 01: Plant of Nyctanthes Arbor-tristis

• Scientific Name: Nyctanthes arbor-tristis Linn.
• Common Names: Night Jasmine, Parijatak, Coral Jasmine, Tree of Sorrow, Shefali, Harisinghar
• Family: Oleaceae

The fragrant white flowers with orange centers that bloom at night and fall by dawn are produced by Nyctanthes arbor-tristis. The picture depicts the fragile, star-shaped blossoms that are frequently found beneath the plant.^[1]

Plant Classification:

• Kingdom: Plantae
• Division: Magnoliophyta
• Class: Magnoliopsida
• Order: Lamiales
• Family: Oleaceae
• Genus: Nyctanthes
• Species: N. arbor-tristis ^[3]

Scientific Classification

• Clade: Angiosperms
• Clade: Eudicots
• Order: Lamiales
• Family: Oleaceae
• Genus: Nyctanthes
• Species: Nyctanthes arbor-tristis L ^[3]

Medicinal Benefits:-

1. Antipyretic (Reduces Fever): Traditional uses for leaf decoctions include reducing sporadic and chronic fevers, such as those caused by dengue and malaria.
   Functions as a natural substitute for artificial antipyretics.^[4]
2. Analgesic and anti-inflammatory; Efficient in lowering joint pain and inflammation. Used to treat sciatica (pain radiating along the sciatic nerve), arthritis, and rheumatism ^[5]
3. Indigestion: This plant helps enhance the Agni, leading to improved digestion due to its Deepan (appetizer) and Pachan (digestion) properties.
4. Antioxidant: Includes phenolic and flavonoid components, which are naturally occurring antioxidants. Protects against the harm caused by free radicals and promotes overall health.
5. Hepatoprotective: It's possible that some extracts can support liver function and protect liver cells.
6. Antidiabetic: Leaf and floral extracts have antibacterial and antiviral properties. Good for small wounds and skin infections.^[6]
7. Anti-Malarial activity: It is used to control blood sugar levels, according to some research. used in conjunction with medical supervision as a supplement to help manage Type 2 diabetes.
8. Antiviral and antibacterial: Some studies have found that parijatak leaves are more beneficial for treating the symptoms of malaria. Parijatak leaves help alleviate malaria fever and reduce the concentration of parasites in the body. The leaves also reduce the inflammation caused by malaria significantly^[7]

MATERIALS AND METHODS

Materials:-

Nyctanthes arbor-tristis leaves were collected from the local area due to their antipyretic, analgesic, and anti-inflammatory activity to cure joint pain and arthritis.

The excipients used in the formulation are,

• Methylcellulose is used as a disintegrating agent
• Magnesium stearate is used as a lubricant
• Fructose is used as a diluent
• Talc is used as a lubricant and gives a pleasant appearance to the tablet
• Tragacanth and sodium alginate, these two excipients are used as a binder for the preparation of tablets by wet granulation

Methods:-

Step 1 Collection: The leaves of Nyctanthes arbor-tristis are collected from the local area

Step 2 Authentication: The leaves of Nyctanthes arbor-tristis were authenticated from the botany department of R. T. M. Nagpur University, Nagpur 440033

Fig. No. 02: Authentication

Step 3: Preparation of dry powder of leaves: Fresh leaves of Nyctanthes arbor-tristis are first collected, properly cleaned, and shade-dried to retain active ingredients before being ground into a dry powder for tablet manufacturing. The leaves are mechanically ground into a fine powder when they have completely dried, and the resulting uniform particle size is then sieved to make it appropriate for tablet compression.

Step 4: Extraction by the Percolation Method: Nyctanthes arbor-tristis leaf percolation: 50 g of coarsely ground, shade-dried leaves are wet with a 70:30 ethanol-water mixture and allowed to sit for four hours. A percolator is filled with the moistened powder, let to macerate for a full day, and then slowly percolated to collect the extract until it is completely gone. If necessary, the collected percolate can be concentrated in a water bath set between 45 - 50°C.

Step 5: Preparation of 1% (W/V) Tragacanth Solution: Take 1 g of tragacanth and dissolve it in 100 ml of distilled water

Step 6: Preparation of 1% (W/V) sodium alginate: Take 1 g of sodium alginate and dissolve it in 100 ml of ethanol

Step 7: Formulation of Tablet by using the Wet Granulation Method: Dried Nyctanthes arbor-tristis leaf extract is combined with diluents and a binder solution to create a wet mass, which is subsequently granulated, dried, and combined with lubricants in the wet granulation process. A tablet press is used to compress the dried grains into tablets.

The tablet made with powdered Nyctanthes arbor-tristis leaves as the main active pharmaceutical ingredient (API) is detailed in the formulation table. The formulation was designed to ensure the optimal tablet properties, including disintegration, mechanical strength, content consistency, and patient compliance. Preliminary experiments and literature references served as the basis for the excipient selection and quantity

Table No. 01: Formulation Table

Pre-formulation study:-

The purpose of the pre-formulation research was to determine whether Nyctanthes arbor-tristis leaves powder was suitable for tablet formulation and to analyse its physicochemical characteristics.
Material preparation involved collecting, cleaning, and ten days of shade drying  Nyctanthes arbor-tristis leaves. A mechanical grinder was used to grind the dried leaves into a homogeneous powder, which was then sieved through a #60 mesh.^[8]

Angle of Repose

The angle of repose is the greatest angle that can be established between a powder pile's surface and the horizontal plane. Particularly for solid dosage forms like tablets, it is a crucial measure for evaluating the flow characteristics of powders during pre-formulation investigations.

Formula,

θ=tan^-1 hr

where,

• θ = angle of repose
• h = height of the pile
• r = radius of the pile base

Bulk Density

The mass of powder per unit volume, including interpartical spacing, is known as bulk density. It is an important pre-formulation characteristic that affects tablet weight homogeneity, compaction, and powder flow.

Formula,            

Bulk Density= Mass of Powder (g)Bulk Volume (cm³)

Tapped Density

The mass of the powder divided by its volume after it has been mechanically tapped until a consistent volume is reached is known as the "tapped density." It measures the powder's packability and is used to evaluate compressibility, which is important when creating tablets.

Formula,

Tapped Density = Mass of Powder (g)Tapped Volume (cm3)

Carr’s Index

Carr's Index gauges a powder's flowability and compressibility. A common method for estimating the rate at which a powder can be converted into tablets is to calculate it using bulk and tapped densities.

Formula,

Carr’s Index = Tapped density-Bulk densityTapped density

Hausner’s Ratio

Hausner’s Ratio is the ratio of tapped density to bulk density. It is an indicator of powder flowability and cohesiveness. Lower values indicate better flow.

Formula,

Hausner’s Ratio = Tapped density Bulk density

Evaluation of Tablet:-

Appearance:

• Colour
• Shape
• Size

2. Weight variation test:

Twenty tablets are chosen at random and weighed one at a time. To determine if a tablet is within the acceptable ranges according to the standards of the pharmacopeia, the average weight is determined and compared to the average weight of each tablet.

Acceptance Criteria (IP):

• For tablets < 80 mg: ±10%
• For tablets 80–250 mg: ±7.5%
• For tablets > 250 mg: ±5%.

3. Hardness (strength of crushing):

• Device: Pfizer, Monsanto, and Digital Hardness Tester
• Range: 4–8 kg/cm²

4. Thickness:

• Instrument: Vernier caliper

5. Friability test:

In a Roche friabilator, twenty pre-weighed tablets are rotated for four minutes at 25 rpm (100 revolutions). The % weight loss is then determined by reweighing the tablets. A weight loss of no more than 1% is considered friable

6. Disintegration time:

At 37 ± 0.5°C, six tablets are put in the disintegration test device with distilled water. The amount of time it takes for every tablet to fully disintegrate into particles small enough to fit through the mesh screen is noted. The dissolution period for uncoated tablets shouldn't be longer than fifteen minutes.

RESULTS

Table for Extract of Nyctanthes Arbor-tristis Leaves

Table No.01: Organoleptic characteristics of aqueous extract

Table for Pre-formulation study

Table No.02: Pre-formulation study

EVALUATION OF TABLET

Table No.03: Evaluation of the formulated table