Research Papar on Formulation and Evalition of Herbal Tablet for Hypertension

Hypertension, commonly known as high blood pressure, is a chronic medical condition that significantly increases the risk of heart disease, stroke, and kidney failure. It affects millions of individuals worldwide and remains one of the leading causes of morbidity and mortality. Despite the availability of numerous synthetic antihypertensive agents, these medications are often associated with adverse side effects, poor patient compliance, and high costs, especially in low-resource settings. Consequently, there is growing interest in alternative and complementary approaches, particularly the use of herbal medicine, for the management of hypertension.

Herbal remedies have been used for centuries in traditional medical systems such as Ayurveda, Traditional Chinese Medicine (TCM), and Unani. Many medicinal plants possess bioactive compounds with antihypertensive properties, including flavonoids, alkaloids, tannins, and phenolic acids. Some of the commonly studied antihypertensive herbs include Rauwolfia serpentina, Terminalia arjuna, Allium sativum (garlic), Andrographis paniculata, and Camellia sinensis (green tea), among others. These plants exert their effects through various mechanisms such as vasodilation, diuresis, antioxidant activity, and inhibition of angiotensin-converting enzyme (ACE).

Drugs And Excipients profile:

1. TULSI (Ocimum sanctum)

The biological name of Tulsi is:

Ocimum tenuiflorum (syn. Ocimum sanctum)

Tulsi is a sacred plant in Hinduism and is known for its medicinal and spiritual properties.

Tulsi is also known as Holy Basil, and its scientific classification is:

- Kingdom: Plantae

- Family: Lamiaceae

- Genus: Ocimum

- Species: O. sanctum

-Tulsi several active compound.

1. Eugenol : volatile oil present in holy basil, eugenol exhibits antioxidant and anti-inflammatory properties. 

2.Rosmarinic acid: A phenolic acid, rosmarinic acid is a potent antioxidant and anti-inflammatory compound. 

3.Flavonoids: Holy basil contains several flavonoids, including apigenin, orientin, and cirsimaritin which also possess antioxidant and anti-inflammatory properties. 

Fig 1: Tulsi

Uses:

1.Teas and infusions: Tulsi leaves are used to make teas and infusions frelaxation and stress relief.

2.Cooking: Tulsi leaves are used in various Indian dishes, such as curries and stir-fries.

3.Hindu rituals: Tulsi is considered a sacred plant in Hinduism, often used in spiritual practices and rituals.

4. Stress relief: Tulsi is used to reduce stress, anxiety, and fatigue.

Benefits of tulsi :

1. Stress relief: Tulsi is known for its adaptogenic properties, helping the body cope with stress.

2. Respiratory health: Tulsi may help alleviate respiratory issues such as bronchitis, asthma, and allergies.

3. Antioxidant properties: Tulsi's antioxidant properties may help protect against oxidative stress and cell damage.

4. Immune system support: Tulsi may help boost the immune system and protect against infections.

B)COLEUS:

IT tropical plant native to India and southeast Asia, also know as( Indian coleus/ forskolin )The common Coleus plant’s biological name is Plectranthus scutellarioides. It’s also known as Solenostemon scutellarioides and Coleus blumei, so these are synonyms

- Kingdom: Plantae

- Family: Lamiaceae

- Genus: Coleus (or Plectranthus)

- Species: C. forskohlii (or P. barbatus)

Main Active compound:

Forskolin It is active compound in coleus responsible for medicinal properties.

-It found root and leaves of coleus plant.

Mechanism of Action:

1. Adenylate cyclase activation: Forskolin activates adenylate cyclase, increasing cAMP levels.

2. CAMP :Increased cAMP levels can influence various cellular process

Fig 2.   Coleus (Forskolin)

Benefits:

1. Blood pressure management: Forskolin may help lower blood pressure.

2. Cardiovascular health: Forskolin may support overall cardiovascular health 

3. Asthma relief: Forskolin may help alleviate asthma symptoms.

4. Anti-inflammatory effects: Forskolin may have anti-inflammatory properties.

5. Antioxidant effects: Forskolin may have antioxidant effects.                    

c) GARLIC (ALLICIN):

Garlic (Allicin sativum) is plant used culinary medicinal and spiritual purposes.

The biological name of Garlic is:

## Allium sativum

Garlic belongs to the family Amaryllidaceae (or Alliaceae in some classifications).

- Kingdom: Plantae

- Family:  Amaryllidaceae

- Genus: Allium

- Species: A. sativum

API GARLIC:

1.Allicin:

-Standardized extracts: Garlic extracts can be standardized for allicin content.

- Potential health benefits: Allicin may support cardiovascular health and have antimicrobial properties.

mechanism of action:

1) Cardiovascular Effects:

- Vasodilation: Garlic may help relax blood vessels, improving blood flow.

- Lipid-lowering effects: Garlic may help reduce cholesterol and triglyceride levels.

2) Antimicrobial Effects:

-Allicin's antimicrobial properties: Allicin may help combat bacterial, viral, and fungal infections.

3) Antioxidant Effects:

- Antioxidant activity: Garlic's sulfur compounds may help protect against oxidative stress.

4) Other Potential Effects:

- Anti-inflammatory effects: Garlic may help reduce inflammation.

- Immune system support: Garlic may help support immune function.

Uses:

1. Natural remedy: Garlic has been used as a natural remedy for various health issues.

2.Digestive health.

3.Ayurvedic Medicine.

4. Acne treatment: Garlic's antimicrobial properties may help reduce acne.

5. Skin infections: Garlic may help treat skin infection

6. Insect repellent: Garlic's strong scent may repel insects.

7. Food preservation: Garlic's antimicrobial properties may help preserve food.

EXCIPIENT:

1.ACACIA: Acacia, commonly known as Gum Arabic, is widely used as a natural binder in herbal tablet formulations.

 2.STARCH POWDER: Starch is a widely used natural excipient in herbal tablet formulations, valued for its binding, disintegrating, and filler properties.

3.AGAR-AGAR POWDER: Agar-agar powder, a natural poly saccharide derived from red algae is occasionally used as a disintegrant in herbal tablet formulations.

4.MAGNESIUM STERATE: Magnesium stearate is a commonly used lubricant in the manufacturing of herbal tablets.

5.LACTOSE: Lactose is a widely used diluent (filler) in herbal tablet formulations.

MANUFACTURING OF TABLET:

In the tablet pressing process, the appropriate amount of active ingredient must be in each tablet. Hence, all the ingredients should be well-mixed. If a sufficiently homogenous mix of the components cannot be obtained with simple blending processes, the ingredients must be granulated prior to compression to assure an even distribution of the active compound in the final tablet. Two basic techniques are used to granulate powders for compression into a tablet: wet granulation and dry granulation.

? Method of preparation:

Types of granulations:

? Wet granulation

? Dry granulation

o Wet Granulation

The most widely used process of agglomeration in pharmaceutical industry is wet granulation. Wet granulation process simply involves wet massing of the powder blend with a granulating liquid, wet sizing and drying.

? FORMULATION OF TABLET

? Preparation of Granules:

o Wet Granulation

Important steps involved in the wet granulation:

1. drug and excipients accurately weighed and dry mixed manually in mortar. except

lubricant and glidant.

2. Drug and excipients were passed through 300 sieve.

3. Wet mass pass through sieve was prepared using mucilage of gum as a binder

4. which was previously prepared in sufficient water using the concentration mentioned

in table

5. Mixing of binder solution with powder mixture to form wet mass screens.

6. Wet mass was passed through 140 sieve and obtained granules.

Fig. granulations of wet mass of Tablet

1. Drying of moist granules for 60min at temperature not exceeding 60oC

2. The dried granules were passed through 20# sieve

3. Mixing of screened granules with disintegrant, glidant, and lubricant.

  Final dry granules

Fig. final dry granules

These granules were evaluated for angle of repose, bulk density, tapped density.

? Preparation herbal tablets:

Magnesium stearate and Agar-Agar powder were sieved through a 300 sieve and were first mixed for 30 min. This mixture was added in 20- 40 #  herbal granules prepared as above, and the mixing was continued for further 5 min. Tablets of 300 mg in weight and 12 mm in diameter were prepared by compression using a single-punch tablet compression machine. Tablets are prepared by forcing particles into close proximity to each other by powder compression, which enables the particles to cohere into a porous, solid specimen of defined geometry. The compression takes place in a die by the action of two punches, the lower and the upper, by which the compressive force is applied. Powder compression is defined as the reduction in volume of a powder owing to the application of a force. Because of the increased proximity of particle surfaces accomplished during compression, bonds are formed between particles which provide coherence to the powder i.e. a compact is formed. Compaction is defined as the formation of a solid specimen of defined geometry by powder compression.

? Process of tablet formation can be divided into two stages:

1. Die filling

This is normally accomplished by gravitational flow of the powder from a hopper via the die table into the die. The die is closed at its lower end by the lower punch.

2. Tablet formation

The upper punch descends and enters the die and the powder is compressed until a tablet is formed. During the compression phase, the lower punch can be stationary or can move upwards in the die. After maximum applied force is reached, the upper punch leaves the powder, i.e. the decompression phase. During this phase the lower punch rises until its tip reaches the level of the top of the die. The tablet is subsequently removed from the die table by a pushing device.

fig: final compressed tablet                                                                                                                                                                                         

FORMULATION TABLE OF HERBAL TABLET:

? EVALUTION OF TABLET:

Loss on drying:

The method adopted was that specified for acacia in the British Pharmacopoeia. One gram of the sample was transferred into each of several Petri dishes and then dried in an oven (NOVA Thermostatic Hot Air Oven) at 105°C until a constant weight was obtained. The moisture content was then determined as the ratio of weight of moisture loss to weight of sample, expressed as a percentage.

PH:

This was done by shaking a 1%w/v dispersion of the sample in water for 5min and the pH determined using a pH

Friability Test:

To evaluate the degree of friability of the tablets from each batch, ten tablets were randomly selected, dusted and weighed. The tablets were placed in a Roche fryolator (Eweka, Germany) and subjected to its tumbling actions at 25 rpm for 4min. afterwards; the tablets were once again dusted and reweighed to determine the percentage loss of weight.

Disintegration Test (D.T.):

Six tablets from each batch were utilized for disintegration studies in distilled water at 37°C using disintegration test apparatus (Electro lab, India). The disintegration time was taken to be the time no granule of any tablet was left on the mesh of the apparatus.

Hardness Test: A Monsanto tablet hardness tester (Copley Scientific Ltd, U.K.) was employed to determine the mechanical strength of the tablets. Test was performed in triplicate.

RESULTS AND DISCUSSION:

Preliminary phytochemical analysis of the individual herbal extracts (Tulsi, Coleus, Garlic)the presence of key constituents known to aid in hypertension management:

Tulsi (Ocimum sanctum): Flavonoids, phenolic compounds, alkaloids, and essential oils.

Coleus (Coleus forskohlii): Forskolin, diterpenoids, and flavonoids.

Garlic (Allium sativum): Allicin, sulfur compounds, and flavonoids.

Table No.3: Post Compression test / Evaluation of formulation