Formulation and Evaluation of Herbal Immunity Powder for Pediatrics

Pediatric immunodeficiency has become a significant health issue because of widespread dietary and micronutrient deficiencies in children. Lack of essential nutrients like vitamins A and D, iron, zinc, and proteins can harm the development and function of the immune system, affecting both the innate and adaptive immune responses. This makes children more prone to repeated respiratory and gastrointestinal infections, slows down recovery, and leads to poor general health. Poor eating habits, limited variety in the diet, frequent illnesses, and socioeconomic factors can further weaken a child's immunity. Immune deficiency in early life may also affect growth, cognitive development, and how well vaccines work (1). In Ayurveda, immunity is known as Ojas, which represents the body's ability to defend against disease. The immune system fights pathogens such as bacteria, viruses, fungi, and parasites through innate and adaptive mechanisms. Herbal medicines containing bioactive compounds with antioxidant, anti-inflammatory, and antimicrobial properties have shown promise in boosting immunity (2,3,4).

Immunity

Immunity is the body's way of protecting itself against harmful microorganisms like bacteria, viruses, fungi, and parasites. (2) There are two main types of immunity: innate and acquired (also known as adaptive). Innate immunity is something a person is born with, works quickly, and provides general protection through things like skin, mucus, white blood cells, and inflammation. Acquired immunity develops after the body is exposed to specific harmful substances called antigens. It takes longer to respond but offers precise protection and has a memory so the body can fight off the same pathogen again more effectively. (5) In young children, the immune system is not yet fully developed. Their T-cells and B-cells, which are important for fighting infections, are less active. They also make fewer antibodies and don't form strong immune memories as easily. This makes them more prone to getting sick and less responsive to vaccines. Herbal immunomodulators can help improve immune function by boosting both innate and acquired immunity. (3,4)

Herbal Immunity Powder

Herbal immunity formulations work by combining various bioactive plant components that have immunomodulatory, anti-inflammatory, antioxidant, and antimicrobial properties. When multiple herbs are used together in a polyherbal mixture, they provide a more effective immune boost compared to using a single herb. Essential nutrients like zinc and vitamins A, C, D, and E also play a key role in supporting and strengthening the immune system (6). Pomegranate is recognized for its antiviral, antioxidant, and anti-inflammatory properties, which help reduce oxidative stress, regulate cytokines, and improve the function of immune cells (7). Amla, also known as Emblica officinalis, is high in vitamin C and minerals, and it has strong antioxidant and immunomodulatory effects that help increase resistance to diseases (8). Giloy, or Tinospora cordifolia, supports immunity by activating macrophages, increasing antioxidant activity, and regulating inflammation, making it beneficial for people who suffer from frequent infections (9,10). Tulsi, or Ocimum sanctum, supports both the body's innate and adaptive immune responses by reducing oxidative stress and enhancing immune function (11). Vitamin D3 is especially important for children's immunity, as it helps regulate immune cells, reduce inflammation, and prevent infections (12).

Fig.1 Herbal Powders Used in Powder Formulation

MATERIAL AND METHOD

1. Materials:

Herbal Ingredients

1. Pomegranate – Anar, Dalim.

Pomegranate is the fruit from Punica granatum, which is belong to family Lythraceae. It is a type of shrub that loses its leaves seasonally. It contains chemicals like Punicalagin, Punicalin, Gallic acid, Ellagic acid, Ellagitannins, and other polyphenolic compounds. It acts as a powerful antioxidant, anti-inflammatory, and immune regulator. It also helps protect the heart and manage diabetes. It has potential to fight cancer, supports gut and skin health, and is commonly used in health supplements and special foods as a natural healing ingredient (13).

Fig.2 Pomegranate

2. Amla – Amla, Amalaki, Indian Gooseberry.

Amla, is a fruit derived from the tree Phyllanthus emblica, which belongs to the Phyllanthaceae family. The fruit contains various chemical components such as ascorbic acid (vitamin C), gallic acid, ellagic acid, emblicanin A, emblicanin B, tannins, flavonoids, and polyphenols. It is used as an antioxidant, anti-inflammatory, and immunomodulatory agent. It also offers cardioprotective and antidiabetic benefits, supports digestion and gut health, exhibits hepatoprotective and anticancer properties, and is commonly found in nutraceuticals and functional foods (14).

Fig.3 Amla

3. Giloy – Guruchi (Sanskrit), Amrita (Sanskrit), Gulvel (Marathi), Tinospora.

Giloy is derived from Tinospora cordifolia, which belongs to the Menispermaceae family and is a climbing shrub. Its chemical components include alkaloids such as berberine and magnoflorine, glycosides, and steroids. It is used as an immunomodulatory, anti-inflammatory, and antidiabetic agent. It also supports digestion and liver health and is beneficial in treating chronic fever and inflammatory conditions (15).

Fig.4 Giloy

4. Tulsi – Tulsi, Holy Basil.

Tulsi comes from the plant Ocimum sanctum, also known as Ocimum tenuiflorum, which is part of the Lamiaceae family. It is a fragrant and medicinal plant. The plant contains various chemical compounds such as eugenol, ursolic acid, rosmarinic acid, and flavonoids. It is used as an antioxidant, anti-inflammatory, immune-supporting, and antimicrobial remedy. It helps improve immunity, support respiratory health, and ease stress (16).

Fig.5 Tulsi

Excipients

The excipients used in the formulation of Herbal Immunity Powder for Pediatrics are as follows: (17, 18, 19, 20, 21, 22)

• Vitamin D3 (Cholecalciferol).
• Zinc.
• Magnesium stearate.
• Cocoa powder.
• Saccharin.
• MCC (Microcrystalline Cellulose)

2. Method:

Collection of material

Amla, Giloy, pomegranate, and Tulsi were bought from the market, dried, and then ground into powder. Vitamin D3, zinc bisglycinate, and other inactive ingredients were sourced from Shraddha Institute of Pharmacy. Cocoa powder was purchased locally. All the materials used were of analytical grade.

Method of preparation

1. Washing

Rinse raw material under running water to remove dirt or impurities.

2. Drying

All herbal drugs were shade dried for several days to remove moisture and preserve active constituents.

3. Powdering

The dried materials were finely powdered using a mechanical grinder or mortar & pestle.

4. Sieving

The powders were passed through a sieve (40–80 mesh) to obtain uniform particle size. (23)

5. Mixing of all ingredients

Step 1: Weighing of ingredients

Accurately weigh all ingredients according to the formulation.

Step 2: Mixing of herbal powders

Amla, Giloy, Pomegranate, and Tulsi powders were mixed thoroughly to obtain a uniform blend.

Step 3: Addition of active ingredients

Vitamin D? and zinc were added to the powder mixture and mixed uniformly.

Step 4: Addition of excipients

Microcrystalline cellulose (MCC) and magnesium stearate were added to improve flow and compressibility.

Step 5: Addition of sweetening and flavoring agents

Saccharin and cocoa powder were added to enhance taste and palatability.

Step 6: Mixing

The final mixture was mixed thoroughly using a mortar & pestle or by geometric dilution method to ensure uniform distribution of all ingredients.

6. Packaging

The prepared powder was transferred into clean, dry, airtight containers.

7. Storage

The formulation was stored in a cool, dry place away from moisture and direct sunlight (24)

Formulation table

Table No.1: Formulation Table of Herbal Immunity Powder

Fig.7 Prepared Herbal Immunitty Powder

EVALUATION PARAMETERS

To make sure the herbal pediatric immunity powder is safe, effective, and of good quality, certain parameters were checked. These tests help determine the product's physical properties and whether it is suitable for use in children.

1. Solubility

1 gram of powder was tested in water, milk, ethanol, acetone, hydrochloric acid, and chloroform.

The solubility was noted as soluble, sparingly soluble, or not soluble. Good solubility in water and milk suggests it is suitable for use in children's medicine. (25)

2. Appearance

The appearance was checked by looking at and smell through visual and sensory methods. This helps to make sure the product is acceptable and tasty for children. (26)

3. Particle Size

The particle size was checked using a 40–80 mesh sieve. Only small particles were left behind, which ensures a smooth texture and better taste. (27)

4. Flow Properties

1. Angle of Repose

These measures how well the powder flows. It is calculated using the formula:

                                                 Angel of repose θ= tan-1hr

2.  Bulk Density

A known mass of powder was poured into a graduated cylinder without tapping.

Bulk density was calculated using the formula:

Bulk Density=mass of powder (g)bulk volume (ml)

3. Tapped Density

Measures mass per unit volume after mechanical tapping.

Tapped density was calculated using the formula:

Tapped Density=Mass of PowderTapped volume

4. Carr’s Index

Carr’s Index indicates powder flowability and compressibility.

Calculated using the formula:

Carr's Index=Tapped Density-Bulk DensityTapped Density×100

5. Hausner’s Ratio

Another indicator of flow properties.

 Calculated using the formula:

Hausner Ratio=Tapped DensityBulk Density

 A lower ratio (< 1.25) suggests good flowability. (28)

5. Moisture Content:

Moisture content was determined using a drying method to check stability and how long the product will stay good. (29)

Moisture content was calculated as

Moisture content  %=Initial weight-Final weightInitial weight×100

6. pH

Determines oral compatibility. 1 g powder in 10 mL water (1:10 w/v) is prepared and measured using a pH meter. The ideal pH range is 5–7, which is suitable for pediatric oral administration. (30)

RESULT AND DISCUSSION

Result

Table No. 2: Solubility

Table No. 3:  Appearance

Table No. 4 Flow Properties

Table No. 5: Moisture Content

Table No. 5: pH