Formulation And Evaluation of Polyherbal Syrup for Respiratory Health

1.1 Background

Respiratory disorders represent a significant global health concern affecting millions of people worldwide. According to the World Health Organization, respiratory diseases are among the leading causes of death and disability globally. Conventional treatments often come with unwanted side effects and may lead to resistance with prolonged use. This has led to renewed interest in exploring traditional herbal medicines as alternative or complementary treatments for respiratory conditions. Traditional medicinal systems, particularly Ayurveda, have utilized various plant species for centuries to treat respiratory ailments. These traditional remedies are often effective, have fewer side effects, and address multiple aspects of respiratory health simultaneously. The holistic approach of herbal medicine in treating respiratory conditions has gained scientific validation through numerous pharmacological studies.

1.2 Rationale for the Study

This research aims to develop a scientifically validated polyherbal formulation by combining four potent medicinal plants known for their beneficial effects on respiratory health. The selected plants—Tulsi (Ocimum sanctum), Mulethi (Glycyrrhiza glabra), Giloy (Tinospora cordifolia), and Dry Ginger (Zingiber officinale)—have been extensively studied individually for their therapeutic properties. However, their combined effect in a standardized syrup formulation has not been thoroughly investigated.

The syrup dosage form was chosen due to its ease of administration, better patient compliance (especially among pediatric and geriatric populations), possibility of taste masking, and improved bioavailability of the active constituents. Furthermore, liquid formulations allow for easier dose adjustments based on patient needs.

1.3 Literature Review

1.3.1 Tulsi (Ocimum sanctum) Tulsi, also known as Holy Basil, has been revered in Ayurveda for its diverse therapeutic properties. Scientific studies have demonstrated its efficacy in respiratory conditions due to its:

• Immunomodulatory effects: Enhances the body’s natural defense mechanisms
• Anti-inflammatory activity: Reduces inflammation in respiratory passages
• Antimicrobial properties: Effective against respiratory pathogens
• Antioxidant effects: Protects against oxidative stress

Key bioactive compounds in Tulsi include eugenol, ursolic acid, rosmarinic acid, and carvacrol, which contribute to its therapeutic effects in respiratory disorder.

1.3.2 Mulethi (Glycyrrhiza glabra) Licorice root (Mulethi) has been extensively used in traditional medicine systems worldwide. Its benefits for respiratory health include:

• Expectorant action: Helps in removing mucus from the respiratory tract
• Anti-inflammatory effects: Soothes irritated throat and respiratory passages
• Antimicrobial properties: Active against various respiratory pathogens
• Immunomodulatory activity: Enhances immune response

Glycyrrhizin, liquiritin, and isoliquiritin are the major bioactive constituents responsible for these therapeutic effects.

1.3.3 Giloy (Tinospora cordifolia) Giloy is recognized in Ayurveda as a potent immunomodulator. Its beneficial effects on respiratory health include:

• Enhanced immunity: Strengthens the body’s defense against respiratory infections
• Anti-allergic properties: Reduces hypersensitivity reactions
• Anti-inflammatory activity: Decreases inflammation in respiratory passages
• Antipyretic effects: Helpful in managing fever associated with respiratory infections
• Tinosporine, berberine, giloin, and tinosporaside are the key phytoconstituents contributing to its therapeutic efficacy

1.3.4 Dry Ginger (Zingiber officinale) Ginger has been traditionally used for various respiratory conditions. Scientific evidence supports its:

• Anti-inflammatory effects: Reduces inflammation in the respiratory tract
• Bronchodilatory action: Helps in relaxing constricted airways
• Antitussive properties: Relieves cough
• Immunomodulatory activity: Strengthens immune response against infections

Gingerols, shogaols, and zingerone are the primary bioactive compounds responsible for these effects.

1.4 Objectives of the Study

• To formulate a polyherbal syrup incorporating Tulsi, Mulethi, Giloy, and Dry Ginger extracts for respiratory health
• To standardize the formulation process for ensuring batch-to-batch consistency
• To evaluate the physicochemical properties of the formulated syrup
• To assess the stability of the preparation under various storage conditions
• To develop a palatable and therapeutically effective herbal formulation for respiratory health

2. MATERIALS AND METHODS

2.1 Materials

2.1.1 Plant Materials and Extracts

2.1.2 Excipients and Other Materials

2.2 Equipment

• Analytical balance
• pH meter
• Viscometer
• Hydrometer
• Hot plate with magnetic stirrer
• Filtration assembly
• Amber-colored glass bottles
• Muslin cloth
• Standard laboratory glassware

2.3 Formulation Composition

The polyherbal syrup was formulated with the following composition for a 100 mL batch:

2.4 Method of Preparation

The polyherbal syrup was prepared using the following standardized procedure:

2.4.1 Extraction Process For this formulation, standardized herbal extracts were used. However, if preparing extracts from raw materials, a hydroalcoholic extraction process would be employed: - Coarsely powdered plant materials would be macerated in a mixture of water and ethanol (70:30) - The mixture would be kept with occasional stirring for 48 hours - After filtration, the extract would be concentrated under reduced pressure - The concentrated extract would be standardized for bioactive markers

2.4.2 Preparation of Syrup Base

• In a clean vessel, glycerin (10 mL) and sorbitol solution (20 mL) were mixed thoroughly using a magnetic stirrer at 100 rpm for 5 minutes.
• Citric acid (0.05 g) and sodium benzoate (0.1 g) were dissolved in a small amount of purified water (approximately 10 mL) with gentle heating if necessary.
• This solution was then added to the glycerin-sorbitol mixture under continuous stirring at 100 rpm for another 5 minutes to ensure homogenous mixing.

2.4.3 Addition of Herbal Extracts

4. Under continuous stirring (100 rpm), the herbal extracts were added sequentially:

• Tulsi extract (5 mL) was added first and mixed for 2 minutes
• This was followed by Mulethi extract (5 mL) with mixing for another 2 minutes
• Giloy extract (4 mL) was then added with continued mixing for 2 minutes
• Finally, Dry Ginger extract (2 mL) was incorporated with mixing for

2 minutes

2.4.4 Flavor and Sweetening

• Fresh lemon juice (3 mL) was added to the mixture and stirred for 1 minute.
• Stevia solution (5 mL) was incorporated with stirring for 1 minute.
• Honey (10 g) was added last and mixed thoroughly for 3 minutes to ensure complete distribution.

2.4.5 Volume Makeup and Final Processing

• The mixture was made up to a final volume of 100 mL with purified water and mixed for an additional 5 minutes to ensure homogeneity.
• The prepared syrup was filtered through multiple layers of muslin cloth to remove any potential particulate matter.
• The filtered syrup was filled into pre-sterilized amber-colored glass bottles, sealed properly, and labeled appropriately.

2.5 Evaluation Parameters

The formulated polyherbal syrup was evaluated for the following parameters:

2.5.1 Organoleptic Properties The syrup was evaluated for its appearance, color, odor, and taste by a panel of 5 trained individuals using descriptive analysis.

2.5.2 pH Determination       The pH of the formulation was measured using a calibrated digital pH meter at room temperature (25°C ± 2°C). The target pH range was set at 5.0–6.0 to ensure stability and palatability.

2.5.3 Viscosity Measurement Viscosity was determined using a Brookfield viscometer with appropriate spindle at room temperature (25°C ± 2°C). The measurements were taken in triplicate, and the average value was recorded.

2.5.4 Specific Gravity Determination Specific gravity was measured using a pycnometer/hydrometer at room temperature (25°C ± 2°C). The measurement was performed in triplicate, and the average value was recorded.

2.5.5 Total Solid Content Total solid content was determined by the evaporation method: - 5 mL of the syrup was accurately measured and placed in a pre-weighed evaporating dish - The dish was heated on a water bath until the liquid component evaporated - The dish was then dried in an oven at 105°C until a constant weight was achieved - The percentage of total solids was calculated using the formula: % Total solids = (Weight of residue / Weight of sample) × 100

2.5.6 Microbial Limit Test The formulation was tested for microbial contamination using the standard plate count method as per pharmacopoeial guidelines: - Total aerobic microbial count (TAMC) - Total yeast and mold count (TYMC) - Tests for specific microorganisms (E. coli, Salmonella, S. aureus, P. aeruginosa)

2.5.7 Stability Study Short-term stability studies were conducted by storing the formulation under the following conditions: - Room temperature (25°C ± 2°C) - Refrigeration (4°C ± 2°C) - Accelerated conditions (40°C ± 2°C, 75% RH ± 5% RH) Samples were withdrawn at predetermined time intervals (0, 7, and 15 days) and evaluated for organoleptic properties, pH, viscosity, and microbial contamination.

3. RESULTS AND DISCUSSION

3.1 Formulation Development

The polyherbal syrup was successfully formulated by incorporating the four herbal extracts in an optimized base. Multiple trial batches were prepared with varying concentrations of sweeteners, viscosity enhancers, and preservatives to achieve the desired consistency, stability, and palatability. The final formulation was selected based on its optimal physicochemical properties and sensory attributes.

3.2 Organoleptic Evaluation

The organoleptic properties of the formulated polyherbal syrup are presented in Table 1:

Table 1: Organoleptic Properties of Polyherbal Syrup

The organoleptic evaluation indicated that the formulation had acceptable sensory attributes. The combination of honey, stevia, and sorbitol effectively masked the bitter taste commonly associated with herbal extracts, resulting in a palatable preparation.

3.3 pH Determination

The pH of the formulation was found to be 5.6 ± 0.2, which falls within the target range of 5.0–6.0. This slightly acidic pH contributes to: - Stability of the herbal constituents - Enhanced preservative efficacy of sodium benzoate - Better palatability - Improved absorption of flavonoids and other bioactive compounds

The pH remained stable throughout the observation period, indicating good chemical stability of the formulation.

3.4 Viscosity Measurement

The viscosity of the polyherbal syrup was determined to be 135 ± 5 centipoises

(cP) at 25°C. This moderate viscosity is: - Suitable for a syrup formulation Appropriate for ease of pouring and measuring - Optimal for coating the throat (beneficial for local action) - Stable during the storage period

3.5 Specific Gravity Determination

The specific gravity of the formulated syrup was found to be 1.285 ± 0.012 at 25°C. This value is typical for syrup formulations containing sorbitol and glycerin as viscosity enhancers and is comparable to other marketed herbal syrups.

3.6 Total Solid Content

The percentage of total solids in the formulation was determined to be 38.75

± 1.25%. This relatively high solid content can be attributed to: - Dissolved extractives from herbal materials - Sweetening agents (honey, stevia, sorbitol) Viscosity enhancers (glycerin)

The moderate solid content contributes to the stability and physical characteristics of the syrup.

3.7 Microbial Limit Test

The results of the microbial limit tests are presented in Table 2:

Table 2: Microbial Evaluation of Polyherbal Syrup

The formulation complied with the pharmacopoeial limits for microbial contamination, indicating: - Effectiveness of the preservation system - Good manufacturing practices during preparation - Suitable stability from a microbiological perspective

3.8 Stability Study

The results of the stability study are summarized in Table 3:

Table 3: Stability Study Results of Polyherbal Syrup