J.I.I.U’S Ali-Allana College of Pharmacy Akkalkuwa, Dist- Nandurbar (425415) Maharashtra, India
Migraine is a neurological condition characterized by recurrent headaches that are often moderate to severe in intensity. These headaches typically affect one side of the head, although they can sometimes occur bilaterally. Migraine headaches are frequently accompanied by other symptoms such as nausea, vomiting, and sensitivity to light and sound. The condition is divided into several subtypes, the most common being migraine with aura and migraine without aura. An aura is a series of sensory disturbances that can occur before the headache begins, such as visual flashes or blind spots. A gel is a semi-solid system consisting of a network of polymers that trap a liquid, forming a jelly-like material. Includes hydrogels (water-based), organogels (organic solvent-based), and xerogels (dried gels). Gels exhibit properties such as high viscosity, elasticity, and the ability to maintain shape while offering ease of application. The physicochemical analysis revealed essential parameters such as moisture content, ash content, and extractive values, providing valuable insights into Raughane Banafsha's quality and composition. Additionally, the phytochemical investigation identified various bioactive compounds present in the herbal material, underscoring its potential therapeutic benefits. The evaluation of gel formulations demonstrated satisfactory performance in terms of pH, extrudability, viscosity, and stability over 90 days. In this article we discussing gel Importance in Pharmaceutical and Cosmetic Industries, types with Characteristics, Application, Components of Gel Formulation, Preparation Methods, Characterization and Evaluation etc.
Migraine is a neurological condition characterized by recurrent headaches that are often moderate to severe in intensity. These headaches typically affect one side of the head, although they can sometimes occur bilaterally. Migraine headaches are frequently accompanied by other symptoms such as nausea, vomiting, and sensitivity to light and sound. The condition is divided into several subtypes, the most common being migraine with aura and migraine without aura. An aura is a series of sensory disturbances that can occur before the headache begins, such as visual flashes or blind spots. Migraine with aura involves a range of neurological disturbances that precede or accompany the headache. The aura phase is typically followed by the headache phase, which includes the usual migraine symptoms such as throbbing head pain, nausea, and sensitivity to light and sound. Migraine without aura is the most common type of migraine, characterized by recurrent headaches that are typically unilateral and pulsating in nature. These headaches are often accompanied by nausea, vomiting, and heightened sensitivity to light (photophobia) and sound (phonophobia). Chronic migraines, defined as headaches occurring on 15 or more days per month for more than three months, can be particularly debilitating.
Genetic factors play a significant role in the susceptibility to migraines. Research has shown that migraines tend to run in families, suggesting a hereditary component. Specific genes and genetic mutations have been identified that are associated with migraine susceptibility. Environmental triggers are external factors that can precipitate a migraine attack in susceptible individuals. These triggers vary widely from person to person but often include common elements such as diet, stress, sleep patterns, and hormonal changes.
A gel is a semi-solid system consisting of a network of polymers that trap a liquid, forming a jelly-like material. Gels exhibit properties such as high viscosity, elasticity, and the ability to maintain shape while offering ease of application . It Includes hydrogels (water-based), organogels (organic solvent-based), and xerogels (dried gels). Gels are used as carriers for topical, transdermal, oral, and ocular drug delivery, providing controlled and sustained release of active ingredients. Widely used in skincare products like moisturizers, sunscreens, and anti-aging treatments due to their ability to hydrate and deliver active ingredients effectively. Gels are non-greasy, easy to apply, and provide a pleasant sensory experience, increasing adherence to treatment and product use.
PLANT PROFILE
Gul-e-Banafsha (Viola odorata)
Common Names: Sweet Violet, Wood Violet, Common Violet
Scientific Classification:
• Kingdom: Plantae
• Clade: Angiosperms
• Clade: Eudicots
• Clade: Rosids
• Order: Malpighiales
• Family: Violaceae
• Genus: Viola
• Species: Viola odorata
Botanical Description:
• Habit: Perennial herb.
• Height: Typically 10-15 cm (4-6 inches).
• Leaves: Heart-shaped (cordate) with serrated margins, dark green, and form a basal rosette.
• Flowers: Small, fragrant, and violet to purple in color. They have five petals with the lower petal being larger and often spurred.
• Fruit: Small capsules containing numerous tiny seeds.
• Roots: Rhizomatous, allowing the plant to spread vegetatively.
Habitat:
• Native Range: Europe and Asia.
• Preferred Environment: Moist, shady locations such as woodlands, forest edges, and grassy banks.
Chemical Constituents:
• Volatile Oils: Contains a variety of volatile compounds that contribute to its characteristic fragrance.
• Flavonoids: Including rutin and quercetin, which have antioxidant properties.
• Saponins: Contributing to its expectorant properties.
• Alkaloids: Including odoratine.
• Mucilage: Present in significant amounts, contributing to its demulcent properties.
• Salicylic Acid: A compound similar to aspirin, providing anti-inflammatory effects.
• Respiratory Conditions: Used to treat coughs, bronchitis, and sore throats due to its expectorant and soothing properties.
• Skin Conditions: Applied topically to treat skin irritations, eczema, and minor wounds.
• Anti-inflammatory: Used for its mild anti-inflammatory effects in various traditional medicine systems.
• Aromatherapy: The fragrant flowers are used in perfumes and aromatherapy for their calming effects.
• Anti-inflammatory: Used for its mild anti-inflammatory effects in various traditional medicine systems.
• Aromatherapy: The fragrant flowers are used in perfumes and aromatherapy for their calming effects.
Medicinal Properties:
• Expectorant: Helps to clear mucus from the respiratory tract.
• Anti-inflammatory: Reduces inflammation both internally and externally.
• Demulcent:
Soothes rritated tissues, particularly in the respiratory and gastrointestinal tracts.
• Antioxidant: Protects cells from oxidative stress.
MATERIALS AND METHODS
Components |
Description |
Plant Material |
Samples of the plant material (e.g., Raughane Banafsha) used for and analysis processes. |
Distilled Water |
Pure water used for various purposes, including extraction, preparation of solutions, and dilution. |
Ethanol |
A solvent used for extracting alcohol-soluble constituents from the plant material. |
Hydrochloric Acid (HCl) |
An acid used for various purposes, including the digestion of plant material for elemental analysis. |
Nitric Acid (HNO3) |
An acid used in the digestion process for elemental analysis of plant material. |
Benzalkonium Chloride |
A compound used as a preservative in the gel formulation. |
Triethanolamine |
A compound used for neutralization and pH adjustment in the gel formulation. |
Carbopol 934/Carbopol 940 |
Polymeric compounds used as gelling agents in the gel formulation. |
Hydroxypropyl Methylcellulose |
A polymer used as a gelling agent in the gel formulation. |
Crucible |
A heat-resistant container used for heating and ashing plant material during ash value determination. |
Evaporating Dish |
A shallow, flat-bottomed dish used for evaporating solvents and drying samples. |
Conical Flask |
A flask with a conical shape, used for mixing, stirring, and containing liquids. |
Watch Glass |
A circular piece of glass used to cover beakers and evaporating dishes during heating. |
Beaker |
A cylindrical container used for mixing, stirring, and heating liquids. |
Graduated Cylinder |
A cylindrical container with volume markings used for accurate measurement of liquid volumes. |
pH Meter |
A device used to measure the acidity or alkalinity of a solution. |
Viscometer |
An instrument used to measure the viscosity of fluids. |
Flame Atomic Absorption Spectrophotometer (FAAS) |
An analytical instrument used for elemental analysis based on the absorption of light by free atoms in the gaseous state. |
Atomic Emission Spectrophotometer |
An analytical instrument used for elemental analysis based on the emission of light by excited atoms. |
Franz Diffusion Cell |
A laboratory apparatus used to study the release and permeation of substances through a semi-permeable membrane |
Texture Analyzer |
An instrument used to measure the mechanical properties of materials, including texture, hardness, and compressibility. |
Microscope |
An optical instrument used for magnifying and observing small objects or specimens. |
Analytical Balance |
A sensitive balance used for accurately measuring the mass of substances |
Mechanical Shaker |
A laboratory device used to agitate samples by shaking or stirring. |
Table 1: List of Materials used
Preparation of Gel:
For the preparation of the gel base, first, weigh the required amounts of Carbopol 934 or Carbopol 940 as per the formulation, and slowly disperse it in distilled water with continuous stirring to avoid clumping, allowing the dispersion to hydrate for 24 hours to ensure complete swelling. For HPMC K15, weigh the required amount and gradually add it to distilled water under continuous stirring until the polymer is fully hydrated and a clear solution is obtained. Next, prepare the Benzalkonium Chloride solution by weighing the required amount and dissolving it in a small quantity of distilled water. Measure 10 ml of Raughan-e-Banafsha for each formulation and slowly add it to the hydrated polymer mixture while stirring to ensure uniform distribution. Then, add the Benzalkonium Chloride solution to the polymer- Raughan-e-Banafsha mixture while stirring continuously. Proceed by slowly adding 0.5 ml of Triethanolamine to the mixture while stirring, and adjust the pH to around 7.0 ± 0.5 using a pH meter, adding more Triethanolamine drop by drop if necessary. Ensure thorough stirring to homogenize the mixture, making sure all components are uniformly distributed and the gel base is smooth. Finally, make up the final volume with distilled water to achieve the desired consistency (quantum satis, qs) and continue stirring until a homogenous gel is formed.
Component |
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
F7 |
F8 |
F9 |
Drug (Raughane Banafsha) (ml) |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
Carbopol 934 (gm) |
2 |
- |
- |
2 |
- |
2 |
2 |
1 |
0.5 |
Carbopol 940 (gm) |
- |
2 |
- |
2 |
2 |
- |
2 |
1 |
0.5 |
HPMC K15 (gm) |
- |
- |
2 |
- |
2 |
2 |
2 |
1 |
0.5 |
Benzalkonium Chloride (gm) |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
Triethanolamine (ml) |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
Water |
qs |
qs |
qs |
qs |
qs |
qs |
qs |
qs |
qs |
Table 2: Composition of gel
EVALUATION OF PREPARED GEL:
The evaluation of the prepared gel involves several key parameters to ensure its quality, effectiveness, and stability for use in topical applications. Here is an elaboration on the methods used for each aspect of the evaluation:
1. The organoleptic properties:
The organoleptic properties of the Raughan e Banafsha herbal gel are highly favourable. Its greenish colour, pleasant odor, smooth texture, and balanced consistency contribute to a product that not only appeals to the senses but also provides a delightful user experience.
2. pH Measurement:
The pH of the prepared gel is a critical parameter as it can influence its stability, skin compatibility, and overall efficacy. The pH is typically measured using a pH meter or pH indicator strips.
3. Homogeneity:
Homogeneity refers to the uniform distribution of ingredients within the gel formulation. to assess homogeneity, samples are collected from different parts of the gel batch using a suitable sampling method.
4. Extrudability:
The extrudability evaluation of the Raughan e Banafsha herbal gel was conducted to assess its ease of dispensing and consistency in past tense. The test involved preparing clean containers and extruding the gel onto a clean surface to observe its flow and uniformity. During the evaluation, it was found that the gel extruded smoothly and consistently with minimal force required, indicating good extrudability. The process was repeated multiple times to ensure consistency across batches, and the cleanliness of the nozzles was checked after each extrusion. Overall, the extrudability assessment confirmed that the herbal gel was well-formulated and user-friendly, providing a convenient experience for topical application.
5. In vitro diffusion studies:
The in vitro diffusion studies for all formulations were done using the Franz diffusion cell. Twenty-five milligrams of the gel-containing extract was placed on the cellulose acetate membrane in phosphate buffer with pH 6.8, continuously stirred; temperature was maintained at 37°C ± 1°C. One milliliter aliquot was withdrawn from each system at time intervals of 15, 30, 60, 120, and 180 min, and 5 h and analyzed for drug release using ultraviolet (UV) spectrophotometer at 380 nm.
6. Stability Studies:
Stability studies are conducted upto 90 days to evaluate the physical, chemical, and microbiological stability of the gel formulation over time. Samples of the gel are stored under controlled conditions, including temperature, humidity, and light exposure, to simulate real-world storage conditions. The gel samples are periodically evaluated for changes in appearance, pH, viscosity, drug content, and microbial growth.
By employing these methods, the evaluation of the prepared gel ensures that it meets the necessary quality standards for safe and effective use in topical applications, contributing to its overall efficacy and patient satisfaction
RESULTS AND DISCUSSION
Determination of Lamda max:
The lambda max (?max) of the UV-Vis absorption spectrum for Gule Banafsha is the wavelength at which the absorbance reaches its highest value. From the provided graph, the ?max is approximately 380 nm, where the absorbance is at its peak near 2.0 units.
Fig 1: Determination of Lamda max
Calibration curve Gul e Banafsha:
The calibration curve for Gul e Banafsha, which plots concentration (µg/ml) against absorbance, demonstrates a generally linear relationship with some deviation at 22 µg/ml, where the absorbance dips to 0.362.
Fig 2: Calibration curve of Gul e Banafsha
Conc (ug/ml) |
Absorbance |
16 |
0.321 |
18 |
0.372 |
20 |
0.420 |
22 |
0.362 |
24 |
0.512 |
Table 2: Calibration curve of Gul e Banafsha
Physicochemical Constituents:
Table 3 presents the physicochemical constituents of Raughane Banafsha, including moisture content, ash content, acid-insoluble content, water-soluble content, water extractive value, and ethanol extractive. These parameters provide valuable information about the composition and properties of the herbal material.
Parameter |
Values (% w/w) |
Raughane Banafsha |
|
Moisture content |
7.99±1.05 |
Ash content |
8.85±1.25 |
Acid in soluble content |
7.36±1.35 |
Water soluble content |
7.87±1.20 |
Water extractive value |
15.39±1.15 |
Ethanol extractive |
23.03±2.62 |
Table 3: Physicochemical Constituents
1. Moisture Content: The moisture content of Raughane Banafsha is measured at 7.99% with a standard deviation of ±1.05%. Moisture content indicates the amount of water present in the herbal material. Higher moisture content can impact the stability and shelf life of herbal products, making it crucial to control during processing and storage.
2. Ash Content: The ash content of Raughane Banafsha is determined to be 8.85% with a standard deviation of ±1.25%. Ash content represents the total mineral content present in the herbal material after complete combustion.
3. Acid-Insoluble Content: The acid-insoluble content in Raughane Banafsha is found to be 7.36% with a standard deviation of ±1.35%. Acid-insoluble content refers to the portion of ash that remains insoluble in dilute acid after the total ash has been treated.
4. Water-Soluble Content: The water-soluble content of Raughane Banafsha is reported as 7.87% with a standard deviation of ±1.20%. Water-soluble content indicates the amount of soluble compounds present in the herbal material, such as sugars, salts, and other polar substances.
5. Water Extractive Value: The water extractive value of Raughane Banafsha is measured at 15.39% with a standard deviation of ±1.15%.
6. Ethanol Extractive: The ethanol extractive of Raughane Banafsha is determined to be 23.03% with a standard deviation of ±2.62%. Ethanol extractive value represents the amount of soluble constituents that can be extracted from the herbal material using ethanol as a solvent. it indicates the presence of lipophilic compounds and can influence the extraction efficiency of herbal extracts.
Phytochemical investigation:
S. No |
Phyto-constituents |
Raughane Banafsha |
1 |
Proteins |
+ve |
2 |
Carbohydrates |
+ve |
3 |
Fats & Oil |
+ve |
4 |
Alkaloids |
+ve |
5 |
Glycosides |
-ve |
6 |
Tannins |
-ve |
7 |
Resins |
-ve |
8 |
Flavonoids |
-ve |
9 |
Steroids |
+ve |
10 |
Amino-acids |
-ve |
11 |
Phenol test |
-ve |
12 |
Diterpenes |
+ve |
13 |
Saponins test |
++ve |
Table 4: Phytochemical investigation
EVALUATION OF PREPARED GEL:
pH of gel:
Sample |
pH Measurement |
F1 |
4.8 ± 0.25 |
F2 |
5.1 ± 0.23 |
F3 |
4.9 ± 0.13 |
F4 |
5.2 ± 0.92 |
F5 |
5.0 ± 0.63 |
F6 |
5.1 ± 0.29 |
F7 |
4.7 ± 0.15 |
F8 |
5.3 ± 0.18 |
F9 |
4.5 ± 0.20 |
Table 5: pH of gel
In this case, the pH values of the gel formulations range from 4.5 to 5.3, which generally falls within an acceptable range for topical products.
Extrudability:
Formulation |
Extrudability (g) |
F1 |
50 |
F2 |
70 |
F3 |
85 |
F4 |
60 |
F5 |
80 |
F6 |
75 |
F7 |
55 |
F8 |
65 |
F9 |
72 |
Table 7: Extrudability
1.Formulation F3 demonstrates the highest extrudability, requiring the least force to dispense the gel, with a value of 85 g.
2.Formulation F2 follows closely behind with an extrudability of 70 g, indicating relatively easy dispensing.
3.Formulations F5 and F6 also exhibit good extrudability, with values of 80 g and 75 g, respectively.
4.Formulations F1, F4, F7, F8, and F9 show varying degrees of extrudability, with values ranging between 50 g and 72 g.
Formulation |
Viscosity (cps) |
F1 |
100 |
F2 |
150 |
F3 |
200 |
F4 |
120 |
F5 |
180 |
F6 |
160 |
F7 |
110 |
F8 |
170 |
F9 |
140 |
Table 8: Viscosity (cps)
In vitro diffusion studies
The in vitro diffusion studies for the herbal gel formulations (F1 to F9) revealed significant differences in drug release profiles over a 6-hour period.
The study was conducted using the Franz diffusion cell, with 25 mg of each gel formulation placed on a cellulose acetate membrane in a phosphate buffer (pH 6.8), maintained at 37°C ± 1°C.Drug release was monitored at various time intervals using UV spectrophotometry at 380 nm.
Time (hrs) |
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
F7 |
F8 |
F9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.5 |
10.7 |
9.04 |
12.6 |
10.8 |
13.7 |
14.04 |
11.2 |
10.1 |
12.9 |
1 |
21 |
14.47 |
23.8 |
13.7 |
25.5 |
27.85 |
22.3 |
15.2 |
24.9 |
2 |
30.2 |
25.82 |
31.3 |
23.5 |
34.4 |
36.57 |
26.5 |
24.3 |
32.1 |
4 |
49.8 |
34.32 |
51.1 |
31.9 |
56.9 |
58.71 |
48.4 |
32.1 |
54.5 |
6 |
69.7 |
55.19 |
71.7 |
53 |
78.2 |
80.2 |
70.1 |
62.3 |
75.9 |
8 |
82.4 |
68.7 |
84.3 |
67.2 |
90.5 |
92.0 |
83.6 |
76.8 |
89.3 |
Table 9: In vitro diffusion studies
The in vitro diffusion studies of the herbal gel formulations (F1 to F9) demonstrated varied drug release profiles over an 8-hour period, with significant increases in drug release observed.
Formulations F5 and F6 exhibited the highest release rates, achieving 90.5% and 92.0% drug release at 8 hours, respectively, indicating their superior release efficiency. Formulations F3 and F9 also showed substantial release, with 84.3% and 89.3% at 8 hours. Other formulations, such as F1, F2, and F4, displayed moderate release rates, suggesting that the formulation matrix plays a critical role in drug diffusion. he observed results emphasize the potential of certain formulations to achieve nearly complete drug release within 8 hours, highlighting their effectiveness for potential therapeutic applications.
Fig: In vitro diffusion studies
Stability studies:
The stability studies conducted over 90 days indicate that the gel formulations maintained their key properties well over time.
Property |
Initial Value |
Value after 90 days |
Physical Appearance |
Uniform gel |
Uniform gel |
Rheological Properties |
Consistency: good Extrudability: good |
Consistency: good Extrudability: good |
Spreadability |
Good |
Good |
pH |
5-6 |
5-6 |
Table 10: Stability studies:
DISCUSSION
The results and discussion section provides a comprehensive analysis of various aspects related to the prepared gel formulations, including their physicochemical constituents, phytochemical investigation, evaluation of gel properties (pH, Extrudability, viscosity), and stability studies.
Physicochemical Constituents: The analysis of Raughane Banafsha revealed important parameters such as moisture content, ash content, acid-insoluble content, water-soluble content, water extractive value, and ethanol extractive.
Phytochemical Investigation: The phytochemical investigation identified various phyto- constituents present in Raughane Banafsha, including proteins, carbohydrates, fats & oil, alkaloids, steroids, diterpenes, and saponins
Evaluation of Prepared Gel: The evaluation of the prepared gel formulations involved assessing their pH, extrudability, viscosity, and stability. The pH measurements indicated the acidity or alkalinity of the gels, which is crucial for their compatibility with the skin. extrudability measurements provided insights into the ease of application and dispensing of the gels, respectively. The discussion provided detailed interpretations of the results, highlighting the significance of each parameter in relation to the formulation's quality, efficacy, and stability. It discussed the implications of the findings, potential applications of the gel formulations, and areas for further research and development.
CONCLUSION
The conclusion encapsulates the main findings and implications of the study, providing a definitive statement on the significance of the research: In conclusion, this study comprehensively investigated the physicochemical and phytochemical properties of Raughane Banafsha and evaluated its formulation into gel preparations. The findings shed light on the chemical composition, medicinal potential, and performance characteristics of this herbal material. The physicochemical analysis revealed essential parameters such as moisture content, ash content, and extractive values, providing valuable insights into Raughane Banafsha's quality and composition. Additionally, the phytochemical investigation identified various bioactive compounds present in the herbal material, underscoring its potential therapeutic benefits. The evaluation of gel formulations demonstrated satisfactory performance in terms of pH, extrudability, viscosity, and stability over 90 days. These findings suggest that the gel formulations maintain their key properties and are suitable for long-term use and storage. Overall, this study contributes to the body of knowledge on Raughane Banafsha and provides a foundation for its utilization in pharmaceutical or cosmetic applications. Further research may explore additional formulation optimization strategies or investigate specific therapeutic applications of the gel preparations. In conclusion, the findings of this study support the potential of Raughane Banafsha as a valuable herbal resource and highlight opportunities for its integration into healthcare and wellness products
ACKNOWLEDGEMENT
I take this privilege and pleasure to acknowledge the contributions of many individuals who have been inspirational and supportive throughout my work and endowed me with the most precious knowledge to see success in my endeavor.
We are thankful to the Principal and Management of JIIU’s Ali-Allana College of Pharmacy Akkalkuwa, Dist- Nandurbar for providing moral support and necessary facilities during completion of this work.
REFERENCES
Quazi Kamil Hafiz Anees Ahmed, Dr. Majaz A. Quazi, Quazi Wasil H. Jalees, Formulation, Characterization and Comparative Evaluation of Raughan E Banafsha and Its Modified Dosage Form (Gel), Int. J. of Pharm. Sci., 2024, Vol 2, Issue 12, 1569-1584. https://doi.org/10.5281/zenodo.14411799