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Journal of Drug Delivery and Therapeutics

Open Access to Pharmaceutical and Medical Research

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Open Access Full Text Article                                                                             Research Article

Formulation and Evaluation of Herbal Analgesic Balm

Harshdeep V. Bindod *, Vedika N. Dafe, Pooja R. Hatwar , Ravindra L. Bakal 

Shri Swami Samarth Institute of Pharmacy, At Parsodi, Dhamangaon Rly, Dist -Amravati (444709) Maharashtra, India

 

 

INTRODUCTION:

Balms are prepared topically to be applied to the skin to reduce stiffness and discomfort. An Ayurvedic mixture of potent essential oils, analgesic herbal balm provides immediate relief from colds, headaches, and backaches. Herbal balms with organic essential oils, organic beeswax, and other suitable herbal ingredients are medicinal topical preparations that can be applied to human skin.¹ A vital link between basic illnesses and secondary consequences is pain. It can set off a harmful and dynamic interaction between biological, social, and psychological elements, which can result in patients' impairment and bad prognosis.² According to the International Association for the Study of Pain, pain is a complex phenomenon that includes modulation, affective reactions, nociception, afferents to the central nervous system, endogenous analgesia, behavioral changes, and shifts in social roles.³ A prevalent, complicated, and upsetting issue, chronic pain has a big influence on both society and people. Although it frequently manifests as a consequence of an injury or illness, it is a distinct condition unto itself and not just a symptom of another illness. Thus, chronic pain has a medical definition as well as its own taxonomy.⁴ In effective pain treatment leads to a growing number of health care problems. Inadequate and delayed treatment of acute pain leads to chronic pain, which ultimately results in permanent neural system alterations.⁵ Studies on plant constituents were examined based on their chemical classification of active chemicals, which suggests that medicinal plants may create a biological balance and stop the buildup of medical ingredients.^5,6 When tissue is injured, pain emerges.⁷ An essential natural defensive system, pain can have a big impact on a person's quality of life. Having a thorough understanding of how pain affects the body is crucial for creating innovative pain management strategies. Nociceptor neurons play a crucial role in inflammation and pain.⁸ In response, the person tries to eliminate the unpleasant stimulus.⁷ Socio-demographic, psychological, clinical, and biological factors are among the several risk factors for chronic pain.⁴ One may say that here are three components to pain: Affective, emotional, and sensory. Significant alterations in pain pathways, an increase in excitability, and modifications to gene expressions, enzymes, and receptors are caused by illness, inflammation, and damage to the central and peripheral nerve systems.⁷ Plants are one of the primary sources for the extraction and purification of secondary metabolites due to their chemical variety. However, humans have long been concerned about pain and have looked to natural sources, primarily plants, for treatment. Accordingly, drugs that cause pain relief can be categorized as analgesics (painkillers).⁹ Essential oil constituents are frequently present in foods that impart distinctive flavor and scent. Traditionally employed in aromatherapy for various applications, essential oils are a class of natural compounds with potential biological properties.¹⁰ Numerous natural and synthetic analgesics are available, including opioid analgesics, Aloe vera, Glycyrrhiza glabra, Zingiber Officinale, Eugenia caryophyllata, Cinnamomum camphora, Matricaria pubescens, and others.¹¹

Anatomy of the skin:

The skin, which weighs approximately 3 kg and serves several purposes, is the largest organ in the human body. It offers the body's total body barrier protection, keeping toxins and pathogens out and shielding internal organs and tissues from harm. The three distinct layers that make up the epidermis, dermis, and hypodermis are all crucial to its healthy operation.¹²

 

 

Figure 1: Anatomy of human skin.¹³

 

 

Emotional well-being, quality of life, self-perception, and social relationships have all been demonstrated to be significantly impacted by skin quality.¹⁴ In order to maintain homeostasis, the skin acts as an essential barrier between the body's internal systems and the outside world.¹⁵ The process of wound healing is complicated and requires the coordinated activity of numerous tissues and cell types. It necessitates careful coordination of angiogenesis, inflammation, matrix deposition, migration, and proliferation of cells. Larger injuries from trauma, acute illness, or major surgery can take weeks to heal, leaving behind a fibrotic scar that might affect tissue function, while minor skin wounds heal in a matter of days. A deeper understanding of the cellular and molecular processes underlying wound healing is necessary for the development of treatments that successfully treat chronic wounds and avoids carring.¹⁵ Following an injury, the skin's integrity needs to be promptly restored. A variety of skin cell types interact and communicate with one another throughout the extremely cooperative process of wound healing. Inflammation, tissue creation, and tissue remodeling are the three phases of their pair process.¹⁶ Hemostasis, inflammation, proliferation, remodeling, and total tissue repair are the stages of acute wound healing that usually occur in a well-coordinated order.¹⁷

 

 

Method and materials: 

Preparation of Herbal Balm:

1. Materials 

 

2. Formulation: 

 

 

 

3. Procedure: 

Step 1: Preparation of Extracts:

• Fresh aloe leaf was harvested from the botanical garden (outermost leaves). 
• Wash thoroughly and cut off the spiny edges and slice the leaf open lengthwise. 
• Scoop out the clear gel using a spoon.
• The gel was blended to make it smooth and strained through a muslin cloth to remove the pulp.
• Carrier oil (coconut oil) was gently heated in a double boiler.
• Aloe gel was added to the warm oil in a 1:1 ratio.
• Simmered on very low heat for 1-2 hours, stir occasionally.
• The water from the gel was evaporated and the active compounds infused into the oil.
• The mixture was strained through a muslin cloth.
• Cooled and stored in an airtight container. 

Step 2: Preparation of the base:

• In a double boiler, beeswax and petroleum jelly were melted at 60-70 °C until fully liquefied.
• Coconut oil was added and mixed well. 

Step 3: Addition of active ingredients

• Once the base is fully melted, methyl salicylate, camphor, and peppermint oil were added.
• Stirred well to ensure uniform distribution.

Step 4: Incorporation of herbal extract and oil:

Step 5: Addition of essential oils:

Step 6: Addition of preservative and final mixing:

Step 7: Filtration of the final product:

Step 8: Cooling and packing: 

• The warm mixture was poured into the sterilized jar.
• Let it cool at room temperature until the formulation is solidified.
• Sealed and labeled.

Storage:

Category: 

Directions for use: 

• To be rubbed externally. 
• Rub gently on the skin with the help of finger. 
• Do not apply to deep skin cuts or bleeding areas. 

 Uses: 

• Headache 
• Backache 
• Sore muscles
• Joint pain 
• Leg cramps

EVALUATION PARAMETERS:

1] Physical Parameters:

The physical parameters of the herbal analgesic balm were evaluated to ensure quality, consistency, and stability of the formulation. These parameters included:

1. Color – The balm was visually inspected to confirm uniform color throughout the sample, with no discoloration or patchiness.

2. Odor – The balm's scent was checked to ensure it was pleasant and consistent with the herbal ingredients, without any rancid or unusual smell.

2] pH determination:

pH of the formulation was measured by using a calibrated digital pH meter. Balm Solution was prepared by Weighing about 1 gram of herbal balm, add 10 mL of distilled water in a beaker Mix thoroughly using a glass rod to form a uniform emulsion and let the mixture stand for about 10–15 minutes, stirred occasionally. Filtered the mixture through muslin cloth and obtained a clear filtrate. Calibrate the pH meter with standard buffer solutions (pH 4.0). Rinsed the electrode with distilled water and dried then the electrode is dipped into the balm filtrate. The readings are recorded. Readings were noted.

3] Stability Parameters

Physical stability: The physical stability of the herbal analgesic balm was assessed at normal, below normal, and above normal temperatures. At normal room temperature (25°C), the balm remained stable throughout the observation period, retaining its original color, consistency, and aroma without any signs of phase separation. When stored at below normal temperature (4°C), the balm slightly hardened but returned to its original texture upon warming to room temperature, with no permanent changes observed. However, at above normal temperatures (40°C and 45°C), the balm exhibited minor softening and a slight oily layer on the surface in some samples. Despite these changes, the product did not undergo significant phase separation or degradation, indicating acceptable stability under moderate thermal stress.

4] Skin safety Testing:

Patch test: A patch test was conducted to evaluate the skin compatibility of the herbal analgesic balm. A small area on the inner forearm, measuring approximately 1 inch by 1 inch (2.5 cm × 2.5 cm), was selected and cleaned with an alcohol swab. Around 0.5 grams of the balm was applied evenly to the test site using a sterile cotton swab. The area was then covered with a sterile gauze patch and secured with medical adhesive tape. The patch was left undisturbed for 24 hours, during which the subject was instructed to avoid washing or touching the area. After 24 hours, the patch was removed and the skin was examined for signs of irritation, including redness, itching, swelling, rash, or blistering. A follow-up observation was done after an additional 24–48 hours to detect any delayed skin reactions. No adverse effects indicated the product was safe for topical application on healthy skin.

5] Consistency:

To evaluate the consistency of the herbal analgesic balm, a small quantity of the product was taken using a clean spatula and examined at room temperature. The balm was observed for its texture, spreadability, and uniformity. It was gently pressed and spread on a glass slide or between the fingers to assess whether it was smooth, semi-solid, free from lumps, and homogeneous. The balm was expected to be firm yet pliable, allowing easy application without crumbling or liquefying. Any signs of grittiness, phase separation, or uneven texture were noted. A consistent balm maintained its structure across different portions, indicating good formulation stability.

6] Phase separation:

To assess phase separation, a small amount of herbal analgesic balm was placed in a clean, transparent glass container and observed visually at room temperature. The sample was then subjected to stress conditions, including elevated temperatures of 40°C and 45°C, as well as centrifugation at 3000 rpm for 30 minutes. After each condition, the balm was examined for any visible signs of separation, such as the appearance of an oily layer on the surface, sedimentation at the bottom, or the release of liquid indicating the breakdown of the emulsion. Throughout the testing period, observations were recorded. No separation occurred; the balm was considered physically stable under those conditions.

7] Packaging Evaluation:

Packaging material compatibility: To evaluate the packaging of the herbal analgesic balm, the container was assessed for several key parameters, including functionality, integrity, appearance, and user convenience. The balm was packaged in a sealed, air-tight contain a metal jar with a secure lid to prevent leakage and contamination. The container was examined for leak-proof sealing, ease of opening and closing, and resistance to breakage under normal handling conditions. Additionally, the packaging was checked for compatibility with the product, ensuring that no reaction occurred between the balm and the container material. The overall design and appearance were also considered to ensure it was attractive, informative, and suitable for commercial sales.

8] Washability: 

A small quantity of the herbal analgesic balm was applied to the skin, typically on the forearm, and allowed to remain for a few minutes to simulate normal use. The area was then washed with lukewarm water, both with and without mild soap, to evaluate how easily the balm could be removed. The ease of removal, presence of any oily or sticky residue, and the amount of water or soap required were noted. If the balm was easily washed off without leaving a greasy film or requiring excessive scrubbing, it was considered to have good washability. All observations were recorded to determine the product’s user-friendliness and post-use cleanliness.

 

 

 

RESULT AND DISCUSSION: 

Physical observation

Batches	F1	F2	F3
Colour	Light Yellow	Light Yellow	Yellow
Appearance	Smooth	Smooth	Smooth
Consistency	Semisolid	Semisolid	Semisolid

 

 

Final observation

 

 

DISCUSSION:

Among the three formulations (F1, F2, F3), F3 stands out as the most effective in terms of analgesic potency, herbal balance, and aromatic relief. Here’s a detailed comparison and why F3 is superior:

1.  Stronger Pain Relief: 7.5 ml of methyl salicylate provides more potent analgesic action. Combined with 3 g camphor, 2 ml eucalyptus, and 1.5 ml peppermint oil, the synergy enhances pain and inflammation relief.
2. Well-rounded Herbal Profile: Includes turmeric, aloe vera, dashmool oil, and lavender oil for anti-inflammatory, calming, and skin-healing properties.
3. Aromatic and Soothing: Balanced scent profile from lavender, eucalyptus, clove, and peppermint oils.
4. Preservation: 0.5 g sodium benzoate is appropriate for 50 g balm, ensuring better shelf-life.

Formulation F1: 

1. Low Methyl Salicylate (2.5 ml): Provides mild to moderate analgesic effect, may be insufficient for stronger pain relief.
2. Lacks Peppermint Oil and Aloe Vera: No peppermint oil: Reduces the cooling sensation and synergy with camphor. No aloe vera: Misses out on soothing, healing, and moisturizing effects for the skin.
3. Lower Herbal Synergy: Though it has lavender and dashmool, it’s not as well-rounded in anti-inflammatory or calming herbs.
4. Preservative Dose (0.25 g Sodium Benzoate): Acceptable but minimal could reduce shelf life if moisture is present from other components.

Formulation F2:

1. Very Low Methyl Salicylate (1.5 ml): Too weak for adequate analgesia, especially for moderate or chronic pain.
2. No Peppermint Oil: Loses the cooling and invigorating properties that support pain relief and scent profile.
3. Weak Herbal and Oil Content: Most ingredients are at lower concentrations, including turmeric, clove oil, and dashmool oil, making it less therapeutically robust.
4. Softer Texture Risk: Base oils and aloe vera increase moisture, but beeswax isn’t increased to compensate; this may result in too soft or semi-liquid consistency

 

 

 

Figure 2: Final product of Herbal Balm

 

Conclusion:

The developed herbal analgesic balm, particularly formulation F3, shows significant promise as a topical pain relief product. The combination of natural ingredients, including methyl salicylate, camphor, and essential oils, provides a potent analgesic effect, while the balm's stability and skin safety profiles are favorable. The product's ease of application, spreadability, and washability make it a user-friendly option. With its potential to provide relief from various types of pain and inflammation, this herbal balm could be a valuable addition to the range of pain management options available. Further studies, including clinical trials, would be necessary to establish the efficacy and safety of this product fully. Nonetheless, the findings of this study suggest that the herbal analgesic balm is a promising natural alternative for pain relief, warranting further investigation and development. 

Conflict of Interest: The authors declare no potential conflict of interest concerning the contents, authorship, and/or publication of this article.

Author Contributions: All authors have equal contributions in the preparation of the manuscript and compilation.

Source of Support: Nil

Funding: The authors declared that this study has received no financial support.

Informed Consent Statement: Not applicable. 

Data Availability Statement: The data presented in this study are available on request from the corresponding author. 

Ethical approval: Not applicable.

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