INTRODUCTION:

One of India's oldest medical systems more than 5,000 years old, is Ayurveda. With a history stretching back to 6000 BC, it is also one of the most well-known medical systems in existence. Two words make up the Sanskrit phrase "Ayurveda": "Ayur," which means life, and "Veda," which denotes scared understanding of science.

Consequently, Ayurveda may be referred to as the science of life. It is essentially known as the Upadeha or Atharvaveda, which addresses many plants and herb kinds, the anatomy and physiology of various human organs, and the fundamentals of illness treatment.¹

Role of Herbs in Ayurvedic Formulation:

The origins of life on Earth have always been a contentious and ongoing topic of discussion. However, we can state with certainty that the kingdom of vegetables existed before humans arrived on Earth. As people get more knowledgeable about various plants, they can use them to benefit humanity. It was merely founded on the philosophy, folk practices, and fundamental ideas that were explained and further demonstrated in a number of alternative medical systems. The various indigenous systems such as ayurveda, siddha, unani use several plant species to treat different ailments. Herbal medicines make up an important component of the trend toward alternative medicine.²

Topical Drug Delivery System:

A carrier for a particular medication in contact with and via the skin is known as a topical delivery system. Delivery of drugs over the skin barrier is a hurdle when using them topically. There are two primary categories of topical usage:

· Topical treatment applied topically to the diseased area of skin by spraying, spreading, or dispersing.

· Internal medication administered topically to mucosal membranes via the mouth, vagina, or anorectal tissues for localized effects. Because topical preparations allow drugs to permeate the skin's underlying layers, they typically have a localized impact at the application site. Even though there is a chance of some unintentional absorption, these are typically little concerns and occur in sub-therapeutic levels.³

The purpose of Ayurveda's several Kalpanas (dosage forms) is to extract essential Principles through the use of various mediums, such as oil, water, and ghee. These Kalpanas are formulated using modern technology, increased potency, and improved palatability in consideration. ⁴

Advantages of topical drug delivery system^4,5

1. Avoiding metabolism through first pass.

2. Simple to use and conveniently apply.

3. Medication supplied only to a certain location.

4. There will be no gastrointestinal incompatibility.

5. Easy termination of medications, when needed.

6. Improved patient compliance.

Topical Dosage Form of Ayurveda in Present Era List ^4,6

Table No 1. Topical Dosage Form of Ayurveda in Present Era

Sr No.	Dosage Form
1.	Solution
2.	Ointment
3.	Gel
4.	Poultice
5.	Cream
6.	Taila

Dyspepsia:

Dyspepsia is not an actual disease in and of itself; instead, it is an accumulation of symptoms associated with the upper gastrointestinal tract. Abdominal pain or discomfort, postprandial fullness, abdominal bloating, early satiety, nausea, vomiting, heartburn, and acid regurgitation are just a few of the upper gastrointestinal tract symptoms that characterize it.^7,8

Epidemiology of Dyspepsia:

The disease accounts for 3% to 5% of primary care visits, while the community prevalence of dyspepsia is commonly estimated in the range of 20% to 40%.^{9,10,11,12,13,14} of the patients whose dyspepsia has been studied, over 70% have endoscopic results that are negative, and then between 50% and 60% are categorized as having functional dyspepsia.¹⁵ It is acknowledged that the uneven interpretation of dyspepsia symptoms, the overlap in symptoms with other illnesses, and the different diagnostic criteria employed in prevalence studies make it difficult to estimate the prevalence of functional dyspepsia.¹⁶

Essential oils:

Essential oils are concentrated liquids that are hydrophobic and contain volatile plant-based chemicals. "Volatile" refers to substances that, at room temperature, evaporate readily. Thus, they are also known as “ethereal oils,” “volatile oils,” and “aetherolea.” When using these oils, caution should be taken to prevent skin irritation, rash, allergic response, itching, etc. Thorough understanding of essential oils and their characteristics should be obtained prior to application.¹⁷

Different Ways to use Essential Oils:

The majority of the time, essential oils are applied externally during massages; however, they are extremely rarely taken internally, unless in little amounts or as drops. This research focuses on the formulation development of essential oils for the management of dyspepsia in infants. Topical Ayurvedic preparations for the treatment of dyspepsia can alleviate symptoms by directly addressing the abdominal region.¹⁸

MATERIALS AND METHODS:

Chemicals:

Ethanol, Diethyl Ether, Phenolphthalein, Potassium Hydroxide, Liquid paraffin oil, Castor oil, Peppermint oil, Dill oil was provided by LobaChemie, Mumbai.

Methodology:

Preformulation Studies:

Organoleptic Evaluation:

Organoleptic evaluation of oils was performed by visual observation viz. parameters like colour, odour.¹⁸

Boiling point:

One of the easiest ways to find the boiling point of a compound is to use the Thiele tube method, which has the benefit of requiring minimal amounts of material (less than 0.5mL of sample). A small tube containing the sample and an inverted capillary tube were used. A continuous stream of bubbles coming out of the capillary tube indicates that the setup is heated within a Thiele tube to a temperature that is marginally higher than the compound’s boiling point. The setup is connected to a thermometer.¹⁹

pH:

pH of essential oils was measured by calibrated digital pH meter. The measurements were repeated on every six samples three times and the results were reported.²⁰

Solubility:

Solvent addition method was used to test the essential oil's solubility. The solubility of one millilitre of essential oil was measured by adding one millilitre of solvent to an essential oil beaker. Castor oil and coconut oil is the solvent utilized in the study of essential oil solubility.²¹

Compatibility studies between drug and excipients:

Compatibility studies between drugs and their excipients are an important phase in medication development. The formulation scientist must carefully analyze the medicine's chemical structure, the type of delivery system needed, and the suggested manufacturing procedure before forming the drug into the intended dosage form. Drug ingredients are typically mixed with excipients that have unique particular uses. Excipients can interact chemically and physically with drugs molecules in appropriate conditions, even if they are pharmacologically inert. These interactions have the potential to cause instability, which can give cause the formation of new entities with unique pharmacological and physicochemical characteristics. Studies on the drug-excipient compatibility have been used to determine which excipients to accept or reject for use in pharmaceutical formulations. In this study, we examined infrared analysis to detect any interaction (chemical or physical) or formation of bonds between drug and polymer.

a. Fourier-transform infrared spectroscopy (FT –IR):

For the aim of identifying functional groups and describing covalent bonding data, FTIR is a useful analytical tool. Using an FT-IR spectrophotometer, the infrared absorption spectra of pure oils and their physical mixture with oil basis were recorded in order to assess the essential oil's chemical compatibility with the base.

Formulation Studies:

Weighed accurately all the ingredients. Poured the measured essential oils into the mixing container. Added the carrier oil to the mixing container with the essential oils. Stirred the mixture well to ensure all the oils were thoroughly combined using a mechanical stirrer. Poured the blended oil solution into a storage bottle. Labelled the bottle with the contents, the date of preparation, and all necessary requirements.

Formulation Table:

Table No. 2. Formulation Table

Sr. No	Ingredients	F1	F2	F3
1	Ajwain Oil	3.6 ml	3.6 ml	3.6 ml
2	Ginger Oil	3.6 ml	3.6 ml	3.6 ml
3	Peppermint Oil	3.6 ml	3.6 ml	3.6 ml
4	Dill Oil	1.8 ml	1.8 ml	1.8 ml
5	Castor Oil	-	q.s	q.s
6	Coconut Oil	q.s	-	q.s

EVALUATION OF FORMULATION:

pH:

pH of essential oils was measured by a calibrated digital pH meter. The measurements were repeated on every six samples three times and the results were reported.²⁰

Fourier Transform Infrared Spectroscopy:

(FT-IR):

FT-IR has been used to evaluate the interaction between base and essential oils. FTIR spectrometer was used to get the formulation's infrared spectra. FTIR spectra of the formulation sample were obtained through placing it directly on the spectrometer's stage. The 400–4000 cm-1 scanning range was used.²²

Acid Value:

To calculate the acid value, 50 milliliters of diethyl ether, 50 milliliters of ethanol, and two drops of 1% phenolphthalein is combined. 0.1 M KOH was added to the mixture to neutralize it. In the neutralized solvent combination, five (5 g) of the extracted oil sample was dissolved. The titrant used in the titration process was 0.1 M KOH. The solution turned pink in the end, signifying the end of the process. In the end, the acid value was computed using Equation 1 and the sample weight. The oil is safe if the acid value is less than one (1); if the value is greater than one (1), the oil is dangerous and has turned rancid.²³

Titre value x 5.61

Acid Value = -------------------------------------- ...Eq No.1

weight of oil used mg KOH /g

Viscosity:

The viscometer was cleaned completely using a warm chromic acid solution. An organic solvent, like acetone, was applied and allowed to dry. The viscometer was installed vertically on an appropriate stand. In a dry viscometer, it was filled with water to indicate G. The number of seconds needed for water to travel from mark A to mark B was measured. After the viscometer was rinsed with the test liquid, it was filled with liquid until mark A was reached. The amount of time needed for the liquid to move from mark A to mark B was ascertained. The density/bottle method was used to find the densities of liquids.²⁴

Skin Irritation:

Clean the skin area thoroughly and dried it gently. Apply a small amount of the diluted oil(s) to the test area. Used a cotton swab or a small amount on a clean finger. Allowed the oil (s) to remain on the skin for 24 hours without washing the area. After 24 hours, observe the test area for any signs of irritation or allergic reaction.

RESULT:

Preformulation Studies:

Organoleptic Parameters:

The organoleptic parameters of essential oils are as follows

Table No. 3. Organoleptic parameters

SR. No.	Name of Essential Oil	Parameter	Result
1	Coconut oil	Colour	Clear or Colourless
		Odour	Sweet, Nutty and Tropical
2	Dill oil	Colour	Colourless to pale yellow
		Odour	Slightly sweet aroma
3	Peppermint oil	Colour	Colourless to pale yellow
		Odour	Fresh and minty
4	Ginger oil	Colour	Pale yellow to light amber
		Odour	Warm, spicy and earthy
5	Ajwain oil	Colour	Colourless to pale yellow
		Odour	Pungent or strong
6	Castor oil	Colour	Pale yellow to light amber
		Odour	Slightly nutty or earthy

Boiling point:

The boiling point of essential oil as follows

Table No. 4. Boiling Point

Sr. No	Name of Essential Oil	Reported Boiling Point	Observed Boiling Point
1	Coconut oil	232^oC	230^oC
2	Dill oil	189^oC	186^oC
3	Peppermint oil	215^oC	210^oC
4	Ginger oil	137^oC	134^oC
5	Ajwain oil	175.5^oC	175^oC
6	Castor oil	313^oC	310^oC

The pH of Essential Oil as Follows

Table No. 5. pH

Sr. no	Name of Essential Oil	Reported pHh	Observed pH
1	Coconut oil	8	8
2	Dill oil	7.2	7.5
3	Peppermint oil	7.3	7.5
4	Ginger oil	7.1	7.6
5	Ajwain oil	8	8.2
6	Castor oil	8.2	8.1

Solubility:

The Solubility of Essential Oil as Follows

Table No. 6. Solubility

Sr. No	Name of Essential Oil	Observed Solubility
1	Dill Oil	Miscible
2	Peppermint Oil	Miscible
3	Ginger Oil	Miscible
4	Ajwain Oil	Miscible

Fourier-transform infrared spectroscopy (FT-IR)

Ajwain oil

The FT- IR of ajwain oil is shown below in fig no 1

Fig no 1. FT-IR of Ajwain Oil

Ginger oil

The FT- IR of ginger oil is shown below in fig no 2

Fig no 2. FT-IR of Ginger Oil

Peppermint oil:

The FT- IR of peppermint oil is shown below in fig no 3

Fig no 3. FT-IR of Peppermint Oil

Dill oil

The FT- IR of dill oil is shown below in fig no 4

Fig no 4. FT-IR of Dill Oil

Castor oil

The FT- IR of castor oil is shown below in fig no 5

Fig no 5. FT-IR of Castor Oil

Coconut oil

The FT- IR of coconut oil is shown below in fig no 6

Fig no 6. FT-IR of Coconut Oil

Physical Mixture:

The FT- IR of physical mixture is shown below.

Fig no 7. FT-IR of Physical Mixture

Table No. 7. FT-IR Spectroscopy of Physical Mixture

Functional Group	Absorption Location (cm^-1)	Absorption Intensity
Alkane (C- H)	2922.12	Medium to Strong
Carbonyls (C=O)	1741.14	Strong
Alkene (C= C)	1457.08	Weak to Medium
Amine group (C-N)	1156.02	Medium

Formulation Studies:

The pH pf the formulation is shown in table no 8

Table No. 8. pH

Formulation	Observed pH
F1	7.4
F2	7
F3	6.8

Viscosity:

The viscosity of the formulation is shown in table no 9

Table No. 9. Viscosity

Formulation	Observed Viscosity
F1	36.15 cp
F2	55.10 cp
F3	68.88 cp

Acid Value:

The acid value of the formulation is shown in table no 10

Table No.10. Acid Value

Formulation	Observed Rancidity
F1	0.8
F2	0.6
F3	0.5

Fourier-transform infrared spectroscopy

(FT –IR)

F1 Batch

The FT- IR of F1 batch is shown below in fig no 8

Fig8. FT-IR of F1 Batch

Table No.11. FT - IR Spectroscopy of F 1

Functional Group	Absorption Location (cm^-1)	Absorption Intensity
Alkane (C- H)	2954.86	Medium to Strong
Carbonyls (C=O)	1741.96	Strong
Alkene (C=C)	1462.13	Weak to Medium
Amine group (C-N)	1273.04	Medium

F2 Batch

The FT- IR of F2 batch is shown below in fig no 9

Fig 9. FT-IR of F2 Batch

Table No.12. FT-IR Spectroscopy of F2 Batch

Functinal Group	Absorption Location (cm)–¹	Absorption Intensity
Amine (N-H)	2923.67	Strong
Ester (C=O)	1735.81	Strong
Alkene (C=C)	1455.65	Weak to Medium
Sulphonat (S=O)	1371.53	Strong

F3 Batch:

The FT- IR of F3 batch is shown below in fig no 10

Fig 10: FT-IR of F3 Batch

Table No. 13. FT-IR Spectroscopy of F3 Batch

Functional Group	Absorption Location Cm-¹	Absorption Intensity
Amine (N-H)	2923.31	Strong
Alkane (C-H)	2857.62	Medium to Strong
Alkene (C-H)	1456.44	Weak to Medium
Sulfonate(S=O)	1371.81	Strong

Physical Mixture:

The FT- IR of physical mixture is shown below in fig no 11

Fig. 11. FT-IR of Physical Mixture

Table No. 17. FT-IR Spectroscopy of physical mixture

Functional Group	Absorption Location (cm^-1)	Absorption Intensity
Alkane (C- H)	2922.12	Medium to Strong
Carbonyls (C=O)	1741.14	Strong
Alkene (C= C)	1457.08	Weak to Medium
Amine group (C-N)	1156.02	Medium

Skin Irritation:

The formulation was applied on the skin which shows satisfactory result. Irritation, redness, itching and allergic reaction was not occurred at applied area.

DISCUSSION:

An ayurvedic topical formulation was prepared and evaluated for physicochemical properties and skin irritation studies. The preformulation studies namely organoleptic parameters, boiling point, pH, Solubility and FTIR, results showed that all essential oils are within the standard range.so, the essential oils are found to be pure. Formulation was evaluated for pH, Viscosity, Acid value FTIR, Skin irritation, % drug release. The pH of formulations was found within the range of 6.8 – 7.4 at this pH no skin irritation was occurred. Viscosity of the formulations was obtained within the range of 36.15cp- 68.88cp which was optimum for better spreading of the formulation. Acid value was found within the range of 0.5 to 0.8 which indicates that there is no possibility of rancidity. FTIR spectra of all the batches showed that there is no chemical interaction found between the excipients in the formulation and it indicates that the formulation was stable. Skin irritation studies show satisfactory results. Irritation, redness, itching and allergic reactions was not occurred at the applied area. From these all the parameters batch F1 was found to be optimum.

SUMMARY:

The design and development of an ayurvedic topical formulation for the management of dyspepsia in infants presented a promising approached to addressed this common issue. By utilizing ayurvedic principles and natural ingredients, the formulation offered a gentle and effective remedy. The infant’s skin barrier qualities restricted the drug’s transdermal administration, requiring the inclusion of penetration enhancers in the formulation. An attempt was made to develop and produce an Ayurvedic topical oil solution in the present research. The preformulation studied includes organoleptic parameters solubility, boiling point, pH, Fourier-transform infrared spectroscopy (FT-IR) was carried out. The formulation studied includes ph, viscocity, acid valued, Fourier-transform infrared spectroscopy (ft –ir), skin irritation, % drug release. All the developed formulations were evaluated for their physicochemical properties like organoleptic parameters, pH. values, viscosity, acid value, skin irritation, Fourier-transform infrared spectroscopy (FT-IR). The pH range of formulation was found to be suitable for topical application for infant. The viscosity measurement was done for selected formulations used Ostwald viscometer at room temperature. Skin irritation test shows satisfactory result. Irritation, itching, swelling, redness was not occurred at applied area. Result showed no significant variation with respect to evaluation parameters. Thus, ayurvedic formulation was stable in topical solution formulation and indicating better results in treatment of dyspepsia in infant.

CONCLUSION:

The study focuses on creating an Ayurvedic topical formulation to manage dyspepsia in infants. The research involves developing and designing an effective remedy for digestive issues in babies, utilizing traditional Ayurvedic knowledge and techniques. The goal is to provide a safe and natural solution for treating dyspepsia in infants. The holistic approach of Ayurveda seeks to balance the body and promote overall well-being. Further research and clinical trials are needed to validate the efficacy and safety of this formulation. Overall, this study highlights the potential of Ayurvedic medicine in providing alternative treatments for infant dyspepsia.

ACKNOWLEDGMENTS:

The authors are thankful to the Ashokrao Mane Institute of Pharmaceutical Sciences and Research, Save for providing necessary facilities and platform to conduct research work.

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Received on 23.08.2024 Revised on 28.09.2024

Accepted on 26.10.2024 Published on 28.02.2025

Available online from March 03, 2025

Asian J. Pharm. Res. 2025; 15(1):22-28.

DOI: 10.52711/2231-5691.2025.00005

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.