Formulation and Evaluation of Herbal Transdermal Patch of Olea Europaea to Study Anti-Inflammatory Activity
MD Parveen1, Y. Kondal Reddy2
1Department of Pharmaceutics, Browns College of Pharmacy, Telangana, India.
2Department of Biotechnology, Vishnu Institute of Pharmaceutical Education and Research, Telangana, India.
*Corresponding Author E-mail: kanneaboinak3@gmail.com
ABSTRACT:
Anti-inflammatory remains a significant challenge medicine, necessiting the exploration of innovative therapeutic strategies, Olea europaea, a widely recognized medicinal herb. This study has attention for its potential Anti-inflammatory properties. This study aimed to investigate the efficacy of Olea europaea trans dermal in promoting wound healing. These results suggest that the therapeutic intervention for promoting wound healing. Further research is to elucidate the underlying mechanisms of action and optimize formulation of the patch for clinical application. This study investigates the Anti-inflammatory activity of a transdermal patch containing a Olea europaea extracts. The patch was formulated and evaluated for its efficacy in promoting Anti-inflammatory using in-vitro and in-vivo assays. Overall, this study suggests that the Olea europaea transdermal patch holds promise as a therapeutic option for promoting wound healing.
KEYWORDS: Tdds: Trans Drug Dermaldrug Delivery. CMC: Carboxy methyl cellulose, Oe: Olea europaea.
INTRODUCTION:
The transdermal drug delivery technique has been around for a long time. Historically, creams and ointments were the most often used treatments for dermatological problems. The possibility of systemic adverse effects with certain of these formulas is a good indicator of skin absorption. Many medications have been injected topically to treat the entire body. Transdermal delivery systems, broadly speaking, refer to any drug compositions applied topically with the goal of delivering the active component into the general circulation1. Transdermal drug delivery is topically applied and release pharmaceuticals for a systemic effect at a predefined and controlled rate.
Transdermal medication delivery is a method of administering pharmaceuticals through the epidermal layer of skin. The medicine enters the bloodstream through the skin and circulates throughout the body before reaching its intended target spot. One of the human body’s most intricate processes is wound healing2. It involves a range of cell types that play different roles in the phases of haemostasis, inflammation, growth, re- epithelialization, and remodelling synchronizing both spatially and temporally. In terms of surface area, the human skin is the largest organ. It is the vital component that protects internal tissues from ultraviolet light, microbes, and mechanical harm3. Because of this, it is extremely prone to injury, which could have a serious effect on both individual patients and the cost of healthcare. Several cell types within epidermis, dermis and hypodermis layers must work together at specific times to promote healing when the skin is injured.
MATERIAL AND METHODS:
Herbal extract powders of Olea europaea obtained from the process of extraction of dry leaves and roots respectively. CMC, Gua gum, Ethanol, Propanediol, Glycerol were purchased from Star tech labs, Hyderabad. The other equipment used in the formulation of herbal patches were petri dish, electronic balance, hot water bath, hot air oven, magnetic stirrer, vernier caliper, UV- spectrophotometer and dissolution apparatus, etc.
Experimental Methodology:
Fresh Olea europaea plants were used in this study, which were collected from the local market. Olea europaea plants were cleaned with running tap water and rinsed in distilled water. Then the plant is shade dried for four days and grinded into fine powder by using manual technique. About 10 g of Olea europaea plant power were extracted with 200 ml of Ethanol solvent using Soxhlet apparatus Then the extract is evaporated to produce crude drug, which is then preserved in vials for further use.4
Process of Extraction:
1. Start by placing the powdered material in a thimble, then heat the solvent to its boiling point.
2. The solvent vapor rises through the distillation arm and enters the chamber containing the solid material.
3. The solid gradually absorbs the warm solvent, causing the desired compound to dissolve.
4. Once the chamber is nearly full, the solvent is siphoned out, returning to the distillation flask.
5. This cycle repeats over several hours, with some of the compound dissolving in the solvent during each cycle.
6. After approximately 72 hours, the desired compound becomes concentrated in the distillation flask.
7. Finally, the solvent is evaporated to leave behind the extracted compound5.
Preparation of Transdermal Patch:
Carboxy Methylcellulose (CMC) and Guar gum were used as a polymer material. Propanediols were used as a penetration enhancer and as a plasticizer. CMC (0.50g) and Guar gum (0.25g) were measured in the necessary ratios and combined with 10ml solvent containing distilled water: Ethanol in the ratio of (1:1). Until the mixture dissolves, stir it over a hot water bath. Once the mixture had reached a temperature of 25°C, the Drug was incorporated finally the glycerol & Propanediol (0.5ml) both were added Then the mixture was transferred into a glass petri dish and kept for about 24 hrs without any disturbance. Transdermal patches were carefully removed from the petri dish without rupturing and cut into small pieces of 2×4cm. The patch was collected and stored in desiccator until further use.
Table 1: Formulation Design
|
S. No |
Ingredient |
F1 |
F2 |
|
1 |
CMC |
500mg |
500mg |
|
2 |
Guar gum |
250mg |
250mg |
|
3 |
Propanediol |
0.5ml |
0.5ml |
|
4 |
Glycerol |
0.5ml |
0.5ml |
|
5 |
Ethanol: Water |
10ml |
10ml |
|
6 |
Drug |
50mg |
70mg |
Evaluation of Transdermal Patch:
1. Organoleptic Characteristics: The physical appearance of the patch was analysed by its appearance, colour, clarity, flexibility and smoothness.
2. Thickness of Patch: The thickness of each patch was measured at five distinct locations using a screw gauge or vernier caliper, and the average was determined. The weight variation is calculated by weighing five patches and calculating their average.
3. Weight Uniformity: Take 5 randomly prepared patches from same batch and dry them at 60⁰C for 4 hours. The patch is then put on a computerized balance, which determines its average weight.
4. Folding Resistance: A patch of length 2×4cm were cut and folded multiple times at the same spot until it breaks. The number of folds before breaking determines the folding endurance.
5. pH: The pH of the film was tested using a pH meter. The prepared solution of patch is used for determination of pH, where a 2×4 cm area of patch was dissolved in distilled water and solution is prepared. LT-5001 tabletop pH meter is used to determine the pH.
6. Moisture Content: The films were weighed, placed in a desicator with calcium chloride for 24 hr, and then reweighed to calculate the percentage moisture content by using the formula mentioned below.
%Moisture content = (Initial weight - Final weight) / Initial weight × 100
7. Moisture uptake: The films were weighed and kept in desiccators with a saturated potassium chloride solution to maintain 84% relative humidity for a full day at room temperature. The films were weighed again after a day, and the following formula was used to calculate the percentage of moisture uptake.
% Moisture uptake = (Final weight - Initial weight)/ (Initial weight × 100)
8. Drug Content: A 2×4cm area of the patch was dissolved in a phosphate buffer solution. The solution was stirred to dissolve the film and then transferred to a volumetric flask. The absorbance of the solution was measured at a wavelength of 253nm to determine the drug content9-12.
Drug content (%) = Absorbance / Total amount of drug × 100
In-vitro Study:
1. In this this franz diffusion cell apparatus is used Which consist of two chambers, the first one is donar chamber and second is a receptor chamber.
2. The transdermal system is placed between these two chambers and a skin is placed below this transdermal patch.
3. The two chambers are tightly held together with the help of clamp.
4. The chamber is filled with phosphate buffer solution.
5. On starting the experiment donar chamber diffuses through membrane into receptor chamber.
6. From the receptor chamber a solution is removed for analysis from sampling port.
7. The samples are measured by using a UV- spectrophotometer in every 30 minutes.
8. This test determines the amount of diffusant that has permeated the membrane13.
RESULT AND DISCUSSION:
Using the solvent casting process, a transdermal patch was successfully created with the goal of increasing the combined bioavailability of herbal medications. It was discovered that the prepared film was clear, smooth, flexible, and uniform6. Table 2 displays the findings from thickness experiments conducted on various formulations. These results demonstrate that all of the created formulations' thicknesses (0.523 and 0.520mm) were determined to be uniform. It was found that the weights had low standard deviation values and were consistent across all created formulas Table2 displays the findings from folding endurance tests conducted on various formulations. The created formulations were found to be uniform in terms of folding endurance (136 and 142 folds), as evidenced by the aforementioned statistics. The mechanical properties of the patches are shown by their folding endurance number; a high folding endurance number signifies a high mechanical characteristic of the patches. The pH of each patch is around neutral at 6.2 Thus, the skin won't become irritated in any way7.
Table 2: Evaluation of Herbal Transdermal Patch:
|
Parameter |
F1 |
F2 |
|
Thickness (mm) |
0.511±0.001 |
0.513±0.001 |
|
Weight Uniformity (gm) |
1.31±0.1 |
1.33±0.1 |
|
Folding Endurance (n) |
153±3.6 |
152±3.6 |
|
Surface pH |
6.2 |
6.2 |
|
%Moisture Content |
3.1±0.012 |
4.1±0.008 |
|
%Moisture Uptake |
5.7±0.04 |
5.6±0.04 |
|
Drug (%) Content |
89.32±0.1 |
90.2±0.1 |
|
30 min |
0.261 |
0.350 |
|
60 min |
0.486 |
0.538 |
|
90 min |
0.618 |
0.721 |
|
120 min |
0.875 |
0.933 |
|
150 min |
0.936 |
1.061 |
Values are expressed as the means ± SD, where (n=3).
The moisture content in prepared formulation F1, F2, was found as shown in Table 2. The formulations low moisture content keeps them from becoming a totally dry and brittle layer and helps them stay stable. The patches are shielded from microbial contamination by limited moisture absorption9. Studies on moisture absorption and content offer insights about the formulation's stability. The percentage moisture uptake was found by placing a patch in Desiccator in presence of potassium chloride solution and results are obtain as shown in Table 2. It shows that the drug content percentage for the patches in different formulation ratio codes ranged from 86.45% to 96.86%.
Drug content (%) = Absorbance / Total amount of drug × 100
CONCLUSION:
According to the result, it can be concluded that transdermal drug delivery system for Olea europaea with CMC and Guar gum meet the ideal requirement for transdermal devices which can be an effective means to bypass the first past metabolism and increase bioavailability, the transdermal patches are useful for treating wounds because they offer continuous transdermal administration over extended period of time. It has been discovered via the current experiment that the medications of ayurvedic origin can be used by incorporating in modern dosage form with enhanced efficacy.
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Received on 09.02.2025 Revised on 12.03.2025 Accepted on 03.04.2025 Published on 14.05.2025 Available online from May 16, 2025 Res.J. Pharmacology and Pharmacodynamics.2025;17(2):149-152. DOI: 10.52711/2321-5836.2025.00024 ©A and V Publications All right reserved
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