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Abstract

The primary goal of this study was to create, develop, and test a transdermal drug delivery system containing Metformin hydrochloride to address the key issues associated with the oral route. Metformin hydrochloride transdermal patches were manufactured utilizing the solvent evaporation process. Different formulation trials were conducted by varying the polymer ratios. The thickness, weight fluctuation, and percentage of transdermal patch compositions were all measured. Moisture content, research, and metformin transdermal patches provide a simple and effective means of regulating blood glucose levels in people with type 2 diabetes. Type 2 diabetes can be managed using transdermal metformin patches. The main objective of the this study was to formulate, develop and evaluate a Transdermal drug delivery system containing Metformin hydrochloride to overcome the critical problems related with oral route. Transdermal patch of Metformin hydrochloride were prepared using solvent evaporation technique. Different trial of formulation were carried out by changing the polymer ratio. Transdermal Patch formulations were characterized for Thickness, weight variation. The present study was investigated to transdermal patch formulation of Metformin hydrochloride. Preformulation study was successfully performed in which I drawn the calibration curve in different subvents after solubility study bulk density tapped density was calculated after complex formulation evaluated the uniformity of thickness, folding endurance, weight variation stay moisture content, % swellability, Drug content.

Keywords

Transdermal Delivery, Metformin Hydrochloride, Topical Drug delivery

Introduction

Metformin is a commonly used diabetes medication. Metformin is a frequently used medicine for controlling type 2 diabetes that improves insulin sensitivity and reduces glucose synthesis in the liver. Traditionally, it is given orally in tablet form, but recent advances have resulted in the introduction of transdermal patches as an alternative delivery technique. Metformin transdermal patches are adhesive patches that are put to the skin and gradually deliver the medicine into the bloodstream. This approach skips the digestive system. Potentially minimizing typical adverse effects such as stomach pain. A transdermal patch is a sticker that you apply to your skin. The drug slowly goes through the skin and into the bloodstream.

This strategy may be helpful because:

1. It prevents stomach disorders, such as nausea.

2. The drug is absorbed more evenly over time.

Benefits of Transdermal Patches:

1. Improved Absorption- Reduces breakdown in the stomach, resulting in higher bioavailability.

2. Reduced Side Effects - Reduces digestive problems including nausea and diarrhea

3. Improved Compliance - Easier for those who have difficulties swallowing tablets.

Type 2 diabetes, the most common type of diabetes, is a disease that occurs when your blood glucose, also called blood sugar, is too high. Blood glucose is your main source of energy and comes mainly from the food you eat. Insulin, a hormone made by the pancreas, helps glucose get into your cells to be used for energy. In type 2 diabetes, your body doesn't make enough insulin or doesn't use insulin well. Too much glucose then stays in your blood, and not enough reaches your cells. Hypercholesterolemia is a specific type of hyperlipidemia. The patch is made of layers of special materials, including a drug layer, backing layer, and sometimes a release control layer. It may also include skin enhancers to help the Metformin pass through the skin. Metformin patches could help people manage diabetes better with fewer side effects and improved comfort. A transdermal patch is a small patch that sticks to your skin. It slowly releases the medicine through the skin and into the blood. This kind of patch can:

  • Give a steady amount of medicine all day
  • Help avoid stomach problems
  • Be easier to use-just stick it on and forget it
  • Improve how well the medicine works in the body.

The transdermal drug delivery system has become one of the very most successful and innovative drug delivery system for research in pharmaceutical sciences. Transdermal drug delivery system are used to leading edge injectable and oral routes by increasing patient compliance and avoiding first pass metabolism respectively, Transdermal drug delivery system is not only using controlled, constant administration of the drug, but also allows continuous input of drugs with short biological half-lives and eliminates pulsed entry into systemic circulation. The success of dermatological drug to be used for systemic drug delivery depends on ability of the drug to penetrate through skin in sufficient quantities to achieve the desired therapeutic effect 12, Oral route is the vary most popular route of drug delivery. Although it has some disadvantages including first pass metabolism, drug degradation in gastrointestinal tract due to enzymes, PH etc. To cross these problems, a novel drug delivery system was developed. Transdermal drug delivery system or medicated adhesive patches which deliver therapeutically effective amount of drug across the skin when it placed on skin. Medicated patches or transdermal patches are of different sizes, having more than one ingredient. Once they apply on unbroken skin they deliver active ingredients into systemic circulation passing via skin barriers. A patch containing high dose of drug inside which is retained on the skin for prolonged period of time. Transdermal drug delivery system is a self-contained delivery use for topical application in the form of multi-laminated adhesive patch which gives a specific dose of drug at a predetermined rate and controlled the rate of drug release through skin'. This delivery provides the constant drug release but it also allows the short biological half life drug continuously and eliminates the pulsed entry into the blood circulation. Transdermal drug delivery system provides more benefits than conventional system, such as sustained release delivery reduces the dosing frequency of the drug, it avoid the first pass metabolism, reduces side effect and improve the patient compliance. The Transdermal drug delivery system designed by various methods such as transdermal patches includes matrix, micro reservoir, reservoir, adhesive, and membrane matrix hybrid. Matrix type transdermal patches are most popular as they are easy to costruct. The metformin hydrochloride transdermal patch in this paper also developed by using the Matrix type of transdermal drug delivery system. Metformin hydrochloride is the anti-diabetic agent having the low molecular weight water soluble drug

Fig.1 Transdermal Patches

Metformin hydrochloride:

Polymer

Type

Activity

HPMC

Hydrophillic

Film former

PVP

Hydrophillic

Enhance drug solubility

EC

Hydrophobic

Sustain Release

Carbopol

Mucoadesive

Increase Adhesion

PVA

Film Forming

flexibility

Pioglitazone :

Polymer

Type

Activity

HPMC

Hydrophillic

Control drug release

PVP

Hydrophillic

Plasticizer

EC

Hydrophobic

Film former

Carbopol

Mucoadesive

Control Viscocity

PEG

Plasticizer

Increase flexibility

Repaglinide:

Polymer

Type

Activity

HPMC

Hydrophillic

Controlled release

EC

Hydrophobic

Sustain Release

PVP

Hydrophillic

Enhance drug solubility

Eudragit

Synthetic

Sustain Release

Carbopol

Mucoadhesive

Enhance Skin adhesive

Evalution Parameter:

1.Thickness:

The thickness of the transdermal patches was measured using a digital micrometer screw gauge at three different places, and the mean value along with SD was calculated.

2.Drug Content:

1. Weigh and Cut the 2x2 cm patch accurately.

2. Dissolve the patch in a suitable solvent (e.g., phosphate buffer pH 7.4 or 0.1N HCI).

3. Sonicate or stir until the drug is completely extracted.

4. Filter the solution using Whatman filter paper or membrane filter.

5. Analyze the filtrate using UV-Vis Spectrophotometer at ~232 nm (Amax for Metformin).

6. Calculate the drug content using a standard calibration curve.

3.Weight Uniformity:

1. Cut 5 to 10 patches of equal size (2x2 cm).

2. Weigh each patch individually using a digital balance.

3. Record the weights.

4. Calculate the average weight.

4.Physical appearance:

The patches were visually inspected for colour, flexibility, smoothness and homogeneity.

5. Folding endurance:

The prepared patches were measured manually for folding endurance. The folding of the patches was repeated at the same place till they broke. The accurate value of folding endurance was given by the number of times the patches could be folded at the same place without breaking.

6. Weight variation study:

Three randomly selected patches from each formulation were used. For weight variation test, 3 films from each batch were weighed individually and the average weight was calculated.

CONCLUSION:

The transdermal patch formulation of Metformin Hydrochloride was successfully developed using suitable polymers and excipients. The patches exhibited uniform thickness, weight, and drug content, indicating consistent formulation.  Reduced gastrointestinal side effects: Transdermal delivery may reduce the incidence of gastrointestinal side effects associated with oral metformin hydrochloride. Improved patient compliance: Transdermal patches offer a convenient and non-invasive method of administering metformin hydrochloride, decreasing the requirement for frequent oral dosage.

REFERENCES

        1. Sampath Kumar KP, Debjit Bhowmik and Chiranjib B, RM. Chandira. A review-Transdermal Drug Delivery System A    NovelDrug Delivery System and its market. scope and opportunities. Int J Pharm & Bio Sci 2010;1(2).
        2. Vigersky RA, Filmore-Nassar A, Glass AR. Thyrotropin suppression by Metformin. J Clin Endocrinol Metab 2006;91(1):225.
        3. Indian Pharmacopoeia. Published by the indian pharmacopoeia commission, ghaziabad, 2007;1:142-143.
        4. Jeevanandham S. Formulation and evaluation of dual transdermal patch containing Metformin hydrochloride Metoprolol    tartarate, International journal of Advanced pharmaceutics, (2014). 4(3),160-164.
        5. Gaikwad A.K Transdermal drug delivery system: Formulation aspects and evaluation-A Reviw. Comprehensive Journal of Pharmaceutical Sciences, (2013). 1(1), 1-10.
        6. Selvam R. P, Singh A.K, Sivakumar Transdermal drug delivery systems for antihypertensive drugs A review, International Journal of pharmaceutical and biomedical research, (2010).1(1), 1-8.
        7. Patel D. P, Setty C.M, Mistry G.N, Patel S.L, Patel T. J,Mistry P.C, Rana A.KDevelopment and Evaluation of Ethyl Cellulose-Based Transdermal Films of Furosemide for Improved In Vitro Skin Permeation, American Association of Pharmaceutical Scientists, (2009).10, 437-442.
        8. Darwhekar G, Jain D.K, Patidar V.KFormulation and Evaluation of Transdermal Drug Delivery System of Clopidogrel Bisulfate, Asian Journal of Pharmacy and Life Science (2011).1 (3), 269-278.
        9. Shruthi MV, Parthiban S, Senthilkumar G.P, T. Tamiz mani Evaluation of potential hypoglycemic activity of proliposomal Gel containing Metformin hydrochloride, Asian Journal of Research in Biological And Pharmaceutical Sciences, (2014).2(2), 77-88.
        10. Koteswararao P, Duraivel S. Sampath Kumar KP, Bhowmik D.Formulation and evaluation of transdermal patches of anti-hypertensive drug metoprolol succinate, Indian Journal of Research in Pharmacy and Biotechnology, (2013).1(5), 629-634

Reference

        1. Sampath Kumar KP, Debjit Bhowmik and Chiranjib B, RM. Chandira. A review-Transdermal Drug Delivery System A    NovelDrug Delivery System and its market. scope and opportunities. Int J Pharm & Bio Sci 2010;1(2).
        2. Vigersky RA, Filmore-Nassar A, Glass AR. Thyrotropin suppression by Metformin. J Clin Endocrinol Metab 2006;91(1):225.
        3. Indian Pharmacopoeia. Published by the indian pharmacopoeia commission, ghaziabad, 2007;1:142-143.
        4. Jeevanandham S. Formulation and evaluation of dual transdermal patch containing Metformin hydrochloride Metoprolol    tartarate, International journal of Advanced pharmaceutics, (2014). 4(3),160-164.
        5. Gaikwad A.K Transdermal drug delivery system: Formulation aspects and evaluation-A Reviw. Comprehensive Journal of Pharmaceutical Sciences, (2013). 1(1), 1-10.
        6. Selvam R. P, Singh A.K, Sivakumar Transdermal drug delivery systems for antihypertensive drugs A review, International Journal of pharmaceutical and biomedical research, (2010).1(1), 1-8.
        7. Patel D. P, Setty C.M, Mistry G.N, Patel S.L, Patel T. J,Mistry P.C, Rana A.KDevelopment and Evaluation of Ethyl Cellulose-Based Transdermal Films of Furosemide for Improved In Vitro Skin Permeation, American Association of Pharmaceutical Scientists, (2009).10, 437-442.
        8. Darwhekar G, Jain D.K, Patidar V.KFormulation and Evaluation of Transdermal Drug Delivery System of Clopidogrel Bisulfate, Asian Journal of Pharmacy and Life Science (2011).1 (3), 269-278.
        9. Shruthi MV, Parthiban S, Senthilkumar G.P, T. Tamiz mani Evaluation of potential hypoglycemic activity of proliposomal Gel containing Metformin hydrochloride, Asian Journal of Research in Biological And Pharmaceutical Sciences, (2014).2(2), 77-88.
        10. Koteswararao P, Duraivel S. Sampath Kumar KP, Bhowmik D.Formulation and evaluation of transdermal patches of anti-hypertensive drug metoprolol succinate, Indian Journal of Research in Pharmacy and Biotechnology, (2013).1(5), 629-634

Photo
Harshada Vaid
Corresponding author

Samarth Institute of Pharmacy, Belhe, Maharashtra, India.

Photo
Rachana Kamble
Co-author

Samarth Institute of Pharmacy, Belhe, Maharashtra, India.

Photo
Vaishnavi Rahane
Co-author

Samarth Institute of Pharmacy, Belhe, Maharashtra, India.

Photo
Suhani Bhagat
Co-author

Samarth Institute of Pharmacy, Belhe, Maharashtra, India.

Harshada Vaid*, Rachana Kamble, Vaishnavi Rahane, Suhani Bhagat, A Review on Anti- Diabetic of Transdermal Patches, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 5, 5125-5129. https://doi.org/10.5281/zenodo.15560751

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