INTRODUCTION:

TOPICAL DRUG DELIVERY SYSTEM¹:

The application of a medication containing formulation for the skin in order to treat the cutaneous condition directly is known as topical drug delivery. The topical drug delivery system is typically employed with other routes of administration of drug methods (such as oral, sublingual, rectal, and parental) are unsatisfactory or when local skin infectious diseases, such as a fungal infection, is present. Delivery of medications topically is a desirable method of local and systemic therapy.

The direct accessibility of the skin as a target organ for diagnostic and treatment causes dermatological pharmacology.

CLASSIFICATION OF TOPICAL DRUG DELIVERY SYSTEM²:

Classification of topical drug delivery

↓

Solid Preparation

1.Topical Powder

2.Poultices

3.Plaster

Liquid Preparation

1.Lotions

2.Liniments

3.Paints

Semi Solid Preparation

1.Ointments

2.Creams

3.Pastes

Miscellaneous Preparation

1.Transdermal route

2.Medicated Tapes

FACTORS AFFECTING TOPICAL DRUG DELIVERY SYSTEM^3,4:

Physiological factors:

1. Skin condition

2. Lipid content

3. Blood flow

4. Skin hydration

Physiochemical factor:

1.Partition coefficient

2 Molecular weight

3.Drug concentration

4.Effect on vehicles

PHYSIOLOGY OF SKIN⁵:

The skin is the biggest organ in the human body, measuring 2 m2 and weighing 3.6 kg in adults. It serves as a shield that is waterproof and insulating, guarding the body from environmental pressures. Along with hormones, neuropeptides, and cytokines that have biological effects both locally on the skin and systemically across the entire body, it also produces antimicrobial peptides to prevent infections. The underlying mesenchyme and surface ectoderm work together to form the integumentary system. It is made up of the skin and its appendages, which include hair follicles, nails, sebaceous glands, and sweat glands. The epidermis, dermis, and hypodermis are the three layers that make up the skin. It acts as the human body interface with the external environment, maintaining vital functions like protection, the retention of water and electrolytes, temperature regulation, and the storage of fat and water. It also has a significant impact on the endocrine and immune systems.

Epidermis:

The stratified squamous epithelium layer of the epidermis is mostly made up of keratinocytes and dendritic cells. Keratinocytes have intercellular bridges and large amounts of stainable cytoplasm, which distinguishes apart from transparent dendritic cells.⁶

Epidermis is composed basically of:

Keratinocytes

Melanocytes

Langerhans cells

The epidermis is composed of the following layers:⁷

Stratum Germinativum (Growing Layer)

Malpighian Layer (Pigment Layer)

Stratum Spinosum (Prickly Cell Layer)

Stratum Granulosum (Granular Layer)

Stratum Lucidum

Stratum Corneum (Horny Layer)

Stratum Germinativum (Growing Layer)

Dermis⁶:

The dermis is a unified structure of fibrous, filamentous, and amorphous connective tissue that allows for the entry of fibroblasts, mast cells, macrophages, neuronal and vascular networks upon stimulation.

Hypodermis⁸:

The layer of adipose tissue known as the hypodermis is situated between the dermis, aponeurosis, and fasciae of the muscles. Through the nerve and circulatory systems, the subcutaneous fat tissue is fundamentally and practically closely coordinated with the dermis. The hypodermis layer consists of loose connective tissues, and variations in its thickness are visible on the body surface.

Subcutaneous Tissue⁷:

The superficial fascia, a sheet of fat-rich areolar tissue that forms the layer and connects the dermis to the underlying anatomy. Only the surface area contains large arteries and veins.

INTRODUCTION TO HERBAL EMULGEL:

Emulgels are emulsions oil-in-water or water-in-oil that are combined with an emulsifying agent to form gels. Emulsified gel is a stable and superior delivery system for medications which are insoluble in water and hydrophobic. Emulgels are basically emulsions and gels together.⁹

Types of Herbal Emulgel:

1 Macro-emulsion gel

2 Nano-emulgel

3 Micro-emulsion based emulgel¹⁰

Emulgel Is Made Up of Two Components⁹

1. Emulsion: An emulsion is a biphasic system made up of two immiscible liquids, which is one of finely and consistently propagated as globules throughout the other to form an emulsion.

2. Gel: According to the U.S.P., gels are semisolid systems made up of a dispersion whether large organic molecules or small inorganic particles that are encased and penetrated by liquid.

RATIONALE OF HERBAL EMULGEL¹¹:

Some medicinal treatments that either improve or restore a basic skin function or pharmacologically modify an action in the tissues defined as applied to the skin or mucous membrane. These goods are known as topical or dermatological goods. Ointments, creams, and lotions, which are often used topical agents, have various drawbacks. They have a sticky character that makes patients feel uneasy when applied, a low spreading coefficient that requires rubbing, and they also have stability issues. The usage of transparent gels has increased in both pharmaceutical and cosmetic preparations as a result of all these aspects within the main group of semisolid preparations. Gels have several advantages, but hydrophobic drug delivery is a severe disadvantage. Thus, an emulsion-based technique is being employed to get around this restriction so that even a hydrophobic medicinal property can be successfully integrated and administered through gels.

ADVANTAGES^12,13:

1.Incorporation of hydrophobic drugs

2.Better loading capacity

3.Better stability

4. Controlled release

5. No intensive

6. Production feasibility and low preparation cost

DISADVANTAGES¹⁴:

1. Drugs with high particle sizes are harder to absorb through skin.

2. Some medications have poor skin absorption through the skin.

3. An allergic reaction or skin rash related to contact dermatitis.

4. The appearance of a bubble while the emulgel is being formed.

COMPOSITION OF HERBAL EMULGEL:

1. Aqueous material¹⁵:

This creates the emulsion aqueous phase. E.g. - Water, Ethanol etc.

2. Oils¹⁶:

Oils are used to form an emulsion as the oil phase. Commonly used as topically applied emulsions include mineral oil and soft or hard paraffin, either separately or in combination. E.g.: - Coconut oil

3. Emulsifying Agents¹⁷:

Emulsifying chemicals are used for maintaining stability during shelf life and to promote emulsification during production. For example, Sorbitan mono-oleate (Span 80), Polyethylene glycol 40 stearate, Stearic Acid, Polyoxyethylene sorbitan monooleate (Tween 80), and Sodium stearate.

4. Gelling Agent¹⁸:

Carbopol 934, Carbopol 940, HPMC 2910, HPMC, Carboxy Methyl Cellulose (CMC) sodium, and poloxamer are the most commonly used gelling agents in the creation of emulgel.

5. Preservatives¹⁹:

the majority of the ingredients in topical applications act as substances such as microorganisms, preservatives are added to semisolids to avoid contamination, degradation, and decomposition by bacteria and fungi. For Example: Methyl and propyl parabens.

6. pH adjusting agent¹⁶:

These medications are used to maintain the formulation pH stable. E.g.: - Triethanolamine

GENERAL METHOD OF PREPARATION^20,21:

Emulgel are made by incorporating gel with emulsion. Both the emulsion and gel are prepared separately and mixed. The Aqueous phase and oil phase are taken separately and incorporated to form an emulsion. The gel is produced by applying gelling agent. After preparation, the gel and emulsion are mixed together with moderate stirring. Castor oil, clove oil, liquid paraffin, and other substances are employed as the oil phase. water and alcohol are used as the aqueous phase.

Tween 80 and water are merged to create the aqueous phase, and propylene glycol and paraben are added to form the oil phase. The medication is dissolved in the ethanol, and then the two phases are continuously stirred together. The polymers are then dissolved in water with a pH of triethanolamine is added between 6.0 and 6.5. The formation of emulsion and gel are prepared separately and to form emulgel.

CHARACTERIZATION AND EVALUATION OF HERBAL EMULGEL:

1. Physical Appearance²²:

The colour, consistency, and phase separation of the prepared emulgel are all visually evaluated.

2. pH²³:

The pH of emulgel formulation can be measure by using pH digital meter and the pH meter electrode must be cleaned with pure water before putting it into the formulation. This process was performed triplicate times, and average values are then determined.

3. Viscosity study²⁴:

The viscosity of different emulgel formulations was determined by using Brookfield Viscometer and the required quantity of emulgel formulation was taken and placed into the beaker to determine viscosity of emulgel.

4. Spreadability¹⁸:

The method of Mutimer is used to proposed to determine the spreading coefficient. It is made up of a wooden block with a pulley which is attached to one end. The 'Slip' and 'Drag' are properties of the emulgel are used to calculate the spreading coefficient. Over the wooden block is attached to a ground glass slide and this portion of the slide, emulgel is approximately used for the purpose of study. Then, another glass slide with same diameter as the stable ground slide is placed in between the slide and the emulgel preparation. The hook is included on the other glass slide. To remove air and form a uniform film of emulgel between the two slides, a weight is placed on top of two slide for five minutes. The weight has been measured is put into the pan is hooked onto the pulley. The time on top to travel a distance is recorded. A smaller interval shows a higher spreading coefficient. The formula listed below is used to calculate it.

S = M L T

where M is the weight of tied to upper slide,

L is the length of the glass slides, and

T is the time required to separate the slides.

5. Swelling Index²⁵:

The swelling index is prepared for different formulation of emulgel is determined by taking required amount of gel is placed on a piece of porous aluminum foil and placed separately in a 50 ml beaker with 10 ml of 0.1N Sodium Hydroxide. the Samples were then removed from the beakers at different times interval and placed in petridish at dry place and reweighed.

Using the following formula, swelling index is determined.

Swelling index (SW) % = [(Wt-Wo)/Wo]100

Where Wo = the original weight of the emulgel at time zero following time t,

(SW)% = equilibrium percent of swelling

Wt = weight of the swollen emulgel.

6. Total Ash Value²⁶:

Weight and crucible made of tared silica or a flat, thin porcelain dish and add about 2grams of the powdered drug to the dish or crucible, support it on a pipe-clay triangle that is set on a ring of a retort stand, and heat it with a burner with the dish supported about 7 cm above the flame until the formation of vapours almost stops. Then lower the dish and heat it more intensely until all the carbon is burned off and cool in a desiccator. The ash was weighted and determine the percentage of total ash with reference to the air-dried sample of the crude medication.

7. Loss on drying²⁷:

the powdered drugs should be weighed into a flat, thin porcelain plate and dried at 100 or 105 degrees Celsius until two subsequent weights have no difference by more than 0.5 mg and weigh after cooling in a desiccator. The weight loss is usually recorded as moisture.

8. In-vitro Diffusion Study²⁸:

The drug release studies were carried out using Franz diffusion cells. The membrane surface was equally coated with emulgel. The donor and receptor chambers of the diffusion cell were separated by a clamped membrane. To saturate the receptor chamber with the medication, fresh phosphate buffer of different concentration solutions was used. The magnetic stirrer was used to stir the receptor chamber, which was kept at a temperature of 37.22°C. The samples were taken at different time intervals. After the proper dilutions, samples were examined for drug content using a UV visible spectrophotometer at different wavelength. The amount of medication that was cumulatively released through the barrier was calculated as a function of time.

CONCLUSION:

The dosage forms are enhancing topical drug delivery of natural drugs for various topical problem.

To formulate extract of emulgel is more effective and safer for use

LITERATURE SURVEY:

Sr No	Article Title	Herbs	Excipients used	Conclusion	Ref.
1.	Formulation and evaluation of herbal emulgel loaded with extract of cedrous deodara for its in vitro anti-inflammatory activity	Cedrous deodara extract: - Traditional use	1.Carbopol 940: -Viscosity increasing agent and gelling agent 2.Sodium alginate: -Thickening agent and gelling agent 3.Sodium CMC: - Gelling 4.Propylene glycol: - Maintain moisture 5.Ethanol: - Aqueous phase and Solvent 6.Methyl paraben: -Preservative 7.Propyl paraben: -Preservative 8.Span 20: -Surfactant 9.Tween 80: -Emulsifier 10.Triethanolamine: -pH Adjustment 11.Water: - Vehicle	These emulgel Formulation study of cedrous deodara shows that the cedrous deodara have anti-inflammatory activity due to presence of alkaloids, tannins, carbohydrates, flavonoids, and terpenoids.	29
2.	Formulation and evaluation herbal emulgel of Lantana Camara leaves extract for wound healing activity in diabetic rats	Lantana camara extract	1.Carbopol 934: -Gelling agent and thickening agent 2.Sodium CMC: -Gelling agent 3.Light liquid paraffin: -Moisturizing agent 4.Tween 80: -Emulsifier 5.Span80: - Blending agent and Surfactant 6.Methyl and propyl paraben: - Preservative 7.Triethanolamine: -pH Adjustment	This ethanolic extract of leaf of Lantana Camara Linn showed maximum wound healing effect in rats and effects produced was maximum in alcoholic extract and this concentration was used for the formulation.	30
3.	Formulation and evaluation of herbal emulgel of Pothos Scandens Linn for Burn Wound healing	Pothos Scandens Linn Leaf Extract: - Traditionally use	1.Carbopol 934: -Gelling agent 2.Carbopol 940: -Gelling agent 3.Span 20: -Surfactant 4.Tween 20: - Surfactant 5.Methyl and Propyl Paraben: - Preservative 6.Propylene glycol: -Maintain moisture	In this work, we concluded that the wound healing effect shown by the Pothos scandens Linn can be use as alternative for synthetic marketed burn wound healing formulation.	31
4.	Studies on the Development of Promising Herbal Emulgel of Coccinia Grandis Leaf Extract for Dermatological Complications.	Coccinia grandis leaf extract: - API	1.Carbopol 940: - Viscosity increasing agent and gelling agent 2.Carbopol 934: - Gelling agent 3.Liquid paraffin: - Moisturizing agent 4.Methyl paraben: - Preservative 5.Propyl paraben: - Preservative 6.Propylene glycol: -Emulsifying Agent and Humectant 7.Tween 80: - Emulsifier	This formulation showed good release, rheological characteristics. The emulgel was tested for anti-bacterial activity and the results indicated that, they exhibited good anti-bacterial activity. So, Coccinia grandis herbal extract can be made into an emulgel to treat skin problems.	32
5.	Senna Podocarpa emulgel: Herbal Alternative for chemical burn wound treatment	Senna podocarpa Extract powder: - Extensively used against gonorrhoea, for their purgative properties	1.Carbopol 940: - Viscosity increasing agent and gelling agent 2.Span 20: - Surfactant 3.Tween 20: - Surfactant 4.Methyl Paraben: - Preservative 5.Propyl Paraben: - Preservative 6.Water: - Solvent	In this work, the promotion effect of SP extract and its formulation in the process of wound healing was first reported through a histology evaluation.	33
6.	Development and Evaluation of a novel herbal emulgel for potential anti-inflammatory in-vitro	Leea Indica Leaf Extract: - Anti-inflammatory effect	1.Carbopol 940: - Thickening agent 2.Tween 20: - Surfactant 3.Tween 80: - Emulsifier 4.Camphor: - Counter Irritant 5.Methyl paraben: - Preservative 6.Triethanolamine: - pH Adjustment 7.Distilled Water: - Vehicle	This study was developed more efficacious, cost-effective and safer anti-inflammatory herbal emulgel using L. indica (Burm.f.) Merr. Leaf extract. Emulgel was discovered to be the formulation having most in-vitro anti-inflammatory and anti-oxidant activity in this investigation.	34
7.	Formulation and evaluation of herbal emulgel for treatment of fungal infections	Lemon Grass Oil	1.Carbopol 934: - Gelling agent and Rheology modifier 2.Sodium CMC: - Gelling agent 3.Light Liquid Paraffin: - Moisturizing agent 4.Ethanol: - Solvent 5.Span 80: - Blending agent and Surfactant 6.Tween 80: - Emulsifier 7.Propyl paraben: - Preservative 8.Propylene glycol: - Emulsifying agent and Humectant 9.Triethanolamine: - pH Adjustment 10.Water: - Solvent	This study was a successful attempt to create an herbal emulgel that contains lemon grass extract for the treatment of fungus infections.	24
8.	Formulation and Evaluation of Herbal Emulgel of Ocimum Tenuiflorum and Mentha Arevensis Leaves Extract for Antiacne Activity	Ocinum Tenuiflorum extract: - Antioxidant effect and Mentha Arevensis: - Anti-Inflammatory effect	1.Sodium CMC: - Gelling agent 2.Liquid paraffin: - Moisturizing agent 3.Span 80: - Blending agent and Surfactant 4.Tween 80: - Emulsifier 5.Ethanol: - Solvent 6.Water: - Vehicle	In this study the herbal emulgel containing Tulasi and mint extracts shows anti-acne effectiveness which precise the mechanism causing acne is not been identified.	35
9.	Formulation Design and Evaluation of Anti-Microbial Activity of Emulgel Containing Essential Oil of Myrtus communis L.	Myrtus Communis L.	1.Carbopol 940: - Gelling agent 2.Xanthan Gum: - Gelling agent 3.Propylene glycol: - Emulsifying agent 4.Span 80: - Surfactant 5.Tween 80: - Surfactant 6.Methyl paraben: - Preservative 7.Propyl paraben: - Preservative 8.Water: - Vehicle	The prepared herbal emulgel has shown better physical property	36
10.	Formulation and Evaluation of herbal oral emulgel containing Psidium Guajava Linn Leaves Extract.	Psidium Guajava Linn Leaves Extract	1.Carbopol 934: - Gelling agent 2.Span 80: - Surfactant 3.Tween 80: - Emulsifier 4.Methyl paraben: - Preservative 5.Propyl paraben: - Preservative 6.Glycerine: - humectant 7.Triethanolamine: - pH Adjuster 8.Water: - Solvent	The different formulation of Psidium Guajava leaves extract were prepared and evaluated for physical characteristics, pH, Homogeneity, Spreadability, Viscosity and antimicrobial activity.	37
11.	Formulation and Evaluation of Ginger officinale emulgel.	Ginger Extract (Ginger Officinale): - API	1.Sodium CMC: - Gelling agent 2.Light Paraffin: - Moisturizing agent and soothing agent 3.Tween 80: - Surfactant 4.PEG 200: - Defoaming agent 5.Ethanol: - Solvent 6.Water: - Solvent	The study of ginger shows many components and properties like antibacterial activity due to presence of gingerol and shagols.	38
12.	Formulation Design and Evaluation of Herbal Anti Psoriatic Emulgel.	Commiphora Mukul and Babchi Oil	1.PEG 400, Campul PG 8, Campul MCM: - Cosurfactant 2.Cremophor RH 40: - Surfactant	In this study the herbal emulgel formulation of Babchi oil are prepared and it involves the study of topical immune modulatory effects of Babchi oil emulgel formulation prevents safe alternative to synthetic drugs.	39
13.	Formulation and characterization of ginger oil loaded polyherbal emulgel having extracts of nardostachys jatamansi, Andrographis paniculata and celaestrus paniculatus.	Nardostachys jatamansi, Andrographis paniculata, celaestrus paniculatus extracts: - Traditional use	1.Turmeric Oil 2.Ginger Oil 3.Carbopol 934: - Gelling agent 4.Propylene glycol: - Emulsifying agent, Humectant 5.Methyl paraben: - Preservative 6.Propyl paraben: - Preservative 7.Tween 20: - Surfactant 8.Span 80: - Surfactant 9.Liquid paraffin: - Moisturizing agent 10.Ethanol: - Solvent 11.Triethanolamine: - pH Adjuster 12.Distilled Water: - Vehicle	The phytochemical analysis evaluation parameters of emulgel have more stable and in vitro and in vivo animal model was against inflammation and Rheumatoid Arthritis.	40
14.	Formulation and Evaluation of Emulgel Containing Piper Nigrum and Curcuma Longa Extract for Vitiligo.	Piper Nigrum and Curcuma Longa Extract	1.Carbopol 934: - Gelling agent 2.Carbopol 940: - Thickening agent, Viscosity Increasing agent 3.HPMC K4M 4.Liquid paraffin: - Moisturizing agent and Soothing agent 5.Tween 80: - Surfactant 6.Span 80: - Surfactant 7.Propylene glycol: - Emulsifying agent and Humectant 8.Ethanol: - Solvent 9.Coconut Oil: - 10.Methyl paraben: - Preservative 11.Propyl paraben: - Preservative 12.Triethanolamine: - pH Adjuster 13.Water: - Vehicle	The study of topical dosage form of selected antivitiligo agent of emulgel was formulated and evaluated for conventional treatment for several undesirable side effects.	41
15.	Formulation and Evaluation of Emulgel for the treatment of acne	Green tea Extract	1.Glycerine monostearate: - 2.Cetostearyl Alcohol: - 3.Liquid paraffin: - Moisturizing agent 4.Propyl Myristate: - 5.Avocado Oil: - 6.Propyl paraben: - Preservative 7.Methyl paraben: - Preservative 8.Glycerine: - Humectant 9.Carbopol 934: - Gelling agent 10.Carbopol 940: - Viscosity Increasing agent and Thickening agent 11.Triethanolamine: - pH Adjustment 12.Purified Water: - Vehicle	An Emulgel containing green tea extract and avocado oil was developed which had the potential to be used for Acne treatment.	42

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Received on 12.09.2023 Modified on 05.10.2023

Asian J. Pharm. Tech. 2023; 13(4):297-303.

DOI: 10.52711/2231-5713.2023.00053