SNEDDS – A Novel Technology Approach for Nano Emulsion Based Drug Delivery of Curcumin

Bhagyesh Janugade; Samruddhi Desai; Pratiksha Desai; Harsha Bhosale; Gayatri Atpadkar

doi:10.5281/zenodo.18810583

Review Paper | Open Access
Volume 02 | Issue 03 | Article Id IJMPS/260202032

SNEDDS – A Novel Technology Approach for Nano Emulsion Based Drug Delivery of Curcumin
Bhagyesh Janugade* Samruddhi Desai Pratiksha Desai Harsha Bhosale Gayatri Atpadkar
Krishna Foundation’s Jaywant Institute of Pharmacy, Wathar, Karad, Maharashtra, India, 415539

Abstract

A promising method for improving the solubility and bioavailability of all poorly soluble drugs is SNEDDS (Self Nano-emulsifying drug delivery system). SNEDDS are an isotropic combination of oil, co-surfactant, and surfactant that forms oil in water on its own. nano-emulsion in gastric fluid after slight stirring. The nanosized droplets significantly boost the solubilization, surface area and absorption of lipophilic medicines like curcumin. Curcumin is a natural polyphenolic chemical derived from Curcuma longa, with multiple medicinal effects including anti-inflammatory, antioxidant, antirheumatic, antibacterial action. But it falls under BCS class IV shows both low solubility and poor absorption. However, because of its weak aqueous solubility, low permeability, and fast metabolism, which results in low oral bioavailability, its therapeutic applicability is restricted. The current study focuses on creating and assessing curcumin-loaded SNEDDS to improve solubility and bioavailability in order to address these problems. The Nano carrier technology of SNEDDS boost curcumin loaded capability to be transported and absorbed into diverse organ by improving its ability to cross cell membrane. Different approaches can be used to generate SNEDDS. SNEDDS is an effective method for optimizing the oral delivery of drugs with low water solubility, increasing their bioavailability in the body. The goal of the article is to examine and explore the application of SNEDDS in enriching the solubility as well as bioavailability.

Keywords

SNEDDS, Nanocarrier system, Oral drug delivery, Nano emulsion, BCS Class

Introduction

The rhizome of Curcuma longa, or turmeric, contains a biologically active substance called curcumin. Its numerous biological and pharmacological uses have drawn a lot of interest ^[1]. This naturally occurring compound belongs to the diarylheptanoid family of hydrophobic polyphenols and has the chemical formula C₂₁H₂₂O₄. About 60–70% of the curcuminoid content, a class of structurally similar polyphenolic chemicals, is composed of curcumin. It is made up of two ferulic acid units joined by a methylene bridge. About 77% diferuloylmethane, 17% desmethoxycurcumin, and 3% bisdemethoxycurcumin are found in commercial-grade curcumin. Curcumin has a low oral bioavailability despite its therapeutic potential; just 1% is lost through urine and almost 75% is eliminated through feces ^[2]. In addition to South and Southeast Asia, turmeric is extensively grown in Rajasthan, India. Curcumin dissolves in solvents like ethanol, methanol, acetone, and dimethyl sulfoxide (DMSO), but it is insoluble in water. Both Curcuma longa and Curcuma aromatic can be used to make it ^[3]. However, it falls under Class IV of the Biopharmaceutical Classification System (BCS) due to its low oral bioavailability and non-specific action, which are caused by its poor water solubility, fast metabolism, and restricted membrane permeability. Because of their poor solubility and restricted permeability, drug delivery systems categorized under the Biopharmaceutical Classification System (BCS) Category IV are known for having very low bioavailability ^[4].Researchers have created a number of methods to improve medication absorption and therapeutic efficacy in order to overcome these obstacles. Nanotechnology-based drug delivery systems (NDDS) are one of these breakthroughs that has shown great promise ^[5]. To increase the solubility, stability, and bioavailability of medications that are poorly soluble in water, NDDS employs nanoscale formulations. These methods can ensure controlled release of active medicinal ingredients, overcome biological barriers, and enable targeted delivery. NDDS provide a revolutionary solution to contemporary drug delivery issues by utilizing the special qualities of nanoparticles, such as large surface area, improved permeability, and extended retention time ^[6]. Because of their adaptability, they can be used via oral, injectable, and transdermal methods, among other dosage forms. "Dispersed Nano emulsions enhance gastrointestinal absorption by offering a large surface area and strong adhesion to the intestinal lining."^[7].A variety of physicochemical and performance-based metrics are used in the evaluation of SNEDDS formulations. Dynamic light scattering is used to measure droplet size and polydispersity index (PDI) in order to evaluate dispersion quality and uniformity. While thermodynamic stability tests guarantee durability under a range of storage settings, zeta potential analysis provides insight into colloidal stability ^[8]. To assess release kinetics and solubility enhancement, in vitro dissolution tests are carried out in simulated stomach and intestinal fluids. Curcumin-loaded SNEDDS can boost oral bioavailability by up to 20 times when compared to unformulated curcumin, according to several studies. Improved solubilization, defense against enzymatic degradation, and avoidance of hepatic first-pass metabolism through lymphatic transport are all responsible for this improvement. Additionally, SNEDDS formulations have demonstrated exceptional therapeutic efficacy in oxidative stress, cancer, and inflammation models, confirming their promise for clinical use. A major step toward removing curcumin's solubility and bioavailability obstacles has been made with the creation and assessment of curcumin-loaded SNEDDS. This administration method not only enhances curcumin's pharmacokinetic profile but also creates new opportunities for its incorporation into contemporary pharmaceutical and herbal treatments. ^[9]

Table: 1 Chemical Formula & Structure

Biopharmaceutical Classification System:

A well-known technique for assessing pharmaceutical substances' solubility and capacity to cross biological membranes is the Biopharmaceutical Classification System (BCS). It provides a useful framework for the creation of novel pharmaceutical products and medication formulations. Currently, the US Food and Drug Administration (USFDA) and the World Health Organization (WHO) are in charge of the system. It classifies medications into four primary groups based on how soluble and permeable they are. Medications are categorized using this method according to these two essential characteristics. ^{[10 ,11].}

Solubility:

Based on guidelines provided by the World Health Organization (WHO) and the U.S. A medication is considered highly soluble by the Food and Drug Administration (USFDA) if its maximum dose strength of its marketed oral solid dosage form can dissolve in 250 milliliters or less of aqueous solution, or if the active pharmaceutical ingredient (API) is listed on the WHO Model List of Essential Medicines. The pH range in which this dissolution takes place is 2.0 to 8.0. The same standards apply to the maximum dose strength of the commercial formulation if the API is not on the WHO list. ^[12].

Permeability:

The Biopharmaceutical Classification System (BCS) and the World Health Organization (WHO) define permeability as the rate at which a medication substance crosses the intestinal mucosa and the degree to which it is absorbed into the systemic circulation. When at least 90% of the dose is absorbed, a medication is considered extremely permeable. ^[13].
Biopharmaceuticals can be grouped using multiple classification systems. One widely used approach divides them into four different classes according to their permeability and solubility properties:
Class I: High solubility and high permeability
Class II: Low solubility but high permeability
Class III: High solubility but low permeability
Class IV: Low solubility and low permeability
This system is especially helpful for assessing how medications are absorbed by the body and for directing formulation techniques to increase bioavailability. ^{[14, 15].}

Fig.1. Biopharmaceutical Classification System

Fig 4 Mechanism of Action of SNEDDS:

Excipients Used In SNEDDS Formulation:

Oils:

Oils are used as solubilizing agents for lipophilic active medicinal substances in SNEDDS formulations. Additionally, by encouraging transport via the lymphatic system, they improve drug absorption and aid in the self-emulsification process. Due to their low ability to solubilize significant amounts of pharmacological compounds, conventional cooking oils are typically left out of SNEDDS formulations. This limitation explains their unsuitability for such applications. On the other hand, oils with self-emulsifying properties are usually chosen for SNEDDS, especially when mixed with high surfactant concentrations. As a result, amphiphilic chemicals are used because they have both hydrophilic and lipophilic properties, which makes them perfect for sophisticated drug delivery systems. ^[16]

Surfactants:

Since non-ionic surfactants provide the highest level of safety for human use, they are frequently used in consumable products. These non-ionic surfactants are typically ethoxylated substances, such as glycerides, sorbitans esters, ethoxylated alcohols, and glycol esters. Among these, ethoxylated glycerides have the ability to emulsify oils despite their inability to do so on their own. Despite this limitation, they pose fewer health risks. The chemical composition of natural surfactants is similar to that of synthetic emulsifiers, and they can also serve comparable purposes. Compared to ionic surfactants, non-ionic ones exhibit significantly lower toxicity. Additionally, they exhibit increased intestinal lining permeability. Non-ionic surfactants are less dangerous than their ionic counterparts, according to numerous studies. Their safety profile is further enhanced by their decreased permeability across the intestinal wall. ^[17].

Co -surfactants:

To achieve effective emulsification, a high concentration of surfactants—typically more than 30% w/w—must be used in the formulation of Self-Nanoemulsifying Drug Delivery Systems (SNEDDS). The initial dispersion of the oil phase is facilitated by this high surfactant content. The system becomes more condensed after co-surfactants are added, which further affects the interfacial behavior. Initially, the interfacial tension between the oil and water phases reduces significantly, even reaching negative levels. Nevertheless, this interfacial property changes to a positive value after all formulation ingredients have been fully mixed. This transition happens because the extremely small droplets generated during emulsification are capable of adsorbing the maximum possible quantity of both surfactant and co-surfactant molecules. "Spontaneous emulsification," a thermodynamically advantageous process, results from this adsorption ^[18] where the system self-assembles into a Nano emulsion without the need for external energy input. In this process, co-surfactants play an especially important role. Because they can greatly lower the interfacial tension between the oil and water phases, medium-chain co-surfactants—such alcohols like pentanol—are frequently used. One important element in encouraging the development of a stable microemulsion is this decrease in tension. The inclusion of these co-surfactants improves the fluidity and flexibility of the interfacial coating, allowing for the spontaneous production of uniform, Nano-sized droplets. Ultimately, this results in the production of a grease-like microemulsion structure, which is suitable for enhancing the solubility and bioavailability of poorly water-soluble medications in SNEDDS formulations. ^[19].

Fig 5. Excipients Used in SNEDDS Formulation

Constructing Ternary Phase Diagram:

This is the first step before starting the formulation process. It aids to identify the ideal emulsification zone for oil, surfactant, and co-surfactant combinations. Each corner of the triangle in the ternary phase diagram represents oil, surfactant, and co-surfactant, respectively fig 6. The concentrations of each component are changed to achieve this. The phase diagram is produced using both the titration and water titration techniques. After diluting each mixture with water and titrating it, the droplet size, zeta potential, and polydispersity index (PDI) are analyzed. Droplet size was shown to decrease with increasing surfactant concentration and decreasing co-surfactant concentration ^[20]. When determining the ideal circumstances for creating a self-nanoemulsifying drug delivery system (SNEDDS), the pseudo-ternary phase diagram is essential. Oil, a mixture of surfactants and co-surfactants (Smix), and water are depicted graphically. Either the phase inversion technique or the phase titration method is used to create this diagram. The procedure entails making solutions with different weight ratios of surfactant to co-surfactant, such as 1:1, 2:1, 3:1, and so on, mixed with oil. To guarantee homogeneity, these mixtures are vortexed for five minutes before being assessed for visual clarity. A clear, isotropic solution denotes the successful construction of a nano emulsion (SNEDDS), while a turbid appearance implies the formation of a coarse emulsion. ^[21]

Formulation of SNEDDS: There are other ways to develop SNEDDS, however they are mainly divided into two categories: liquid SNEDDS and solid SNEDDS. To obtain the best possible medication delivery efficacy, each approach entails particular stages and components. ^[22].

Fig .6. Pseudo Ternary Phase Diagram

1. Liquid SNEDDS Formulation

The creation of liquid SNEDDS begins with the production of a formulation blueprint that specifies the appropriate ratio of three important components: oil, surfactant, and co-surfactant. A pseudo-ternary phase diagram, which aids in identifying the area where a stable nano emulsion can develop, is used to carefully select this ratio rather than choosing it at arbitrary. ^[23].

To formulate the liquid SNEDDS:

Different ratios of surfactant and oil are chosen and mixed. After that, the medication is added to this mixture. The formulation is allowed to settle or equilibrate after vigorous mixing. The resulting liquid SNEDDS is deemed fully prepared once the system has stabilized. Usually, these formulations are kept at room temperature until they are needed or assessed. This process assures the creation of an isotropic, thermodynamically stable mixture that can spontaneously emulsify when it comes into contact with gastrointestinal fluids, improving the solubility and bioavailability of medications that are poorly soluble in water ^[24].

1. Solid SNEDDS Formulation

Solid SNEDDS are created by transforming liquid SNEDDS into a solid dose form, which has benefitted such increased patient compliance, stability, and handling ease. The conventional approach entails: Using a mortar and pestle, combine the liquid SNEDDS with an appropriate solid carrier to create a semi-solid or dough-like substance. To achieve a consistent particle size, this mass is subsequently passed through a sieve, usually sieve number 120. The sieved material is heated under controlled conditions, usually at a predetermined temperature (e.g., 20°C or as required by the formulation protocol), to ensure the removal of residual moisture and to solidify the formulation. ^[25]. To improve the effectiveness and scalability of solid SNEDDS production, a number of alternative methods have developed over time. These techniques, which aim to convert the liquid system into a stable, solid-state formulation without compromising its self-emulsifying qualities, include spray drying, freeze-drying, adsorption onto solid carriers, and extrusion-based techniques.

Fig 6 Formulation methods of SNEDDS

Techniques:

1. Microfluidization: A microfluidizer, a device with a positive displacement pump that forces the product into an interaction chamber, is used in microfluidization. Microchannels in this system act as conduits for tiny droplets. The product passes through these microchannels and forms nano-emulsions with incredibly fine droplets in an impingement zone. First, a coarse emulsion is created in the homogenizer when the aqueous and oil phases are mixed. This becomes a transparent and uniformly stable nano-emulsion after additional processing. ^{[26, 27].}

2. High Pressure Homogenizer: To create nano emulsions with exceptionally small particle sizes (usually between 100 and 200 nm), the development of nano-formulations sometimes necessitates the use of high-pressure homogenizers or piston-type devices. The emulsion's droplet size decreases when strong shear forces are applied. This process includes phenomena like cavitation and turbulence, which aid in the reduction of size. ^[28]. By forcing the mixture through a narrow orifice under extremely high pressure (between 500 and 1500 bar), the oil phase is dispersed into the aqueous phase. This produces ultra-fine emulsion particles by subjecting the liquid to intense turbulence and hydraulic shear. The final droplet size of the nano emulsion is influenced by a number of factors, including the type of homogenizer, the sample's composition, and storage conditions like humidity and temperature. One of the best methods for creating nano emulsions is high-pressure homogenization. However, the high energy consumption and temperature increase during processing are its primary drawbacks. ^[29].

3. High Energy Approach: By combining surfactants, oil, and co-solvents, the high-energy approach uses strong mechanical force to promote the creation of nano-emulsions. Because of its efficacy, this technique is frequently used in the formulation of nano-emulsions. Emulsions with high kinetic energy are produced when bigger droplets are broken down into nanoscale ones by the strong disruptive forces produced by mechanical energy. Self-nanoemulsifying drug delivery systems (SNEDDS), on the other hand, rely on the spontaneous process of self-emulsification and use very little energy. ^{[30, 31].}

4. Sonication Method: Sonication is an efficient technique for emulsion production. It makes use of ultrasonication, which uses an apparatus that produces ultrasonic waves. In regular applications, ultrasonication performs better than other high-energy cleaning and processing techniques. By lowering droplet size, the cavitation forces produced by these ultrasonic waves which contribute in the transformation of macro-emulsions into stable, homogenous emulsions. The achievement of nano-emulsion stability depends on this droplet size decrease. Energy input is necessary for sonication to work, and acoustic cavitation is a key component of this process. Cavitation is the process by which variations in the pressure of acoustic waves cause microbubbles to form, expand, and eventually collapse. ^[32,33].

5. Spray Drying: This straightforward, one-step method is used to create solid microparticles or nanoparticles, such as solid SNEDDS (self-nanoemulsifying drug delivery systems). The solid carrier is dissolved and mixed with the liquid formulation in this process using a solvent. The volatile solvents are then evaporated by atomizing the resultant solution into a stream of heated air, which is very important in nano emulsion systems. These solvents could be water-based or organic. Under carefully regulated temperature and airflow conditions, the dried particles are created. The micro/nanoparticles can be compressed or encapsulated into tablet form after drying^{. [34].}

6. Melt Granulation: This method uses a binder or softening agent at relatively low temperatures (usually between 50 and 80°C) to agglomerate powders. Under certain circumstances, the molten binder forms liquid bridges between the particles, resulting in tiny granules that eventually grow into spheroid pellets. Depending on the powder's particle size, the amount of binder used can vary from 15% to 25%. Melt granulation has a number of advantages over traditional wet granulation, including simplifying the process by doing away with the need for liquid additives and subsequent drying steps. ^[35].

Evaluation of Snedds:

Drug Content:

This technique is used to assess the product's overall purity as well as the amount of medication included in the formulation. First, the average weight of twenty tablets is determined by weighing each one separately. After that, these tablets are ground into a fine powder. The HPLC (High-Performance Liquid Chromatography) method is used to analyze a sample that is equal to the average tablet weight. To determine the proportion of the medication released from the SNEDDS formulation, a dissolution test is also carried out. ^{[36, 37].}

Droplet Size:

The droplet size of the SNEDDS formulation can be tested after diluting the solution with distilled water. A 2 mL sample in a cuvette was analyzed using a high-resolution light scattering method, commonly known as dynamic light scattering due to Brownian motion. This technique yields accurate information on the formulation's particle size. A Zeta sizer model NANO-ZS was used for the analysis; the detection angle was set at 90 degrees and the temperature was kept at 25°C. ^{[38, 39].}

Measurement of Viscosity:

The viscosity of the SNEDDS formulation was measured using the Brookfield Viscometer, a well-used tool for evaluating the consistency of different formulations. ^[40,41].

Morphology:

The morphology of SNEDDS droplets were studied using scanning electron microscopy (SEM) and transmission electron microscopy (TEM), both of which have high magnification capabilities. The structure of the sample can be thoroughly examined using TEM and SEM. Prior to analysis, the sample was diluted to an adequate concentration, a little piece was placed on a slide, and then the morphological evaluation was performed.^{[42, 43].}

5. In Vitro Dissolution Studies:

To perform this test, a USP Type II dissolution apparatus was employed. The system employed a phosphate buffer with a pH of 7.4 and a dissolving media of 0.1 N hydrochloric acid with a pH of 1.2, totaling 900 mL in volume. The media were constantly stirred at 100 revolutions per minute and kept at a temperature of 37.5°C to replicate physiological circumstances. Throughout the experiment, sink conditions were maintained. At regular intervals, 5 mL aliquots were taken, replaced with an equal volume of fresh dissolving medium, and filtered through a 0.45-micrometer membrane filter. Spectrophotometric analysis was then used to determine the drug content in the samples. ^{[44, 45].}

6. Centrifugation Study:

This test was conducted to investigate the stability of the SNEDDS formulation. A centrifuge running at 5000 rpm for 30 minutes was used in the process. The final formulation was closely examined following centrifugation to look for any indications of instability. ^[46]

Applications of SNEDDS:

1. Curcumin's anticancer properties:

A naturally occurring substance known for its anticancer qualities is curcumin. It contains a wide range of bioactive chemical components and has a strong inhibitory impact on the abnormal cell proliferation that is a characteristic of the development of cancer. Studies have showed that curcumin exerts its anticancer effects primarily by inhibiting two important processes: angiogenesis and tumor growth. ^{[47, 48, 49].}

2. Antidiabetic Properties

Research reveals that curcumin exhibits beneficial effects in the control of diabetes. Its capacity to reduce the production of superoxide radicals or suppress the activity of vascular protein kinase C is principally responsible for these actions ^[50]. Oxidative stress is regarded a major contributing factor to cellular damage and death in diabetes situations. Curcumin is recognized as a prospective therapeutic agent due to its role in activating cytoprotective enzymes, particularly heme oxygenase (HO), which help alleviate oxidative damage. ^[51,52].

3. Anti-Arthritis Activity

Synovial hyperplasia is a hallmark of arthritis, a chronic inflammatory joint disease. Comparative research was undertaken on individuals with rheumatoid arthritis to evaluate the therapeutic efficacy of curcumin versus diclofenac sodium. Curcumin exhibited encouraging outcomes, attributable to its natural origin and absence of unwanted effects. Moreover, it was proven to be more efficient than diclofenac sodium in reducing inflammation. ^{[53, 54, 55].}

4. Anti -Inflammatory Activity

Steroidal and non-steroidal anti-inflammatory drugs are commonly utilized for the treatment and control of inflammation. Along with its many pharmacological characteristics, curcumin has notable anti-inflammatory actions. Its mode of action involves the reduction of NF-κB activation and the downregulation of several pro-inflammatory cytokines, including TNF-α, IL-1, IL-6, IL-8, and chemokines. A fundamental advantage of curcumin is its natural origin, which adds to its safety profile and absence of adverse effects. ^{[56, 57].}

Wound Healing Properties

The therapeutic potential of curcumin in aiding wound repair has been widely acknowledged. It is essential for promoting collagen synthesis, improving re-epithelialization, and promoting the formation of granulation tissue. Curcumin stimulates a number of growth factors that promote cellular renewal and prevent damaged or malfunctioning cells from proliferating. Notably, transforming growth factor beta 1 (TGF-β1) is highly impacted by curcumin, attributed to its regulatory action in expediting the wound healing process. ^{[58, 59,60].}

Anticoagulant Activity of Curcumin:

Curcumin includes numerous bioactive elements, among which bisdemethoxycurcumin—a prominent derivative—exhibits powerful antithrombotic effects. Curcumin intake has been demonstrated to maintain and enhance anticoagulant action. ^{[61, 62].}

7. Anti-HIV Features:

Anti-HIV activity: The curcumin-based compound [(E)-2-(3,4-dimethoxybenzylidene)-6-(3,4-dimethoxyphenyl)-acetyl cyclohexanone] has demonstrated encouraging potential as an HIV-1 and HIV-2 protease in vitro inhibitor ^[63,64,65].

DISCUSSION:

-The effective creation of tailored curcumin-loaded SNEDDS is highlighted in this paper, demonstrating a notable improvement in curcumin's solubility and oral bioavailability.

-This main objective of this study is to compare curcumin SNEDDS in the present context of creating drug delivery systems that are both economical and minimally hazardous. In contrast to other traditional curcumin delivery methods, which frequently have issues with efficacy and scalability, the study offers a unique curcumin-loaded SNEDDS formulation.

- Experimental design involving several formulation variables was applied to maximize drug loading efficiency.

- This approach intends to develop formulation techniques for the management of critical health situations.

- The purpose of this review is to explore diverse techniques for SNEDDS creation.

CONCLUSION:

A promising platform for formulations with both controlled and sustained release is Self-Nanoemulsifying Drug Delivery Systems (SNEDDS). The findings of this investigation show that curcumin-loaded SNEDDS greatly boost oral bioavailability while minimizing systemic constraints associated with curcumin’s limited water solubility. Improved drug absorption is a result of SNEDDS's mechanism, which includes greater membrane fluidity and avoiding first-pass metabolism. Furthermore, SNEDDS promote improved oral absorption by blocking P-glycoprotein (P-GP) efflux. These systems have showed targeted delivery capabilities to numerous anatomical regions including the colon, lungs, vaginal tract, and particularly, the nasal region. Life-threatening illnesses like cancer, diabetes, arthritis, inflammatory bowel disease, and gastrointestinal diseases have been shown to benefit from their therapeutic efficacy. Moreover, SNEDDS offer great drug loading capacity and hold substantial promise for increasing the therapeutic effectiveness of medicines with restricted solubility and permeability. The drug loading technique is maintained while this optimization is accomplished. SNEDDS formulations can be developed using a range of unique preparation processes that are both time-efficient and cost-effective.

CONFLICTS OF INTEREST:

No any conflict of Interest.

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