Advancing Oral Delivery of Poorly Water-Soluble Drugs Through SNEDDS: Formulation Considerations, Characterization and Pharmaceutical Application

Abstract

Self nanoemulsifying drug delivery systems (SNEDDS) have achieved significant attention in the pharmaceutical field for their ability to enhance the solubility and absorption of poorly water soluble drugs. the successful development of SNEDDS largely depends on the precise composition of its componentsand their proper selection to achieve desired goals in solubility enhancement.The review is based on recently published articles retrieved from reputable scientific databases (PubMed, ScienceDirect, Taylor & Francis, Springer, Scopus, and Web of Science). This review aimed to summarize the Self Nanoemulsifying Drug delivery System as a most efficient system for enhancement of solubility of BCS class II and class IV drugs.it includes general considerations for the formulation of SNEDDS along with oil, surfactant, cosurfactant, and candidate drug selection. this exhaustive review also offers an explicit discussion on various methods for the preparation of SNEDDS and their Characterization techniques such as droplet size analysis, zeta potential, percent transmittance(%T), self emulsification time, TEM, dissolution studies, thermodynamic stabili this review also include the lists of pharmaceutical applications of the SNEDDS in solubility and bioavailability enhancement of various poorly water soluble drugs through various routes

Keywords

Introduction

For medications to have the desired pharmacological effect and reach the required concentration in the systemic circulation, solubility is essential [1]. Drug formulations, drug physicochemistry properties, and gastrointestinal physiology all interact intricately to determine oral drug absorption in the gastrointestinal tract (GIT).[2] Oral administration of many novel pharmacological substances is often associated with low water solubility or high lipophilicity, which leads to poor and highly variable oral bioavailability and lack of dosage proportionality.[3] Solubility testing and in vitro transport studies are commonly used as a predictive tool to predict oral absorption in the initial phase. Later on, more permeation techniques are frequently added to the toolbox along with in vitro dissolution tests. [4]  Only 34% fall into class I according to the BCS classification, with the remaining half falling into classes II–IV (17% to class II, 39% to class III, and 10% to class IV). [5]   The majority of medications found so far fall into class II (low solubility, high permeability) and class IV (low solubility, low permeability) according to the BCS (Biopharmaceutical Classification System). Because of their poor solubility or membrane permeability, these substances showed poor oral bioavailability after oral administration. Thus, the development of novel drug carriers for oral administration is imperative.[6]  A stable emulsion may provide a wide interfacial area for drug partitioning between the oil and water phases, as well as a higher rate of dissolution and improved bioavailability. [7]

 The Self-Nanoemulsifying Drug Delivery System (SNEDDS) is a dosage form that dramatically accelerates the dissolution of active pharmaceutical ingredients, particularly when taken orally[8].Unlike traditional lipid-based medication delivery systems, the digestive motility of the gastrointestinal tract provides the agitation needed for the creation of nanoemulsions in the human body. Because of their more consistent physicochemical characteristics and lower surface free energy, SNEDDS have demonstrated a significant improvement in the solubility and oral bioavailability of hydrophobic drugs, particularly those in BCS classes II and IV. They can also increase the oral bioavailability of poorly water-soluble drugs[9]

 

 

Figure1. SNEDDS Structure

Advantages of SNEDDS:

• Compared to micro emulsions (SMEDDS), SNEDDS have a significantly greater surface area and free energy[33].
• increase the bioavailability of medications that are poorly soluble in water[10].
• SNEDDS appears to be an attractive choice of formulation as it requires simple and cost-effective manufacturing facilities[11].

 Disadvantages of SNEDDS:

• High concentration of surface active agent in formulation may cause GIT irritation.
• Traditional dissolution methods do not work for the SNEDDS[12].
• Lack of reliable predictive in vitro models for evaluating the formulations due to the failure of conventional dissolve techniques and the possibility that these formulations depend on digestion before drug release[13].

 FORMULATION CONSIDERATION FOR SNEDDS:

The drug’s solubility in lipid, surfactant, and co-solvent is taken into consideration while choosing lipid, surfactant, and co-surfactant.[14]. The composition and concentration of the formula determine the successful formation of SNEDDS[15].

Oil Phase Selection:

In order to increase the amount of medication that passes through the intestinal lymphatic system and improve absorption, the oil is employed in the SNEDDS formulation to solubilize the lipophilic drug and facilitate self-emulsification[17]. Fixed oils and other oils with very long hydrocarbon chains are thought to be challenging for nanoemulsions. Compared to medium-chain, tri-, di-, and monoglycerides (such as glycerol mono caprylocaprate, acetic, citric, and iacetyl tartaric acids), long-chain triglycerides have demonstrated a stronger ability to improve intestinal lymphatic drug transport because they are thought to be in charge of blocking the first-pass metabolism of medications[18].

Surfactant Selection:

Another crucial factor in the creation of SNEDDS is the selection of surfactant. The nanoemulsification process, self-nanoemulsification region, and nanoemulsion droplet size are all significantly impacted by the surfactant's characteristics, including HLB (in oil), viscosity, and affinity for the oily phase. The droplet size of nanoemulsions is significantly influenced by the surfactant content in the SNEDDS[19]. Non-ionic  surfactants  with a  relatively  high  hydrophilic-lipophilic balance   (HLB)   are   commonly   recommended to use in the formulation of SNEDDS[20]. Common surfactants include lecithin, copolymer, and polysorbate 80. Because an excessive concentration can upset the stomach, selecting the right surfactant is crucial[21].

Co-Surfactant Selection:

These substances cooperate with surfactants to increase medication solubility and surfactant dispersion in the oil phase, which enhances the nanoemulsion's overall homogeneity and stability.[1]. By increasing the fluidity between the emulsion phases, co-surfactants improve the emulsification process and stop liquid crystallization. The co-surfactant is chosen based on how well it can maximize the emulsification area when combined with the designated surfactant[22].

Drug Candidate Selection:

Lipid formulations have emerged as a successful new approach to increasing the solubility of poorly soluble drugs belonging to the Biopharmaceutics Classification System (BCS) class II.Self-nanoemulsifying drug delivery systems (SNEDDS) are one of the most common and commercially applicable lipid-based approaches for poorly water-soluble drugs[23]  Lipinski’s rule of five has been widely proposed as a qualitative predictive model for oral absorption trends. In the discovery setting, the ‘rule of five’ predicts that poor absorption or poor permeation is more likely when there are more than five H-bond donors, there are more than ten H-bond acceptors, the molecular weight >500 and the calculated log P > 5[29] Surfactants and lipid components used in SNEDDSs can cooperate to enhance the GI absorption drugs. Furthermore, these components can be modified easily according to the need to make SNEDDSs feasible for both hydrophilic and hydrophobic drugs[24].

GENERAL STEPS INVOLVED IN PREPAREATION OF SNEDDS:

1. Solubility Studies

In order to choose appropriate ingredients for lipid-based formulations, the shake-flask method is frequently used to assess the solubilization capacity of different oils for poorly water-soluble BCS Class II medicines[25]. SNEDDSs were created by Khattab et al. to improve the oral absorption of aliskiren hemifumarate. From the solubility investigation, Capryol® 90 (oily phase), Cremophor® RH and Tween® 20 (surfactants), and Transcutol® HP (cosurfactant) were chosen. A pseudo-ternary phase diagram was used to further improve the formulations and identify an area of emulsification.[6] The mixtures were swirled, sonicated for 30 minutes, and then shaken at 37 °C for 48 hours using a water bath shaker after the medication was added in excess to 3 ml of each component. The mixtures were centrifuged for 30 minutes at 5000 rpm after being allowed to attain equilibrium at room temperature for 24 hours. To determine the drug content using the HPLC method, 1 ml of supernatant from each vehicle was taken out and diluted with methanol[26].

2. Construction Of ternary Phase Diagram

 As crucial as the solubility tests is the creation of phase diagrams. Phase diagrams are primarily used to describe various equilibrium phases, as those found in a thermodynamically stable microemulsion system. There is no real equilibrium between the phases in nanoemulsions since they are thermodynamically unstable. In order to ascertain the excipient ratios that can form a nanoemulsion, pseudo ternary phase diagrams were created in this study[27]. Each point on the phase diagram was evaluated for its capacity to self-emulsify by diluting one gram of the relevant ternary mixture up to 10 mL with distilled water in a sealed vial. The vial was then magnetically agitated for three minutes at 37 °C and a rotation speed of 125 rpm. The diluted mixes' phase separation was then assessed visually. Dispersions that appeared clear or slightly bluish were classified as being in the diagram's nanoemulsion region[28].

 

 

Fig2. Ternary phase diagram in two-dimensional plot (A, B, C illustrate three components of SNEDDS including oil surfactant and co-surfactant)

3. Methods Of Snedds Preparation

1. High Energy Approach

The synthesis of the blend, the combination that contains surfactants, cosurfactants, cosolvents, and other helpful compounds, and the application of energy for the combination's readiness determine the arrangement of nanoemulsion, a high energy technology. The emulsification process is mechanically handled to create nanoemulsion[30].

A. High Pressure Homogenization

This is a significant method that involves sucking the oil and water surfactant mixture through a resistive valve while it is under high strain. The strong shear pressure is responsible for the organization of small emulsion beads. Two theories—choppiness and cavitation—combine to explain the decrease in bead size during homogenization. The high speed of the resulting combination gives the fluid in the homogenizer valve a lot of energy, which causes amazing turbulent vortexes that are the same size as the mean measurement drop (MDD). Because eddie flows were separated from beads, the drop size was reduced. Cavitation, additional swirls and disturbances, and a decrease in the pushing factor across the valve all happen at the same time. The pushing factor of the drop rises as the hole size decreases, increasing the degree of cavitation. If there is enough surfactant to completely cover the produced oil-water interface and the adsorption energy is strong enough to prevent drop coalescence, this approach can provide emulsion beads with diameters as tiny as 100 nm[31].

 

 

Figure3. High pressure homogenization method

 

 

Figure4. Ultrasonication Method

 

 

Figure5. Microfluidization method for SNEDDS preparation

 

 

Figure6. Phase Inversion Method

 

 

Figure7. Continuous Emulsification Method

4. CHARACTERIZATON PARAMETERS OF SNEDDS

1. Particle Size

The particle size of SNEDDS is crucial when administering drugs orally because it can directly affect both in vivo activity and in vitro tests (such as stability and release kinetics). According to reports, SNEDDS's tiny droplet size improves the bioavailability of medications that are delivered[34].

2. Zeta Potential

Zeta seizer is used to determine the charges of oil droplets in prepared SNEDDS; because fatty acids are present, the charges of oil will likewise be negative.[38] SNEDDS will have good stability and a long shelf life if it has higher potential. The emulsion will crack if the zeta potential is low because the attractive forces will enhance the repulsion between solubilizers[35].

3. Percent Transmittance  Determination (%T)

Since the nanoemulsion created by diluting SNEDDS formulations is an optically isotropic mixture of water, oil, and a combination of surfactant and co-surfactant, it is important to assess the clarity of this solution because it is a single thermodynamically stable solution[36].

4.  Self Emulsification Time (Min)

Quick self-nanoemulsification throughout the gastrointestinal tract is ensured by an emulsification time of less than one minute. Under mild stirring in aqueous solutions, this crucial characteristic is evaluated visually[37].

5. Transmission Electron Microscopy

Transmission electron microscopy (TEM) was used to examine the size and shape of the synthesized SNEDDS formulation (JEOL JEM1010, Tokyo, Japan). Prior to analysis, a 120 kV High-Contrast/High-Resolution Digital TEM JEM1010 was used to investigate the diluted SNEDDS (1:100) on a carbon-coated copper grid[38].

6.  Dissolution Studies

Hard gelatin capsules (HGC) of size "00" were filled with the drug-loaded SNEDDS formulation and powdered Dasatinib, both of which were equivalent to 10 mg of the medication. These HGC were placed in 900 ml of pH 1.2 and 6.8 dissolving media at 37±0.5 °C in a USP type II (paddle) equipment running at 50 rpm. Fresh buffer media (1 ml) was added following each sampling, and 1 ml aliquots were taken at prearranged intervals. Each sample was filtered using membrane filters. UV spectrophotometry was used to measure the drug release of dasatinib SNEDDs[39].

7.  Thermodynamic Stability Test

SNEDDS were subjected to a thermodynamic stability analysis using the described methodology [11]. The chosen formulations were examined with the unaided eye for 30 minutes at 13000 rpm in a centrifuge machine (Z-206A, Hermle Labortechnik, Wehingen, Germany). For every 48 hours, the formulations without phase separation were kept at 4°C and 45°C. For 48 hours, the stable formulations were subjected to -21°C and 25°C, and their clarity, phase separation, and drug precipitation were monitored[44].

Pharmaceutical Applications Of SNEDDS

1. Drug Administration As A SNEDDS Through Nasal Route

Because it avoids the liver and gives significantly better compensation than parenteral and enteral delivery, nasal transmissions have attracted a lot of attention. Nano-emulsions increase absorption by dissolving the drug in the emulsion's inner phase and extending the amount of time the emulsion droplets are in contact with the nasal mucosa. Insulin and testosterone are two medications that can be delivered through the nose[40].

2. Controlled Release Solid SNEDDS

Similar to traditional oral formulations, SNEDDS's pharmacokinetic characteristics lead to quick absorption, which produces a high Cmax and a low Tmax. This may result in variations in the concentration of the drug in the plasma, requiring careful observation.Controlled-release SNEDDS, which offer prolonged and controlled-release qualities without sacrificing bioavailability, have been created to address this problem. Better bioavailability, a decreased Cmax, a longer mean residence time (MRT), a delayed Tmax, and less plasma drug fluctuations are all provided by controlled-release SNEDDS. Reconstituted nano-sized emulsions are released from the tablet's surface at a zero-order kinetic rate to produce controlled medication release[41].

3. SNEDDS In Cosmetic Science

increasingly crucial for optimal dispersion of active substances in skin layers and regulated cosmetic delivery. They facilitate skin penetration and are useful for carrying lipophilic substances, which raises the concentration of active ingredients.Because they don't cream, sediment, flocculate, or coalesce, they can be used in cosmetics[42].

4. SNEDDS In Delevering Antimicrobial Agents

SNEDDS is a technique for improving drug solubility that is unaffected by the impact of pH on solubility. Self-nano emulsifying drug delivery systems were created using cefpodoximeproxetil (CFP), a high-dose, poorly bioavailable antibiotic with pH-dependent solubility. When compared to a pure CFP, the resulting SNEDDS have a higher release rate[18].

5. SNEDDS In Mucoadhesive Drug Delivery

Recently, there has been increased interest in creating mucoadhesive SNEDDS. To improve muco-adhesion, muco-penetration, and site-specific distribution, the process entails thiolating SNEDDS with polymers like Pluronic® and chitosan and/or coating the formulation with stronger muco-adhesives like alginate and Carbopol®[16]

6. SNEDDS In Targeted Drug Delivery

Through surface functionalization, SNEDDS can distribute drugs in a targeted manner. It is possible to keep nanoemulsion droplets in the bloodstream for extended periods of time. Additionally, cationic nanoemulsions have the ability to adhere directly to anionic membrane barriers.The most straightforward method of targeting the liver and spleen is for the lipid-based SNEDDS to be absorbed by these organs. Additionally, SNEDDS have the potential to target macrophages and are selectively helpful for drugs that target the lymphatic system[43].

CONCLUSION

SNEDDS offer a crucial way to increase the oral bioavailability of substances that are poorly soluble in water. Nonetheless, the choice of formulation ingredients and their proportionate amounts is crucial and varies depending on the medicine. The best formulation choice is primarily determined by each drug's physicochemical characteristics. One of the key factors in achieving the appropriate medication concentration in the systemic circulation to generate therapeutic activity when taken orally is the drug's solubility. This study thoroughly establishes the effectiveness of a self-nanoemulsifying system-based medication delivery method in resolving present bioavailability issues. In order to create the foundation for even greater success in the field, this reevaluation outlines the current methods and concerns in favor of thriving self-nanoemulsifying base drug administration.

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