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Soybean Oil: A Versatile Asset in Pharmaceutical Drug Delivery

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Biswaranjan Mohanty, Amulyaratna Behera, Tapan Kumar Shaw, Sk. Habibullah and Biswajeet Acharya

Submitted: 25 December 2023 Reviewed: 24 April 2024 Published: 25 July 2024

DOI: 10.5772/intechopen.115033

Soybean Crop - Physiological and Nutraceutical Aspects IntechOpen
Soybean Crop - Physiological and Nutraceutical Aspects Edited by Jose C. Jimenez-Lopez

From the Edited Volume

Soybean Crop - Physiological and Nutraceutical Aspects [Working Title]

Dr. Jose C. Jimenez-Lopez and Dr. Julia Escudero-Feliu

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Abstract

Soybean oil (SO), a lucrative and widely utilized vegetable oil, is used not only in the pharmaceutical industry but also to produce green diesel and several biomedical applications. SO is rich in healthy fats, including linoleic acid (54%), oleic acid (23%), palmitic acid (11%), linolenic acids (8%), and stearic acid (4%). Its high unsaturated fatty acid content makes it ideal for medicinal purposes. In topical application, SO provides anti-inflammatory and soothing benefits. The presence of SO in lipid-based medication improves the therapeutic efficacy and bioavailability of poorly water-soluble drugs. Its emulsifying properties support the development of Self-Emulsifying Drug Delivery Systems (SEDDS) and Self-Micro Emulsifying Drug Delivery Systems (SMEDDS), helping the oral administration of hydrophobic drugs. Additionally, soybean oil is included in total parenteral nutrition (TPN) solutions to provide essential fatty acids to patients unable to swallow. SO, biocompatibility, stability, and low toxicity make it a brilliant base for transcutaneous and topical delivery systems, enlightening the absorption of active medicinal ingredients. In gist, unique properties and a wide variety of applications make SO a star material in pharmaceuticals to enhance solubility, bioavailability, and the development of safe and effective drugs.

Keywords

  • oils
  • absorption
  • formulations
  • solubility
  • permeability

1. Introduction

Cultivation of annual crop started in China between 4000 and 5000 years ago. After that, it went to Europe in 1712 and then to the United States in the middle of the eighteenth century. Soybean has many benefits, including being an excellent cycle crop that can fix nitrogen, growing well in a wide range of soils and temperatures, producing more protein than any other crop, and being helpful in many ways. Using edible fats and oils has been an essential part of human diets for a long time. They contain vital fatty acids, fat-soluble vitamins, and other valuable substances. They carry out necessary biological and physiological functions in the body. Soybean oil (SO) comes under long-chain triglycerides (C16-C22). The oil serves as vegetable oil and is also used as fixed oil in many other cases [1]. Generally, oils have been categorized into two parts: fixed oil and volatile oil.

From ancient times, SO has been used as cooking oil until its nutritional benefits were not explored. But now, it will be used in formulation development as a surfactant to stabilize the emulsion, to protect from cardiovascular disease, and as a food supplement in different countries. SO was obtained from the seed of Glycine max (L.) Merr belongs to the family Fabaceae. China, the United States, Brazil, and Argentina are the top countries responsible for large SO production. A significant amount of oleic, linoleic, and linolenic acid is present in vegetable oil, making it a promising drug delivery candidate. All three components of SO regulate its efficacy in drug delivery [2]. SO was used for the fabrication of pharmaceutical and cosmeceutical applications. It will have an outstanding impact on drug delivery applications. The literature shows that SO has different activities like anti-inflammatory, emollient effects, soothing effects, and enhanced drug permeation, and is also used in cardiovascular diseases. The presence of different compositions of SO makes it a suitable excipient-like surfactant in biphasic dosage form and enhances the drug’s solubility.

The unsaturated fatty acid composition of bean oils makes it an excellent pharmaceutical delivery option, rich in beneficial fats, including those mentioned above three fatty acids. About 54% of regular soybean oil is linoleic acid (18:2), 23% is oleic acid (18:1), 11% is palmitic acid (16:0), 8% is linolenic acid (18:3), and 4% is steric acid (18:0) [3]. In many nations, SO is an essential source of dietary PUFAs. Linoleic acid (LA), which contains n-6 PUFA, is the primary fatty acid in SO. It makes up about 51% of the total fat [4]. Oleic acid also plays an essential role in drug delivery. It acts as a solubilizer and helps penetrate the drug to the deeper skin area [5]. SO is also used in cardiovascular diseases (CVD) and coronary heart diseases. SO raises the amounts of lipids and lipoproteins in the blood, which are the main goals for preventing and treating CVD. After a review of the relevant data, the US Food and Drug Administration (FDA) officially recognized this cholesterol-lowering replacement effect in 2017 when it accepted a qualified health claim for soybean oil and coronary heart diseases [6]. SO’s wide-ranging usage and economic importance make it a promising pharmaceutical research and development component. The biochemical skeleton of SO made a unique environment that burst the utility of oil in the pharmaceutical sector. Other factors associated with it, like organic composition, physical properties, and medicinal uses, brighten its potential as a multidimensional pharmacological performer [7]. Lipid-based drug delivery has gained so much attention in the last decayed as it enhances the solubility of poorly water-soluble drugs, which was a difficult task in pharmaceutical research design.

As SO contains all the essential fatty acids, it plays a crucial role in lipid-based drug development [8]. SO reduces the mononuclear cell proliferation in healthy humans and enhances the pharmaceuticals’ stability as they contain phospholipids, which are amphiphilic and act as former in many lipid pharmaceutical product developments [9, 10]. In developing pharmaceutical delivery systems like SEDDS and SMEDDS, an emulsifier was necessary to conjugate between hydrophilic and lipophilic ends. As SO contains major phospholipids phosphatidylcholine (PC) 39%, phosphatidyl ethanolamine (PE) 23% and approximately 20% phosphatidyl inositol (PI), it will act like an emulsifier and enhance the stability [11]. Oral delivery of hydrophobic drug solubility was improved by incorporating SO as an excipient and facilitating absorption in the gastrointestinal tract [12]. It was well established that the presence of oil in the pharmaceutical formulations enhanced the delivery of the drug and increased the permeation in topical applications by increasing lipophilicity [13]. SO’s natural and non-irritating nature makes it a versatile excipient in topical delivery; also, including SO in the transdermal application provides anti-inflammation and soothing to the skin with desired nutritional fulfillment to the patient, making it a star element in diverse pharmaceutical applications [14]. Enhancing the solubility and bioavailability of active pharmaceutical ingredients and ensuring the safety and effectiveness of pharmaceutical formulations transforms them into a practical tool for drug delivery. While demonstrating promising potential for medication delivery, additional research is essential to fully unveil its therapeutic capabilities and explore alternative avenues in pharmaceutical development [15]. In gist, the unique biochemical composition, physical properties, and medicinal uses of SO make it an essential pharmacological excipient in drug delivery field. SO has promising medication delivery potential, but further study is needed to unlock its full therapeutic potential and explore new pharmaceutical development alternatives. SO might revolutionize medication distribution and therapeutic interventions as the pharmaceutical sector evolves [16]. SO also plays an integral part in developing intravenous nutrition solutions, particularly in total parenteral nutrition (TPN) formulations. TPN provides essential nutrients, especially fatty acids, for those patients who are subconscious or unconscious [17].

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2. Preparation and extraction of SO

The choice of preparation technique affected the final product of SO, which has significant consequences for its use in medicines and other sectors. Solvent evaporation method, cold press, or supercritical fluid extraction affect SO output, purity, and nutritional value [18]. Extraction efficiency, solvent choice, and processing conditions must be optimized for pure SO. To remove impurities and improve SO quality, solvents and processing conditions must be wisely chosen [19]. This accuracy was quite challenging when SO was used in developing pharmaceutical formulations, where excipient quality affects the final medication safety, therapeutic stability, and yield value. The optimization of preparation procedures also concerns sustainability and environmental effects. Compact solvent use, energy consumption, and trash creation help produce more ecofriendly procedures, coinciding with the pharmaceutical and food sectors’ focus on green and sustainable practices [20]. For extraction of SO, dried soybean seeds were collected and cleaned. Then it is subjected to cracking to remove the outer layer, and the process is called flaking. After the process, the flakes were subjected to an extraction process using different methods (like solvent extraction, supercritical fluid extraction, mechanical extraction, or cold press extraction). Then, by condensing, the oil was collected, and for the medicinal grade, it was filtered and refined. After this process, pure SO was collected. The detailed protocol for synthesizing SO from Soybean seeds is depicted in Figure 1 [21].

Figure 1.

Extraction protocol of soybean oil from soybean.

2.1 Selection of high-quality soybeans

Medicinal-grade soybeans were collected by a meticulous selection procedure. High-quality soybeans, free from contamination and genetically modified, were chosen for medicinal uses. Nongenetically modified soybeans obtained the best quality SO [22].

2.2 Cleaning and sorting

After selection, beans are systematically cleaned to remove contaminants, mud, and external particles. Only clean soybeans go to the next step after carefully sorting [23]. This process affected the quality and purity of the final products.

2.3 Crushing or flaking

In the next step, the beans were subjected to increase the surface by either being crushed or flaked. Beans were broken into small particles in crushing, whereas flaking makes them thin flakes. Both approaches aid oil extraction in the following processes [24].

2.4 Conditioning

After compactification of crushing or flaking, beans undergo a conditioning process. Oils were separated from the cellular structure when beans were at the appropriate temperature [25]. In this step, extraction efficiency was boosted, and quality was also achieved.

2.5 Extraction methods

Various extraction methods are employed to obtain SO, each with advantages and suitability for pharmaceutical applications (Table 1).

Extraction MethodBasic PrincipleApparatus UsedSolvent UsedYieldAdvantagesDisadvantagesReferences
Solvent ExtractionExtracts oil using a solvent (usually hexane)Continuous or batch extractor, evaporator, and desolventizerHexaneHigh yield (around 98%)Efficient for large-scale production, thorough extractionEnvironmental concerns, potential solvent residue[26, 27]
Cold Press ExtractionMechanical pressing to extract oil without external heatExpeller press or screw pressNo solvent usedLower yield (typically 65–70%)Retains natural flavors and nutrients, no heat damageInefficient for large-scale production, lower yield[28, 29]
Supercritical Fluid ExtractionUses supercritical carbon dioxide as a solventSupercritical fluid extractorSupercritical CO2High yield (comparable to solvent)No residual solvent, minimal heat damageExpensive equipment, requires expertise, energy-intensive[30, 31]

Table 1.

Basic principles and procedures involved in the extraction of SO.

2.5.1 Solvent extraction

Solvent extraction is a conventional method where food-grade solvents extract the oil from the beans’ meals [32]. SO was collected, followed by the evaporation process. It is an ideal methodology for extracting SO on a large scale for commercial applications [33].

2.5.2 Cold press extraction

Cold press extraction involves mechanically pressing the soybean seed to extract the oil without using heat or chemicals. This method is considered more natural and retains the nutritional qualities of the oil [34]. Applying heat or chemicals may lead to the destruction of temperature or chemically sensitive phenolic compounds. Also, heat may be a reason for the initiation of the oxidation process. SO obtained from cold press methods preserved all the bioactive properties of the oil. Cold-pressed SO benefited pharmaceutical applications as all the natural properties were retained. Although it may yield lower quantities compared to solvent extraction, it is valued for its potential to produce high-quality, minimally processed oil suitable for pharmaceutical use [35]. To clean cold-pressed oils, only wash them with solvent (mostly water), filter them, and spin them in a centrifuge at high rpm. In this process, all the nutritional benefits of the oils were preserved and will help improve therapeutic efficacy. As all the components will be preserved in the cold press methods, they provide a strong flavor, color, and unique smell, and consumers are more attracted to the cold press methods than all other methods.

2.5.3 Supercritical fluid extraction (SFE)

Extraction executive above the temperature and pressure in which a substance acts as both gaseous and liquidus state called SFE. Supercritical fluid extraction is an advanced method that utilizes carbon dioxide (CO2) in its supercritical state to extract oil from soybeans [36]. CO2 was mainly used in the pharmaceutical field due to its very low critical temperature and pressure (Tc = 304.2 K and Pc = 7.38 MPa). This mild environmental condition was very advantageous to the thermo-sensitive drugs, mainly peptides, proteins, and phenolic compounds. Also, CO2 was recognized by the US US-FDA as generally regarded as safe (GRAS) product. Also, it is cheap in quality and non-flammable in nature [37]. CO2 is a safe solvent with a high threshold limit value of 5000 ppm. So, this method collected high-quality oils by keeping the bioactive component safe. It is considered environmentally friendly and is suitable for pharmaceutical applications where a pure and solvent-free product is desired [26, 27, 28, 29, 30, 31, 38].

2.6 Filtration

After extraction, there are some possibilities of residues like waxes, pigments, or other unwanted materials. Filtration was carried out in different capillary membrane pore sizes. According to the pore size, filtration has been carried out in 100-10,000 nm, 10–100 nm, or 1–10 nm are called microfiltration, ultrafiltration, and nanofiltration, respectively. According to the high purity, the medicinal used carefully chose the filtration process as it was executed under high pressure. Microfiltration requires a minimum pressure of 1.38–2.76 × 105 Pa, whereas in ultrafiltration, nanofiltration requires a pressure of 6.89 × 105 Pa [39]. Filtration is essential for medicinal oil purity and safety. [34]. It plays a crucial role in meeting the stringent quality standards required for pharmaceutical-grade SO; to meet the purity level, different filtration techniques were chosen.

2.7 Refining

The refining process was involved in obtaining purified and stabilized SO. Various processes involved in the step are degumming, neutralizing, bleaching, and deodorizing. Acidity and phospholipids were diminished with the help of acidity and degumming, respectively. Color and odor should be removed by bleaching and deodorization [36]. These refining steps collectively enhance the SO’s quality, appearance, and stability for pharmaceutical formulations.

2.8 Quality control and testing

The final product undergoes rigorous quality control and testing to ensure it meets the stringent standards for pharmaceutical applications. Parameters such as purity, composition, absence of contaminants, and compliance with specified quality standards are carefully evaluated [40]. Quality control measures are implemented at each stage of the production process to guarantee the consistency and safety of the pharmaceutical-grade SO.

2.9 Packaging

The pharmaceutical-grade SO is carefully packaged in suitable containers under controlled conditions. This packaging is designed to prevent contamination and maintain the quality of the oil until it reaches pharmaceutical manufacturing facilities [41]. Stringent measures are implemented to ensure that the final product retains its purity and efficacy throughout the storage and transportation processes.

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3. Factors affecting the bioavailability, solubility, and permeability process of soyabean oil

The incorporation of SO into lipid-based drug formulations, such as SEDDS and SMEDDS, is driven by its remarkable capacity to significantly enhance poorly water-soluble drugs’ solubility, bioavailability, and permeability [42]. SO provides a lipophilic environment by contributing to the presence of fatty acids in them, which makes the gastrointestinal tract (GI) environment lipophilic and increases the solubility of the drug. Increasing the solubility makes the absorption higher, enabling the therapeutic efficacy of the drug in systemic circulation [43]. It has been established that SO is a long-chain triglyceride. In oral drug delivery, incorporation of SO binding with drug molecules. The presence of triglycerides in the SO encapsulated the drug molecules. As triglycerides were lipophilic, and the drug was encapsulated in the triglycerides, it quickly passed through the diffusion membrane of the GI tract [44]. By encapsulation, SO enhanced the solubility of poorly water-soluble drugs in the GI system (Figure 2). The formation of fine droplets or emulsions induced by SO is pivotal in augmenting the bioavailability of these drugs, ensuring a substantial portion of the administered dose reaches systemic circulation for therapeutic action. These increase systemic availability and foster more consistent and predictable therapeutic effects [45].

Figure 2.

Physiological processes involved in the drug absorption.

Additionally, the permeability of drugs across the intestinal membrane is facilitated by SO within lipid-based formulations, a critical factor for drugs encountering challenges in traversing biological barriers [46]. By leveraging natural lipid pathways and potentially bypassing efflux transporters, SO further elevates drug absorption. Considering these multifaceted contributions, SO emerges as a valuable and versatile component, playing a pivotal role in optimizing the performance of oral drug delivery systems for poorly water-soluble drugs under diverse influencing factors [47]. Figure 2 describes a general pathway in which lipids help the drug molecule to absorb. Several processes like lipid-based nanoemulsion, solid dispersion, and pH adjustment are some basic techniques in which the solubility of the drug molecule is enhanced, ultimately increasing the drug absorption and permeation. Surfactant, cosurfactant, or polymeric materials are mainly used as drug carriers. Detailed information about the methods used to improve SO’s solubility, permeability, and biocompatibility can be found in Table 2 [48, 49, 50, 51, 52, 53, 54, 55, 56]. Oral drug delivery was the convenient root for transporting medication to blood tissue. SO increases the solubility of a drug by different methods, such as a fusion of solvent, melt extrusion, high-pressure homogenization, coprecipitation, freeze-drying, and microencapsulation. By acquiring these processes, the pharmaceutical company can enhance the drug efficacy and reduce the dose requirement; ultimately, it is beneficial for patient compliance by reducing side effects and toxicity.

MethodTypeSubtypesTechniquesChemicalsPropertiesPharmaceutical ApplicationReferences
NanoemulsionsNanotechnologyOil-in-water (O/W), water-in-oil (W/O)High-pressure homogenization, ultrasonicationSurfactants, cosurfactantsIncreased surface area, improved stability, enhanced bioavailabilityImproved delivery of poorly water-soluble drugs[48, 49]
Micelle FormationSurfactant-basedSelf-micellization, cosolvencySolubilization, cosolvencySurfactants, cosolventsIncreased solubility, improved bioavailabilityEnhanced oral delivery of hydrophobic drugs[50]
Solid DispersionSolid-state dispersionAmorphous, crystallineFusion, solvent evaporation, melt extrusionPolymers, carriersIncreased solubility, enhanced stability, improved permeabilityImproved dissolution rate and absorption of drugs[51]
Lipid-Based FormulationsLipid-basedSelf-emulsifying drug delivery systems (SEDDS), liposomesFormulation design, high-pressure homogenizationLipids, surfactantsImproved solubility, increased bioavailability, controlled releaseEnhanced delivery of lipophilic drugs[52]
Cyclodextrin ComplexationComplexationInclusion, molecular encapsulationCoprecipitation, freeze-dryingCyclodextrinsIncreased solubility, enhanced stability, improved bioavailabilityStabilization and solubilization of drug compounds[53]
pH AdjustmentPhysicochemical modificationAcidification, alkalizationpH adjustmentAcids, basesEnhanced solubility under specific pH conditions, improved bioavailabilityUtilized for drugs sensitive to pH changes[54]
Cosolvent ApproachSolvent-basedBinary, ternarySolvent selection, concentration optimizationCosolventsIncreased solubility, improved bioavailabilityUseful for enhancing the solubility of lipophilic drugs[55]
Particle Size ReductionMechanical modificationMicronization, nanosizingMilling, grindingNoneIncreased surface area, improved permeabilityImproved dissolution and absorption of poorly soluble drugs[56]

Table 2.

Methodologies for achieving good solubility, permeability, and biocompatibility in SO.

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4. Nutraceutical and chemical profile of soybean oils

SO, a commonly used cooking oil has nutraceutical qualities that go beyond its nutritional value and provide economic utility. Oil plants harbor lipids principally self-possessed of triacylglycerols, rich in mono and polyunsaturated fatty acids. These serve as vital nutritional elements and a concentrated energy reservoir. Lipids play essential physiological roles within the human body, contributing to cellular membranes and the brain’s white matter. Oil plants serve as valuable reservoirs of essential fatty acids, phospholipids, and phytosterols, as well as antioxidants like tocopherols, carotenoids, and polyphenolic compounds [57]. A triglyceride is mainly composed of glycerol units with three fatty acids. In SO, linolenic, linoleic, and oleic acid were the main three components present in excess amounts, from which significant amounts are found in unsaturated fatty acids like linolenic (48–58%) and linoleic acid (4–10%). These acids are necessary for human growth and development [58]. All the essential components of the SO were schematically figured in Figure 2. It is suggested that polyunsaturated fats (PUFA) be used in favor of saturated fats (SFAs) to lower the risk of coronary heart disease (Figure 3) [59]. ω-6 (nω-6) PUFA or a high dietary ratio of nω-6 to ω-3 (nω-3) fatty acids leads to proinflammatory and pro-oxidative states. From the literature, it has been proved that free radicals oxidize the cells and initiate a disease state. LA, an essential n-6 PUFA, is the main fatty acid in SO. It makes up about 51% of the total fat content. There is evidence that switching from SFAs to SO raises blood lipid and lipoprotein levels, which are the main goals for preventing and managing CVD [4]. Also, SO is a rich source of tocopherols and sterols, mainly 91% beta-sitosterol, stigmasterol, and campesterol. The main biological work of β-Sitosterol was to prevent cholesterol deposition in arteries, anticancer activities, anti-inflammatory activities, and protection against CVD [32]. Vitamin E is another component that is present in SO and potentially reduces free radical and safe the cells from oxidative damage, with significant benefits toward anti-aging effect [60]. A trace amount of isoflavones and phytoestrogens have the potential to regulate the hormone and favor menopausal symptoms. The primary mechanism of the phytosterols, vitamin E, isoflavones, and phytoestrogens is that they carry potent antioxidants, protecting cells from oxidative damage, which prevents heart attack or stroke in the heart vessel. Lipid molecules contain phosphorus called phospholipids, which are defined as natural phospholipids obtained from natural sources like sunflower, rapeseed, and soybean seeds. Additionally, the presence of phospholipids acts as an emulsifier, which gives a better excipient for industrial uses. Phospholipids contain a polar head group and a lipophilic tail and are basically amphiphilic in nature. They are used in emulsifiers, wetting agents, solubilizers, and liposome former [10]. Vegetable oils are susceptible to oxidative breakdown, known as lipid oxidation. The extent of this process is influenced by the types of fatty acids present and the quantity of antioxidants within the oils. Tocopherols are very important for this. Zaunschirm et al. performed an experiment where their finding described that among all the vegetable oils (canola, sunflower, SO), SO shows high stability due to the presence of tocopherols [61]. In short, it can be concluded that SO is used for healthy human health and prevents various diseases by providing necessary nutraceuticals for resources and development. The role of phytosterol, vitamin E, and fatty acids in preserving the heart cell is described in Table 3. The contributing role of the above phytoconstituent to the human being and nutraceuticals and chemical potential of SO fo health benefits was also described [62, 63, 64, 65, 66]. With these neutraceutical benefits, SO also has some pharmaceutical benefits, which are described below.

Figure 3.

Essential components present in soybean oil.

Nutraceutical ComponentTypeSubtypesValues/ContentDietary RequirementsHealth BenefitsReferences
Fatty acidsLipidsSaturated, monounsaturated, polyunsaturatedBalanced profile of fatty acids, including omega-6 and omega-3No specific dietary requirements; moderation advisedSupports heart health, brain function, and anti-inflammatory responses.[62]
Vitamin EAntioxidantsTocopherolsRich in alpha-tocopherolAdequate intake varies; adults need around 15 mg/dayActs as a powerful antioxidant, protecting cells from oxidative damage; supports skin and immune health.[63]
PhytosterolsPlant compoundsSitosterol, CampesterolSimilar to cholesterol structureNo specific dietary requirements; dietary intake beneficialHelps lower low-density lipid (LDL) cholesterol levels, supporting heart health.[64]
AntioxidantsPlant compoundsTocopherols, polyphenolsHigh levels of tocopherols and polyphenolsNo specific dietary requirements; dietary intake beneficialCombats oxidative stress, reduces inflammation and may lower the risk of chronic diseases.[65]
Nutrient absorptionBioactive compoundsUnsaponifiablesEnhances absorption of fat-soluble vitaminsNo specific dietary requirements; dietary intake beneficialFacilitates the absorption of fat-soluble vitamins, supporting overall nutrient utilization.[66]

Table 3.

Types of nutraceuticals and chemical constituents present in soybean oils and their potential health benefit.

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5. Prospective use of SO in pharmaceutical applications

The pharmaceutical sector uses vegetable oils in many ways, and these uses have different effects. One important example is the ongoing research into vegetable oils as an alternative way to treat wounds due to their well-balanced mix of fatty acids that come from natural sources. More and more people are interested in using bioactives from vegetable oil to make pharmaceuticals perform effectively. At the same time, nanoformulations are being made to improve the health benefits of chemicals obtained from vegetable oil. Additionally, the study of vegetable oils to improve their preserving benefits in food, medicine, and cosmetics shows how important beneficial substances from these oils are for protecting human health and the long-term use of the world’s natural resources. Figure 4 shows the use of SO in the pharmaceutical industry.

Figure 4.

Broad spectrum application of SO in pharmaceuticals.

5.1 Drug delivery systems

Bioavailability was one of the biggest limitations in developing new dosage forms, which hinders the therapeutic properties of dose forms taken orally. Until now, more than 40% of drug molecules suffer from low bioavailability, mainly Biopharmaceutical Classification System (BCS) II and IV. To enhance the absorption orally or topically, SO was the best excipient that the formulations scientists may use. The most common method is that hydrophobic drugs are dissolved or spread out in oil and then enclosed in the delivery matrix to make them more bioavailable. Bioavailability is increased by making the drugs more soluble, protecting them from stomach conditions, and releasing the drugs in a controlled way. SO may be one of the excipients that will be doing a three-dimensional evolution in drug delivery technology.

5.1.1 The challenge of poor water solubility

The active pharmaceutical products were classified into four types according to the BCS standard. Mainly, BCS II and IV suffer from poor solubility problems. Incorporation of SO may dissolve the problem to a specific extent. SO is enriched with linoleic acid (18:2), 23% is oleic acid (18:1), 11% is palmitic acid (16:0), 8% is linolenic acid (18:3), and 4% is steric acid (18:0). SO contains large amounts of unsaturated fatty acids like linolenic (48–58%) and linoleic acid (4–10%). SO is a rich source of tocopherols and sterols, mainly 91% beta-sitosterol, stigmasterol, and campesterol. SEDDS and SMEDDS are the best delivery matrices for overcoming the solubility issue.

5.1.2 SO as an effective carrier

It has been established that SO is a long-chain triglyceride. In oral drug delivery, SO binding is incorporated with drug molecules. The presence of triglycerides in the SO encapsulated the drug molecules. As the long chain contains 16–22 carbon atoms so, the drug molecule will be easily entrapped in the triglycerides (TG) molecule. It will act as an effective delivery carrier in topical and oral delivery.

5.1.3 Emulsions: a symphony of lipids

Emulsions represent a classical yet highly effective lipid-based drug delivery system where SO plays a key role. In pharmaceutical emulsions, SO forms the lipid phase, creating a colloidal dispersion of oil droplets in an aqueous medium [67]. This architecture provides a stable platform for drug incorporation and facilitates the dispersion of lipophilic drugs, enhancing their absorption in the gastrointestinal tract. The amphiphilic nature of SO makes it a harmonious conductor in this symphony of lipids, contributing to the success of emulsion formulations [68].

5.1.4 Micelles

Micellar drug delivery systems represent an elegant choreography of amphiphilic molecules in an aqueous environment. SO, with its lipophilic prowess, it becomes an integral part of this molecular ballet. The hydrophobic core of micelles, formed by surfactants and aided by SO, is a haven for lipophilic drugs [69]. The incorporation of these drugs into the hydrophobic core not only improves their solubility but also enhances their bioavailability. The use of SO in micellar systems showcases its versatility as a carrier in creating an aqueous environment conducive to drug absorption [70].

5.1.5 Lipid nanoparticles

The advent of lipid nanoparticles, including nanoemulsions and solid lipid nanoparticles, marks a revolutionary step in drug delivery technology. In these systems, SO assumes a prominent role in shaping the lipidic matrix [71]. In nanoemulsions, SO creates tiny droplets that encapsulate lipophilic drugs, ensuring their stability and facilitating their absorption. On the other hand, solid lipid nanoparticles utilize SO as part of the solid lipid matrix, providing a controlled release mechanism for the incorporated drugs [72]. The utilization of SO in lipid nanoparticles represents a sophisticated approach to overcoming the challenges of drug solubility, offering precise control over drug release kinetics.

5.1.6 Solubilizing agents

SO brings additional advantages beyond its role as a solubilizing agent. The presence of natural antioxidants, primarily vitamin E in the form of gamma-tocopherol, contributes to the stability of lipid-based formulations [73]. These antioxidants act as a shield, protecting the drugs and the carrier from oxidative degradation during storage and administration. Furthermore, the synergy between the lipids in SO and certain drugs may enhance therapeutic outcomes, showcasing the intricate interplay between carrier and cargo in lipid-based drug delivery [74].

5.2 Total parenteral nutrition (TPN) overview

Total parenteral nutrition represents a sophisticated and lifesaving approach to delivering essential nutrients directly into the bloodstream. This method becomes imperative when individuals face challenges in oral food intake due to severe gastrointestinal issues, post-surgical recovery, or conditions hindering normal nutrient absorption [75]. TPN formulations are meticulously designed to encompass a comprehensive mix of macronutrients, micronutrients, and, notably, essential fatty acids.

5.2.1 The essence of essential fatty acids

SO is a composite of four fatty acids: α-linolenic acid, linoleic acid, oleic acid, and saturated fatty acid. Among them, LA was nearly enriched, about 51%, and contains PUFA; ω-6, which are essential for the human diet and also directly associated with the decreased risk of cardiovascular disease and reductions in concentrations of cardiovascular disease risk markers, like total cholesterol, LDL cholesterol, and plasma triacylglycerol. ω-6 fatty acid is also associated with immunosuppressive effects [76]. These fatty acids are labeled ‘essential’ because the human body cannot synthesize them independently, emphasizing their critical role in maintaining health. Omega-6 fatty acids, predominantly found in SO, contribute to cellular structure, signaling pathways, and metabolic functions [77]. Till now, it has been a controversial topic, and no proof or evidence has been satisfactory yet. TPN’s cellular pathway may follow the below pathway (Figure 5) [78]. Including these fatty acids in TPN reflects a profound understanding of their significance in sustaining the fundamental aspects of human physiology.

Figure 5.

Signaling pathway and cellular response of SO with respect to TPN.

5.2.2 Cellular integrity and organ support

The relevance of essential fatty acids derived from SO in TPN extends beyond their role as structural components. These fatty acids are integral to maintaining cellular integrity, ensuring the fluidity of cell membranes, and participating in cellular signaling cascades [79]. In organs such as the liver, heart, and brain, essential fatty acids are vital for optimal function. Incorporating SO into TPN formulations aligns with the physiological demands of various tissues, promoting organ health and resilience [80].

5.2.3 Metabolic harmony and energy production

The metabolic dance within the human body requires a harmonious symphony of nutrients, and essential fatty acids contribute significantly to this intricate ballet. In TPN, SO-based lipid emulsions provide energy through the metabolism of fatty acids [81]. As a concentrated energy source, SO aids in meeting the elevated energy demands of individuals undergoing TPN, supporting their metabolic processes and fostering a state of nutritional equilibrium [82].

5.2.4 Balancing the fatty acid spectrum

SO-based lipid emulsions provide a balanced spectrum of fatty acids, mirroring the diverse requirements of the human body. While saturated fats contribute to the stability of the emulsion, monounsaturated and polyunsaturated fats, including essential fatty acids, offer nutritional diversity [82]. The balance achieved in SO-based emulsions underscores the meticulous formulation necessary to meet the dynamic nutritional demands of individuals undergoing TPN [83].

5.3 Emulsifying agents

In pharmaceutical formulations, the natural emulsifiers found in SO, particularly lecithin, take center stage as versatile and invaluable components. Lecithin, extracted from SO, possesses remarkable emulsifying properties that make it a stabilizing force in various liquid formulations, including emulsions and suspensions [84]. This natural emulsifier plays a crucial role in enhancing the stability and dispersion of active pharmaceutical ingredients (APIs), ensuring uniform distribution, and facilitating the administration of medications. In this exploration, we delve into the intricate world of SO-derived lecithin, unraveling its significance in pharmaceutical sciences and its impact on developing stable and effective liquid formulations [85].

5.3.1 Role of lecithin in SO

Lecithin is a byproduct of vegetable oil extracted from raw crude oil. Phospholipids (PL) affect how lecithin (an amphiphilic substance) works because of their physical features and geometrical structure. In particular, PLs ability to self-assemble and its lower surface tension makes it possible to make different supramolecular structures and oil-in-water emulsions. In the following parts, we’ll look at some of the functional qualities, like self-assembly and interfacial properties, of lecithin and PL in micelles, liposomes, and oil-in-water emulsions. In soybean lecithin, the PL composition includes 15% phosphatidylcholine (PC), 10% phosphatidylinositol (PI), 11% phosphatidylethanolamine (PE), and 4% phosphatidic acid (PA) [86].

5.3.2 Stabilizing force in emulsions

Emulsions, characterized by the dispersion of one immiscible liquid phase (e.g., oil) within another liquid phase (e.g., water), are commonplace in pharmaceutical formulations. Lecithin derived from SO is pivotal as a stabilizing force in emulsions [87]. The amphiphilic nature of lecithin allows it to position itself at the oil-water interface, forming a protective layer that prevents coalescence and separation of the dispersed phase. This stabilization is crucial for the shelf life and quality of emulsion-based pharmaceutical products [12].

5.3.3 Emulsifying properties

The emulsifying properties of lecithin stem from its ability to reduce interfacial tension between oil and water phases. This reduction in tension facilitates the formation and stabilization of tiny droplets of the dispersed phase within the continuous phase [88]. In the context of pharmaceutical emulsions, this translates to improved dispersion of lipophilic APIs, ensuring their uniform distribution and enhancing bioavailability upon administration.

5.3.4 Ensuring uniform dispersion of APIs

Active pharmaceutical ingredients (APIs) often pose formulation challenges due to their hydrophobic nature or poor aqueous solubility [89]. When incorporated into pharmaceutical formulations, lecithin serves as a bridge between water and lipophilic APIs, facilitating their dispersion in aqueous vehicles. This dispersion is critical for achieving homogeneous formulations where the API is evenly distributed, allowing for precise dosing and consistent therapeutic effects [90].

5.3.5 Stabilizing suspensions

Beyond emulsions, lecithin from SO stabilizes suspensions – systems where solid particles are dispersed in a liquid medium. In pharmaceutical suspensions, lecithin helps prevent sedimentation or settling of solid particles over time [87]. The amphiphilic nature of lecithin imparts a protective coating to the suspended particles, hindering their agglomeration and maintaining a stable and homogeneous suspension.

5.3.6 Lipid-lowering agents and cardiovascular health

Lecithin’s role extends beyond its emulsifying properties and contributes to the potential health benefits associated with specific pharmaceutical formulations [91]. For example, lecithin has been explored in developing lipid-lowering agents that positively impact cardiovascular health. By modulating lipid profiles, these formulations highlight the multifaceted nature of lecithin in pharmaceutical research [92].

5.3.7 Formulation challenges and lecithin solutions

In formulating pharmaceutical products, addressing challenges related to stability, solubility, and bioavailability is paramount. Lecithin, a natural emulsifier, is a valuable solution to these hurdles [93]. Particularly beneficial for poorly water-soluble drugs, lecithin facilitates the creation of stable emulsions or suspensions, thereby enhancing drug solubility and overall formulation performance. The effectiveness of lecithin in pharmaceutical formulations is heightened by its synergistic interactions with other excipients. Combining lecithin with surfactants or coemulsifiers enhances formulation stability and emulsifying properties, allowing precise customization of characteristics like viscosity, droplet size, and overall stability [94]. Beyond conventional applications, the utility of lecithin extends to nanotechnology, notably in lipid-based nanoparticles within drug delivery systems. As a fundamental component, lecithin contributes to the formulation of liposomes or nanoemulsions, facilitating the encapsulation of drugs for targeted and controlled release [95]. This represents a cutting-edge frontier where lecithin’s emulsifying properties play a pivotal role in shaping the future landscape of pharmaceutical nanotechnology.

5.4 Topical formulations

In the expansive domain of dermatological formulations, SO emerges as a natural and multifaceted ingredient, finding its place in creams, lotions, and ointments. Renowned for its emollient properties, SO is a versatile base for topical pharmaceuticals, contributing to moisturization and skin barrier enhancement [96]. Beyond its emollient prowess, SO harbors compounds with potential anti-inflammatory and antioxidant effects, elevating its significance in formulations designed to promote skin health. This comprehensive exploration delves into the intricate interplay between SO and dermatological formulations, unraveling its contributions to nurturing skin health and its potential impact on advanced skincare solutions [97].

5.4.1 Emollient excellence

The oil smooths out dry, curled ends and fills in the spaces between corneocytes that are losing their skin. These effects strengthen the bonds between cells, making the surface smooth and soft to the touch. It also slides more efficiently and gives a soft glow from more light reflection. The presence of LA was responsible for the emollient effect.

5.4.2 Moisturization dynamics

The stratum corneum, the outermost layer of the skin, acts as a protective barrier and is instrumental in regulating moisture levels. When incorporated into creams and lotions, oil interacts harmoniously with the skin’s natural lipid matrix [98]. Its lipid content helps prevent transepidermal water loss (TEWL), reinforcing the skin’s natural barrier function and maintaining optimal hydration levels. This dynamic interaction contributes to the soothing and hydrating effects of skincare formulations enriched with SO [99].

5.4.3 Skin barrier enhancement

The skin barrier is a complex interplay of lipids, proteins, and other constituents that safeguard the body against external aggressors. SO’s lipid profile, including essential fatty acids like linoleic acid, aligns closely with the composition of the skin’s natural lipids [100]. Skincare products can enhance the skin barrier by incorporating SO into topical formulations, reinforcing its integrity and resilience. This barrier-strengthening effect mainly benefits individuals with dry or compromised skin [101].

5.4.4 The role of linoleic acid

Linoleic acid, an omega-6 fatty acid abundant in SO, is pivotal in maintaining skin health. This essential fatty acid synthesizes ceramides, essential skin lipid barrier components. Ceramides are crucial in retaining moisture, preventing dehydration, and fortifying the skin against environmental stressors [102]. Incorporating SO, rich in linoleic acid, thus complements the skin’s natural lipid composition, promoting a robust and well-hydrated epidermal layer.

5.4.5 Anti-inflammatory potential

SO was mainly used in the topical formulation as it shows an anti-inflammation effect [103]. Also, from the literature, it has been found that SO is enriched with 51% ⍺–linolenic acid, a leading active constituent, to reduce inflammation in the site of action [104]. The presence of SO provides a soothing effect to the skin. These properties make it valuable in formulations designed for individuals with sensitive or reactive skin conditions.

5.4.6 Antioxidant armor

Antioxidants are pivotal in neutralizing free radicals and mitigating oxidative stress – a process implicated in premature aging and skin damage. SO, enriched with vitamin E in the form of tocopherols, serves as a natural antioxidant reservoir [105]. Vitamin E’s ability to scavenge free radicals contributes to the overall antioxidant profile of SO-infused formulations. This antioxidant armor addresses oxidative stress and enhances skincare products’ longevity and stability [106].

5.4.7 Versatility in formulations

The adaptability of SO extends across various formulations, catering to diverse skincare preferences and requirements. In creams, the emollient nature of SO imparts a luxurious texture, promoting smooth application and rapid absorption [107]. Lotions containing SO, offer a lighter consistency suitable for daily use, ensuring broad coverage and ease of application. With their occlusive properties, ointments leverage the emollient prowess of SO to create protective barriers, making them ideal for targeted skincare applications [108].

5.5 Soft gelatin capsules

Soft gelatin capsules stand out as a versatile and widely employed dosage form in pharmaceutical formulations. SO plays a pivotal role as a filling material in their production. Soft gelatin capsules provide an efficient and convenient means of delivering a variety of medications, leveraging the liquid nature of SO to encapsulate both lipophilic and hydrophilic drugs [109]. Ditzinger et al. filed a patent describing that SO passed all required parameters among all the used oils and was widely accepted. The presence of triglyceride in the SO was responsible for the self-assembly in soft gelatin capsules [110]. The possible stability was due to drug encapsulation in the TG molecule. Some regulatory bodies listed SO as an active ingredient in capsule formation [111].

5.5.1 Liquid gold for drug encapsulation

SO, derived from the seeds of the soybean plant, emerges as a key player in producing soft gelatin capsules. Its liquid state at room temperature is a defining feature that lends itself to encapsulating a wide array of pharmaceutical compounds [112]. This liquid versatility allows SO to serve as an ideal vehicle for lipophilic and hydrophilic drugs, accommodating a diverse range of therapeutic agents.

5.5.2 Liquid at room temperature

The liquid nature of SO at room temperature is a pivotal advantage in the context of soft gelatin capsule production [113]. Unlike solid dosage forms, such as tablets or hard gelatin capsules, soft gelatin capsules are inherently more accommodating to drugs in liquid or solubilized forms. SO, as the filling material, facilitates the incorporation of drug substances with varying solubilities, expanding the repertoire of pharmaceutical compounds that can be effectively delivered through this dosage form [114].

5.5.3 Encapsulation of lipophilic drugs

Lipophilic drugs, characterized by their affinity for lipid-based environments, find a seamless encapsulation process within soft gelatin capsules filled with SO [115]. The compatibility between SO and lipophilic compounds ensures homogeneity in the fill material, preventing the segregation of drug components. This uniform distribution of lipophilic drugs within the liquid matrix of SO contributes to enhanced drug dissolution upon administration, promoting efficient absorption in the gastrointestinal tract [116].

5.5.4 Advantages of liquid fill

The liquid fill-in soft gelatin capsules, facilitated by SO, offers inherent advantages regarding drug bioavailability. The liquid state promotes rapid and uniform drug dissolution, a critical factor influencing the rate and extent of drug absorption [117]. This advantage becomes particularly relevant for drugs with solubility challenges, where the liquid matrix aids in overcoming barriers to dissolution and facilitates the absorption of therapeutic agents into the systemic circulation [118].

5.5.5 Improved drug dissolution

Drug dissolution is a crucial step in the absorption process, and SOs liquid nature plays a pivotal role in enhancing this phase of drug delivery [119]. The homogeneous dispersion of drug substances within the liquid fill promotes efficient dissolution, ensuring the drug is readily available for absorption in the gastrointestinal tract. This improvement in dissolution kinetics contributes to the efficacy of medications delivered through soft gelatin capsules [120].

5.5.6 Stability and shelf life

The liquid fill-in, soft gelatin capsules, contribute to the stability of certain pharmaceutical compounds. The encapsulation of drugs in a liquid matrix, such as SO, can protect them from specific degradation processes, contributing to an extended shelf life for the formulated products [121]. This advantage is precious for medications sensitive to factors such as oxidation or moisture, where the protective encapsulation helps maintain drug stability over time [122].

5.6 Sustained-release formulations

In the dynamic landscape of pharmaceutical formulation, the unique fatty acid composition of SO emerges as a beacon of innovation, particularly in the realm of sustained-release formulations [123]. Rich in polyunsaturated fats, SO offers a versatile lipid matrix that can be harnessed to control the release rate of drugs, paving the way for prolonged therapeutic effects and the potential for reduced dosing frequency [124]. This intricate interplay between SO and sustained-release formulations represents a cutting-edge approach in drug delivery science, holding promise for improved patient compliance and enhanced therapeutic outcomes.

5.6.1 The fatty acid tapestry of SO

SO, derived from the seeds of the soybean plant, boasts a rich and diverse fatty acid composition that sets it apart in the world of lipids [125]. Notably, it is characterized by a significant proportion of polyunsaturated fats, including linoleic acid (an omega-6 fatty acid) and, to a lesser extent, alpha-linolenic acid (an omega-3 fatty acid). This unique fatty acid tapestry forms the foundation for the distinctive role of SO in sustained-release formulations [126].

5.6.2 Polyunsaturated fats

The presence of polyunsaturated fats, with their distinct molecular structures, is instrumental in the development of sustained-release pharmaceutical formulations. Unlike saturated fats, polyunsaturated fats contribute to the fluidity and flexibility of lipid matrices, enabling precise modulation of drug release kinetics [126]. This characteristic makes SO an ideal candidate for creating lipid-based matrices that can control the release of drugs over extended periods.

5.6.3 Lipid matrices

Sustained-release formulations leverage lipid matrices as architectural frameworks to control the release of drugs. SO, as a key component in these matrices, SO imparts a unique character that allows for manipulating drug release profiles [127]. The lipid matrix acts as a reservoir, gradually releasing the incorporated drug in a controlled manner, offering a sustained and prolonged therapeutic effect.

5.6.4 Controlled release mechanisms

The mechanisms underpinning controlled release in lipid matrices are intricate and finely tuned [128]. SO contributes to sustained drug delivery through diffusion, erosion, and matrix swelling. The rate at which the drug diffuses through the lipid matrix, the matrix’s erosion, and the matrix’s swelling in bodily fluids collectively influence the release kinetics, allowing for tailored, sustained delivery [129].

5.6.5 Extended therapeutic effects

The incorporation of SO in sustained-release formulations extends the therapeutic effects of drugs, often achieving a delicate balance between maintaining therapeutic concentrations and minimizing potential side effects [129]. By controlling the drug release rate, SO facilitates prolonged action within the body, reducing the need for frequent dosing and enhancing patient convenience and compliance.

5.6.6 Reduced dosing frequency

One significant advantage of sustained-release formulations with SO is the potential for reduced dosing frequency [130]. Traditionally, immediate-release formulations may necessitate multiple daily doses to maintain therapeutic levels. On the other hand, sustained-release formulations, driven by SO’s role in modulating drug release, enable less frequent dosing [131]. This reduction in dosing frequency represents improved patient compliance, addressing a critical aspect of long-term treatment regimens.

5.6.7 Bioavailability enhancement

The sustained-release characteristics facilitated by SO extend therapeutic effects and contribute to bioavailability enhancement [132]. By controlling the drug release rate, SO allows for optimal absorption, ensuring that drug molecules are released in a manner conducive to efficient uptake in the gastrointestinal tract. This bioavailability enhancement further underscores the value of SO in sustained-release formulations [133].

5.6.8 Biocompatibility and safety profile

SO listed in the GRAS product by US-FDA regulation. All the GRAS products were used as pharmaceutical excipients. So, it can be concluded that SO was safe for biomedical applications. Different authors will formulate by using SO, and toxicity assessment shows that all the formulations have a good compatibility assessment [134].

5.7 Excipient in tablet formulations

In pharmaceutical formulations, excipients play a crucial role in shaping the characteristics and performance of oral solid dosage forms, such as tablets. SO, a natural and versatile ingredient, finds its place as an excipient in tablet formulations, contributing to various aspects of tablet manufacturing and performance [135]. This inclusion is driven by its lubricating properties and its ability to aid in the disintegration and dissolution of tablets. In this exploration, we delve into the multifaceted role of SO as an excipient, unraveling its impact on tablet quality, disintegration, and dissolution processes [136]. Vegetable oils are susceptible to oxidative breakdown, known as lipid oxidation. The extent of this process is influenced by the types of fatty acids present and the number of antioxidants within the oils.

5.7.1 Lubricating excellence

Lubricants are integral to tablet formulations, ensuring smooth and efficient manufacturing processes. SO, with its inherent lubricating properties, serves as a valuable excipient in tablet manufacturing [137]. During the compression stage, where the tablet blend is compressed into its final form, SO helps reduce friction between the tablet formulation and the surfaces of the compression tools. This lubricating action facilitates the easy and uniform compression of tablets, preventing sticking and capping issues and contributing to the overall efficiency of the tablet production process [138].

5.7.2 Role in disintegration

Qi et al. [139] prepared self-micro emulsifying dispersible tablets. The author reported that olive oil shows good droplet size after several attempts. SO oil was not required to meet all the parameters. It may be assumed that incorporating SO may faster the release of a drug because, in self-assembly, the drug will bind with the excipient in a very loose force. In the presence of the GI tract, it may disintegrate quickly. The disintegration of tablets in the gastrointestinal tract is a critical factor influencing drug release and absorption. SO contributes to this process by aiding in the disintegration of tablets. Disintegration refers to the breakdown of the tablet into smaller particles, promoting the rapid release of the drug for subsequent dissolution and absorption [111]. SO’s involvement in disintegration is particularly relevant in formulations where rapid drug release is desired, ensuring that the therapeutic agent becomes readily available for absorption [140].

5.7.3 Dissolution facilitation

Dissolution is a process where a solid substance undergoes powder form, a rate rate-limiting step in drug delivery. SO plays a role in enhancing the dissolution of tablets, thereby maximizing the bioavailability of the drug [141]. The solubilizing properties of SO contribute to the breakdown of tablet components in the gastrointestinal fluids, facilitating the release of the drug into a form that the body can absorb. This is especially crucial for drugs with low aqueous solubility, where SO aids in overcoming solubility challenges and promoting effective drug dissolution [142].

5.7.4 Lipid-based formulations

In addition to its lubricating, disintegration, and dissolution-promoting roles, SO is a key player in the development of lipid-based tablet formulations. Lipid-based formulations are employed to modify the release profiles of certain drugs [143]. By incorporating SO into these formulations, formulators can tailor the drug release kinetics, allowing for sustained or controlled release of the therapeutic agent. This versatility in release profile modulation contributes to optimizing drug delivery for improved efficacy and patient compliance [144].

5.7.5 Compatibility with active pharmaceuticals

SOs compatibility with a wide range of active pharmaceutical ingredients (APIs) is a significant advantage in tablet formulations. Its ability to function effectively as a lubricant and aid in disintegration and dissolution spans diverse drug classes [145]. Formulators appreciate this versatility, as it allows for incorporating SO across a spectrum of pharmaceutical formulations, ensuring consistent performance and compatibility with various therapeutic agents [146].

5.7.6 Enhancing palatability and swallowability

Tablets are designed for therapeutic efficacy and patient acceptance and adherence. SO, in addition to its functional roles in tablet formulations, may enhance the palatability and swallowability of tablets [147]. A lubricating agent like SO can impart a smoother texture to tablets, making them more palatable and easier to swallow. This is especially relevant for patients with difficulty swallowing large or uncoated tablets [148].

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6. Future prospects

The future prospects of SO in pharmaceutical applications appear promising, as its unique attributes, encompassing biocompatibility, stability, and low toxicity, position it prominently in innovative drug delivery systems. Researchers are actively exploring novel applications where SO could play a pivotal role in overcoming drug solubility and bioavailability challenges. The ongoing exploration of SO in nanotechnology, especially in lipid-based nanoparticles for drug delivery, presents exciting opportunities for creating more targeted and controlled drug release systems aligning with personalized medicine principles. Additionally, integrating SO with emerging technologies in pharmaceuticals like 3D printing can revolutionize drug manufacturing processes, allowing for the production of customized dosage forms tailored to individual patient needs and optimizing therapeutic outcomes. As sustainability gains momentum, SO’s natural origin positions it favorably for developing ecofriendly pharmaceutical formulations, contributing to global efforts for greener and more sustainable practices in the pharmaceutical industry. In conclusion, ongoing research and innovation in leveraging the unique properties of SO are poised to usher in a new era in pharmaceutical science, offering exciting possibilities for advancements in nanotechnology, personalized medicine, and sustainable drug development, ultimately enhancing patient care on a broader scale.

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7. Conclusion

In conclusion, applying SO in the pharmaceutical industry represents a dynamic and promising frontier. Its unique chemical composition, rich in beneficial unsaturated fats, positions it as a versatile candidate for various drug delivery systems. The remarkable biocompatibility, stability, and low toxicity make SO valuable in developing reliable and effective pharmaceutical formulations significant in lipid-based drug formulations, especially in augmenting the bioavailability of inadequately water-soluble drugs, highlighting its crucial role as an excipient. The versatility of soybean oil is further emphasized in its use within self-emulsifying and self-micro-emulsifying drug delivery systems, showcasing its adaptability for the oral administration of hydrophobic drugs. Beyond oral delivery, SO’s integral role in intravenous nutrition solutions, such as total parenteral nutrition (TPN) formulations, underscores its importance in providing essential fatty acids to patients with limited oral intake.

Additionally, its application in topical drug delivery systems showcases its non-irritating nature, promoting the absorption of pharmaceutical ingredients through the skin in transdermal and topical applications. While the promise of SO as a drug delivery medium is evident, ongoing research is crucial to unlock its full medicinal potential and explore novel avenues in pharmaceutical development. As we navigate the evolving landscape of pharmaceutical sciences, the multifaceted contributions of SO stand poised to shape innovative solutions, ultimately contributing to the formulation of safer, more effective, and patient-centric pharmaceutical products.

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Written By

Biswaranjan Mohanty, Amulyaratna Behera, Tapan Kumar Shaw, Sk. Habibullah and Biswajeet Acharya

Submitted: 25 December 2023 Reviewed: 24 April 2024 Published: 25 July 2024