A Comprehensive Monograph on Sucrose (DB02772): Physicochemical Properties, Metabolism, and Applications in Medicine and Pharmacology

Section 1: Compound Identification and Physicochemical Properties

Sucrose, a small molecule identified by DrugBank Accession Number DB02772 and CAS Registry Number 57-50-1, is one of the most well-known organic compounds in biology and commerce.[1] While universally recognized as table sugar, its roles extend far beyond simple nutrition, encompassing specific therapeutic applications and critical functions in advanced pharmaceutical manufacturing. This section provides a detailed characterization of its chemical identity and physicochemical properties, which form the basis for its behavior in biological and pharmaceutical systems.

1.1 Nomenclature and Chemical Structure

The compound is most commonly known by its generic name, Sucrose. However, it is referenced by a wide array of synonyms that reflect its natural sources and chemical nature. These include Saccharose, Sacarosa, Sacharose, cane sugar, and beet sugar.[1] In pharmaceutical and commercial contexts, it may also be referred to as confectioner's sugar, granulated sugar, or rock candy.[2]

From a chemical standpoint, sucrose is a disaccharide, meaning it is composed of two simpler monosaccharide units: glucose and fructose.[2] Specifically, it is formed from a molecule of α-D-glucopyranose and a molecule of β-D-fructofuranose.[5] The systematic IUPAC name precisely defines its stereochemistry and linkage: (2R,3R,4S,5S,6R)-2-oxy-6-(hydroxymethyl)oxane-3,4,5-triol.[2]

The bond connecting the two monosaccharide units is an O-glycosidic bond formed between the anomeric carbon of the glucose unit (C1​) and the anomeric carbon of the fructose unit (C2​).[1] This specific linkage is a defining feature of sucrose and has profound chemical consequences. Because the anomeric hydroxyl groups of both constituent sugars are involved in the glycosidic bond, there are no free hemiacetal or hemiketal groups available to act as reducing agents. Consequently, sucrose is classified as a

non-reducing sugar.[1]

This non-reducing characteristic is not merely a chemical footnote; it is fundamental to the molecule's stability and its utility in pharmaceutical science. Unlike reducing sugars such as glucose or lactose, sucrose does not readily participate in the Maillard reaction, a chemical process involving the reaction of a reducing sugar with an amino acid. This reaction leads to browning and the formation of complex products that can degrade sensitive pharmaceutical ingredients, particularly proteins.[6] The chemical inertness endowed by its non-reducing structure prevents sucrose from spontaneously reacting with cellular macromolecules and makes it an exceptionally stable excipient for formulating fragile biologic drugs, a topic that will be explored in detail in Section 5.[6]

1.2 Key Chemical and Physical Identifiers

Sucrose is a white, odorless solid that typically exists in a crystalline or powdered form and possesses a characteristically sweet taste.[2] It crystallizes in a monoclinic structure.[5] It is highly soluble in water but only slightly soluble in ethanol.[7] Upon heating to temperatures above 186 °C (459 K), it undergoes thermal decomposition to form caramel, a complex mixture of compounds.[4] The fundamental chemical and physical properties of sucrose are summarized in Table 1 for ease of reference.

Table 1: Key Chemical and Physical Identifiers for Sucrose (DB02772)

Parameter	Value / Identifier	Source(s)
Identification
Generic Name	Sucrose	1
IUPAC Name	(2R,3R,4S,5S,6R)-2-oxy-6-(hydroxymethyl)oxane-3,4,5-triol	2
Common Synonyms	Saccharose, Cane Sugar, Beet Sugar, Table Sugar	1
DrugBank ID	DB02772	1
CAS Number	57-50-1	1
PubChem CID	5988	2
ChEBI ID	CHEBI:17992	2
Chemical Properties
Molecular Formula	C12​H22​O11​	1
Average Molecular Weight	342.30 g/mol	2
Monoisotopic Mass	342.116211546 Da	1
Physical Properties
Physical Form	White, odorless, crystalline or powdery solid	2
Density	1.587 g/cm³	4
Solubility in Water (20 °C)	2039 g/L	7
Melting Point	Decomposes at 186 °C (459 K)	4

Section 2: Pharmacology and Human Metabolism

While chemically simple, the pharmacological and metabolic profile of sucrose is complex, driven by the distinct biological fates of its constituent monosaccharides. Sucrose itself does not enter the systemic circulation; instead, it serves as a delivery vehicle for glucose and fructose.[11] Understanding its journey from ingestion to cellular utilization is key to appreciating both its nutritional role and its specific therapeutic mechanisms.

2.1 Pharmacokinetics: Digestion, Absorption, and Distribution (ADME)

As a disaccharide, sucrose is too large to be absorbed directly through the intestinal wall.[12] Its pharmacokinetic profile begins with rapid and efficient digestion in the gastrointestinal tract.

Digestion and Absorption: The process of sucrose digestion primarily occurs in the small intestine. The enzyme sucrase, which is part of the sucrase-isomaltase glycoside hydrolase complex located on the brush border membrane of intestinal microvilli, is responsible for this breakdown.[6] Sucrase efficiently hydrolyzes the glycosidic bond of the sucrose molecule, liberating one molecule of glucose and one molecule of fructose.[6] While some hydrolysis can occur in the stomach due to gastric acid, the enzymatic cleavage in the duodenum is the principal mechanism.[6]

Following hydrolysis, the resulting monosaccharides are rapidly absorbed into the portal bloodstream. Glucose is transported across the intestinal epithelium mainly by the sodium-dependent glucose cotransporter 1 (SGLT1), an active transport mechanism. Fructose is absorbed via a different transporter, the facilitated diffusion transporter GLUT5.[12] A crucial aspect of sucrose absorption is the synergistic relationship between its components. The presence of glucose has been shown to significantly enhance the rate and capacity of fructose absorption in a dose-dependent manner.[14] This means that consuming fructose as part of a sucrose molecule leads to a more efficient and complete absorption of the fructose load compared to consuming fructose alone. This makes sucrose a particularly effective system for delivering a large bolus of both sugars to the liver.

Distribution, Metabolism, and Excretion: Once absorbed, glucose and fructose enter the portal circulation and are transported first to the liver and then distributed throughout the body.[12] The parent sucrose molecule is not found in the systemic circulation in any significant amount, as it is almost entirely hydrolyzed prior to or during absorption.[11] Therefore, traditional pharmacokinetic parameters such as volume of distribution, protein binding, and excretion pathways do not apply to sucrose itself but rather to its metabolic products, which are handled by the body's normal carbohydrate metabolism pathways.

2.2 Metabolic Pathways and Fate of Constituent Monosaccharides

The physiological effects of sucrose consumption are dictated by the divergent metabolic pathways of glucose and fructose. This metabolic dichotomy is central to understanding the complex relationship between sucrose intake and health.

Glucose Metabolism: Glucose is the body's preferred and most readily available source of cellular energy.[12] After a sucrose-containing meal, the rise in blood glucose triggers the release of insulin from the pancreas. Insulin facilitates the uptake of glucose into most of the body's cells, including muscle and adipose tissue.[12] Inside the cells, glucose enters the glycolysis pathway, where it is oxidized to produce pyruvate, generating ATP (the cell's energy currency) and NADH.[17] When energy needs are met, excess glucose is stored as glycogen in the liver and muscles for short-term use. Any further excess is converted into fatty acids and stored as triglycerides in adipose tissue for long-term energy storage.[12] The body maintains tight homeostatic control over blood glucose levels through the interplay of insulin and other hormones like glucagon.[12]

Fructose Metabolism: Fructose metabolism differs markedly from that of glucose. It is primarily metabolized in the liver in a process that is largely independent of insulin.[14] Upon entering hepatocytes, fructose is rapidly phosphorylated to fructose-1-phosphate. This step bypasses the main rate-limiting enzyme of glycolysis, phosphofructokinase, which is tightly regulated by cellular energy status. This lack of feedback regulation means that the liver can be flooded with metabolic intermediates derived from fructose, irrespective of the cell's immediate energy needs. These intermediates, primarily triose phosphates, can be readily shunted into the pathway of

de novo lipogenesis, leading to the synthesis of triglycerides and cholesterol.[14] These newly synthesized fats can accumulate in the liver or be packaged into very-low-density lipoproteins (VLDL) and released into the bloodstream. This unique, unregulated hepatic metabolism of fructose is the primary mechanism linking high sucrose consumption to adverse metabolic outcomes like fatty liver disease and dyslipidemia.

2.3 Pharmacodynamics and Mechanism of Action (Analgesic Effect)

Beyond its role as a nutrient, sucrose has a well-defined pharmacodynamic effect as a mild analgesic, particularly in infants. The mechanism of this action is not systemic but is a fascinating example of a taste-mediated neurobehavioral response.

The analgesic effect is triggered by the interaction of sucrose with sweet taste receptors on the anterior part of the tongue.[18] This sensory signal is transmitted to the brainstem, where it is believed to stimulate the release of endogenous opioids, such as endorphins.[19] These naturally occurring opioid peptides then act on the central nervous system to modulate the perception of pain, resulting in a calming and analgesic effect.[18]

Several lines of evidence support this orally mediated opioid pathway. First, the analgesic effect of sucrose in animal models can be blocked by the administration of naloxone, a classic opioid receptor antagonist.[21] This demonstrates a direct link to the endogenous opioid system. Second, the onset of action is rapid, with peak effectiveness occurring approximately two minutes after administration, and the duration is short, lasting only five to eight minutes in newborns.[18] This time course is consistent with a rapidly acting neurological reflex rather than a process requiring systemic absorption and distribution. Finally, and most definitively, administering sucrose directly into the stomach via a nasogastric tube produces no analgesic effect.[18] This critical observation confirms that the sweet taste sensation on the tongue is the necessary and sufficient trigger for the analgesic response.

Section 3: Systemic Physiological Effects

The consumption of sucrose has widespread physiological effects that are highly dependent on dose, frequency, and dietary context. While it serves as a vital and rapid source of energy, its overconsumption in modern diets, particularly in the form of "added sugars," is linked to a range of metabolic disturbances. Conversely, its ability to supply glucose to the brain can have beneficial effects on cognitive function.

3.1 Impact on Cardiometabolic Health

As an easily assimilated carbohydrate, sucrose provides a quick source of energy to the body, causing a rapid increase in blood glucose upon ingestion.[6] This can be beneficial during periods of high energy demand. However, the chronic and excessive consumption of sucrose is a major contributor to a cluster of cardiometabolic disorders.

The adverse effects are primarily associated with "added" or "free" sugars, which are sugars added to foods and beverages by the manufacturer, cook, or consumer, plus sugars naturally present in honey, syrups, and fruit juices.[23] High intake of these sugars is strongly associated with several negative health outcomes:

• Insulin Resistance and Type 2 Diabetes: Frequent consumption of high-sucrose foods and beverages leads to recurrent, sharp spikes in blood glucose and insulin. Over time, this can lead to insulin resistance, a condition where cells become less responsive to insulin's effects. This is a key precursor to the development of type 2 diabetes.[23]
• Obesity and Weight Gain: Sucrose-rich foods are often high in calories but low in essential nutrients and fiber, earning them the label of "empty calories." Their high palatability can promote overconsumption, leading to a positive energy balance and subsequent weight gain and obesity.[6]
• Non-Alcoholic Fatty Liver Disease (NAFLD): As detailed in Section 2.2, the hepatic metabolism of the fructose component of sucrose can drive de novo lipogenesis. Chronic high intake can lead to a significant accumulation of fat in the liver, a condition known as NAFLD.[13]
• Dyslipidemia: The increased production of triglycerides in the liver can lead to elevated levels of VLDL and triglycerides in the bloodstream, a condition known as dyslipidemia, which is a significant risk factor for cardiovascular disease.[14]
• Metabolic Syndrome: The co-occurrence of these conditions—central obesity, insulin resistance, dyslipidemia, and often hypertension—is defined as metabolic syndrome, a state that dramatically increases the risk for both type 2 diabetes and cardiovascular disease.[23]

It is crucial to recognize that the metabolic impact of sucrose is profoundly influenced by its dietary context. The distinction between sucrose from whole foods and sucrose as an "added sugar" is not merely semantic but has a clear physiological basis. When sucrose is consumed in its natural matrix, such as in a piece of fruit, it is accompanied by fiber, water, and various micronutrients.[23] The dietary fiber slows gastric emptying and forms a viscous gel in the intestines, which reduces the rate of sugar absorption.[23] This blunts the postprandial glucose and insulin spikes, allowing the body's metabolic systems to manage the sugar load more effectively. In contrast, sucrose in a sweetened beverage is delivered as a liquid bolus without fiber, leading to rapid absorption and a dramatic metabolic challenge to the pancreas and liver. This explains why studies often show that moderate substitution of sucrose for starch (up to 25% of energy) within an isoenergetic diet does not necessarily have adverse effects in healthy adults, underscoring the primary importance of total calorie intake and the overall dietary pattern.[14]

3.2 Effects on Cognitive Function

The human brain has a uniquely high metabolic rate and relies almost exclusively on a continuous supply of glucose from the bloodstream to function optimally.[11] An adult brain requires approximately 140 grams of glucose per day, which can account for up to 50% of the body's total carbohydrate consumption.[11]

By providing a readily available source of glucose, the consumption of sucrose can have positive effects on cognitive performance. Studies have associated the intake of sucrose-sweetened foods or beverages with measurable improvements in various cognitive domains, including mental alertness, memory recall, reaction time, attention, and the ability to perform mathematical calculations.[11] It has also been shown to reduce the subjective feeling of fatigue.[11] These benefits have been observed not only in healthy individuals but also in patients with cognitive impairment, such as those with Alzheimer's disease, highlighting the fundamental importance of adequate glucose supply for neuronal integrity and function.[11]

Section 4: Therapeutic and Pharmaceutical Applications

Beyond its ubiquitous role in nutrition, sucrose has specific and well-established applications in clinical medicine and pharmaceutical development. Its primary therapeutic use is as a non-pharmacological analgesic for infants, while it also serves as a demulcent in certain over-the-counter products. Its appearance in various clinical trials often reflects its role as a formulation component or a research tool rather than as an investigational drug.

4.1 Primary Therapeutic Indication: Procedural Analgesia in Infants

Oral sucrose is widely recognized as a safe, effective, and convenient mild analgesic for mitigating pain and distress associated with minor, short-term procedures in infants.[18] This application is supported by extensive clinical evidence and is incorporated into the standard of care in many neonatal and pediatric units.

Clinical Indications and Efficacy: The clinical indication for oral sucrose is the reduction of procedural pain in infants, typically from birth up to 18 months of age.[18] It is effective for single-event procedures such as heel pricks for blood sampling, venipuncture, intramuscular injections, intravenous (IV) catheter insertion, nasogastric tube (NGT) insertion, and retinopathy of prematurity (ROP) examinations.[19] It can also be used as an adjunctive therapy alongside stronger analgesics for more painful procedures like chest drain insertion.[18]

High-quality evidence, including multiple Cochrane systematic reviews, has consistently demonstrated that oral sucrose significantly reduces validated pain scores (e.g., Premature Infant Pain Profile, PIPP) and decreases crying time during these common procedures.[19] Its efficacy is well-established for mild to moderate procedural pain. However, it is important to note that it is not considered sufficient for managing more severe pain, such as that from circumcision, for which pharmacological analgesia is required.[29]

Dosage and Administration: The administration of oral sucrose for analgesia follows specific clinical guidelines to maximize efficacy and ensure safety. The key principles are summarized in Table 2. The solution, typically at a concentration of 24% to 33%, is administered directly onto the anterior part of the infant's tongue.[18] It is given approximately two minutes prior to the procedure to coincide with its peak analgesic effect.[19] The effect is enhanced when combined with non-nutritive sucking (NNS) via a pacifier, as the two interventions appear to have a synergistic calming effect.[18] Doses are small and are often administered incrementally throughout the procedure as needed to maintain the analgesic effect.

Table 2: Summary of Clinical Guidelines for Oral Sucrose Administration for Infant Procedural Analgesia

Patient Group (Corrected Age)	Recommended Dose per Procedure	Maximum Doses per 24 hours (Example)	Key Administration Notes	Source(s)
Preterm (< 32 weeks)	0.05–0.2 mL	~1 mL	Use very small volumes. Dose to effect. May be applied with a swab for NBM infants.	18
Preterm (≥ 32 weeks to term)	0.2–0.5 mL	~2.5 mL	Administer 2 minutes prior to procedure.	18
Term (0–1 month)	0.2–1 mL	~5 mL	Synergistic effect with non-nutritive sucking (pacifier).	18
Infant (1–18 months)	1–2 mL	~5-10 mL	Effect is shorter-lived (1-3 minutes) in older infants. Observe and dose to effect.	18
Note: Dosing guidelines can vary between institutions. This table represents a synthesis of common practices. Always refer to local institutional protocols.

4.2 Secondary Therapeutic Roles

Sucrose also functions as an active ingredient in some pharmaceutical preparations due to its demulcent properties. A demulcent is a substance that forms a soothing, protective film over an inflamed or irritated mucous membrane.[33] In the context of cough and cold remedies, sucrose is included in syrups to coat and soothe the throat.[7] This viscous layer can help relieve the discomfort and irritation associated with a dry, non-productive cough.[35] Several over-the-counter products, such as Benylin Children's Dry Cough & Sore Throat Syrup and Boots Glycerin and Blackcurrant Linctus, list sucrose as an active ingredient for this purpose, often in combination with glycerol, another common demulcent.[36]

4.3 Investigational Uses

Sucrose is listed as a component in several clinical trials on platforms like DrugBank, covering a range of conditions from Tick Borne Encephalitis (NCT00163618) to Dental Plaque (NCT05852145).[37] A careful analysis of these trials reveals that sucrose is not being investigated as a primary therapeutic agent for these conditions. Instead, its role is contextual:

• In Vaccine Trials: In studies for vaccines against Tick Borne Encephalitis and Norwalk Virus, sucrose serves as a stabilizing excipient in the vaccine formulation.[38] As will be detailed in the next section, sucrose is critical for maintaining the stability and potency of biologic products like vaccines.
• In Oral Health Studies: In trials investigating dental plaque or the oral effects of sweeteners, sucrose is used as a positive control or challenge agent.[37] Because it is a well-known cariogenic substrate, it provides a benchmark against which the effects of other substances, such as the non-caloric sweetener stevioside, can be measured.

This distinction is important for accurately interpreting the clinical research landscape. Sucrose's role in these investigations is that of a vital formulation component or a standardized research tool, not a novel therapeutic candidate for the conditions being studied.

Section 5: Sucrose as a Pharmaceutical Excipient

While its therapeutic applications are specific, the role of sucrose as a pharmaceutical excipient is vast and indispensable. Legally defined as an inactive ingredient, this classification belies its critical function in enabling the formulation, stability, and delivery of a wide range of pharmaceutical products, from conventional tablets to the most advanced biologic therapies.

5.1 Multifunctional Roles in Conventional Drug Formulation

In traditional pharmaceutical manufacturing, sucrose is a versatile workhorse excipient employed in numerous dosage forms. Its functions include:

• Sweetener and Flavor-Masking Agent: This is its most traditional role. The inherent sweetness of sucrose is highly effective at masking the often bitter or unpleasant taste of active pharmaceutical ingredients (APIs), thereby improving patient adherence, which is particularly important for pediatric and geriatric populations.[41]
• Filler, Diluent, and Binder: In solid dosage forms like compressed tablets, granules, and powders, sucrose provides necessary bulk to formulations containing potent, low-dose APIs. It also acts as a binder, helping to hold the tablet together after compression.[43] Specialized grades, such as compressible sugar, are engineered with specific particle sizes and flow properties to facilitate high-speed, direct-compression tableting.[42]
• Coating Agent: Sugar coating is a long-established technique used to apply a smooth, polished outer layer to tablets. This coating serves multiple purposes: it protects the API from degradation by air and moisture, masks unpleasant tastes and odors, makes the tablet easier to swallow, and allows for color-coding for easy identification.[42]
• Viscosity-Modifying Agent: In liquid formulations such as syrups, elixirs, and suspensions, sucrose increases the viscosity of the solution. This provides a more pleasant mouthfeel, can help to keep insoluble APIs suspended uniformly, and can contribute to the product's stability.[43]

Owing to this versatility, sucrose is found in a vast array of dosage forms, including chewable tablets, lozenges, syrups, dry syrups for reconstitution, sachets, and granules.[41]

5.2 Advanced Applications in Biopharmaceutical Formulation

The most critical modern application of sucrose is in the formulation of biopharmaceuticals. The rise of therapeutic proteins, monoclonal antibodies (mAbs), vaccines, and cell-based therapies has created a demand for excipients that can protect these large, fragile molecules from degradation. Sucrose has emerged as a premier agent for this purpose.

Stabilizer, Cryoprotectant, and Lyoprotectant: High-purity, low-endotoxin sucrose is extensively used to stabilize biologics during all stages of their lifecycle, including liquid formulation, freezing and thawing (cryopreservation), and freeze-drying (lyophilization).[42] It functions as both a cryoprotectant (protecting during freezing) and a lyoprotectant (protecting during drying).

The mechanism of stabilization is multifaceted. In liquid formulations, sucrose is preferentially excluded from the protein's surface, which favors a more compact, native protein conformation. It also forms hydrogen bonds with the protein, creating a protective "hydration shell".[48] During freezing and lyophilization, its role is even more critical. As water is removed, sucrose forms a highly viscous, amorphous (non-crystalline) "glassy matrix" in a process called vitrification.[48] This glassy state physically immobilizes the protein molecules, preventing them from unfolding, aggregating, or denaturing. This phenomenon is often described by the "water replacement theory," where sucrose molecules effectively replace the water that was hydrogen-bonded to the protein surface, thereby preserving its native structure in the dried state.[49]

This stabilizing function is so crucial that sucrose should be viewed not as a passive filler but as an enabling technology. The therapeutic potential of a vast number of modern biologic drugs, which are inherently unstable, could not be realized without highly effective stabilizers like sucrose. It is an indispensable component that ensures these life-saving medicines remain safe and effective from the point of manufacture to administration to the patient.

For these applications, particularly for parenteral (injectable) products, the purity of the sucrose is paramount. Pharmaceutical manufacturers use multi-compendial, current Good Manufacturing Practice (cGMP) grade sucrose that is rigorously tested to ensure extremely low levels of impurities such as endotoxins, heavy metals, and residual solvents. This is essential to prevent pyrogenic reactions and other adverse effects in patients.[46]

5.3 Examples of Pharmaceutical Products Containing Sucrose

Sucrose is a component in a vast number of pharmaceutical products, both as an excipient and, less commonly, as an active ingredient.

• As an Excipient: One analysis of biologic formulations found that sucrose was present in nearly 24% of unique products, highlighting its prevalence in this sector.[50] In conventional drugs, products like Adderall XR and Duloxetine utilize "sugar spheres" (made of sucrose and starch) as the inert core onto which the active drug is layered for controlled-release formulations.[41]
• As an Active Ingredient: As noted previously, various cough and sore throat syrups, such as those from the Benylin brand, list sucrose as an active ingredient for its demulcent properties.[36] Additionally, the anti-nausea medication Children's Emetrol contains sucrose and phosphoric acid as its active ingredients.[1]

Section 6: Safety Profile and Regulatory Standing

The safety profile of sucrose is well-characterized, reflecting its long history of human consumption and extensive use in food and pharmaceuticals. However, a comprehensive assessment requires distinguishing between its acute toxicity, the chronic effects of dietary overconsumption, specific clinical contraindications, and its formal regulatory status. A critical point of clarification is also needed regarding drug interactions erroneously attributed to sucrose in some databases.

6.1 General Toxicity and Adverse Effects

From a toxicological perspective, sucrose is considered essentially non-toxic.[41] It is not classified as a hazardous substance by the Occupational Safety and Health Administration (OSHA).[51] The acute oral toxicity is extremely low, with a reported LD50 (lethal dose for 50% of subjects) in rabbits of 29,700 mg/kg.[8]

The primary adverse effects associated with sucrose are not related to acute toxicity but to the long-term metabolic consequences of chronic overconsumption. As discussed in Section 3, excessive dietary intake is a major contributing factor to dental caries, the exacerbation of type 2 diabetes, and weight gain leading to obesity.[23] In occupational settings, finely dispersed sucrose dust can pose a combustible or explosive hazard under specific conditions.[51] Prolonged skin contact in industrial environments, such as in bakeries, has been reported to cause dermatoses.[51]

6.2 Contraindications and Precautions in Therapeutic Use

When used therapeutically as an oral analgesic for infants, there are specific contraindications and precautions that must be observed:

• Absolute Contraindications: The use of oral sucrose is contraindicated in infants with known genetic metabolic disorders that prevent the proper digestion or metabolism of its components. These include congenital sucrase-isomaltase deficiency (CSID), hereditary fructose intolerance, and glucose-galactose malabsorption.[18] It is also contraindicated in infants who are muscle-relaxed, as their ability to swallow safely may be compromised.[18]
• Precautions and Relative Contraindications: Caution is advised, and medical consultation is often required, for infants with certain conditions. These include suspected or confirmed necrotizing enterocolitis (NEC), an unrepaired tracheo-oesophageal fistula (TOF), a nil-by-mouth (NBM) status, or any condition that results in an altered or impaired gag and swallow reflex.[18]

6.3 Clarification on Drug-Drug Interactions

A significant point of confusion exists in several prominent pharmacological databases regarding drug interactions for sucrose. Many sources list extensive interactions for a substance named "Iron Sucrose" (DrugBank ID DB09146) and incorrectly associate them with sucrose (DB02772).[54]

It is imperative to clarify this error. Iron Sucrose is a distinct pharmaceutical entity, a complex of iron(III)-hydroxide in a sucrose shell, administered intravenously for the treatment of iron deficiency anemia. The drug interactions attributed to it—such as decreased absorption of oral medications like quinolone antibiotics, tetracyclines, and bisphosphonates due to chelation by iron—do not apply to sucrose (DB02772).[54]

Sucrose, when consumed orally, is not a systemically available drug. It is a carbohydrate that is completely hydrolyzed in the intestine to glucose and fructose, which are then absorbed and enter normal metabolic pathways.[6] These monosaccharides do not engage in the types of pharmacokinetic interactions (e.g., chelation, alteration of gastric pH) that characterize the iron-containing complex. Therefore, there are no clinically significant drug-drug interactions documented for sucrose itself when used as a food, excipient, or oral analgesic. This disambiguation is critical for safe clinical practice, as a healthcare provider consulting a database might otherwise be led to mistakenly withhold a safe and effective analgesic like oral sucrose from an infant based on irrelevant interaction warnings.

6.4 Regulatory Status

In the United States, sucrose is regulated by the Food and Drug Administration (FDA) and holds the status of "Generally Recognized as Safe" (GRAS).[57] This designation is formally codified in the Code of Federal Regulations under

21 CFR § 184.1854.[58]

The regulation specifies that sucrose is obtained from sugar cane or sugar beet and must be of a purity suitable for its intended use.[58] Under its GRAS affirmation, it can be used in food with "no limitation other than current good manufacturing practice".[58] This status is based on its long and widespread history of common use in food prior to 1958.[57]

While its GRAS status is legally established, it is important to acknowledge the ongoing scientific and public health discourse surrounding the consumption of "added sugars." Some public health advocates have argued that, in light of the strong evidence linking high intake of added sugar to chronic diseases, its GRAS status should be re-evaluated.[62] This reflects a broader regulatory challenge: distinguishing between the acute safety of a substance (which for sucrose is very high) and the potential long-term public health consequences of its ubiquitous use at high levels in the modern food supply.

Section 7: Conclusion

Sucrose (DB02772) is a molecule of profound duality. On one hand, it is a fundamental carbohydrate, a rapid source of metabolic energy that fuels cellular processes and supports cognitive function. Its metabolism, however, reveals a complex dichotomy between its constituent monosaccharides, with the unregulated hepatic processing of its fructose component being a primary driver of the adverse health outcomes—including obesity, type 2 diabetes, and non-alcoholic fatty liver disease—associated with its chronic overconsumption as an added sugar. This underscores the critical importance of dietary context, as the metabolic impact of sucrose is significantly modulated by the food matrix in which it is consumed.

On the other hand, sucrose is a sophisticated and indispensable tool in modern medicine and pharmaceutical science. Its specific taste-mediated pharmacodynamic effect provides a safe and effective method for mild procedural analgesia in the vulnerable infant population, a practice supported by high-quality clinical evidence. Even more significantly, its unique physicochemical properties—particularly its non-reducing nature and its ability to form a protective glassy matrix—have established it as a critical excipient for the stabilization of fragile biologic drugs. In this capacity, sucrose is not merely an inactive filler but an enabling technology that is essential to the viability of a large and growing class of advanced therapeutics, including monoclonal antibodies and vaccines.

A comprehensive understanding of sucrose requires an appreciation of these multifaceted roles. It is simultaneously a simple nutrient with complex metabolic consequences, a targeted therapeutic agent for a specific patient population, and a high-performance material crucial for the formulation of modern medicines. Accurate interpretation of its properties, particularly the clear distinction from the drug complex "Iron Sucrose" in pharmacological databases, is essential for its safe and effective use in both clinical and industrial settings. Ultimately, the scientific profile of sucrose is a compelling illustration of how a simple, naturally occurring molecule can have a complex and far-reaching impact on human health and technology.

Works cited

1. Sucrose: Uses, Interactions, Mechanism of Action | DrugBank Online, accessed August 27, 2025, https://go.drugbank.com/drugs/DB02772
2. Sucrose | C12H22O11 | CID 5988 - PubChem, accessed August 27, 2025, https://pubchem.ncbi.nlm.nih.gov/compound/Sucrose
3. Sucrose - the NIST WebBook - National Institute of Standards and Technology, accessed August 27, 2025, https://webbook.nist.gov/cgi/cbook.cgi?ID=C57501&Type=THZ-IR-SPEC&Index=1
4. Structural Formula Of Sucrose (Table Sugar) - BYJU'S, accessed August 27, 2025, https://byjus.com/sugar-formula/
5. Sucrose (C12H22O11) - GeeksforGeeks, accessed August 27, 2025, https://www.geeksforgeeks.org/chemistry/sucrose/
6. Sucrose - Wikipedia, accessed August 27, 2025, https://en.wikipedia.org/wiki/Sucrose
7. Sucrose is a molecule composed of two monosaccharides, namely glucose and fructose. This non-reducing disaccharide has a chemical formula of C 12 H 22 O 11 - BYJU'S, accessed August 27, 2025, https://byjus.com/chemistry/sucrose/
8. Sucrose | 57-50-1 - ChemicalBook, accessed August 27, 2025, https://www.chemicalbook.com/ChemicalProductProperty_EN_CB4337508.htm
9. CAS RN 57-50-1 - Fisher Scientific, accessed August 27, 2025, https://www.fishersci.com/us/en/browse/cas/57-50-1
10. D-Sucrose | C12H22O11 - ChemSpider, accessed August 27, 2025, https://www.chemspider.com/Chemical-Structure.5768.html
11. [Importance of sucrose in cognitive functions: knowledge and behavior] - PubMed, accessed August 27, 2025, https://pubmed.ncbi.nlm.nih.gov/23834099/
12. Sucrose vs. Glucose vs. Fructose: Differences and Effects - ZOE, accessed August 27, 2025, https://zoe.com/learn/sucrose-vs-glucose
13. Sucrose vs Glucose vs Fructose: What's the Difference? - Healthline, accessed August 27, 2025, https://www.healthline.com/nutrition/sucrose-glucose-fructose
14. The Effects of Sucrose on Metabolic Health: A Systematic Review of Human Intervention Studies in Healthy Adults - ResearchGate, accessed August 27, 2025, https://www.researchgate.net/publication/236579340_The_Effects_of_Sucrose_on_Metabolic_Health_A_Systematic_Review_of_Human_Intervention_Studies_in_Healthy_Adults
15. The Effects of Sucrose on Metabolic Health: A Systematic Review of Human Intervention Studies in Healthy Adults - PubMed Central, accessed August 27, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC3630450/
16. Full article: The Effects of Sucrose on Metabolic Health: A Systematic Review of Human Intervention Studies in Healthy Adults, accessed August 27, 2025, https://www.tandfonline.com/doi/full/10.1080/10408398.2012.691574
17. Carbohydrate Metabolism | Anatomy and Physiology II - Lumen Learning, accessed August 27, 2025, https://courses.lumenlearning.com/suny-ap2/chapter/carbohydrate-metabolism-no-content/
18. Sucrose (oral) for procedural pain management in infants - The Royal Children's Hospital, accessed August 27, 2025, https://www.rch.org.au/rchcpg/hospital_clinical_guideline_index/sucrose_oral_for_procedural_pain_management_in_infants/
19. Oral sucrose for procedural pain, neonates (1210) - Right Decisions, accessed August 27, 2025, https://rightdecisions.scot.nhs.uk/shared-content/ggc-clinical-guidelines/neonatology/oral-sucrose-for-procedural-pain-neonates-1210/
20. Sucrose Analgesia - Starship Hospital, accessed August 27, 2025, https://www.starship.org.nz/guidelines/sucrose-analgesia/
21. The Analgesic Properties of Intraoral Sucrose - CEConnection, accessed August 27, 2025, https://nursing.ceconnection.com/ovidfiles/00149525-201104000-00004.pdf
22. Oral sucrose and a pacifier for pain relief during simple procedures in preterm infants: a randomized controlled trial - PMC - PubMed Central, accessed August 27, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC2813645/
23. Everything you need to know about Sucrose - Ultrahuman Blog, accessed August 27, 2025, https://blog.ultrahuman.com/blog/sucrose-how-it-impact-on-the-body/
24. Both Sucrose and High Fructose Corn Syrup Linked to Increased Health Risks | UC Davis, accessed August 27, 2025, https://www.ucdavis.edu/health/news/both-sucrose-and-high-fructose-corn-syrup-linked-increased-health-risks
25. The Slimaceous Herbs Betzy Bancroft, RH 2015 Intro ~ Demulcents, or mucilages, are a vitally important, but perhaps, accessed August 27, 2025, https://vtherbcenter.org/wp-content/uploads/2012/01/demulcents-class-handout.pdf
26. Effects of glucose and sucrose administration on the working ability of young women, accessed August 27, 2025, https://www.oatext.com/effects-of-glucose-and-sucrose-administration-on-the-working-ability-of-young-women.php
27. www.rch.org.au, accessed August 27, 2025, https://www.rch.org.au/rchcpg/hospital_clinical_guideline_index/sucrose_oral_for_procedural_pain_management_in_infants/#:~:text=Assessment-,Indications,of%20pain%20during%20minor%20procedures.
28. Oral Sucrose for Pain Relief - Together by St. Jude™, accessed August 27, 2025, https://together.stjude.org/en-us/medical-care/medication-management/oral-sucrose.html
29. Sucrose for analgesia (pain relief) in newborn infants undergoing painful procedures, accessed August 27, 2025, https://www.cochrane.org/evidence/CD001069_sucrose-analgesia-pain-relief-newborn-infants-undergoing-painful-procedures
30. Sucrose for analgesia in newborn infants undergoing painful procedures - PubMed, accessed August 27, 2025, https://pubmed.ncbi.nlm.nih.gov/27420164/
31. Paediatric Medication Administration: Sucrose 24% - Children's Health Queensland, accessed August 27, 2025, https://www.childrens.health.qld.gov.au/__data/assets/pdf_file/0032/179681/paediatric-medication-administration-Sucrose-24-percent.pdf
32. P&P: Pain Medicine: Oral Sucrose Administration for Analgesia - ChildKind International, accessed August 27, 2025, https://childkindinternational.org/wp-content/uploads/Oral-Sucrose-Admin-for-Analgesia.pdf
33. Demulcents – Knowledge and References - Taylor & Francis, accessed August 27, 2025, https://taylorandfrancis.com/knowledge/Medicine_and_healthcare/Pharmaceutical_medicine/Demulcents/
34. Demulcent Foods & Herbs List: An Ayurveda Perspective - Joyful Belly, accessed August 27, 2025, https://www.joyfulbelly.com/Ayurveda/herbal-action/demulcent
35. What is the Role of Over 100 Excipients in Over the Counter (OTC) Cough Medicines?, accessed August 27, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC7502433/
36. Medicines containing the active ingredient sucrose - (emc), accessed August 27, 2025, https://www.medicines.org.uk/emc/ingredient/1386
37. Plaque, Dental Not Yet Recruiting Phase 1 Trials for Sucrose (DB02772) | DrugBank Online, accessed August 27, 2025, https://go.drugbank.com/indications/DBCOND0092704/clinical_trials/DB02772?phase=1&status=not_yet_recruiting
38. Sucrose Completed Phase N/A Trials for Tick Borne Encephalitis (TBE) | DrugBank Online, accessed August 27, 2025, https://go.drugbank.com/drugs/DB02772/clinical_trials?conditions=DBCOND0047137&status=completed
39. Sucrose Completed Phase 1 / 2 Trials for Norwalk Virus Infection / Gastroenteritis Acute Prevention | DrugBank Online, accessed August 27, 2025, https://go.drugbank.com/drugs/DB02772/clinical_trials?conditions=DBCOND0044602%2CDBCOND0044603&phase=1%2C2&purpose=prevention&status=completed
40. PH Not Yet Recruiting Phase 1 Trials for Sucrose (DB02772) | DrugBank Online, accessed August 27, 2025, https://go.drugbank.com/indications/DBCOND0052280/clinical_trials/DB02772?phase=1&status=not_yet_recruiting
41. Sucrose: What is it and where is it used? - Drugs.com, accessed August 27, 2025, https://www.drugs.com/inactive/sucrose-74.html
42. What is Sucrose? It's Types And Pharmaceutical Applications - MB Sugars, accessed August 27, 2025, https://mbsugars.com/what-is-sucrose-its-types-and-pharmaceutical-applications/
43. Sucrose-Based Excipients for Pharmaceutical Products - suedzucker.com, accessed August 27, 2025, https://www.suedzucker.com/products/sucrose-based-excipients/
44. Sucrose EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,NF - Pharma Excipients, accessed August 27, 2025, https://www.pharmaexcipients.com/product/sucrose-emprove-essential/
45. Sucrose - Pharma Excipients, accessed August 27, 2025, https://www.pharmaexcipients.com/stabilizer/sucrose/
46. DFE Pharma Excipients - BioHale® Sucrose - Biopharma, accessed August 27, 2025, https://dfepharma.com/excipients/biohale-sucrose/
47. Impact of Excipients Blending on Sugar-Stabilized Therapeutic Proteins, accessed August 27, 2025, https://www.pharmaexcipients.com/news/sugar-stabilized-proteins/
48. Sucrose Low Endotoxin Excipient- GMP- High Purity - Low Metals - Pfanstiehl, accessed August 27, 2025, https://pfanstiehl.com/en/high-purity-ingredients/sucrose/
49. DFE Pharma Excipients - BioHale® Sucrose for Inhalation - Stabilizer, accessed August 27, 2025, https://dfepharma.com/excipients/biohale-sucrose-inhalation/
50. A Comprehensive Scientific Survey of Excipients Used in Currently Marketed, Therapeutic Biological Drug Products, accessed August 27, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC9010397/
51. Sucrose - Santa Cruz Biotechnology, accessed August 27, 2025, https://datasheets.scbt.com/sc-204311.pdf
52. Sucrose SDS, 57-50-1 Safety Data Sheets - ECHEMI, accessed August 27, 2025, https://www.echemi.com/sds/sucrose-pid_Seven41256.html
53. SUCROSE - CAMEO Chemicals - NOAA, accessed August 27, 2025, https://cameochemicals.noaa.gov/chemical/12695
54. Iron sucrose: Uses, Interactions, Mechanism of Action | DrugBank Online, accessed August 27, 2025, https://go.drugbank.com/drugs/DB09146
55. Iron sucrose Interactions Checker - Drugs.com, accessed August 27, 2025, https://www.drugs.com/drug-interactions/iron-sucrose.html
56. Venofer (iron sucrose) dosing, indications, interactions, adverse effects, and more, accessed August 27, 2025, https://reference.medscape.com/drug/venofer-iron-sucrose-342162
57. October 1, 2023 Re: GRAS Status – Sucrose – 21 CFR 184.1854 Sugar products produced ... - United Sugar, accessed August 27, 2025, https://unitedsugarpr.com/wp-content/uploads/2024/01/20231001_USPR_GRAS_STATEMENT_v001.pdf
58. 21 CFR § 184.1854 - Sucrose. | Electronic Code of Federal Regulations (e-CFR) | US Law, accessed August 27, 2025, https://www.law.cornell.edu/cfr/text/21/184.1854
59. 21 CFR § 184.1854 - Sucrose. - Content Details - CFR-2025-title21-vol3-sec184-1854, accessed August 27, 2025, https://www.govinfo.gov/app/details/CFR-2025-title21-vol3/CFR-2025-title21-vol3-sec184-1854
60. 21 CFR 184.1854 -- Sucrose. - eCFR, accessed August 27, 2025, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-184/subpart-B/section-184.1854
61. 21 CFR Ch. I (4–1–24 Edition) § 184.1854 - GovInfo, accessed August 27, 2025, https://www.govinfo.gov/link/cfr/21/184?link-type=pdf§ionnum=1854&year=mostrecent
62. Just a Spoonful of Sugar Will Land You Six Feet Underground: Should the Food and Drug Administration Revoke Added Sugar's GRAS Status? - Institute for Food Laws and Regulations, accessed August 27, 2025, https://www.canr.msu.edu/resources/just-a-spoonful-of-sugar-will-land-you-six-feet-underground-should-the-food-and-drug-administration-revoke-added-sugar-s-gras-status