Polyalditol

Polyalditol: A Comprehensive Reference

1. Identity, Chemical Names, and Natural Source

Polyalditol is the trade and common name for a specific, pharmaceutical-grade form of hydrogenated starch hydrolysate (HSH). Polyalditols are a family of nonreactive polyols whose reducing power is reduced to less than 1% dextrose equivalent (DE) by catalytic hydrogenation of malto-oligosaccharides. In its most precisely defined pharmaceutical form, polyalditol is the preferred HSH excipient, comprising approximately 1% sorbitol, 3.5% maltitol, and 95.5% higher-order polyols.

The broader class to which polyalditol belongs — hydrogenated starch hydrolysates — carries several synonyms in regulatory and commercial contexts. Hydrogenated starch hydrolysates (HSHs), also known as polyglycitol syrup (INS 964), are mixtures of several sugar alcohols (a type of sugar substitute). Sugar alcohols, because of being produced from their respective aldose sugars, are also known as alditols. These are low molecular weight easily digestible carbohydrates obtained by substituting the aldehyde group with a hydroxyl group. Additional synonyms include polyglucitol, hydrogenated glucose syrup, and polyglycitol syrup; the CAS registry number for the broader HSH class is 68425-17-2.

Sugar alcohols are primarily classified as hydrogenated monosaccharides (sorbitol, mannitol), hydrogenated disaccharides (isomalt, maltitol, lactitol), and mixtures of hydrogenated mono, di, and/or oligosaccharides (hydrogenated starch hydrolysates). Polyalditol, by definition, falls into the last category and is distinguished by the predominance of higher-order polyols.

In terms of natural occurrence, polyols occur naturally in some fruits and vegetables, but they can also be produced through industrial processes. However, polyalditol as a defined pharmaceutical or food-grade product does not occur in nature in its refined form; it is a manufactured substance derived from starch.

2. Manufacturing Process and Primary Sources

Hydrogenated starch hydrolysates are produced by the partial hydrolysis of starch — most often corn starch, but also potato starch or wheat starch. This creates dextrins (glucose and short glucose chains). The hydrolyzed starch (dextrin) then undergoes hydrogenation to convert the dextrins to sugar alcohols.

Because in HSHs the starch is not completely hydrolyzed, a mixture of sorbitol, maltitol, and longer-chain hydrogenated saccharides (such as maltotriitol) is produced. When no single polyol is dominant in the mix, the generic name hydrogenated starch hydrolysates is used. However, if 50% or more of the polyols in the mixture are of one type, it can be labeled as "sorbitol syrup," or "maltitol syrup," etc.

The specific polyalditol products are produced via catalytic hydrogenation of maltodextrins. PD30, a well-studied polyalditol, has an average molecular weight of approximately 1,000 Daltons and a DE value of less than 0.5. Its properties have been compared with those of maltodextrin M180 (the precursor of PD30), which has a DE of 16.5 to 19.5. In comparison with the maltodextrin form, the polyalditol form has better thermal stability, improved color fastness, and very low chemical reactivity with amino acids and proteins (i.e., reduced Maillard reactions). Two polyalditol products, PD30 and PD60, are currently available.

3. Common Forms and Preparations

Polyalditol and related HSH products are encountered in several physical forms across pharmaceutical, food, and cosmetic applications:

• Syrup (liquid): Hydrogenated starch hydrolysates, including hydrogenated glucose syrups, maltitol syrups, and sorbitol syrups, are a family of pleasant-tasting bulk sweeteners used in a variety of products. They are exceptionally well suited for sugar-free candies because they do not crystallize. They blend well with flavors and are synergistic with low-calorie sweeteners.
• Powder (dry/spray-dried form): Polyalditol provides a protective matrix for spray drying, lyophilization, and coagglomeration. It has excellent compression properties and can provide a non-reactive excipient base for direct compression.
• Tablet and lozenge excipient: Within the pharmaceutical sector, HSH is employed as an excipient in the formulation of tablets and lozenges. The humectant qualities of this substance prevent the brittleness of pharmaceutical tablets, while its low reactivity makes it an appropriate ingredient in many formulations.
• Chewable tablet ingredient: Polyalditol appears as a listed inactive ingredient in commercial chewable tablet formulations, such as certain lactase enzyme supplements, where it serves as a bulking and binding agent alongside mannitol and microcrystalline cellulose.

Hydrogenated starch hydrolysate is a polyol mixture derived from the controlled hydrogenation of starch hydrolysates, typically presented as a white, crystalline powder or granules. It is renowned for its high water solubility and stability under a range of pH conditions, functioning as a versatile carbohydrate compound.

4. Historical Development and Use

Polyalditol in its modern, precisely defined form is not a traditional botanical or herbal ingredient with an ancient history of use. Rather, it is a product of 20th-century food and pharmaceutical technology. HSHs were developed by a Swedish company in the 1960s and have been used by the food industry for many years, especially in confectionery products.

The broader class of sugar alcohols that comprise HSH products has a somewhat longer history. Amongst these sugar alcohols, sorbitol has gained significant attention because of its wide usage as a pharmaceutical excipient and its influence on the disposition and pharmacokinetics of certain drugs. Sorbitol (i.e., d-glucitol) is a six-carbon sugar alcohol that was discovered by a French chemist in the berries of the mountain ash in 1872.

The development of HSH technology specifically addressed a practical limitation in confectionery: when the known hydrolysates were not cariogenic, it was difficult to use them in confectionery, notably for the manufacture of "hard candies," because of their lack of "body" and their too pronounced hygroscopic character; conversely, hydrolysates that were technologically useful in confectionery were found to be cariogenic. The object of subsequent invention was to provide a hydrolysate complying simultaneously with these two requirements which had appeared contradictory — being non-cariogenic while also being technologically suitable for confectionery.

More broadly, the use of polyol-based sweeteners in food and medicine traces to the early 20th century. Sugar replacers (polyols) have been used in foods around the world for many years. An Expert Committee of the World Health Organization has carefully reviewed them and concluded that they are safe for human consumption. In the U.S., the Food and Drug Administration (FDA) classifies some as Generally Recognized as Safe (GRAS) and others as approved food additives.

Historically, the uses of polyol-containing materials in medicine have included their role as low-glycemic sweeteners for diabetic patients and as osmotic agents. In medicinal history, polyalditols were incorporated as gentle laxatives, particularly sorbitol and mannitol, which helped to alleviate occasional constipation due to their ability to draw water into the intestines.

5. Key Constituents and Chemical Composition

The defining chemical feature of polyalditol is its oligomeric polyol composition. Hydrogenated starch hydrolysate is a mixture that contains not less than 50% of hydrogenated polysaccharides containing more than 3 d-glucopyranosyl units terminated with a d-glucityl unit, calculated on the anhydrous basis. Other ingredients can include sorbitol, maltitol, and other sugar polyols.

The specific pharmaceutical-grade polyalditol product contains: approximately 1% sorbitol, 3.5% maltitol, and 95.5% higher-order polyols. This composition distinguishes polyalditol from lower-grade HSH products, which may contain substantially higher proportions of sorbitol and maltitol.

In the USP monograph for HSH, the degree of polymerization (DP) spectrum is described in detail. A typical non-cariogenic HSH composition for confectionery purposes, for instance, contains less than 3% of polyols whose DP is higher than 20, less than about 60% of maltitol (DP 2), and less than about 14% of sorbitol (DP 1). The relative proportions of these components vary by grade and intended application.

Owing to its composition of sugar alcohols such as sorbitol, maltitol, and hydrogenated oligosaccharides, HSH offers sweetness while containing fewer calories compared to conventional sugar. Polyols are sweet in taste and provide fewer calories compared to regular sugar. They have a lower caloric value because they are not fully absorbed by the body, resulting in fewer calories per gram. The caloric content of polyols varies, but they generally provide around 2 to 3 calories per gram, compared to 4 calories per gram for sugar.

6. Established Mechanisms of Action

6.1 Incomplete Intestinal Absorption

The fundamental mechanism underlying most of polyalditol's functional properties is its incomplete digestion and absorption in the small intestine. Polyols are incompletely digested and absorbed in the small intestine. As a result, they have a reduced impact on blood sugar levels and insulin response.

HSH ingestion as a single carbohydrate ingredient results in decreased glycemia relative to glucose in individuals with and without diabetes. Decreased glycemia results from altered small intestinal carbohydrate absorption. This reduced absorption is the primary mechanism behind the lower glycemic response, the lower caloric value, and the osmotic laxative effects seen at higher doses.

6.2 Non-Reactivity (Reduced Maillard Reactivity)

Catalytic hydrogenation of the precursor maltodextrin eliminates the reducing end groups that drive the Maillard reaction (a non-enzymatic browning reaction between reducing sugars and amino acids). The compound's resistance to non-enzymatic browning and low reactivity with amino groups make it valuable for studies involving Maillard reactions and sugar alcohol metabolism. This non-reactivity is particularly important in pharmaceutical applications where co-formulation with proteins or peptide drugs must not degrade the active ingredient.

6.3 Cryoprotection and Glass Transition

Polyalditol's physical chemistry as a cryoprotectant is well characterized. Thermal desorption study showed that PD30 binds significantly less water than M180 at temperatures above 45°C. Glass transition temperature (Tg) of concentrated PD30 solutions was measured with differential scanning calorimetry. The Tg of PD30 is lower than that of M180 at the same solute concentration, suggesting that water is a more effective plasticizer for PD30 than for M180. The onset Tg of the maximally freeze-concentrated PD30 aqueous solution is −24.5 ± 1.2°C.

6.4 Oral Bacterial Non-Fermentability (Dental Mechanism)

Hydrogenated starch hydrolysates are non-cariogenic because they are only slightly (or not at all) fermented by cariogenic oral microorganisms and inhibit sucrose utilization by Streptococcus mutans (especially strain GS-5). This resistance to oral bacterial fermentation means that, unlike sucrose, HSH does not serve as a substrate for acid production on the tooth surface, and therefore does not promote the acid-mediated demineralization of enamel that underlies dental caries.

6.5 Osmotic Laxative Mechanism (at Higher Doses)

At higher doses, the unabsorbed polyol fraction exerts an osmotic effect in the colon. Disaccharide polyols are generally better tolerated than monosaccharide polyols secondary to the latter exerting a greater osmotic load in the gastrointestinal tract, leading to an increased concentration of water in the colon and a consequent greater laxative effect. Accelerated small bowel transit time seen with polyol ingestion also results in increased osmosis and water retention within the small bowel lumen and correlates with increased abdominal discomfort in healthy individuals.

7. Scientific Evidence by Area of Use

7.1 Blood Glucose Management and Diabetes

Clinical evidence (moderate quality, limited study sizes): The most direct clinical evidence for HSH's reduced glycemic effect comes from controlled human studies. A randomized double-blind crossover study published in Diabetes Care examined glycemic responses: the objective was to determine whether HSHs, bulking/sweetening agents used in hard candies, produce a diminished postmeal glycemic response relative to glucose in individuals with and without diabetes. This study followed a randomized double-blind crossover design and was performed in 12 individuals with diabetes (6 non-insulin dependent, 6 insulin dependent) and 6 nondiabetic individuals, each group consisting of 3 men and 3 women. After an overnight fast, each subject was challenged with 50 g of glucose, HSH 5875 (7% sorbitol/60% maltitol), and HSH 6075 (14% sorbitol/78% hydrogenated maltooligosaccharides) per 1.73 m² of body surface area in random order on 3 successive days.

For all groups, the order of plasma glucose responses over 5 hours post-challenge was glucose > HSH 6075 > HSH 5875 (p < 0.001 for glucose vs. HSH). Pooled data confirmed that HSH 6075 resulted in greater glycemia than HSH 5875 (p < 0.05).

A separate study of Lycasin HBC, a high-boiled confectionery HSH product, likewise assessed glycemic and insulinemic responses: six healthy and six type 2 diabetic men participated. Each subject absorbed, after an overnight fast, a challenge of either 50 g of glucose or 50 g of Lycasin HBC using a randomised double-blind crossover design. Blood samples were collected during a 3-hour period. The calculated glycaemic index of Lycasin HBC was 47 ± 10% in healthy subjects and 25 ± 6% in patients with type 2 diabetes mellitus. The insulinaemic index was 23 ± 4% and 39 ± 14%, respectively.

Strength of evidence: This evidence is consistent and biologically plausible, but all available studies use small sample sizes (typically 6–12 subjects) and measure acute glycemic responses rather than long-term outcomes. No long-term randomized controlled trials of polyalditol specifically (as opposed to the broader HSH class) on diabetes management outcomes exist in the peer-reviewed literature. These findings are best characterized as moderate evidence for a short-term reduction in postprandial blood glucose when HSH replaces glucose, with the magnitude of the effect depending on the specific HSH composition.

7.2 Dental Health / Caries Prevention

Evidence: Moderate (mechanistic and regulatory recognition; limited dedicated RCT evidence): The non-cariogenic character of HSH is well established through microbiology research and regulatory determinations. Polyols, including HSH, are resistant to metabolism by oral bacteria that break down sugars and starches to release acids that may lead to cavities or erode tooth enamel. They are, therefore, non-cariogenic and safe for teeth. The usefulness of polyols as alternatives to sugars and as part of a comprehensive program including proper dental hygiene has been recognized by the American Dental Association.

Mechanistically, the hydrogenated starch hydrolysate in combination with sucrose has been found to inhibit growth of Streptococcus mutans strains of bacteria, such as Streptococcus mutans GS-5, a prime contributor to formation of dental plaque and tooth decay. In fact, it has been found that hydrogenated starch hydrolysate inhibits sucrose utilization by Streptococcus mutans GS-5.

HSH is considered less effective than xylitol in actually preventing caries, as xylitol has additional anti-cariogenic properties. Strength of evidence: The non-cariogenic property of HSH is strongly supported by in vitro microbiological data and has been recognized by regulatory and dental professional bodies. However, clinical trial evidence specifically for polyalditol as a defined product in caries prevention outcomes is limited.

7.3 Pharmaceutical Formulation (Cryoprotection, Excipient Function)

Evidence: Well-established in pharmaceutical science (formulation studies): The use of polyalditol as a pharmaceutical excipient is supported by a substantial body of formulation research, including the study of its glass transition behavior and water sorption properties.

Polyalditol products provide preservation of efficacy of sensitive actives during spray drying or lyophilization. The high solubility provides an outstanding matrix for co-spray drying applications while the cryoprotectant properties are beneficial in freeze-drying.

A peer-reviewed study published in Cell Preservation Technology specifically characterized PD30: polyalditols are a new family of nonreactive polyols whose reducing power is reduced to less than 1% dextrose equivalent (DE) by catalytic hydrogenation of malto-oligosaccharides. PD30 is a polyalditol with an average molecular weight of approximately 1,000 Daltons and a DE value of less than 0.5. It was concluded that catalytic hydrogenation treatment of M180 alters water sorption property and glass transition behavior of PD30, which has significant implications in drying process development and product stability.

A US patent (US8614255B2) covering pulmonary pharmaceutical formulations specifies polyalditol as an excipient partner for parathyroid hormone fragments: one preferred composition comprises about 4.7% by weight of parathyroid hormone or fragment thereof, about 80% by weight of polyalditol, and about 15.3% by weight of sodium citrate. These formulation studies underscore polyalditol's functional role in stabilizing sensitive peptide and protein-based therapeutics. This use is supported by strong physicochemical evidence, though it is not a "health benefit" in the traditional dietary supplement sense.

7.4 Constipation and Laxative Effect

Evidence: Moderate, dose-dependent; principally applies to the sorbitol component: The laxative effect of the polyol components within HSH (especially sorbitol) is well documented. Most healthy individuals tolerate approximately 10 g sorbitol per day with only mild gastrointestinal discomfort, such as flatulence or bloating. However, doses of 20 g sorbitol per day can evoke more distressing symptoms of abdominal pain and diarrhea.

Given that pharmaceutical-grade polyalditol contains only approximately 1% sorbitol by composition, the laxative effect at typical excipient-level exposures is negligible. This effect becomes relevant at higher cumulative doses of HSH-containing products.

8. Body Systems and Health Areas Associated with Polyalditol / HSH

• Endocrine / Metabolic System: Reduced postprandial glycemic and insulinemic response compared to glucose; relevant in diabetes management when used as a sugar substitute. Control of blood glucose, lipids and weight are the three major goals in diabetes management today. HSH absorption is slow and incomplete.
• Oral / Dental Health: Non-cariogenic; does not promote acid formation by oral bacteria; recognized by the American Dental Association as a useful alternative to fermentable sugars.
• Gastrointestinal System: Incompletely absorbed in the small intestine; at higher doses, unabsorbed fraction exerts osmotic effects in the colon, producing a laxative action. In the human body, HSHs may be metabolized to sorbitol, maltitol and glucose.
• Pharmaceutical / Drug Delivery: Stabilizes sensitive biologics (proteins, peptides, enzymes) during spray drying and freeze-drying; used as an inert compression excipient in tablets and lozenges.
• Cosmetic / Dermatological (topical use context): Hydrogenated starch hydrolysates serve as versatile ingredients in cosmetics, primarily functioning as humectants and film-formers to enhance hydration and provide a protective barrier on the skin without causing irritation. In skincare formulations such as lotions, moisturizers, and serums, HSH attracts and retains moisture, improving product texture and efficacy for dry or sensitive skin types.

9. Dosage Forms and Dosages Reported in Studies

Polyalditol does not carry a defined therapeutic dosage in the manner of a traditional medicinal herb, as it functions primarily as an excipient or food ingredient rather than an active pharmaceutical ingredient. The following dosages reflect those described in the cited sources:

• Clinical glycemic studies (HSH, oral challenge): Randomized double-blind crossover study used 50 g of HSH per 1.73 m² of body surface area administered as a single oral dose after an overnight fast.
• Lycasin HBC glycemic study: Six healthy and six type 2 diabetic men received a challenge of either 50 g of glucose or 50 g of Lycasin HBC using a randomised double-blind crossover design.
• Pharmaceutical excipient (pulmonary formulation): At least one HSH is present in biocompatible particles in an amount of at least 5% by weight. The HSH is present in the particles in an amount ranging from about 50% to about 95% by weight.
• Pharmaceutical excipient (parathyroid hormone formulation): One preferred composition comprises about 4.7% by weight of parathyroid hormone or fragment thereof, about 80% by weight of polyalditol, and about 15.3% by weight of sodium citrate.
• Cosmetic formulations: Typical concentrations range from 1% to 3.8% to control viscosity and ensure stability.
• Safety threshold for osmotic diarrhea (HSH class): If consumed in amounts greater than 125 grams per day, HSHs can trigger diarrhea.

10. Safety, Toxicology, and Regulatory Status

10.1 Regulatory Status

In the United States, Generally Recognized as Safe (GRAS) petitions for HSH products have been accepted for filing. Once a GRAS affirmation petition has been accepted for filing, food manufacturers may use the ingredient. Products from the HSH family are approved in many other countries, including Canada, Japan and Australia.

HSH is sometimes listed as maltitol syrup, hydrogenated glucose syrup, polyglycitol, polyglucitol, or simply HSH. In the United States, the FDA classifies some polyols as Generally Recognized As Safe, whereas others are approved food additives.

10.2 Toxicology Studies

A 1993 comprehensive review, including a 24-month chronic feeding study in rats, multigenerational reproduction studies, and teratology assessments, found no treatment-related adverse effects, even at high doses up to 10% of the diet. Similarly, the European Food Safety Authority (EFSA) concluded in 2009 that HSH exhibit no toxicological concerns, supporting unrestricted use in food.

A formal safety assessment published in Food and Chemical Toxicology described the evidence base: some of the animal feeding studies important to a full safety assessment for HSH substances, while long available to international safety expert organizations, have never been published in the literature. Three of these studies — a chronic (24-month) feeding study, a multigeneration reproduction study, and a teratology study — are reported, together with metabolic information. The results of this evaluation establish HSH substances as safe food ingredients.

The FDA has separately issued guidance identifying hydrogenated starch hydrolysate as a "high-risk drug component" in the context of potential contamination with diethylene glycol (DEG) or ethylene glycol (EG) — not because of any inherent toxicity of HSH itself, but because reports about fatal poisonings of consumers who ingested drug products in liquid dosage form (such as cough, allergy, analgesic, and antiemetic drug products) were manufactured with DEG- or EG-contaminated components sourced from polyol supply chains. This is a manufacturing purity and contamination concern, not an intrinsic safety issue with polyalditol.

10.3 Gastrointestinal Effects

The principal safety consideration with polyalditol, as with all HSH-class polyols, is gastrointestinal tolerance at higher doses. Higher dose or over-intake of sorbitol (a component of HSH) causes bloating, flatulence, cramping, abdominal pain and diarrhea both in adults and in children. The laxative threshold varies from person to person.

Disaccharide polyols are generally better tolerated than monosaccharide polyols secondary to the latter exerting a greater osmotic load in the gastrointestinal tract, leading to an increased concentration of water in the colon and a consequent greater laxative effect. Since pharmaceutical-grade polyalditol is specifically formulated to contain only approximately 1% sorbitol and 3.5% maltitol (with over 95% higher-order polyols), its potential for osmotic laxative effects is lower than that of sorbitol-rich HSH grades, though this has not been studied independently in dedicated clinical trials.

10.4 Allergenicity and Gluten Considerations

Allergenicity is low, as HSH are highly processed polyols with minimal protein content; products derived from corn starch are gluten-free, while wheat-derived variants may contain trace gluten up to 40 mg/kg. Individuals with celiac disease or wheat allergy should therefore confirm the starch source of any HSH-containing product.

10.5 Dental Health and Cariogenicity

Unlike sucrose and fermentable carbohydrates, polyalditol is non-cariogenic. According to the FDA, sugar alcohols are "not technically considered artificial sweeteners" and "are slightly lower in calories than sugar and do not promote tooth decay or cause a sudden increase in blood glucose."

10.6 Interactions

No drug interactions unique to polyalditol as a defined product have been identified in the peer-reviewed literature. In its role as a pharmaceutical excipient, its principal functional feature is chemical inertness — its very low reactivity with amino groups and proteins means it is deliberately selected to avoid interaction with co-formulated drug substances. These unique carbohydrates are designed for use with pharmaceutical actives, enzymes, proteins, etc., where an inert excipient is required.

11. Important Limitations and Evidence Gaps

Several important limitations apply to the available evidence base for polyalditol specifically (as opposed to the broader HSH class):

• No long-term randomized controlled trials exist specifically for polyalditol (as defined by its ~95.5% higher-order polyol composition) on any health outcome.
• The clinical glycemic studies cited were conducted with different HSH preparations (e.g., Lycasin HBC, HSH 5875, HSH 6075) that may differ in composition from pharmaceutical-grade polyalditol.
• As noted, "polyalditol" in the context of ingredient labels (e.g., on chewable lactase tablets) may refer to the broader HSH class rather than the specifically defined pharmaceutical-grade formulation characterized in research studies.
• The primary scientific literature on polyalditol as a distinct entity (PD30, PD60) is focused on its physicochemical role as a pharmaceutical excipient — not on clinical health outcomes in humans.
• No published systematic reviews or Cochrane reviews specifically addressing polyalditol have been identified. Evidence for related health areas derives from broader polyol/HSH research.

References

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• ResearchGate: Physical Properties of Polyalditols PD30 and PD60 (Table Data)
• US Patent 8614255B2 – Pulmonary Pharmaceutical Formulations (polyalditol as HSH excipient), Google Patents
• Hydrogenated starch hydrolysates – Wikipedia
• USP Monograph: Hydrogenated Starch Hydrolysate
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• FDA Guidance: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution for Diethylene Glycol and Ethylene Glycol
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• US Patent 4508713 – Method of Reducing Dental Caries (USPTO)
• Erythritol: An In-Depth Discussion of Its Potential to Be a Beneficial Dietary Component. PMC/NCBI, 2023.