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Spray Dried Lactose Monohydrate is a sugar composed of galactose and glucose subunits and has the molecular formula C12H22O11.
Spray Dried Lactose Monohydrate is a white, odorless, and crystalline powder that is commonly used as a filler, binder, and diluent in the pharmaceutical industry.
Spray Dried Lactose Monohydrate is also used in the food industry as a sweetener and bulking agent.
CAS Number: 64044-51-5
Molecular Formula: C12H24O12
Molecular Weight: 360.31
EINECS Number: 613-418-9
Synonyms:5989-81-1, alpha-Lactose monohydrate, DTXSID1052828, alpha-D-Glucopyranose, 4-O-beta-D-galactopyranosyl-, monohydrate, RefChem:1076517, DTXCID90820517, 611-913-4, Lactose monohydrate, alpha-D-Lactose monohydrate, D-Lactose monohydrate, 64044-51-5, a-Lactose monohydrate, Respitose, a-D-Glucopyranose, 4-O-b-D-galactopyranosyl-, monohydrate, alpha-lactose hydrate, Lactose monohydrate [NF], (2R,3R,4S,5R,6S)-2-(hydroxymethyl)-6-[(2R,3S,4R,5R,6S)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol;hydrate, EWQ57Q8I5X, Inhalac 120 (contains b anomer), 4-O-beta-D-Galactopyranosyl-alpha-D-glucose, Lactose monohydrate (NF), MFCD00150747, lactose hydrate, 10039-26-6, |A-lactose monohydrate, Microtose, Pharmaose, Lactopress, Lactose, hydrous, (2R,3R,4S,5R,6S)-2-(hydroxymethyl)-6-[(2R,3S,4R,5R,6S)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol hydrate, (2R,3R,4S,5R,6S)-2-(hydroxymethyl)-6-{[(2R,3S,4R,5R,6S)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy}oxane-3,4,5-triol hydrate, (2S,3R,4R,5S,6R)-6-(Hydroxymethyl)-5-(((2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2,3,4-triol hydrate, 66857-12-3, Spherolac 100, Lactose(Monohydrate), Lactose (TN), NSC-760401, UNII-EWQ57Q8I5X, Pharmatose, Lactochem, Lactohale, Wyndale, Wynhale, Lactose hydrous, .alpha.-D-Glucopyranose, 4-O-.beta.-D-galactopyranosyl-, monohydrate, Pharmatose dcl ii, Supertab 11sd, Supertab 14sd, Supertab 30gr, Supertab 50 odt, lactose spray-dried, Supertab 11sd nz, Pharmatose dcl 11, Lactopress spray dried, Lactose (JP17), Lactose fastflo 316, |A-Lactose (hydrate), alpha-Lactose (hydrate), LACTOSE,MONOHYDRATE, |A-D-Lactose monohydrate, alpha -lactose monohydrate, SCHEMBL16787, LACTOSE HYDRATE [JAN], LACTOSE, HYDROUS [II], D-Glucose, 4-O-beta-D-galactopyranosyl-, monohydrate, orb2278570, alpha-D(+)-Lactose monohydrate, PHARMATOSE DCL II [II], D-Glucose, 4-O-.beta.-D-galactopyranosyl-, monohydrate, LACTOSE MONOHYDRATE [II], MSK3219, CHEBI:189432, alpha-Lactose, analytical standard, 4-O-A-D-Galactopyranosyl-D-glucose, LACTOSE MONOHYDRATE [USP-RS], LACTOSE MONOHYDRATE [WHO-IP], AKOS015896871, FS-3862, HY-W087904, NSC 760401, OL02402, OL05009, LACTOSE MONOHYDRATE [EP MONOGRAPH], OL176363, CS-0128727, LACTOSUM, MONOHYDRATE [WHO-IP LATIN], NS00099491, D03226, E80712, EN300-1608278, /b-D-galactopyranosyl-(1,4)-D-glucose monhydrate, F321958, alpha-4-O-(beta-D-galactopyranosido)-D-glucopyranose, Q27277391, 4-O-b-D-Galactopyranosyl-a-D-glucopyranose monohydrate, alpha-Lactose monohydrate, >=99% total lactose basis (GC), -D-Glucopyranose, 4-O-BATE-D-galactopyranosyl-, hydrate(1:1), Alpha-D(+)-Lactose Monohydrate(Discontinued,See C4X-214913), alpha-D-Glucopyranose, 4-O-beta-D-galactopyranosyl-, hydrate, |A-D-Glucopyranose, 4-O-|A-D-galactopyranosyl-, hydrate(1:1), alpha-Lactose monohydrate, BioXtra, >=99% total lactose basis (GC), alpha-Lactose monohydrate, suitable for cell culture, BioReagent, .alpha.-D-Glucopyranose, 4-O-.beta.-D-galactopyranosyl-, hydrate (1:1), 4-O-b-D-Galactopyranosyl-D-glucopyranose monohydrate;b-D-Gal-(1,4)-D-Glc, (2R,3R,4S,5R,6S)-2-(hydroxymethyl)-6-[(2R,3S,4R,5R,6S)-4,5,6-trihydroxy-2-(hydroxymethyl)tetrahydropyran-3-yl]oxy-tetrahydropyran-3,4,5-triol;hydrate, ^a-D-Lactose monohydrate, ACS;Lactose, D(+)-, Monohydrate;LACTOSE extrapure AR;β-D-Gal-(1-4)-D-Glc, 4-O-β-D-Galactopyranosyl-D-glucose, Lactosum monohydricum, Milk sugar;β-D-Gal-(1-4)-D-Glc, 4-O-β-D-Galactopyranosyl-D-glucose, Milk sugar;Lactose, Monohydrate, Powder, Reagent;alpha-D-Lactose monohydrate, ACS;D-(+)-LACTOSE MONOHYDRATE EP STANDARD
Spray Dried Lactose Monohydrate is a type of lactose.
Spray Dried Lactose Monohydrate is composed of D-galactose and D-glucose.
Spray Dried Lactose Monohydrate can be used as sweetener or excipient.
Spray Dried Lactose Monohydrate is a special pharmaceutical-grade form of lactose that is produced by a technique called spray drying, in which an aqueous solution or suspension of lactose is rapidly dried using hot air to yield fine, free-flowing spherical particles that contain a single molecule of water of crystallization, making it a monohydrate form.
This method of production is specifically designed to improve the flowability, compressibility, and blending properties of lactose compared to the standard crystalline grade, which often has more irregularly shaped particles that may not perform as well in certain manufacturing processes.
Because of its excellent flow characteristics and good compaction behavior, spray dried lactose monohydrate is one of the most widely used excipients in the pharmaceutical industry, particularly in the manufacture of direct compression tablets, where it acts as a diluent or filler, ensuring that active pharmaceutical ingredients (APIs) can be accurately and evenly processed into tablets without segregation or uneven distribution.
In addition, its spherical particle shape and controlled moisture content contribute to reduced dust formation, better mixing uniformity, and smoother tablet surfaces, which are critical factors in high-speed tablet production lines.
Due to the unique spray-drying process, Spray Dried Lactose Monohydrate has a unique spherical shape and narrow particle size distribution that results in superior flow characteristics, compressibility, and packing properties that results in consistent content uniformity, dissolution, and stability verses other forms of lactose.
Spray Dried Lactose Monohydrate is highly soluble in water and has excellent flow properties, making it ideal for use in tablet and capsule formulations.
Additionally, lactose monohydrate spray dried powder is used in the production of infant formula and other nutritional products.
Spray Dried Lactose Monohydrate, also known as milk sugar or simply sugar, is a disaccharide.
Spray Dried Lactose Monohydrate is important because it is often used in manufacturing and various aspects of the consumable industry.
Spray Dried Lactose Monohydrate is derived from milk processing plant waste materials during the manufacturing process. it has white to yellowish colour, no bitter taste ,good solubility. it can be added in any beverage like instant beverage, infant formula, chocolate drink, yogurt to increase nutritional value Spray Dried Lactose Powder is used in bakery products, dairy product, infant food, soups, sauces, etc.
Spray Dried Lactose Monohydrate is also applicable in chocolate industry for making dry mixes for chocolate drinks.
Spray Dried Lactose Monohydrate has advantages when compared to other powder forms of lactose in industries, it does not require the use of stabilizers and fillers.
Beyond its use in direct compression, spray dried lactose monohydrate is also applied in the production of capsules, powders for inhalation, and certain dietary supplements, where its solubility, compatibility with other ingredients, and stability make it a versatile and reliable excipient.
Its monohydrate crystalline form is chemically stable under normal storage conditions, which helps maintain the integrity of pharmaceutical formulations over long shelf lives.
Melting point: ~215 °C (dec.)
Density: 1.525
Storage temperature: Room temp
Solubility: 0.1 g/mL in H2O, clear, colorless
Form: Crystalline
Specific Gravity: 1.525
Color: White
pH: 3.5–6.0 (25 °C, 0.5 M in H2O)
Optical activity: [α]22/D +52.4°, c = 4.5 in H2O
Water/Ethanol/Organic Solubility: Soluble in warm water (0.1 g/mL), very slightly soluble in ethanol, insoluble in chloroform and ether
UV λmax: λ: 260 nm, Amax: 0.02; λ: 280 nm, Amax: 0.02
Merck: 14,5343
BRN: 3768231
Stability: Stable, incompatible with strong oxidizing agents
LogP: -3.409 (est)
Spray Dried Lactose Monohydrate is essentially a pharmaceutically optimized form of lactose that has been engineered to improve the performance of lactose as an excipient by using spray drying technology, which transforms a lactose solution into fine, uniform, porous, and spherical granules containing one molecule of crystallization water.
This specialized process not only changes the particle morphology but also provides lactose with superior flow properties, compressibility, and blending capabilities, which are highly desirable in pharmaceutical manufacturing environments where consistency and precision are critical.
In practical use, Spray Dried Lactose Monohydrate is most commonly employed in the direct compression method of tablet production, where powders are compressed into tablets without requiring an additional granulation step.
Because it exhibits excellent binding properties and high mechanical strength, it ensures that tablets hold together firmly while still being able to disintegrate quickly upon administration, releasing the active ingredient effectively.
This makes it especially important in the formulation of over-the-counter medicines, dietary supplements, and prescription drugs, where manufacturers need a reliable filler that works across a wide range of active pharmaceutical ingredients.
Spray Dried Lactose Monohydrate formed by the condensation of one galactose and one glucose molecule.
Spray Dried Lactose Monohydrate is the major sugar in the milk of most species, typically present between 2-8%.
The enzyme lactase hydrolyzes lactose to its constituent monosaccharides.
In neonates, Spray Dried Lactose Monohydrate released via the action of lactase is a major energy source.
Spray Dried Lactose Monohydrate is a chemically and physically pure, white colored powder.
Spray Dried Lactose Monohydrate is made from the partial hydrolysis of lactose. Spray Dried Lactose is used as a sweetener and as a carrier of other substances.
Spray Dried Lactose Monohydrate can also be used as an excipient and used in the manufacture of pharmaceuticals.
Spray Dried Lactose Monohydrate has sugars which are not easily absorbed in the body hence it makes you feel full for a longer time after having food Lactose is a milk sugar.
Spray Dried Lactose Monohydrate (or spray dried milk) is used like crystalline lactose, which it closely resembles in taste and sweetness, but has different properties.
Like all sugars it has the potential to elevate blood glucose levels; thus, it is not suitable for diabetics or hypoglycemics.
Spray Dried Lactose Monohydrate is essentially lactose that has been spray dried into the form of small white crystals.
This creates small hygroscopic particles that are free-flowing and easier to use than regular crystals.
Spray Dried Lactose Monohydrate is not as sweet as sucrose, but twice as sweet as glucose.
Spray Dried Lactose Monohydrate is about half as sweet as sucrose, and sweeter than corn syrup, fructose,
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Another major advantage of Spray Dried Lactose Monohydrate is its spherical, free-flowing particle shape, which helps powders pass smoothly through hoppers, feeders, and tablet presses without clogging or uneven dosing.
This property significantly improves manufacturing efficiency, reduces downtime, and enhances dose uniformity, which is vital to ensuring patients receive the correct amount of medication in every tablet or capsule.
Furthermore, its solubility in aqueous systems allows it to dissolve readily, which is useful not only in oral solid dosage forms but also in powders for reconstitution and dry powder inhalers, where quick solubilization or dispersion is required.
Beyond pharmaceutical applications, spray dried lactose monohydrate can also be used in nutraceuticals, infant nutrition, and specialized food formulations, where its smooth mouthfeel, bland taste, and low hygroscopicity contribute to stable, high-quality products.
In dietary supplements, for instance, it serves as a carrier for vitamins, minerals, and herbal extracts, while ensuring that the product is both stable during storage and easy to swallow when compressed into tablets.
Spray Dried Lactose Monohydrate is not simply a sugar but a specialized functional ingredient that plays a key role in modern drug formulation and manufacturing by combining the natural properties of lactose with the technological advantages of spray drying, providing both performance benefits in processing and reliability in final dosage forms.
Uses Of Spray Dried Lactose Monohydrate:
Spray Dried Lactose Monohydrate can be used as chromatographic adsorbent.
Spray Dried Lactose Monohydrate is primarily used in the pharmaceutical industry as a multifunctional excipient, where its excellent flowability, compressibility, and binding properties make it particularly suitable for the direct compression method of tablet manufacturing, allowing active pharmaceutical ingredients to be compacted into strong, uniform tablets without the need for complex wet or dry granulation processes.
This property not only simplifies production but also reduces manufacturing time and costs, which is especially valuable in large-scale, high-speed pharmaceutical operations where efficiency and consistency are essential.
In addition to being a filler or diluent in tablets, spray dried lactose monohydrate is also widely used in the production of capsules, chewable tablets, effervescent tablets, and orally disintegrating tablets (ODTs), where its smooth particle structure and rapid solubility in water ensure that the dosage forms are both palatable and capable of releasing the active drug quickly upon administration, improving patient compliance and therapeutic effectiveness.
Spray Dried Lactose Monohydrate is equally important in powder blends for reconstitution and in dry powder inhalation systems, where its fine, free-flowing nature ensures uniform distribution of the active drug and consistent dosing with each inhalation.
Beyond its role in pharmaceuticals, spray dried lactose monohydrate is used in the nutraceutical and dietary supplement industries, where it serves as a carrier or bulking agent in vitamin tablets, mineral supplements, and herbal formulations, providing a stable matrix that supports the incorporation of delicate active compounds while maintaining ease of swallowing and acceptable taste.
Spray Dried Lactose Monohydrate can also be employed in certain food applications, particularly in specialized nutritional products such as infant formulas, sports nutrition powders, and medical nutrition supplements, where it contributes to texture, flow properties, and stability during storage.
In some cases, spray dried lactose monohydrate is used in laboratory and research settings as a standard excipient in formulation development and tableting studies, since its well-characterized properties make it a model compound for evaluating compression behavior, flow performance, and drug–excipient compatibility in solid dosage forms.
Overall, the uses of spray dried lactose monohydrate are not limited to one field but extend across pharmaceutical, nutraceutical, food, and research applications, with its consistent performance and multifunctional properties making it an indispensable excipient for industries that require reliable flow, high compressibility, rapid solubility, and stability under processing and storage conditions.
Spray Dried Lactose Monohydrate is most widely employed in the pharmaceutical industry, where it has become one of the preferred tablet excipients due to its ability to combine excellent flowability, uniform particle size distribution, and superior compressibility, making it especially suitable for direct compression tableting, a method that eliminates the need for time-consuming granulation steps and allows for the rapid production of robust and uniform tablets with high mechanical strength.
This property is critical in the large-scale manufacturing of over-the-counter drugs, prescription medicines, and generic formulations, where efficiency, reproducibility, and cost-effectiveness must be guaranteed without compromising product quality.
In addition to its role as a filler and binder in standard tablets, spray dried lactose monohydrate is also a common choice in the production of more advanced dosage forms, including chewable tablets, effervescent tablets, dispersible tablets, and orally disintegrating tablets (ODTs), where its pleasant taste, smooth particle morphology, and rapid water solubility enhance patient acceptability and ensure that the active pharmaceutical ingredient is released quickly and efficiently once the dosage form is consumed.
Spray Dried Lactose Monohydrate is also used in capsule formulations, both as a bulking agent and as a stabilizer for active ingredients, providing uniform dosing and preventing the segregation of powders during filling operations.
A particularly important application is in the formulation of dry powder inhalers (DPIs), where spray dried lactose monohydrate functions as a carrier substance that ensures uniform distribution of micronized active drug particles, improving aerosolization performance and guaranteeing that each inhaled dose contains the correct amount of medication.
Its smooth spherical particles, controlled particle size, and low hygroscopicity make it especially suitable for this application, which requires precise particle engineering to ensure efficient delivery of drugs to the lungs.
Beyond pharmaceuticals, spray dried lactose monohydrate is also widely used in the nutraceutical and dietary supplement industries, where it serves as a diluent, bulking agent, and stabilizer in the manufacture of vitamin tablets, mineral supplements, herbal extracts, and sports nutrition products, offering not only functional advantages in processing but also a bland taste and good solubility profile that make final products more consumer-friendly.
In the field of medical nutrition and infant formulas, it is sometimes used as a carbohydrate source and processing aid, since lactose is naturally digestible for most individuals and contributes to the overall nutritional balance of specialized food products.
Safety Profile Of Spray Dried Lactose Monohydrate:
In addition to intolerance, there is the possibility of allergic reactions, although true lactose allergies are extremely rare.
In some cases, people may confuse lactose intolerance with allergic responses, but excipients like spray dried lactose monohydrate can sometimes carry trace contaminants from the milk source, potentially causing hypersensitivity in individuals with severe milk protein allergies if not properly purified.
Although Spray Dried Lactose Monohydrate is generally recognized as safe for use in pharmaceutical, food, and nutraceutical applications, there are several potential hazards and safety considerations that must be taken into account during its handling, processing, and consumption.
From a health and occupational safety perspective, one of the primary concerns relates to its form as a fine, spray-dried powder, which can easily become airborne during large-scale manufacturing, blending, or tableting processes, thereby creating a risk of dust inhalation for workers.
Prolonged or repeated inhalation of lactose dust may cause respiratory tract irritation, coughing, and discomfort in the throat, and in rare cases, it may lead to occupational asthma-like symptoms or hypersensitivity reactions in sensitive individuals.
This is why industrial hygiene controls such as dust extraction systems, local exhaust ventilation, and protective masks are often recommended in facilities that process spray dried lactose on a large scale.
Another important hazard is related to lactose intolerance, a condition where individuals lack sufficient levels of the enzyme lactase, which is necessary for breaking down lactose in the digestive system.
For such individuals, the ingestion of spray dried lactose monohydrate in tablets, capsules, or food products can result in gastrointestinal discomfort, bloating, abdominal cramps, flatulence, and diarrhea, particularly if taken in larger amounts or repeatedly.
Although the amount of lactose used as an excipient in pharmaceutical formulations is often relatively small, it may still be significant enough to trigger symptoms in people with high sensitivity to lactose.
