Abu Fara, Deeb, et al. Drug Development and Industrial Pharmacy 44.12 (2018): 2038-2047.
This study explores the application of α-lactose monohydrate in the preparation of direct-compression pharmaceutical excipients through roller compaction. Crystalline α-lactose monohydrate served as the starting material, while amorphous lactose was produced by freeze-drying a 10% (w/v) aqueous solution under controlled thermal gradients, followed by secondary drying and storage under anhydrous conditions.
Roller compaction was performed on 3.0 kg batches of crystalline α-lactose monohydrate using a production-scale TFC-520 Roller Compactor. Key process variables-including compaction pressure (1000-20000 kPa), number of compaction repetitions (1-4), and screw-to-roller speed ratios (SR, ranging from 3 to 10)-were systematically adjusted to evaluate their effects on the transformation of the crystalline structure.
Results demonstrated that increasing compaction pressure and repetition induced partial amorphization, facilitating improved compressibility and flow properties of the resulting powder. A screw-to-roller speed ratio of 5 yielded optimal conversion, striking a balance between mechanical energy input and material stability. Milled and sieved compacted sheets exhibited desirable characteristics for direct tableting applications.
These findings highlight α-lactose monohydrate's utility as a functional excipient adaptable via roller compaction to modify crystallinity and enhance pharmaceutical processability. This process provides an efficient pathway for producing tailored lactose-based excipients, critical for formulating robust and reproducible solid dosage forms.
Kalliantas, D., Kallianta, M., Kordatos, K., & Karagianni, C. S. (2020). J. Nanomed, 3(1), 1024.
In the context of preparing ultra-high diluted succussed solution medicinal products, α-lactose monohydrate plays a critical role as a frictional medium for the trituration of solid-origin raw materials. This study investigates whether the trituration process, conducted in accordance with the German Pharmacopoeia, alters the physicochemical integrity of α-lactose monohydrate during extensive manual grinding (up to 360 minutes).
Comparative evaluations were performed using sodium chloride and calcium carbonate triturated in α-lactose monohydrate. Analytical techniques were employed to assess any changes in chemical composition, electrical conductivity, and pH.
Results confirm that α-lactose monohydrate remains chemically and physically stable throughout the trituration process, showing no detectable molecular alteration. Notably, variations in pH and conductivity observed in the final products were attributed solely to the nature of the raw materials rather than any transformation of the lactose itself.
This case study confirms the inertness and reliability of α-lactose monohydrate as a trituration medium in pharmaceutical processing. Its ability to facilitate particle size reduction down to the micro/nano scale without compromising its own molecular structure ensures consistency and safety in the preparation of ultra-high diluted medicinal products derived from inorganic sources.
López-Pablos, A. L., Leyva-Porras, C. C., Silva-Cázares, M. B., Longoria-Rodríguez, F. E., Pérez-García, S. A., Vértiz-Hernández, Á. A., & Saavedra-Leos, M. Z. (2018). International Journal of Polymer Science, 2018(1), 5069063.
Alpha-lactose monohydrate (αL·H₂O), a widely used disaccharide in pharmaceutical and food industries, serves as a key starting material for the synthesis of anhydrous β-lactose (βL)-a polymorph of interest due to its unique physicochemical properties. Although β-lactose is rarely encountered in nature, it can be synthesized through controlled polymorphic transformation processes.
In this study, α-lactose monohydrate was subjected to base-catalyzed conversion using a mild methanolic sodium hydroxide solution (0.2% wt) at a 1:10 solid-to-liquid ratio. Incubation was conducted under static conditions at temperatures ranging from 27 to 32 °C for 72 hours without agitation. These parameters were chosen based on findings that non-stirred environments promote nucleation and crystalline growth of the β-lactose form.
Following the reaction, filtration, and ambient desiccation drying, the resulting material was confirmed to be β-lactose, demonstrating that αL·H₂O can be effectively transformed under simple, low-energy conditions without the need for acetylation, vacuum drying, or agitation.
This case study highlights the utility of α-lactose monohydrate as a precursor for β-lactose synthesis via an efficient and scalable process, supporting its continued relevance in polymorph engineering and lactose derivative development within pharmaceutical applications.
What is the molecular weight of Alpha-Lactose monohydrate?
The molecular weight of Alpha-Lactose monohydrate is 360.31.
What is the CAS number for Alpha-Lactose monohydrate?
The CAS number for Alpha-Lactose monohydrate is 5989-81-1.
What are synonyms for Alpha-Lactose monohydrate?
Synonyms for Alpha-Lactose monohydrate include Alpha-D-Glucopyranose and 4-O-beta-D-galactopyranosyl- monohydrate.
What is the physical state of Alpha-Lactose monohydrate?
The physical state of Alpha-Lactose monohydrate is solid.
What are typical applications of Alpha-Lactose monohydrate?
Typical applications of Alpha-Lactose monohydrate include use as an emulsion stabilizer and dispersing agent.
What percentage of actives does Alpha-Lactose monohydrate contain?
Alpha-Lactose monohydrate contains 95% actives.
How many oxygen atoms are in the molecular formula of Alpha-Lactose monohydrate?
There are 12 oxygen atoms in the molecular formula of Alpha-Lactose monohydrate.
What role does Alpha-Lactose monohydrate play in emulsions?
Alpha-Lactose monohydrate is used as an emulsion stabilizer.
What is the chemical formula for Alpha-Lactose monohydrate?
The chemical formula for Alpha-Lactose monohydrate is C12H24O12.
What is the main carbohydrate component of Alpha-Lactose monohydrate?
The main carbohydrate component of Alpha-Lactose monohydrate is Glucopyranose.
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