1-lactose monohydrate

WjU 4-0-/ -D-Galactopyranosyl-a-D-glucopyranose, monohydrate (a-lactose, monohydrate) LACTOS01, 10 30 453... 

Ludipress a-Lactose monohydrate, povidone, crospovi-done BASF... 

Explosion hazards of mixtures of lactose monohydrate with potassium chlorate, potassium nitrate or potassium perchlorate are assessed. 

Flow behavior of powders is also of interest in direct compression. It is generally accepted that the flow rate initially increases with particle size, achieves a maximum in the range of 100-400 /um, and then decreases [85]. An excipient that has been well characterized is lactose, which undergoes particle fragmentation when compacted. For a-lactose monohydrate, it has been shown that the... 

In another study, thermodiffractometry was used to study phase transformations in mannitol and paracetamol, as well as the desolvation of lactose monohydrate and the dioxane solvatomorph of paracetamol [56]. The authors noted that in order to obtain the best data, the heating cycle must be sufficiently slow to permit the thermally induced reactions to reach completion. At the same time, the use of overly long cycle times can yield sample decomposition. In addition, the sample conditions are bound to differ relative to the conditions used for a differential scanning calorimetry analysis, so one should expect some differences in thermal profiles when comparing data from analogous studies. 

Zhou, Q., Armstrong, B., Larson, I., Stewart, P. J., Morton, D. A. V. Improving powder flow properties of a cohesive lactose monohydrate powder by intensive mechanical dry coating. J. Pharm. Sci., 99, 2010, 969-981. 

Excipients Calcium carbonate, candeUUa wax, croscarmeUose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystaUine cellulose, polysorbate 80, simethicone emulsion... 

Excipients Croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, and titanium dioxide... 

Frake et al. compared various chemometric approaches to the determination of the median particle size in lactose monohydrate with calibration models constrncted by MLR, PLS, PCR or ANNs. Overall, the ensuing models allowed mean particle sizes over the range 20-110/tm to be determined with an error less than 5 pm, which is comparable to that of the laser light diffraction method nsed as reference. Predictive ability was similar for models based on absorbance and second-derivative spectra this confirms that spectral treatments do not suppress the scattering component arising from differences in particle size. 

P. Frake, I. Gill, C.N. Luscombe, D.R. Rudd, J. Waterhouse and U.A. Jayasooriya, Near-infrared mass median particle size determination of lactose monohydrate, evaluating several chemometric approaches. Analyst, 123, 2043-2046 (1998). 

The Storage to Initial Ratio of two tablet parameters crushing strength (S) and disintegration time (D) were measured for a combination of one filler-binder (a-lactose monohydrate) and one disintegrant (rice starch), at three concentration levels. 

The used tablet ingredients were a-lactose monohydrate (Ph.Eur grade, 100 mesh), rice starch (Ph.Eur. grade) and magnesium stearate (Ph.Eur. grade). Before use the magnesium stearate was sieved through a 210 im sieve. Prior to use, the materials were stored at 20 1 °C and 45 5% relative humidity (RH) for at least one week. 

Just as may be expected, the initial disintegration time of a-lactose monohydrate/starch tablets is influenced by the starch concentration. The compression load level has a small effect on the initial disintegration time. The effect of the concentration is influenced by the level of the compression load. 

Tablets were prepared either with an insoluble (dicalcium phosphate dihydrate), a soluble (6-lactose) or a moderately soluble filler-binder (a-lactose monohydrate). As a disintegrant four different starches (com, rice, potato and tapioca) were used. As a comparison the effect of two super-disintegrants (crospovidone and sodium starch glycolate) was studied. The disintegrants were added at two concentration levels. The compression load was adjusted in order to obtain tablets with comparable initial cmshing strengths.

Figure 8.3a Storage to Initial Ratio of crushing strength (SIR(S)) of a-lactose monohydrate/tapioca starch tablets (20% w/w disintegrant) as a function of the storage time...

Native starches are used as disintegrants, diluents, and wet binders. However, their poor flow and high lubricant sensitivity make them less favorable in direct compression. Different chemical, mechanical, and physical modifications of native starches have been used to improve both their direct compression and controlled-release properties (Sanghvi, 1993 van Aerde and Remon, 1988). Schinzinger and Schmidt (2005) used potato starch as an excipient and compared its granulating behavior with a-lactose-monohydrate and di-calcium phosphate anhydrous in a laboratory fluidized bed granulator using statistical methods. 

Gereg and Capolla developed process parameters determined by a model laboratory bench scale Carver press, model C (Carver Inc. Savannah, Georgia, U.S.A.), which were translated to production scale compactor parameters (6). Their study provided a method to predict whether a material is suitable for roller compaction. Their study objectives were to characterize properties of the material to identify process parameters suitable to achieve the necessary particle size and density using the dry granulation process and then translate laboratory information to a production scale roller compactor. Actually, information developed from a Carver press was correlated and scaled-up to a production scale Fitzpatrick roller compactor. Model IR 520 (Fitzpatrick Co., Elmhurst, Illinois, U.S.A.) The compactor produced very similar powder granule characteristics as the Carver press. Various lactose materials, available as lactose monohydrate or spray dried lactose monohydrate, were used as the model compounds. Results indicated that a parametric correlation could be made between the laboratory bench Carver press and the production scale compactor, and that many process parameters can be transferred directly. 

Coprocessing of a-lactose monohydrate with cornstarch helped in improving its compressibility, and provided dual benefits of enhanced binding capacity and better disintegration potential, the attributes associated to starch (48). This effect was a result of binding of small starch particles together with a-lactose monohydrate crystals into compound particles. 

Lactose monohydrate (93%), Kollidon 30 (3.5%), and Kollidon CL (3.5%) Ludipress BASF AG, Ludwigshafen, Germany Lower hygroscopicity, good flow ability, tablet hardness independent of machine speed... 

Wagner KG, Dressier JA. A corn starch/alpha-lactose monohydrate compound as a directly compressible excipient. Pharm Technol (Europe) March 2003. 

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