Lactose spray dried

Winfield AJ. 2006. Lactose, spray-dried. In Rowe RC, Sheskey PJ, Owen SC, editors. Handbook of pharmaceutical excipients, 5th ed. London and Washington, DC Pharmaceutical Press and American Pharmaceutical Association 396-401. 

See also Lactose, Monohydrate Lactose, Spray-Dried. 

Other directly compressible lactoses are spray-dried lactose and anhydrous lactose. See Lactose, Spray-Dried, Lactose, Anhydrous. 

Lactose, Spray-Dried (for monohydrate) 396 607.03 Calcium Stearate 102... 

Ultrafiltration. Membranes are used that are capable of selectively passing large molecules (>500 daltons). Pressures of 0.1—1.4 MPa (<200 psi) are exerted over the solution to overcome the osmotic pressure, while providing an adequate dow through the membrane for use. Ultrafiltration (qv) has been particulady successhil for the separation of whey from cheese. It separates protein from lactose and mineral salts, protein being the concentrate. Ultrafiltration is also used to obtain a protein-rich concentrate of skimmed milk from which cheese is made. The whey protein obtained by ultrafiltration is 50—80% protein which can be spray dried. 

The availabihty of spray-dried lactose, microcrystaUine cellulose, and other excipients allows for the use of granular rather than powdered phases. This eliminates some of the problems of particle segregation according to size (demixing) and even flow to the die. Direct compression eventually may be the preferred method of tablet preparation. 

A similar study has been conducted in which the interaction of d-amphetamine sulfate with spray-dried lactose was investigated [32], Upon storage at elevated temperatures, discoloration of the powder blends was noted, and the new absorption bands characterized. One maximum was noted at 340 nm, and this was attributed to the chemisorption of the amine onto the lactose particles. The other band appeared at 295 nm and was attributed to the new compound ([Pg.47]

Table 3 Comparison of Several Measures of the Powder Flow of Mixtures of Bolted Lactose and Spray-Dried Lactose...

In a slightly different form, Eq. (6) is commonly referred to as the Warren spring equation. Representative yield loci determined utilizing the simplified shear cell are shown in Fig. 7 for spray-dried lactose, bolted lactose, and sucrose. The yield locus for each material relates the shear strength to the applied load. 

Fig. 7 Yield loci of spray-dried lactose, bolted lactose, and sucrose as determined using the simplified shear cell apparatus. (Adapted from Ref. 48 with permission of the publisher.)...

The range of application of shear cell testing methodology is seen in Tables 2-6. Table 3 relates the flow properties of mixtures of spray-dried lactose and bolted lactose. These mixtures, in combination with the excipients tested, cover a broad range of flow. Tables 4 and 5, for example, show lot to lot variations in the flow properties of several materials, and Table 6 shows the variation in flow properties of bolted starch, sucrose, and phenacetin at different relative humidities (RH). Figure 8 presents the yield loci of sucrose at four different consolidation loads. Also shown in the figure are the shear indices determined at each consolidation load. 

A direct comparison of the results obtained by the simplified shear cell methodology and the Flowfactor Tester of Jenike and associates is difficult since the experimental procedures differ. Figures 10 and 11 show the yield loci obtained using both methods. For free flowing spray-dried lactose the yield loci are very similar (Fig. 10) and nearly linear, as is generally observed [45]. Bigger... 

Table 10 Properties of Compacts of Mixtures of Spray-Dried Lactose and Sucrose...

Methenamine Spray-dried lactose Fracture Index... 

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. 

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