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Lachman and Lieberman - The Theory and Practice of Industrial - Ebook download as PDF File .pdf) or read book online. The Theory and Practice of Industrial Pharmacy 3rd Edition By Leon Lachman In "Clinical Pharmacy". Industrial Pharmacy · YP - Admin; April. lachman, Vol. 3. Pages · · MB · 4, Downloads ·English. aulton pharmaceutics aulton. Preview Essentials of Chinese Medicine Volpdf.

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The Observer helps a request catalog where an hand been as a j is a community of books reading on it discs , long signifying them of any networks to technology. Jesus from Judaism to Christianityuploaded by busterLouis H. This is usually accomplished by means of paddles; revolving blades or other devices within the mixer arranged so as to move adjacent volumes of the fluid in different directions, thereby shuffling the system in three dimensions.

Within a turbulent fluid there are, however, small groups of molecules moving together as a unit, referred to as eddies An eddy is the portion of fluid moving as a unit in a direction often contrary to that of the general flow. Turbulent mixing alone may therefore leave small unmixed areas within eddies and in areas near the container surface which will exhibit streamlined flow. It is readily apparent that such temporal and spatial velocity differences as result from turbulence within a body of fluid produce a randomization of the fluid particles.

For this reason, turbulence is a highly effective mechanism for mixing. Thus, when small eddies are predominant, the scale of turbulence is low. An additional characteristic of turbulent flow is its intensity, which is related to the velocities with which the eddies move.

It can also occur if stirring is relatively gentle and may exist adjacent to stationary surfaces in vessels in which the flow is predominantly turbulent. When two dissimilar liquids are mixed through laminar flow, the shear that is generated stretches the interface between them. If the mixer employed folds the layers back upon themselves, the number of layers, and hence the interfacial area between them, increase exponentially with time. This relationship is observed because the rate of increase in interfacial area with time is proportional to the instantaneous interfacial area.

The sample sizes that are removed approximate a tablet unit dose. This allows assay of the entire sample after it has been removed, which eliminates inadvertent excessive handling of a large sample in the lab to obtain a small enough sample to assay.

This eliminates possible segregation before the sample has been assayed. Excessively handled, large samples usually do not represent the population removed from the sampled enclosure, or the Page 32 population being samples in the enclosure drum, mixer, storage hopper, etc.

Probably the most significant measure of quality of a mixture is how the blend actually performs, and the uniformity of the final product. Material Properties: Basic Concepts of Dry BlendingThe Unit Particle Since mixing plays such an important role in tableting, an understanding of the characteristics of the materials being mixed is paramount.

Many of the studies presented in the literature, and used previously in examples, deal with binary mixtures of physically and chemically similar materials which can easily be differentiated for the study by color, size, or assay.

However, pharmaceutical, binary, particulate systems in tableting are the exception, and results dealing with binary systems have limited applicability in industrial practice.

Each component in a mixture has distinct physical characteristics which contribute to, or detract from, the completeness uniformity of a mixture. Therefore, it is important to define and characterize the unit particles that make up the mixture, whether it is a premix of a wet granulation, a direct compression formula, or the addition of lubricants, etc.

Figure 21 is an illustration of several different types of particles handled in tablet granulation mixing. The unit particles in a system may range from the less-than-1 mm-size pure substance raw material particle to the 8 to 12 mesh multicomponent granule held together by a binder. Since dry mixing is a dynamic state of an assemblage of particles, the properties of the unit particle must be discussed in terms affecting these dynamics.

There are three properties intrinsic to each component in the mixture: composition physicochemical structure , size and size distribution , and shape [31]. Composition of each particle is its qualitative and quantitative makeup [32]. Each unit of pure substance has its own molecular composition and arrangement that distinguishes it from all other materials, and dictates its behavior in part as a powder per se, or in combination with other tablet mixture ingredients.

Chemical composition is important, because chemical reactivity limits a material's use with other tableting components, e. The same applies to components that may affect the stability of a mixture such as the potential Schiff Base reaction between certain sugars and amines when in contact even in the dry state. Physically, the molecular makeup determines crystallinity manifested as color, hardness, tackiness, general appearance, etc.

Particle size and size distribution of the unit particles have considerable impact on the flow properties of powders and therefore, the dynamics of mixing. Table 5 shows, in general, the effect of particle size on the flow properties of powders.

Table 6 is a list of some common substances used in the pharmaceutical industry, and their flow characteristics. A very complete and detailed list of materials and their characteristics Page 33 Figure 21 Several different types of particles encountered in tablet granulation dry blending.


Smaller particles Page 34 Table 5 Effect of Particle Size on Powder Flow Particle Type of flowa Reason size Flow is usually good if Mass of individual particles is shape is not interfering relatively large mm b mesh Flow properties may be a Mass of individual particles is small problem with many pure and increased surface area amplifies mm substances and mixtures effects of surface forces 60 mesh mm Figure 22 Effect of electrical forces on fine particles.

Page 35 the agglomerated particles behave as a single large mass particle Fig.

Flow may be better in this case, but the dynamics of distributing these small particles during mixing is very poor. Fine powder particles also create potential dust conditions which may require operators to wear respirators for safe handling, and may also create potentially dangerous dust explosion hazards. Particle size distribution of unit particles as suggested in the above discussion may also have an effect on the flow of a powder, i.

Although it has been stated that cohesive forces are strong in powders composed of particles 10 mm or less in size, each powder has a critical size where cohesive forces begin to affect the powder flow properties.

An example of this is shown in Table 7. The angle of repose a or the angle of slip is a relative measure of the friction between powder particles but also is a measure, for the most part, of the cohesiveness of fine particles.

The angle of repose may be measured in several ways as shown in Figure Methods 1 and 2 are both dynamic angle of repose measurements: the powder in Method 1 flows from a filled powder funnel onto a smooth surface where the angle is measured as illustrated, and in Method 2 the powder is moving in a rotating drum while the angle is measured as shown. Method 3 gives the static angle of repose, because the powder container is removed and the powder does not, or is not flowing before the measurement.

Since many factors enter into the angle of repose such as particle size, shape, moisture content, etc. However, certain generalizations can be made regarding the angle of repose: 1. Material is hygroscopic which decreases flowability Very dusty. Material is hygroscopic which decreases flowability Fluid powder The two density powders are slippery and very dusty.

Material Fluid cohesive powder is hygroscopic which decreases flowability Cohesive powder Flow becomes extremely poor if packed 0. Flow becomes poor when packed. Some 0. Flow becomes poorer when packed Source: Carr, R. Page 38 Figure 23 Angle of repose. Page 39 Table 7 Critical Particle Size of Raw Materials Raw material Critical particlea Wheat starch mm Boric acid mm aCohesive forces diminish at this particle size range and have little affect on raw material flow properties as the particle size increases above this range.

Size distribution of a powder also has an effect on the packing characteristics, and therefore the bulk density of the powder. This is illustrated in Figure 24, which shows how the smaller particles of a size distribution occupies interstices between the larger particles creating a more densely packed powder.

Densely packed powders usually have flow difficulties. Particle shape affects powder inter-particle friction, and consequently the flow properties of the powder. Figure 25 shows general particle shapes and their effects on powder flow. Materials composed of particles with rounded edges such as a and b in Figure 25, will flow more readily than those with sharper edges c , or two dimensional flat, flake-like particles e. Poor flow is usually encountered with particles having Figure 24 Effects of particle size distribution on the bulk density of a powder.

Page 40 Figure 25 General particle shapes and their effect on power flow. Bridging refers to the stoppage of powder flow as a result of particles which have formed a semirigid or rigid structure within the powder bulk. It is apparent that particle shape affects the angle of repose of a powder, particularly powders with low magnitude surface forces as found with particles greater than mm, and some low free-surface energy-fine powders such as talc hydrous magnesium silicate and cornstarch [34].

It must be remembered that all of the properties discussed above are intimately interrelated, and, although each one must be considered individually, they must also be considered as an entire group of variables when evaluating powder flow properties.

Mixing Equipment A general classification of mixers is shown in Table 8. Types of mixers can be divided first into two broad categories: a batch type, and b continuous. By far and large, the most prevalent type used in the pharmaceutical industry today is the batch type that mixes a sublot or total lot of a formula at one time, i. The continuous mixer, on the other hand, is usually dedicated to a single high-volume product. Ingredients are continuously proportioned into the mixer and collected from the continuous discharge.

The lot size is usually determined by a specified length of mixing time which may range from 8 to 24 hr, depending on the process. Batch-Type Mixers.

The first general class of mixers are those that create particle movement by rotation of the entire mixer shell or body. A schematic of four types listed in Table 8 is seen in Figure 26, while a slant, double-cone mixer a modification of the double cone is shown in Figure Batch Type 1. Rotation of the entire mixer shell or body with no agitator or mixing blade a. Barrel b. Cube c. V-shaped d. Double cone e. Slant double cone 2. Rotation of the entire mixer shell or body with a rotating highshear agitator blade a.

V-shaped processor b. Double cone formulator c. Slant double cone formulator 3. Stationary shell or body with a rotating mixing blade a. Ribbon b. Sigma blade c. Planetary d. Conical screw 4. High-speed granulations stationary shell or body with a rotating mixing blade and high-speed agitator blade a. Bowl 5. Air mixerstationary shell or body using moving air as agitator a.

Fluid bed granulator b. Fluid bed drier B. Page 43 Figure 27 The twin shell V-blender. However, the V-shaped blender Fig. The term blending is used in relation to these pieces of equipment because they mix the dry powders with a minimum of energy imparted to the powder bed as a result of tumbling the powders.

The rotating shell blenders with no high speed agitator bar are used only for dry mixes and have no packing glands seals around shafts entering the chamber to cause potential problems. Modifications, such as the addition of baffles, to increase mixing shear have been made to these types of blenders.

The slant, double cone design is unique in that it eliminates the dead spot that may occur in the double cone mixer Fig. The advantage of using the V-shaped, doublecone, and slant double-cone blenders include: Page 44 Figure 28 Double-cone blender.

Minimal attrition when blending fragile granules 2. Large capacity equipment available 3. Easy to load and unload 4.

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Easy to clean 5. Minimal maintenance The primary disadvantages are: 1. High head space needed for installation particularly with V-shaped mixers 2.

Segregation problems with mixtures having wide particle size distribution and large differences in particle densities 3. Tumbling-type blenders not suitable for fine particulate systems because there may not be enough shear to reduce particle agglomeration 4. Serial dilution required for the addition of low dose active ingredients if powders are free flowing Page 45 Figure 29 Slant double-cone mixer. Courtesy Gemco, Middlesex, New Jersey.

Blending efficiency is affected by the load volume factor as shown in Table 9. Blender speed may also be a key to mixing efficiency in that the slower the blender, the lower the shear forces. Although higher blending speeds provide more shear, more dusting may be prevalent causing segregation of fines, i.

There is also a critical speed which, if approached, will diminish blending efficiency of the mixer considerably. As the revolutions per minute rpm increase, the centifugal forces at the extreme points of the mixing chamber will exceed the gravitation forces required for blending, and the powder will gravitate to the outer walls of the blender shell. It should be noted that bench scale blenders turn at much higher rpm than the large blenders, usually in proportion to the peripheral velocity of blender extremes.

Page 46 Table 9 Effect of Powder Fill on Blending Time of Double-Cone Blendersa Volume percent of blender Approximate blend time minutes filled with powder charge in production-size blenders 50 10 65 14 70 18 75 24 80b 40b aBlending done in double-cone blenders and times measured to obtain comparable blends bUniform blend not attainable with this fill level Source: Sweitzer, G. The double-cone blender is usually charged and discharged through the same port, whereas the V-shaped blender may be loaded through either of the shell hatches or the apex port.

Emptying the V-shaped blender is normally done through the apex port.

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The second general class of mixers is a modification of the tumbling blenders shown schematically in Figure 30 with the addition of a high-speed rpm agitator mixing blade. This agitator blade is situated as shown in Figure 31, and gives added versatility to the tumbling blenders by virtue of the high shear attainable.

The advantages with the addition of the agitator bar to the tumbling blender include: 1. Good versatility in that both wet and dry mixing can be accomplished in the blender. Figure 31 V-shaped blender with agitator mixing assembly. Courtesy of Gemco, Middlesex, New Jersey. Page 48 2. A wide range of shearing force may be obtained with the agitator bar design permitting the intimate mixing of very fine as well as coarse powder compositions.Wedding Invitation Clinical or comparative bioavailability studies may be used to assure this.

These units, known as processors or formulators may also have a steam jacket around the shell of the blender for heating the wet powder or granulation, and a vacuum system to remove the granulating liquid vapors during drying. The properties are shown as hurdles to be surmounted if a dosage form is to achieve effective systemic delivery. Any personal information you provide to us including and similar to your name, address, telephone number and e-mail address will not be released, sold, or rented to any entities or individuals outside of V R Pharma.

It must be remembered that all of the properties discussed above are intimately interrelated, and, although each one must be considered individually, they must also be considered as an entire group of variables when evaluating powder flow properties.

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