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Pharmaceutical engineering cvs size reduction part 1

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Document 163

Pharmaceutical engineering cvs size reduction part 1

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hadiyaabdulnazar
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© © All Rights Reserved
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Chapter 3 Size Reduction “ Mechanisms of Size Reduction “+ Modes of Stress Applied in Size Reduction Classification of Size Reduction Equipment Size Reduction Equipment “Selection of a Mill * Theories of Comminution + Energy of Comminution LEARNING OBJECTIVES After reading this chapter, the reader should be able to: | © Understand the principles of size reduction, mechanisms involved, modes | applied and applications. | ® Explain the designs of industrial scale mills in terms of principles, working | and uses. i @ Select the size reduction equipment more scientifically based on the prop- | erties of materials, design of mills. t © Evaluate the efficiency of mills using relevant theories (Rittinger’s, Bond’s and Kick’s) and equations. Size reduction is a process of reducing large solid unit masses (vegetable eee. substances) into small unit masses, i.e. coarse particles or fine icles, Normally, pharmaceutical powders are polydisperse, i.e. consisting ee of different sizes. Polydisperse powders create considerable dif- size) ee production of dosage forms. Particles of monosize (equal ae ef ¢ ideal for pharmaceutical purposes. In practice, powders with them forthe — size distribution can obviate the problems in processing RartoW-size ize reduction alone is not sufficient to obtain mono-size or are combined fo Gone Therefore, size reduction and size separation 0 powders fee dia powders of desired size. (The fundamental aspects Wok, “Textbook of Physio Ph and methods of evaluation are given in the allabh Py, nbastanst) 2 i armaceutics-II” by C.V.S. Subrahmanyam, Bere a PHARMACEUTICAL ENGINEE Rig a—_—_ Size reduction process is also termed as comminution ot diminution pulverisation. Normally, size reduction may be achieved by two m eth, namely precipitation or mechanical process. In the ‘tation method, the substance 1s dissolved in an appr ate Parade er it is finely precipitated by the addition of er solvent, which is miscible with the first, but in the later the substance ig insoluble. This method is suitable for the production of raw materials ang bulk drugs. Inorganic chemicals, such as calcium carbonate, magnesium carbonate and yellow mercuric oxide, are prepared by precipitation meth. od. Other methods are crystallization and drying a fine spray of solution. In the mechanical process, the substance is subjected to mechanical forces using grinding equipment (¢.g. ball mill, roller mill, hammer mill, etc.). In general, dry milling is used in the production of tablets and cap- sules, while wet milling is used in the preparation of suspensions, emul- sions and ointments. The method of milling is applied either in the produc- tion of raw materials or as a part of the production cycle in the manufacture of dosage forms. Size reduction of substances offers several advantages. These are as follows: Content uniformity : Mixing of different ingredients can be effec- tive, if the particle size is uniform and small. Size reduction ensures this objective. As the size of particles is small, the number of particles per watt weight (dose) is large. The larger the number of particles, the better is the mixing. Thus, better content uniformity can be obtained for a given dose. This is particularly important in formulations containing potent and low dose drugs. Uniform flow : Smaller particle size and controlled size distribute? promote the flow of the powder into dies during compression of The same principles are used in the production of capsules. Effective extraction of drugs : Smaller particles allow rapid pens tion of menstruum or solvent into the tissue or cells of vegetable and ant mal origin (liver and pancreas). As a result, extraction or leaching of active constituents becomes effective and complete in preparation of galenica> The time required for extraction can be shortened, For example, par is subjected to grinding action for the extraction of insulin. . Normally, fine powders are preferred for compound powders vn moderately coarse powders are used for the preparation of ti" Coarse powders without fines are employed in percolation process ; ree Effective drying : Drying of a granular mass can be rapid and oa tive, if the size of granules is small and uniform. Such techniques are ———E we in the production of tablets. Similarly, drying of medicinal plant parts can be quick and fast after size reduction. Improved physical stability : In case of suspensions and emulsions, the rate of sedimentation decreases to a large extent if particle size is small. Improved dissolution rate : Size reduction increases surface area, which facilitates intimate contact of solid particles with gastric or intestinal juices. Thus, the rate of dissolution enhances. For example, size reduction of griseofulvin led to the development of oral tablet with a dose half that of the originally marketed product. In case of insufflations (preparations inhaled directly into the lungs), the drug should be usually smaller than 5 um. Micronized powder of aspirin is used in the preparation of tablets, e.g. microfined aspro (analgesic and anti-inflammatory agent). Improved rate of absorption : The smaller the particle size, the fast- er is the absorption, because of enhanced dissolution. Chloramphenicol has been shown to absorb faster, when given with particle size of 50 um compared to particle size of 400 um. Keeping in view of the advantages, pharmacopoeia specifies particle size as a quality control tool. For exam- ple, griseofulvin (antifungal antibiotic) should have surface area of not less than 1300 to 1700 m2/kg (as per IP). If it is less, the absorption of the drug decreases. Sulphonamides attain their antibacterial activity at powder sizes of about 1 pm or below. Increased antiseptic action has been demonstrated when the particle size of calomel has been reduced. The disadvantages of size reduction process are as follows: (1) Drug degradation : Drug decomposition is possible due to the heat produced during milling. Thermo-labile substances are the most affected. The increased surface area also facilitates drug decomposition, owing to enhanced dissolution. Cooling support systems are provided to decrease the heat in mill- ing equipment. Drugs containing waxy materials become soft due to heat generated during milling. Therefore, the feed is chilled before milling. (2) Poor mixing : Normally, very small particles possess strong co- hesive forces, hence, aggregation of particles is possible. Aggre- gation inhibits the effective blending of different additives. An increase in surface area may promote the adsorption of air, which may inhibit wettability of the drug during production. Therefore, optimum particle size is desirable to improve blending and to avoid poor mixing. Contamination : During milling, the grinding surfaces wear off (e. g. ceramic or iron equipment), the particles of which are present as (3) PHARMACEUTICAL ENGINEERIN Do , Such type of mills should be avoide re required. n is SO profound that it is used in th i s tablets, capsules, suspensions, emu .ction of all dosage forms such as table 1 i aoa injections and galenicals. The principles of size Usuerae tea tion ‘and working of equipment are discussed in this chapter. The equip ment, which are used in pharmaceutical industry, are given importance, n of a powder give polydisperse par. the powde f high purity The importance of size reductiot impurities in when drugs 01 Comment 3-1. Why does size reductio ticles, not monodisperse? Comment 3-2. Size reduction of Explain. a material enhances the action of drugs, | MECHANISMS OF SIZE REDUCTION The mechanism of size reduction may vary with the nature of materi- al. Therefore, each drug may require a separate treatment. However, the general mechanisms may be described in Figure 3-1. Smaller particle and Flaws i k ale particle oh additional surface Further impact Unmilled Flaws develo i i P Cleavage of particle particle to cracks to smaller size Smaller particles Attrit 6

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