Manufacturing Pharmacy (II) PDF
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This document is lecture notes on Manufacturing Pharmacy (II). It covers topics such as size enlargement, granulation methods (wet and dry), and equipment used in both processes.
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Total Faith & Recognition For The GOD Father of Industrial Pharmacy, MUST University Professor Dr. Mohamed Farid El-Miligi Professor of Pharmaceutics & Industrial Pharmacy, Cairo University 6 Size Enlargement Size enlarg...
Total Faith & Recognition For The GOD Father of Industrial Pharmacy, MUST University Professor Dr. Mohamed Farid El-Miligi Professor of Pharmaceutics & Industrial Pharmacy, Cairo University 6 Size Enlargement Size enlargement deals with the production of portions of matter having sizes greater than that of component particles. Granulation This can be achieved by: Flocculation Extrusion Compression Coating Major objectives of size enlargement are: 1. As an important manufacturing step, e.g. in tableting (preventing air-trapping and consequences of varying powder densities) 2. To increase the flowability of the material e.g. in hoppers and in dies 3. To increase the bulk density of the material for more convenient storage and transportation. 4. To prevent dust losses in subsequent treatment steps e.g. drying, filling or shipping. 5. To reduce dust nuisance and hazard, e.g. in case of irritating or otherwise harmful material. 6. Reduction of surface area for hygroscopic or reactive substances, in order to minimize water absorption and enhance stability. Granulation Methods Granulation methods can be divided Wet methods (which utilize liquid in the process) into two types: Dry methods (no liquid is used) A. Wet Granulation This involves massing of the powder mix using non-toxic & volatile solvent 1. Shear Granulation. 2. Granulation by Fusion. 3. Spray Granulation. 4. Granulation by Extrusion 5. Granulation by Spheronisation. 1. Shear Granulation Planetary mixer e.g. Hobart Mixer, is often used for massing of the powder. The moist mass then granulated in suitable shear granulator, sieved and dried. 2. Granulation by Fusion: ► Mixtures containing suitable or wax binders can be agglomerated by means of heating and can be reduced to granules after cooling. 3. Spray Granulation: ► Fluidized powder is granulated by introducing suitable spray of granulating liquid, and resultant fluidized granules instantaneously dried. ► Another approach is granulation by spray drying. ► Resultant granules are free-flowing hollow spheres of good compression properties due to distribution of adhesive in such granules. 4. Granulation by Extrusion: ► This technique is similar to the mincing of meat in house-hold mincer. 5. Granulation by Spheronisation: ► For some applications, dense, spherical pellets of good flow properties are needed. ► Spheronising or pelletising equipment e.g. Freund Granulator is used. B. Dry Granulation: 1. Slugging by Tablet Presses. 2. Roller Compaction. B. Dry Granulation: 1. Slugging by Tablet Presses. 2. Roller Compaction. ► Employed when the active ingredients are sensitive to moisture, heat or both. ► Certain formulations, e.g. calcium lactate, resist compression when prepared by the wet granulation methods. 1. Slugging by Tablet Presses: ► Granulation by compression of the finely divided powder mix into the dies of large capacity tablet press and compacting by means of flat- faced punches. ► The slugs are then screened or milled to produce granular form. ► Slugging utilizes less equipment and space than wet granulating, and eliminates the need to binder solutions and subsequent drying. 2. Roller Compaction: ► The powder mix is fed between certain rollers to form compressed sheets, which are then subjected to breaking, e.g. by hammer mill. EQUIPMENT A. Wet Granulators 1. Oscillating Granulator. 2. Reciprocating Horizontal Granulator. 3. The Perforated Roller Granulator. 4. The Perforated Basket Granulator. 5. Fluidized-Bed Granulator. 6. Extruder. 7. Freund Granulator. B. Dry Granulation: 1. Slugging Tablet Press. 2. Chilsonator. A. Wet Granulators 1. Oscillating Granulator: 2. Reciprocating Horizontal Granulator: 3. The Perforated Roller Granulator: 4. The Perforated Basket Granulator: 5. Fluidized-Bed Granulator: 6. Extruder: 7. Freund Granulator: B. Dry Granulators: ► The necessary pieces of equipment for dry granulation are: 1. Machine for compacting the dry powder 2. Mill for breaking the compacts so produced. ► Compacting machines for dry granulation may be one of the following types: 1. Slugging Tablet Press. 2. Chilsonator. Slugging Tablet Press: Chilsonator:
