particularly if dry granulation is employed. These ingredients will be mixed before granulation. Dry granulation The dry granulation process is used to form granules without using a liquid solution because the product to be granulated may be sensitive to moisture and heat. Forming granules without moisture requires compacting and densifying the powders. In this process the primary powder particles are aggregated under high pressure There are two main processes. Either a large tablet (known as a slug) is produced in a heavy-duty tabletting press (a process known as 'slugging') or the powder is squeezed between two rollers to produce a sheet of material (roller compactor or chilsonator). In both cases these intermediate products are broken using a suitable milling technique to produce granular material, which is usually sieved to separate the desired size fraction. The unused fine material may be reworked to avoid waste. When a tablet press is used for dry granulation, the powders may not possess enough natural flow to feed the product uniformly into the die cavity, resulting in varying degrees of densification. The roller compactor (granulator-compactor) uses an auger-feed system that will consistently deliver powder uniformly between two pressure rollers. The powders are compacted into a ribbon or small pellets between these rollers and milled through a low-shear mill. When the product is compacted properly, then it can be passed through a mill and final blend before tablet compression.
Roller-compaction or dry-granulation equipment offers a wide range of pressures and roll types to attain proper densification. This equipment is loud and dusty compared with other process machinery. Material feed rates are critical for attaining the final objective. The process may require repeated compaction steps to attain the proper granular end point. Typically, a percentage of product Again, successful compaction depends on the compatibility of the products being compressed. If fines are not removed or reprocessed, then the batch may contain too many of them, a situation that can contribute to capping, laminating, weight, and hardness problems on the tablet press. The need for screening large amounts of fines is common to roller compaction, and the degree to which it can be managed depends on the nature of the ingredients. Wet granulation Wet granulation involves the massing of a mix of dry primary powder particles using a granulating fluid (the process of adding a liquid solution to powders). The fluid contains a solvent which must be volatile so that it can be removed by drying, and be non-toxic.
Typical liquids include water, ethanol and isopropanol, either alone or in combination. The granulation liquid may be used alone or, more usually, as a solvent containing a dissolved adhesive (also referred to as a binder or binding agent) which is used to ensure particle adhesion once the granule is dry. The density of each granule is increased by increasing the amount of binding solution as well as the mechanical action of the mixer. Therefore, controlling the amounts of solution, binder, and mechanical action allows one to control the strength and density of the granule. Water is commonly used for economical and ecological reasons (safer to nature and operator). Its disadvantages as a solvent are that it may adversely affect drug stability, causing hydrolysis of susceptible products, and it needs a longer drying time than do organic solvents. This increases the length of the process and again may affect stability because of the extended exposure to heat. The primary advantage of water is that it is non-flammable, which means that expensive safety precautions such as the use of flameproof equipment need not be taken. Organic solvents are used when water-sensitive drugs are processed, as an alternative to dry granulation, or when a rapid drying time is required.
PENGLAI INDUSTRIAL CORPORATION LIMITED
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