2020/06/30

Introduction To Solid Preparations-Tablets

Introduction Tablets are solid dosage forms usually containing active pharmaceutical ingredient and excipients in powder, crystalline or granular form with or without diluents which is prepared either by moulding or compression process. They are solid, biconvex or flat in shape and vary in size, shape and weight which is depends on the medicaments which are used for preparation. They are also varying in hardness, disintegration; dissolution characteristics and thickness depend on their intended use and method of manufacture. Tablets are the most widely used solid dosage forms because of their advantages and popularity increasing day by day. Tablet usually contains filler, diluents, binders, lubricants, glidants, disintegrants, antiadherent, colouring agents and flavouring agents as excipients. Advantages of tablets Unit dosage forms with accurate, stable dose and great precision and least variability. Most stable with respect to physical, chemical and microbiological attributes. Cheapest oral dosage form, easy to handle, use and carry out with attractive and elegant appearance. Cheap, easy to swallow and production does not require and additional processing steps. Provide protection of medicaments from atmospheric conditions like air, moisture and light, etc. Provide prolonged stability to medicaments.

2020/06/30

The Future Of Anaerobic Granulation

Anaerobic treatment is well over 100 years old. Its initial development was for the treatment of domestic wastewaters, it then progressed in application to separate sludge digestion, then to treatment of dilute industrial waste-waters. Several processes have been developed that accomplish efficient treatment of wastewaters at short detention times. The anaerobic granulation system has been known for its unique ability to convert highly objectionable wastes into useful products. With global concerns over energy shortages and greenhouse gas formation through combustion of fossil fuels, more efforts towards renewable energy supplies is clearly needed. Greater efforts are now needed for broader applications of anaerobic granulation system for ridding the environment of unwanted organic materials by converting them into methane, a renewable energy source. The anaerobic granulation process leading towards efficient methane production from wastewaters clearly fits this need. Research towards even broader application is clearly of importance. Problems that need addressing are process reliability, toxicity causes and effects, odor production and control, and better understanding of refractory organic degradation. From all the numerous and the latest published research on anaerobic processes, cited in the earlier section, it is arguably the most promising wastewater treatment system that is able to meet the desired stringent criteria for future technology in environmentally sustainable development. Anaerobic granulation process would be the one that is able to minimize environmental harm while increasing industrial productivity and improving quality of life. At the moment, the most popular treatment process is the UASB reactor. However, with the recent development of EGSB and "Staged Multi-Phase Anaerobic" (SMPA) reactor systems, this may lead to a very promising new generations of anaerobic treatment system (Lettinga et al., 1997). These concepts behind the EGSB will provide a higher efficiency at higher loading rates, are applicable for extreme environmental conditions (e.g. low and high temperatures) and to inhibitory compounds. Moreover, by integrating the anaerobic process with other biological methods (sulfate reduction, micro-aerophilic organisms) and with physical-chemical methods, a complete treatment of the wastewater can be accomplished at very low costs, while at the same time valuable components can be recovered for reuse.

2020/06/30

What Is A Freeze Dryer? How Does It Work?

Freeze dryer and lyophilizer are synonymous names for the same equipment. A freeze dryer executes a water removal process typically used to preserve perishable materials, to extend shelf life or make the material more convenient for transport. Freeze dryers work by freezing the material, then reducing the pressure and adding heat to allow the frozen water in the material to sublimate. A Freeze Dryer’s 3 Primary Stages A freeze dryer works in three phases, with the first and most critical being the freezing phase. Proper freeze drying can reduce drying times by 30%. Freezing Phase Freeze dryers use various methods to freeze the product. Freezing can be done in a freezer, a chilled bath (shell freezer), or on a shelf in the freeze dryer. The freeze dryer cools the material below its triple point to ensure that sublimation, rather than melting, will occur. This preserves the material’s physical form. A freeze dryer most easily freeze dries large ice crystals, which can be produced by slow freezing or annealing. However, with biological materials, when crystals are too large they may break the cell walls, and that leads to less-than-ideal freeze drying results. To prevent this, the freezing is done rapidly. For materials that tend to precipitate, annealing can be used. This process involves fast freezing, then raising the product temperature to allow the crystals to grow. Primary Drying (Sublimation) Phase A freeze dryer’s second phase is primary drying (sublimation), in which the pressure is lowered and heat is added to the material in order for the water to sublimate. The freeze dryer’s vacuum speeds sublimation. The freeze dryer’s cold condenser provides a surface for the water vapor to adhere and solidify. The condenser also protects the vacuum pump from the water vapor. About 95% of the water in the material is removed in this phase. Primary drying can be a slow process. Too much heat can alter the structure of the material. Secondary Drying (Adsorption) Phase A freeze dryer’s final phase is secondary drying (adsorption), during which the ionically-bound water molecules are removed. By raising the temperature higher than in the primary drying phase, the bonds are broken between the material and the water molecules. Freeze dried materials retain a porous structure. After the freeze dryer completes its process, the vacuum can be broken with an inert gas before the material is sealed. Most materials can be dried to 1-5% residual moisture.

2020/06/30

FLUID BED DRYER USES AND APPLICATIONS

Fluid bed dryers. The average consumer has most likely never even heard of them. But in the world of bulk processing, fluid bed dryers have established themselves as dependable and multi-functional processors; capable of completing a variety of critical tasks. Fluid Bed Dryer Uses and Applications General Kinematics Valve Fluid bed dryers, as their name suggests, are used for drying materials such as granules, tablets, powders, fertilizers, and plastics. They are particularly popular in production industries like: l Chemical l Pharmaceutical l Food l Dairy l Metallurgical l Dyes l Other process industries Fluid bed dryers work on the principle of fluidization, a process in which hot gas or air is introduced into the spaces between solid particles. Upward forces on the particles increase as the air’s velocity increases causing them to equal the gravitational forces below. A state of fluidization now exists as the particles are suspended in what appears to be a boiling bed of liquid. Each particle is in direct contact with, and surrounded by, the hot gas or air – creating an efficient and uniform drying process.

2020/06/30

Film Coating Process In The Pharmaceutical Industry

The coating process is important step in the manufacture of modern pharmaceutical tablets. The coating itself can serve several functions – it can strengthen the tablet, control the release of active ingredients, improve its taste, provide colour, make it easier to package and handle, and protect it from moisture. Sugar coating was one of the earliest methods developed to coat tablets and is still practised for some products, especially confectionery. Other methods include fluidized bed coating, dry coating, but the most widely used method in the pharmaceutical and nutraceutical industry today is that of film coating. This article describes the essential process steps and equipment required for film coating tablets. Basic Film Coating Equipment At the heart of a modern film coating facility is the coating pan or drum and a spraying system. Also, required is an air handling unit and dust collector, and the associated controls. Depending on the application, a humidifier or dehumidifier may also be necessary. The modern coating pan is usually a perforated rotating drum that is housed within a cabinet. The cabinet provides the means of controlling the environment within the drum i.e., temperature and pressure, air flow rate and rotational speed of the drum. The film coating process begins with the loading of a batch of tablets into the coating drum. These are heated in a stream of flowing air and time allowed for dust to settle and a steady temperature of the outlet air to be reached (typically 40 to 46°C). This usually takes about 15 minutes. Spray guns within the drum are then activated to create a fine mist of coating solution that dries as soon as it reaches the surface of the tablets. As the water or solvent evaporates from the mist, it leaves the solids behind to form a thin film. The secret of film coating is very similar to spray-painting – it is best to spray lightly and evenly so that successive thin coatings are allowed to build up to create a robust dense layer on the surface of the tablet. The time taken to achieve this can range from a few minutes to several hours and is governed by the particular characteristics of the coating material, as well as the process parameters such as drum speed, temperature, pressure and spray rate. Above all these parameters must be carefully controlled for the whole length of the coating process. Disruption of spray rate, for example, will often produce defective tablets. Spraying and distribution The first requirement during the coating process is that the coating suspension must be distributed evenly on the tablet bed. To do this spraying guns are used. Most often these are atomizers that use compressed air to atomize the coating solution or suspension. There are three common atomizer gun types – 2-port, 3-port and 4-port. The simple 2-port gun has one port for the liquid coating solution and the other is for the atomizing air. The only control available for a 2-port gun is the pressure of air on the one port. With a 3-port system, the atomization and spray activation pressures can be controlled independently which allows the spray width to be controlled. With the 4-port gun, three ports are for air and one for liquid, and these allow for the independent control of activation pressure, atomization pressure and spray width. Spray Rate – Film Coating Process

2020/06/30

GMP Qualifications And Validations In The Pharmaceutical World

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food and pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

2020/06/30

Where Tableting Technology Is Heading

The tablet making industry is currently going through a period of significant change. An increasing number of patents are expiring giving tool makers and tablet manufacturers plenty of opportunity to innovate in a range of technologies. There is also an increase in the number of manufacturers of generic products and specialists under contract to the large established pharmaceutical companies. Another dynamic force in the business environment is the increase in competition brought about by the opening of markets in developing countries and companies that are relocating their facilities and operations to take advantage of these opportunities. Consequently there is pressure on tablet manufacturers to provide their clients, both the established pharmaceutical companies, specialist contractors and those who manufacture generic tablets, with equipment that increases production volume and at the same time lowers operating costs. The need for standards In 1966 Engineer Swarz (employed by the then Smith Kline French company—presently known as Glaxo Smith Kline) acknowledged that there was a need for international standards for tablet compression tooling in the pharmaceutical industry. At that time he saw a need to develop a compression tool that could be sourced from providers other than the original equipment manufacturer (OEM). At that time, the lead time for purchasing new tooling could exceed 6 months, which significantly extended the time necessary to introduce new products onto the market. The standardization of the tooling that was envisaged in the 1960s and developed in subsequent years has enabled manufacturers to source tooling equipment for various tablet presses in a much shorter time frame. The American Pharmaceutical Association supported the introduction of standards for tablet making by publishing their standard guideline manual (the IPT manual). The publication, known today as the Tableting Specification Manual or the TSM Standard, is currently in its 7th edition. The manual continues to be one of the leading resources for helping tablet press and tooling manufacturers to specify tablet compression tooling equipment. After the release of the third edition of the TSM, a British company – I Holland Ltd. realized the need for a European equivalent of the TSM guideline the European community. This led to the introduction of the I Holland Eurostandard which is now the most comprehensive guide available for the standardisation of tablet punches and dies. It is used worldwide for European-built tablet presses. The 2010 edition has been modified to be compatible with the ISO 18084:2005(E) standard. Unfortunately there are shortcomings with current standards. For example, these fail to address the position of the upper punch key, which is required for shaped tablets such as ovals. The lack of a specification in this instance means that manufacturers can build presses with the key in different positions. This prevents the possibility of interchanging the tooling for common presses. For example, two different manufactures may fabricate the same tooling equipment and follow the “B” format standard assuming they will be interchangeable. The problem is manifest during the ejection cycle of the tablet making process, if the tooling is not interchangeable the punch may not be properly align with the die and consequently the tablets may need to rotate or spin during ejection. This can cause the tablets to accumulate on the die table, leading to damaged tablets and reduced the output. The random keyway could result in high operation costs as many tablet manufacturers may be unaware of the problem. Additional costs may be incurred to overcome the problem by purchasing additional sets of the same tooling equipment. This example clearly shows that there is still work to be done on developing universal standards and the industry, including the tooling vendors and users should support the update to ISO 18084 and help complete the standardization for the key type and location.Innovation drivers Ever increasing production costs and addressing issues such as the keyway problem are examples of what drives innovation in the industry. Such issues also spur refinement and internal organization of the complete manufacturing process. The capital tied up in the machinery asset base is just one cost element for pharmaceutical companies. Equipment efficiency, waste reduction, time to market and the inventory cost of assets should also be taken into consideration as potential areas where innovation could make a big difference. Another specific example of innovation in tablet making machinery is the Continuous Weight Control System, which allows a tablet to be checked for weight at least once in every turret revolution. As all the stations are checked at the same time, it permits continuous checking of the tablets and ensures that precise weight data is collected and stored for the equipment, thus ensuring that quality is m

2020/06/30

Belt Dryer Common Faults And Maintenance During Use

Although the belt dryer is relatively energy efficient dryer, but in practice there is a failure, and we have done is to identify the cause of the fault to be eliminated, so that belt dryer best energy efficiency for us service. So when customers buy a belt dryer, pay attention to the configuration of the dryer, the selection filter on the belt dryer to the dryer tooth channel and the aperture adapted, generally selected mesh filter diameter is dried machine into the channel or aperture to 0.2 times. ??? Belt dryer is in use common fault which how to resolve how to do maintenance to tell you about a few: 1, before starting to deal with triple gas source to check the water in the discharge and to ensure adequate oil level. 2. Make sure the dryer has a good grounding device, temperature meter on the device should be subject to verification. 3, parts inspection and maintenance, such as lubricating the bearing, adjust the pulley, check the electrical wiring, door rocker, pipe joints and so on and fixed. 4, raw fire fault may be drying machine equipment design, material or go suck not cause a fire inside the dryer and the like. In addition, there may be caused by human factors, such as to achieve the drying effect of the force is too small dryer heating caused by fire. In this case the transformation is best to replace the dryer equipment, check the dryer is installed correctly, leaks or increase the pressure and the like. The proper use of the dryer, the dryer cautiously increasing temperature, so as not to cause a fire. 5, appear raw disposable baking quit problem, which is mainly due to the dryer is too small or cause improper use of dryer and other reasons. In addition, wind network pressure, flow calculation is wrong also cause such a failure. You can replace or re-modify the drying equipment, or require manufacturers to recalculate pressure, flow and other changes to the program. If it is due to improper operation, the operator in strict accordance with the instructions for proper operation. 6, to ensure that no loose bolts fixed base, support spring elastic fit connection, computer control panels, wind turbines, heat exchangers, with good flexibility. 7, to keep equipment clean, wipe the equipment daily, to clean up the dust tank fluff to ensure ventilation. After regularly clean the inside of the lid opening device.