Techceuticals

Common Tablet Defects — Making tablets batch after batch without an occasional defect would be unusual. Some products start up with problems and end with them. Tablet to tablet weight variations create tablet defects. Consistent tablet weight is essential to making a good tablet. Without good and consistent weight control, solving other defects will be difficult (if not impossible) because of how a tablet press operates. Some of the most common tablet defects are: Weight variation Friability variation Picking and Sticking Capping Laminating Chipping Mottled Double Pressing Often problems with compression can be associated with many root causes. One very common issue is machine start up. The tablet press is cold. the steel is cleaned and bare metal can allow granules to stick to these metal surfaces. The reason a lubricant is in the product is to prevent granules from sticking. Many companies are very accustomed to a double start up. The first one distributes powders wh...

The Manufacturing Process — Part 5 Encapsulation — Commonly referred to as a capsule filler, the encapsulation machine has the ability to fill many different products. Powders, granulations, liquids, tablets and capsules can be filled into a two piece capsule. Encapsulation machinery technology varies a great deal from one manufacturing to the next. Not all machines can fill a wide variety of products; most are designed to handle free flowing powders much like powders that are prepared for a tablet press. The capsule filler must first position all of the incoming capsules into an upright position (rectification), separate the cap from the body (top from bottom), attain the proper fill volume (capsule weight), and then the product filled body is rejoined with the cap and ejected from the machine. Some capsule filling machines have the ability to compress or tamp the powder for proper filling volume and weigh control. Encapsulators can be defined as 1) Hand operated 2)...

Tablet Compression — While an experienced operator can take a marginal granulation and make a good quality tablet, an inexperienced operator (not fully understanding tablet press operation) will be unable to produce a quality tablet. Understanding the machine operation and being able to identify the difference between a machine issue and a granulation issue is important. Operators should be qualified, tested and certified in the operation of a tablet press. While tablet presses are used for many applications, the basis of formula development is the same for each application. The final granulation to be compressed must have three basic characteristics, all of which are critical: Flow, Compress and Eject. A tablet press can be fully automated to the point that it can be operated in a lights out operation. This puts all the emphasis on the cleaning and proper set up of the machine. This is also true of a non automated machine. The emphasis is on cleaning and proper setup. W...

Dry Granulating — Dry granulating, also called Slugging, Chilsonating or Roller compaction, involves the pressing of mixed powders into an object to be reground into a precise powder. This action increases particle density, improves powder flow and captures fines. The Dry Granulating method is used over other technologies for one or more of the follow reasons: Granulate materials which are sensitive to heat and/or moisture Produce a uniform particle size range Improve flow properties Control dust Control bulk density Produce uniform blends Control particle hardness Improve wetting or dispersion rates Powders can be compacted using a tablet press; this is called Slugging. Once slugging is completed or powders are compacted on a Chilsonator or Roller Compactor, they are milled. It is best to Mill densified powders using a low shear mill for best results. Using a high shear mill may over-mill or result in an over production of fine particles. Milling Milling equipment...

The Formula — We have determined that a formula contains many ingredients other than just the active ingredient. The ingredients within the formula in addition to the active are called excipients. Excipients are needed to make a good quality tablet at the required tablet press speed. They help the flow, compressibility and the ability of the tablet to eject from the tablet press without falling apart. Excipients also enhance the hardness, disintegration, appearance, color, taste, and the overall performance of the tablet. As stated previously, a formula that is designed on a slow speed tablet press may not work on a high speed press. Even the best tablet press with all the best design features may not be able to compress a formula at any speed. Each formula has a limit to how fast it can be compressed. In order to increase the speed, the formula must be changed. Why Granulate? To improve powder flow. To improve compressibility. To reduce fines. To control the tendency...

The Manufacturing Process was created for companies and individuals to gain a complete understanding of the basic requirements needed to make tablets and capsules. The objective is that the reader will gain a quick, yet comprehensive understanding of solid dosage operations used in the manufacturing process. The focus will be a step by step explanation of each unit dose operation, common equipment, and practical knowledge of each operation. The main topics are Formulation, Blending, Milling, Granulation, Drying, Final Blending, Tabletting, Tablet Press Tooling, Coating, and Encapsulation. Common tablet & capsule defects and problem solving are also part of the objective. Designed for new & experienced employee training, the expectation is that having this information will create a common denominator; thus producing an opportunity for better communication between manufacturing groups. The company will no longer hear that the problem is the fault of another department. T...

When things go wrong in the compression department, they can go wrong very quickly. Identifying the root cause can be difficult unless certain things have been done upfront. Inspect the working length of each set of tooling and maintain very close tolerances. New tooling varies by as much as 0.002 inch (0.05 millimeter), and any greater variation may cause or exacerbate weight, thickness, hardness, and friability problems. Match the working lengths o f the upper and lower punches to balance the compression forces. For example, along upper should be matched with a short lower. Inspect dies for wear rings, and note that dies wear at different rates than the punches. Install dies so they all face the same direction and they wear at the same rate. Then turn them all over to double their life expectancy. Set punch penetration as high in the die as possible. That allows air to release more quickly during compression, which improves hardness and reduces the chance of sticking. Replace l...