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Diagram of a Pellet
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Microsphere formulations can be designed as Multiple Unit Systems. The dose is administrated as a capsule, which contains about 300 individual pellets, which in turn contain the active ingredient, such as Vitamin C or Glucosamine.
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The application of a membrane or layer on the small pellets is a unique way of obtaining a controlled or regulated release rate of the product. Membrane coating offers great control in regulating the product's delivery. For the TR Caps products, a detailed and lengthy "coating pan" process is used in order to ensure that the product is coated sufficiently in order to receive the "time release" categorization. There are many parameters that cause variations in the coating quality of a single pellet. One of the most important parameters is temperature. For example, if the temperature is too high or it is too warm, the coating will be hard and brittle. On the other hand, if the temperature is too low or it is not warm enough the pellets may stick together. Therefore, |
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the dissolution profiles of our products are carefully analyzed up to a 12 hour period in order to verify that the product has been coated properly and is dissolving slowly over time.
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Effective nutritional formulations can be designed as multiple unit systems. With this system the product is administered as a capsule containing the pellets. This concept is characterized by the fact that the dose is administered as a number of subunits, each containing the active ingredient.
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The diameter of coated pellets, when split into two equal halves, ranges between .50 mm and 1.50 mm in size.
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Time-release technologies can be utilized to sustain an ingredient's release at a specific rate over a defined period of time while maintaining the required ingredient plasma concentration range. This type of ingredient release profile can prevent toxicity and reduce dosing frequency.
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TR Caps™ Time-release Pellets
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The time release technology is our main technology. Each ingredient inside each time release capsule is protected or covered by a membrane. This membrane controls the release rate of the active ingredient. Since the membrane is like a "protector" or "thick layer" the ingredient in the inside of the pellet is regulated. The ingredient leaves the inside slowly or it is released in a "timely fashion."
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Diagram of a Pellet
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"Sustain release, Sustained release |
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Sustain-release or Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin) pills are tablets or capsules formulated to dissolve slowly and release a
drug over time. The advantages of sustained-release tablets or capsules are that they can often be taken less frequently than instant-release
formulations of the same drug, and that they keep steadier levels of
the drug in the bloodstream. Sustained-release tablets are formulated
so that the active ingredient is embedded in a matrix of insoluble substance (various: some acrylics, even chitin, these are often patented)
so that the dissolving drug has to find its way out through the holes
in the matrix. In some SR formulations the matrix physically swells up
to form a gel, so that the drug has first to dissolve in matrix, then
exit through the outer surface.
There are certain considerations for the formation of sustained release formulation:
- If the active compound has a long half-life (over six hours), it is sustained on its own.
- If the pharmacological activity of the active is not related to its blood levels, time releasing then has no purpose.
- If the absorption of the active involves an active transport, the development of a time-release product may be problematic.
- Finally,
if the active has a short half-life, it would require a large amount to
maintain a prolonged effective dose. in this case, a broad therapeutic
window is necessary to avoid toxicity; otherwise, the risk is unworthy
to take and another mode of administration would be recommended.
Difference
between controlled release and sustain release or sustained release is
that controlled release is perfectly zero order release that is,the
drug releases with time irrespective of concentration.On the other
hand,sustain release or sustained release implies slow release of the
drug over a time period.It may or may not be controlled release."
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IR Caps™ Immediate Release Pellets
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Our immediate release technology is a convenient way to take those products that need to be delivered in the stomach without developing the potential for a sour stomach. Most B-vitamins should be delivered immediately. With our IR-Caps the product will be delivered immediately, the effect throughout the stomach will be homogeneous, and the potential for irritation of the stomach will be reduced.
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MR Caps™ Modified Release Pellets
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MR Caps™ is a combination of TR Caps™ and IR Caps™ inside the same capsule. The modified release (MR) technology is ideal for formulations that need to act immediately in the stomach and then later in the gastro-intestinal tract. For example, MR Caps™ products can be developed in immediate release form and time-released form simultaneously.
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This type of release profile can:
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 | Reduce the number of doses taken by a patient |
| Provide rapid onset of action and timed release benefits within a single dose |
| Provide controlled escalation levels throughout a defined period of time |
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GR Caps™ Gastro-resistant Pellets
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Gastro-resitant enzymes as digestive aids and carb-burners
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Since most enzymes can be easily destroyed by stomach acid, our gastro-resistant enzymes have a special pH sensitive coating that is not digestible by stomach acid, but is sensitive to the alkaline environment of the duodenum or small intestine, thereby insuring substantial survival of all of the enzymes |
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Since nutrients are absorbed in the duodenum or the small intestine, this is by far the most efficient way to deliver protein digesting enzymes to your system |
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This is one product that is best delivered in a "pelletized" gastro-resistant (GR) form |
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Our GR Caps™ will not break down until after they have passed through the stomach and into the duodenum and small intestine. Without the gastro-resistant layer, a significant amount of occasional heartburn can be produced coupled with a complete disintegration of the product in the stomach |
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Gastro-resistant enzymes aid the digestion of food after meals and help burn carbohydrates faster |
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| Enzyme | Minimum Dose USP units | Dose in USP Our product |
| Lipase | 11,000 | 19,715 |
| Amylase | 53,950 | 86,532 |
| Protease | 31,250 | 72,061 |
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| Product reaches small intestine at hour 2 with dosage listed below | Leftover |
| Lipase | 11,000 | 17,696 | 89.76% |
| Amylase | 53,950 | 71,625 | 82.77% |
| Protease | 31,250 | 56,375 | 78.23% |
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| Release rate after 2nd hour |
| Hour 2-3 | 100% |
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