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Introduction of several timed and controlled release technical routes

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Introduction of several timed and controlled release technical routes

1. Osmotic pump controlled release technology

Its technical principle is to use a semi-permeable membrane to coat the tablet core. After consumers swallow the tablet, a small molecule of water penetrates through the semi-permeable membrane and enters the tablet core. After the tablet core is dissolved,an osmotic pressure will be generated. Driven by the osmotic pressure,the active ingredients will be released through the small holes made by the laser on the film. This is why this technical route is called "osmotic pump".

Since the saturated concentration of the soluble substance,that is to say the saturated osmotic pressure is constant at a certain temperature, the biggest advantage of this technical route is that the constant osmotic pressure can be used to release the effective ingredients at a uniform rate, which is zero in pharmacy. Grade release, so as to achieve the purpose of controlled release.

Osmotic pumps are divided into single-chamber osmotic pumps and double-chamber osmotic pumps. They have different requirements for active ingredients. The single-chamber osmotic pump is the active ingredient itself soluble in water, and the active ingredient is released through the osmotic pressure generated by itself. The double-chamber osmotic pump is insoluble in water, and the tablet core is divided into two layers. One layer contains effective ingredients and the other contains no effective ingredients, but it can provide osmotic pressure and push the effective ingredients out of the small holes.

For slow and controlled release technology, uniform release is consistent with the absorption time of the human digestive tract,and release time is the highest pursuit. For these two points, osmotic pump technology can achieve.

The most familiar drugs is Nifedipine controlled-release tablets, which is a double-chamber osmotic pump.

The biggest disadvantage of osmotic pump technology is that it requires expensive special equipment, and the cost is also very high. It is the highest cost of all slow and controlled release technologies. Taking Nifedipine controlled-release tablets as an example, the cost of the effective ingredient nifedipine per tablet is less than 0.01 Chinese Yuan, while the cost of the entire production process is close to 1 Chinese Yuan. The difficulty and complexity of the process result in its process cost being much higher than its raw material cost.

2. Pellets (granules) coating technology

Its technical principle is to coat the pellets with a boiling coating machine, and the coating film is a semi-permeable membrane. If the active ingredient is soluble in water, it can be directly coated. If the active ingredient is not soluble in water, use sucrose as the core of the pellet, and first include the coating film of the active ingredient, and then wrap the semi-permeable membrane type sustained-release film. After coating and filling in capsules. After being swallowed, the pellet core continuously absorbs water through the semi-permeable membrane. When the osmotic pressure exceeds the pressure that the coating membrane can withstand, the coating membrane ruptures, thereby releasing the effective ingredients.

In order to achieve the purpose of sustained sustained release rather than delayed release, the pellet coating technology will adopt two solutions. One is multi-layer coating, that is one pellet which coats the active ingredients and semipermeable membrane multiple times. When released from the outside to the inside, multiple bursts and releases. Or it is to control the swelling and bursting rate of different pills by absorbing water, and then fill them into a capsule after mixing the different pills.

The advantage of this technology is the use of special equipment, but the boiling coating machine is much cheaper and more efficient than the laser drilling machine,and the overall cost is much lower than that of the osmotic pump. And through multiple releases, the effect of approximately uniform release can be achieved,and the action time can also reach 24 hours.

The disadvantage is that the cost is still high and special equipment is required.

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3. Skeleton timed-release technology

Its technical principle use the effective ingredients and the framework material to mix, granulate, and press together, and the effective ingredients and the framework material are interlocked with each other. When the active ingredient is soluble in water, use water-insoluble or water-insoluble materials as the framework material. When the effective ingredients are insoluble in water, a material with a slower dissolving and swelling is used as the framework material. The framework material is dissolved layer by layer, allowing the effective ingredients embedded in the framework to be released layer by layer. This kind of framework slow-release technology is also called "erosion type".

The skeleton timed-release can be derived from many types, such as the "erosion type" mentioned above, in addition to gel type, hot melt type and other technical models.

Its advantage is that, in addition to the hot melt type,it generally does not require special equipment and the cost is relatively low. It is also the most widely used sustained-release technology.

Its disadvantage is that the process control points are many and complicated. Small-scale trial production and large-scale production will have large differences in process parameters, and it is difficult to scale up the process. Quality stability is more dependent on the process stability of on-site operators. That is human factors have a great influence on the stability of product quality.

4. Controlled release technology of molecular membrane osmotic pump

It is the latest timed and controlled release technology. It is a patent from our new invention. Like the principle of ordinary osmotic pump controlled release technology, it also uses saturated osmotic pressure to release the active ingredients at a uniform speed.

Ordinary osmotic pump technology, the bread outside the chip core is a semi permeable membrane, water can go in and the effective components cannot be released. It is necessary to drill holes in the semi permeable membrane with a laser to release the effective components from the small holes.

Molecular membrane osmotic pump controlled release technology, the bread outside the chip core is molecular membrane. Water can enter through the molecular membrane to form osmotic pressure. After the effective components are wrapped and dissolved by water, they are released through the micro-pores on the coating membrane under the promotion of osmotic pressure.

Therefore, the controlled release technology of molecular membrane osmotic pump has the advantages of uniform release and long release time of ordinary osmotic pump technology,and avoids the disadvantages of ordinary osmotic pump. Like skeleton timed-release technology, it does not need special and special equipment and has low cost. It also avoids the shortcomings of skeleton slow-release technology, with few process control points, low difficulty, little interference of human factors on product quality stability and simple process amplification.