Osmotic pump controlled release tablet with milnacipran selected-time delayed controlled release function and method for preparing osmotic pump controlled release tablet
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A technology of osmotic pump controlled release and milnacipran, applied in the field of milnacipran time-delayed controlled release osmotic pump controlled release tablets and its preparation, can solve the blank period of drug onset, difficult to achieve effective drug controlled release, Low bioavailability and other problems, to reduce the use and environmental pollution and harm to the operator's body, improve bioavailability, and reduce production costs
Inactive Publication Date: 2018-11-27
SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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However, some preparations and compositions of milnacipran have poor stability and low bioavailability.
[0003] For example, the invention patent application with the application number CN1232387A discloses a galenic preparation for prolonged release of milnacipran. Resin coating, in which the acrylic resin and the components of milnacipran microparticles work separately, this preparation cannot achieve the same release behavior in gastric juice and intestinal juice
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Embodiment 1
[0028] refer to figure 1 Shown:
[0029] Preparation of drug-containing layer 1: pass milnacipran, PVPS630, and PEG2000 through a 60-mesh sieve respectively, mix them according to the mass ratio = 8:1:1, and place them in the hopper of the extruder at a speed of 20r / min. The temperature is 120°C, the material is extruded in the shape of strips through the die hole of the machine head, cooled at room temperature, passed through a 40-mesh sieve with a granulator, taken out, and set aside.
[0030] Preparation of push layer 2: Take 75g of polyoxyethylene (PEO, molecular weight: 6 million), 300.5g of povidone k, 8g of sodium chloride, and 2g of iron oxide red, mix well, add ethanol to stir and granulate, and dry at 45°C Dry for 2 hours, let cool to room temperature, take out, sieve with 24 mesh, add 0.42g of magnesium stearate, and mix well.
[0031] Tablet compression: 100 double-layer tablets are compressed by double-layer tablet technology, and the weight of the drug-containi...
Embodiment 2
[0035] The preparation process of this example continues the preparation process of Example 1, the difference is that milnacipran, PVPS630, and PEG2000 are respectively passed through a 60-mesh sieve, and mixed according to the mass ratio = 8:2:1, and the others are the same as in Example 1. same.
Embodiment 3
[0037] The preparation process of this example continues the preparation process of Example 1, the difference is that milnacipran, PVPS630, and PEG6000 are respectively passed through a 60-mesh sieve, and mixed according to the mass ratio = 8:1:1, and the others are the same as in Example 1. same.
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Abstract
The invention discloses an osmotic pump controlled release tablet with a milnacipran selected-time delayed controlled release function and a method for preparing the osmotic pump controlled release tablet. The osmotic pump controlled release tablet comprises a tablet core and a semi-permeable membrane with medicine release holes. The tablet core comprises a medicine containing layer and a propulsion layer, the medicine containing layer comprises hot-melt extrusion substances, the hot-melt extrusion substances are prepared from milnacipran and hot-melt excipients, the hot-melt excipients preferably are compositions of PVP (polyvinyl pyrrolidone) and PEG (polyethylene glycol), and a weight ratio of the PVP to the PEG is 4:1-10:1; the propulsion layer comprises polyoxyethylene, osmotic pressure active substances, povidone and the like; the medicine containing layer and the propulsion layer are compressed to obtain a double-layer tablet, then the semi-permeable membrane wraps the double-layer tablet, and the semi-permeable membrane is perforated. According to the technical scheme, the osmotic pump controlled release tablet and the method have the advantages that medicines can be effectively released in a controlled manner, medicine onset blanking periods can be shortened, the osmotic pump controlled release tablet which is prepared by the aid of hot-melt extrusion processes can becompletely released in an in-vitro manner and effectively conforms to zero-order release characteristics, and the bioavailability and the stability of the osmotic pump controlled release tablet whichis a product can be improved.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a milnacipran time-delayed controlled-release osmotic pump controlled-release tablet and a preparation method thereof. Background technique [0002] Milnacipran (milnacipran, trade name is Ixel, chemical name is 1-phenyl-2-aminomethylcyclopropane-N, N-diethylformamide,) is developed by French Pierre Fabre pharmaceutical company A drug for the treatment of depression developed and launched in 1997, milnacipran belongs to the serotonin and norepinephrine reuptake inhibitor (SNRI), the drug is the fourth generation of antidepressants, can simultaneously Inhibiting the reabsorption of serotonin and norepinephrine by neurons with similar strength, this product can also be used for the treatment of diseases such as fatigue, pain, fibromyalgia and irritable bowel syndrome. However, some formulations and compositions of milnacipran have problems such as poor stabilit...
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