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Weight losing tablet containing orlistat

A technology of orlistat and slimming tablets, which is applied in the field of medicine, can solve problems such as poor fluidity, low dissolution rate, slow progress, etc., and achieve the effect of avoiding thermal decomposition, avoiding damp heat decomposition, and improving dissolution rate

Inactive Publication Date: 2017-12-01
天津双硕医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In the production process of orlistat preparations, it was found that: 1. Due to the low melting point of orlistat, it is prone to hydrolytic degradation and thermal degradation in humid air or dry air above 35°C, and is prone to occur during the process. Problems such as adhesion, cohesion and re-aggregation; and orlistat is relatively fluffy and has poor fluidity, and it cannot even be successfully filled into capsules or compressed
2. The dissolution rate of the prepared preparation is low and cannot meet the treatment requirements
This technology was originally an industrialized large-scale production technology widely used in polymer modification molding (plastic, rubber, cable and rubber-plastic blending), food processing, feed production and veterinary drug development. In 1966, Speiser et al. began to try It was applied in the field of pharmacy, but it did not attract enough attention. In the following period, the relevant research was intermittent and the progress was slow.

Method used

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  • Weight losing tablet containing orlistat
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Example 1 Preparation of 60 mg specification orlistat tablet (unit: g)

[0075]

[0076] Preparation Process:

[0077] Step 1. Take orlistat and microcrystalline cellulose, pulverize them, pass through a 100-mesh sieve, and set aside;

[0078] Step 2. Take the prescribed amount of orlistat, microcrystalline cellulose, polymer, and colloidal silicon dioxide, put them in a turbulent flow mixer, and mix for about 4 minutes;

[0079] Step 3: Continuously feed the mixed material at a certain rate, and continuously extrude the twin-screw extruder through an orifice with a certain aperture at a melt temperature of 45° C. to obtain a strip-shaped semi-solid intermediate;

[0080] Step 4, cutting the strip intermediate obtained in step 3 according to a certain thickness to obtain orlistat tablets;

[0081] Step 5: Packing the orlistat tablet obtained in step 4 with PVDC / aluminum foil having high moisture-proof performance as the packaging material to obtain a finished produ...

Embodiment 2

[0082] Example 2 Preparation of 120mg Orlistat Tablets (Unit: g)

[0083]

[0084]

[0085] Preparation Process:

[0086] Step 1. Take orlistat and microcrystalline cellulose, pulverize them, pass through a 100-mesh sieve, and set aside;

[0087] Step 2. Take the prescribed amount of orlistat, microcrystalline cellulose, polymer, and colloidal silicon dioxide, put them in a turbulent flow mixer, and mix for about 4 minutes;

[0088] Step 3: Continuously feed the mixed material at a certain rate, and continuously extrude the twin-screw extruder through an orifice with a certain aperture at a melt temperature of 45° C. to obtain a strip-shaped semi-solid intermediate;

[0089] Step 4, cutting the strip intermediate obtained in step 3 according to a certain thickness to obtain orlistat tablets;

[0090] Step 5: Packing the orlistat tablet obtained in step 4 with PVDC / aluminum foil having high moisture-proof performance as the packaging material to obtain a finished produc...

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Abstract

The invention belongs to the technical field of medicines and particularly relates to a weight losing tablet containing orlistat and a preparation method thereof. A low-temperature hot-melt extrusion and cutting technology is designed by the inventor and used for preparing the orlistat tablet. In this way, an orlistat raw medicine is molten with a low-melting-point polymer jointly beside the melting point of the orlistat raw medicine to form a dispersion body, compared with technologies such as micronization, the dissolution degree of a final preparation is greatly increased, and meanwhile owing to the fact that low-temperature melting is conducted and water is not involved, medicine wet and heat decomposition is avoided; owing to the fact that a conventional tabletting technology is not adopted, the problem of sticking of the conventional tabletting technology does not exist; and finally, whole mixing is conducted, the melting process is conducted in a sealed cavity of a screw extruder and does not make contact with air, and therefore the heat decomposition problem in the air is avoided.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a slimming tablet containing orlistat and a preparation method thereof. Background technique [0002] Obesity has become a global epidemic. The main cause of obesity is that the body's energy intake exceeds consumption, and the excess energy is stored in the form of fat. The energy balance of the body is affected by multiple factors such as diet, exercise, endocrine diseases and genetics. A combination of energy restriction and increased exercise is recommended as an effective weight loss strategy. Even so, with the forward development of the domestic economy and the continuous improvement of people's living standards, obese patients will continue to increase, and the number of obese patients in different ages, regions, occupations and other groups will increase, so the demand for weight loss drugs will still increase significantly . [0003] Orlistat was develop...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/10A61K47/04A61K31/365A61P3/04
CPCA61K9/2009A61K9/2031A61K9/2054A61K9/2095A61K31/365
Inventor 不公告发明人
Owner 天津双硕医药科技有限公司
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