Coating membrane for micro pill tabletting and preparation method for coating membrane

A technology of pellet coating and coating materials, which is applied in the field of pharmaceutical preparations, can solve the problems of increased process difficulty, large dosage, and slow release of pellets, and achieve the effects of reducing side effects, reducing dosage, and improving fracture strain

Active Publication Date: 2012-02-01
GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Patent CN1325300A discloses a prescription of omeprazole enteric-coated pellets, adopts enteric-coated acrylic resin Eudragit L30D-55, adds a large amount of plasticizer triethyl citrate, although the prepared enteric-coated pellets It is suitable for tablet compression, but the amount of plasticizer triethyl citrate in the prescription is more than 30% of the dry weight of the polymer, and the amount is large, which will easily lead to slow release of the pellets
[0009] On the basis of applying L30D-55 and NE 30D mixed suspension (weight ratio 80:20), Chen Meimei and others used small-sized initial sucrose pellet cores (60-80 mesh in size) and added 20% triethyl citrate ester, and successfully developed pantoprazole enteric-coated pellet-type tablets (Chen Meimei et al. Development of pantoprazole enteric-coated pellet-type tablets. Acta Pharmaceutica Sinica, 2011, 46(1): 96-101), added The amount of plasticizer is moderate, but too small initial pellet core makes the coating process more difficult

Method used

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  • Coating membrane for micro pill tabletting and preparation method for coating membrane
  • Coating membrane for micro pill tabletting and preparation method for coating membrane
  • Coating membrane for micro pill tabletting and preparation method for coating membrane

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Coating film prescription:

[0048]

[0049] Adjust the pH of L30D-55 and NE30D to 5.0 with 1mol / L NaOH(aq) and 1mol / L HCl(aq) respectively, and slowly pour NE30D into L30D-55 on a magnetic stirrer. Weigh double-distilled water in a small beaker, add the weighed polyethylene glycol 6000 and propylene glycol into the double-distilled water, stir fully until dissolved, slowly pour the dissolved mixed solution into the mixed suspension of the polymer, and keep stirring at a low speed State 5h. The dosage of the macromolecule plasticizer for the coating film is 20% of the dry weight of the polymer.

[0050] Pass the above suspension through a 80-mesh sieve, pour it into a flat 20cm×10cm×3cm glass pool, spread it evenly with a smear bar, and dry it in a blast oven at 40°C for 5 hours. Measure the thickness of the dried film with a vernier caliper, take a film with a thickness of 180 μm to 220 μm, and cut it into a dumbbell shape. According to the standard DIN ISO 527-3...

Embodiment 2

[0061] Coating film prescription:

[0062]

[0063]The preparation method of coating liquid is the same as embodiment 1. The amount of the macromolecule plasticizer polyethylene glycol 6000 in the coating film prescription is 20% of the dry weight of the polymer, and the amount of the small molecule plasticizer propylene glycol is 5% of the dry weight of the polymer. Compared with the embodiment 1 that the addition of small molecular plasticizer propylene glycol is 3%, the results are shown in Table 2.

[0064] Table 2

[0065]

[0066] As can be seen from the results in Table 2, in L30D-55 / NE 30D (80:20), after adding polyethylene glycol 6000 of 20% polymer dry weight, along with the addition of small molecule plasticizer propylene glycol from 3% To 5%, the breaking strain of the coating film increases from about 290 to about 400 thereupon. If the amount of propylene glycol continues to increase, it can be found in practical application that the viscosity of the coati...

Embodiment 3

[0068] Diclofenac sodium (DS) enteric-coated pellets

[0069]

[0070] DS drug-loaded pellets are prepared by adding drug to a blank pellet core, adding 1.5% (w / w) HPMC E5 solution to DS to prepare a 10% (w / w) DS drug solution, spraying drug on the bottom of the fluidized bed, 100% weight gain on medication. The preparation method of the enteric layer is the same as that in Example 1, using the fluidized bed bottom spray coating method, based on the actual coating weight, the enteric coating is wrapped on the basis of the DS drug-loaded pellets, and the macromolecular plasticizer polyethylene glycol 6000 The dosage is 20% of the dry weight of the polymer, and the weight gain of the enteric layer is 10% of the weight of the DS drug-loaded pellets. After the coating is finished, spread it flat on a tray and place it in a 38°C oven for aging for 12 hours.

[0071] DS enteric-coated pellets and tablets

[0072]

[0073]

[0074] The DS enteric-coated pellets prepared a...

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Abstract

The invention relates to the field of medicinal preparations, relates to a formula of a coating membrane which is suitable for micro pill tabletting and a preparation method for the coating membrane, in particular to a formula of a coating membrane for enteric micro pill tabletting. The medicinal micro pill coating membrane is characterized by consisting of an acrylic resin coating material, a macromolecular plasticizer and a micromolecular plasticizer, wherein the macromolecular plasticizer is macromolecular polyethylene glycol. In the formula, the toughness of the coating membrane can be improved obviously under the synergetic effect of the micromolecular plasticizer and the macromolecular plasticizer, and the coating membrane is applied to coated micro pills to ensure that the micro pill coating membrane is not crushed in the tabletting process, so that the coated micro pills are more suitable for the tabletting.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and relates to a coating film formulation suitable for pellet compression and a preparation method thereof, in particular to a coating formulation applicable to enteric pellet compression. Background technique [0002] Oral sustained-release preparations play an important role in pharmaceutical preparations because of their convenience in administration, improved safety and bioavailability of drug release. Multiple unit type preparations (such as pellets, microspheres, microcapsules, etc.) and single unit type preparations (such as tablets, capsules, etc.) are two major categories of oral sustained and controlled release preparations. Multi-unit preparations are dose-dispersed preparations. After oral administration, a uniformly dispersed particle system is formed in the gastrointestinal tract, which avoids irritation to the gastric mucosa caused by excessive local drug concentration, f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/34A61K9/26
Inventor 操锋朱雄陈宴谢称石原素张兰
Owner GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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