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Gabapentin soft chewable tablet preparation, and preparation method and application thereof

A technology of gabapentin and soft chewing, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc. It can solve problems such as unsatisfactory stability, improve subjective initiative, reduce the formation of impurities, and administer food and drug convenient effect

Pending Publication Date: 2022-02-11
上海汉维生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after many tests, the author found that its stability is not ideal. The author passed the accelerated experiment at 40°C and 75% for 6 months. The results showed that the lactam content was 0.1wt% in one month and 0.2 wt%, the three-month content is 0.3wt%, and the six-month content is 0.5wt%, exceeding the domestic standard of 0.4wt%

Method used

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  • Gabapentin soft chewable tablet preparation, and preparation method and application thereof
  • Gabapentin soft chewable tablet preparation, and preparation method and application thereof
  • Gabapentin soft chewable tablet preparation, and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The gabapentin soft chewable tablet preparation of the present embodiment comprises the following components by weight:

[0041] Formula per 1000 tablets:

[0042]

[0043] The preparation method of the gabapentin soft chewable tablet preparation of the present embodiment comprises:

[0044] Add 100g of gabapentin, 300g of chicken liver powder, 250g of microcrystalline cellulose and 250g of cornstarch into the mixer one by one, and stir evenly. Then, 320 g of glycerin and 80 g of PEG 3350 were dissolved and mixed in an 80° C. water bath. After the dissolution is complete, keep warm at above 60°C and evenly add it to a wet granulator for granulation to obtain a soft material. Pass the soft material through a 20-mesh sieve for granulation to obtain evenly sized particles. Tablet compression, compression with a mold 22cm × 18cm tablet press, finally obtain the gabapentin soft chewable tablet preparation, the difference in tablet weight is within ± 5%. The weight of ...

Embodiment 2

[0052] The gabapentin soft chewable tablet preparation of the present embodiment comprises the following components by weight:

[0053] Formula per 1000 tablets:

[0054]

[0055] The preparation method of the gabapentin soft chewable tablet preparation of the present embodiment comprises:

[0056] Add 100g of gabapentin, 300g of chicken liver powder, 250g of microcrystalline cellulose and 250g of cornstarch into the mixer one by one, and stir evenly. Then, 280 g of glycerin and 120 g of PEG 3350 were dissolved and mixed in an 80° C. water bath. After the dissolution is complete, keep warm at above 60°C and evenly add it to a wet granulator for granulation to obtain a soft material. Pass the soft material through a 20-mesh sieve for granulation to obtain evenly sized particles. Tablet compression, compression with a mold 22cm × 18cm tablet press, finally obtain the gabapentin soft chewable tablet preparation, the difference in tablet weight is within ± 5%. The weight of...

Embodiment 3

[0064] The gabapentin soft chewable tablet preparation of the present embodiment comprises the following components by weight:

[0065] Formula per 1000 tablets:

[0066]

[0067]

[0068] The preparation method of this embodiment is the same as that of Example 1.

[0069] Formability:

[0070] The appearance is smooth, the friability is less than 1%; the hardness is 122N, no fracture, and the deformation is 0.04mm.

[0071] stability:

[0072] The strengthening test results of this embodiment are shown in Table 3.

[0073] table 3

[0074]

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Abstract

The invention provides a gabapentin soft chewable tablet preparation, and a preparation method and application thereof. The gabapentin soft chewable tablet preparation comprises gabapentin, a phagostimulant, a filler and a wetting agent, the wetting agent is a mixture of glycerol and polyethylene glycol, the content of polyethylene glycol is 20-40 wt%, the phagostimulant is selected from chicken liver powder, beef powder or chicken powder and the like, and the filler comprises common auxiliary materials such as microcrystalline cellulose, corn starch, potato starch or pregelatinized starch. The preparation method comprises the following steps: mixing gabapentin, the phagostimulant and the filler in a wet type granulator, then dropwise adding the wetting agent into the wet type granulator, and carrying out granulation, granule finishing and tabletting. According to the invention, feeding and administration are convenient, and the subjective initiative of pet eating can be improved by adding the phagostimulant; and soft tablets chewable in the mouth can be prepared through the high viscosity property of a moisturizer such as glycerin, and meanwhile the moisturizer such as glycerin can just play a role of a stabilizer for gabapentin.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a gabapentin soft chewable tablet preparation and a preparation method and application thereof. Background technique [0002] Gabapentin, also known as Neurontin, has been shown to prevent epilepsy in various animal models. It is the first anti-epileptic drug developed by Warner-Lambert in the United States, and it was first listed in the UK in 1993. [0003] In recent years, in addition to the treatment of epilepsy, gabapentin can also be used as an adjuvant drug for postoperative analgesia and reduce the use of antiemetics; [0004] In addition, gabapentin has the characteristics of high therapeutic index and safety, mainly characterized by good tolerance, low toxicity, no teratogenicity, mutagenicity, and short-term and mild side effects. [0005] Therefore, this product is mainly used for pain relief (neuropathic pain, chronic pain) and emotional comfort and anx...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/46A61K47/10A61K31/196A61P25/08
CPCA61K9/2068A61K9/2013A61K9/0056A61K31/196A61P25/08
Inventor 秦翔马利平霍丽萍
Owner 上海汉维生物医药科技有限公司
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