Method for preparing soft chewing dosage form for drug delivery

A technology of soft chewing and medicine, which is applied in the field of medicine, can solve the problems of high equipment performance requirements, preparation technology and technology that cannot be mass-produced, astringent punching, etc., and achieve the effect of getting rid of restrictions and shackles and facilitating large-scale production and application

Inactive Publication Date: 2018-12-04
BEIJING ORBIEPHARM +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent CN105963270A (application number 201610507054.6) discloses a soft chewable benazepril hydrochloride tablet and its preparation method. In this patent, the raw material drug of benazepril needs to be treated by fluidized bed coating, and the relevant molding process is not described. Therefore, the preparation process and technology in this patent cannot be mass-produced in the field of veterinary drugs; and the ratio of coating materials and raw materials in this patent cannot achieve a good taste-masking effect at all. For specific ratios, please refer to Chinese patent CN1652754B ( Application No. 03810571.3) mentioned in the process parameters for benazepril coating treatment
[0006] Chinese patent CN100488376C (application number 200480021551) discloses a palatable plastic and chewable veterinary composition, that is, the corresponding Interceptor Plus. The applicable active ingredient of this patent is an insect repellant (both inside and outside the body), and it has high requirements for extrusion equipment ( At least Buhler BCTG-62 / 28D model or above), and at the same time require extrusion to be carried out at low temperature (below 10°C). This patented method undoubtedly increases production costs and is not conducive to large-scale production and promotion in China use
[0007] Chinese patent CN101909605B (Application No. 200880124524.4) discloses a method for manufacturing a soft chewable dosage form for drug delivery and its products. This patent also mentions the need for fluidized bed coating of raw materials, which increases production costs. , has high requirements on equipment performance, and is not suitable for large-scale production and popularization in China
None of the equipment used in the production process of these methods is industrial equipment for pharmaceutical production, or equipment with special requirements is used, such as low temperature is required, or special treatment (such as fluidized bed coating) is required for the raw material drug, all It is not conducive to the realization of industrialized mass production of drugs
Although foreign patents (patent No. US4327077) first mentioned the use of conventional tablet presses to prepare soft chewable preparations, due to the phenomenon of stickiness and astringency when tableting with ordinary tablet presses, the patent at that time did not solve these problems

Method used

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  • Method for preparing soft chewing dosage form for drug delivery
  • Method for preparing soft chewing dosage form for drug delivery
  • Method for preparing soft chewing dosage form for drug delivery

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1: Active Ingredient Containing Vetacoxib - Prescription 1 - Formulation

[0031] The composition of the formula is as follows (4000 batches, specification 80mg):

[0032]

[0033]

[0034] making process:

[0035] Mix the prescribed amount of glycerin, soybean oil and water at room temperature for about 15 minutes to make it uniform; use a wet granulator to mix the prescribed amount of solid excipients at room temperature for about 20 minutes to make it uniform; mix the liquid binder Slowly add to the well-mixed dry auxiliary materials and continue to stir for 10 minutes to obtain wet granules; use a drying oven (non-circulating air, set temperature 25 degrees) to slowly dry the wet granules until the moisture reaches 3-8%, Preferably 4-6%; use nylon sieve or steel sieve to granulate, and the mesh number of the screen is less than 80 mesh (preferably 16-24 mesh); use extruder or molding machine to form, or use tablet press to select appropriate punch Fo...

Embodiment 2

[0046] Example 2: Active ingredient containing benazepril - prescription 2 - formulation

[0047] The composition of the formula is as follows (4000 batches, specification 5mg):

[0048]

[0049]

[0050] Preparation process: with embodiment 1.

[0051] Prescription 2 was carried out palatability study and stability study, the results are as follows:

[0052] (1) Soft Chewing Prescription 2 Dog / Cat Palatability Test

[0053] The dog / cat palatability test is shown in the table below. The results showed that the palatability of formulation 2 in both dogs and cats was very good (greater than 80%).

[0054]

[0055] (2) Stability test of soft chewing prescription 2

[0056] The soft chews of prescription 2 were packaged in bottles and placed under accelerated conditions for 6 months (40°C ± 2°C, RH75% ± 5%) to observe the stability of the soft chews, the results are shown in the table below. The quality of prescription 2 soft chews was stable under accelerated condit...

Embodiment 4

[0058] Example 4: Active ingredients containing anthelmintics or antibiotics - prescriptions 3-8 - preparations

[0059] The formula is composed as follows (4000 batches):

[0060]

[0061]

[0062] Remarks: The active ingredients used in prescriptions 3-5 are compound preparations of praziquantel and milbexime, the active ingredients used in prescriptions 6-8 are preparations of mapoxacin, and the essences used in prescriptions 3-8 are natural chicken flavor, natural Chicken liver flavor, natural bacon flavor, artificial chicken flavor, artificial chicken liver flavor, artificial bacon flavor. Preparation process: with embodiment 1.

[0063] The palatability of prescriptions 3-8 was investigated, and the results are as follows:

[0064] (1) Soft chewing prescription 3-8 dog / cat palatability test

[0065] The dog / cat palatability test is shown in the table below (50 animals). The results showed that the flavors tested had good palatability in both dogs and cats, and ...

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Abstract

The invention relates to a method for preparing a soft chewing dosage form for drug delivery, and belongs to the technical field of drugs. The suitable soft chewing pharmaceutical preparation containsinactive components, and the preferred inactive components include a liquid binder system and a solid excipient. The preferred prescription of the prescription composition not only can adopts a traditional extruder or moulding machine to form the preparation, but also can adopt a commonly used tablet press for tabletting to prepare the soft chewing drug preparation, so as to get rid of the restriction on a forming device. The prepared usable soft chewing drug carrier has no need of heat during mixing, the water content of the finished product is low, and the stable concentration of the activecomponents is stably provided for producing the soft chewing drug carrier having good palatability to dogs / cats and uniform quality and texture.

Description

technical field [0001] The invention relates to a method for manufacturing a soft chewing dosage form for drug delivery, which belongs to the technical field of medicine. Background technique [0002] The palatability of drugs can increase the patient acceptance of drugs, especially for animals, and cats among animals are more picky about the palatability of drugs; animals tend to swallow solid preparations in the form of tablets or capsules, but many active substances The mouthfeel itself is extremely bad (as bitter taste, astringent taste, etc.), which makes the palatability of animals very poor when taking medicine. [0003] Flavoring, flavoring or palatable agents are used to improve the palatability of pharmaceutical formulations. For example, animal-derived flavoring agents (such as beef powder, chicken liver powder, pork powder, beef bone powder, liver powder, milk, gelatin, eggs, etc.) or vegetable-derived flavoring agents (such as soybean protein, etc.) are used in...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/10A61K31/4439A61K31/55A61K31/4985A61K31/365A61K31/5395
CPCA61K9/0056A61K9/2013A61K9/2031A61K9/2095A61K31/365A61K31/4439A61K31/4985A61K31/5395A61K31/55A61K2300/00
Inventor 周晶侯文彬吴汝林崔海峰李靖刘传立潘友武王繁业华洁周福军单淇
Owner BEIJING ORBIEPHARM
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