Natural lubricant for direct compression and method for preparing natural tablet using the same

Abstract

The present invention relates to a natural lubricant for direct compression and a method of preparing a synthetic additive-free natural tablet using the same. More particularly, the invention provides a crude fat-containing bean powder, which is used as a natural lubricant, and a method of preparing a natural tablet using the bean powder by a dry granulation process which is carried out using a roller compactor.

Claims

1. A tablet comprising an active ingredient and a bean powder, wherein said bean powder is suitable for use as a natural lubricant in a tablet.

2. The tablet of claim 1, wherein the tablet a solid pharmaceutical or food formulation.

3. A method for preparing a natural tablet, the method comprising the steps of: a) mixing an active ingredient, a binder, an excipient and a disintegrant to prepare mixed powder; b) adding to and mixing with the mixed powder the natural lubricant of claim 1; and c) compacting the mixed powder using a roller compactor so as to form a sheet and granulating the sheet.

4. The method of claim 3, wherein the binder is a natural calcium material selected from the group consisting of seaweed calcium powder, shell calcium powder, and eggshell calcium powder.

5. The method of claim 3, wherein the binder is added in an amount of 0-60 wt % based on the total weight of the natural tablet.

6. The method of claim 3, wherein the natural lubricant is added in an amount of 0.1-10 wt % based on the total weight of the natural tablet.

7. The method of claim 3, wherein the method further comprises, after granulating the sheet in step (c), a step of additionally adding the natural lubricant to the granules and compressing the mixture directly into a tablet.

8. The method of claim 7, wherein the natural lubricant is additionally added in an amount of 0.1-10 wt % based on the natural tablet.

Description

EXAMPLES

(1) Preparation of Tablet

(2) The preparation of the natural tablet according to the present invention was based on mixing an active ingredient and an excipient (binder or disintegrant) to form a first mixture and then adding white bean powder (crude fat content: 16±4%) as a natural lubricant to the first mixture to form a second mixture, followed by direct compression.

(3) If necessary, the mixture was subjected to a compaction process using a roller compactor in order to improve the flowability of the mixture, and then granulated, and the granules were compressed into a tablet using a rotary tablet compression machine.

(4) Compaction molding conditions in the roller compactor are as follows:

(5) Compaction molding conditions

(6) Vector roller compactor TF 156

(7) Roll speed: 8 rpm

(8) Feed screw speed: 30 rpm

Example 1

(9) 47 wt % of mixed plants extract powder and 53 wt % of seaweed calcium powder were mixed with each other, and the mixed powder was uniformly mixed in a double cone mixer for 30 minutes. Then, the mixture was compressed into tablets with a total weight of 800±50 mg and an average hardness of 10±3 kg using a rotary tablet compression machine.

Example 2

(10) White bean powder (crude fat content: 16±4%) was added to and mixed with the mixed powder of Example 1 for 5 minutes in an amount of 3 wt % based on the total weight of the mixture. Then, the mixture was compressed into tablets with a total weight of 800±50 mg and an average hardness of 10±3 kg using a rotary tablet compression machine.

Example 3

(11) White bean powder (crude fat content: 16±4%) was added to and mixed with the mixed powder of Example 1 for 5 minutes in an amount of 6 wt % based on the total weight of the mixture. Then, the mixture was compressed into tablets with a total weight of 800±50 mg and an average hardness of 10±3 kg using a rotary tablet compression machine.

Example 4

(12) White bean powder (crude fat content: 16±4%) was added to and mixed with the mixed powder of Example 1 for 5 minutes in an amount of 3 wt % based on the total weight of the mixture. The resulting mixture was compacted using a roller compactor, and then granulated, and the granules were compressed into tablets with a total weight of 800±50 mg and an average hardness of 10±3 kg using a rotary tablet compression machine.

Example 5

(13) White bean powder (crude fat content: 16±4%) was added to and mixed with the mixed powder of Example 1 for 5 minutes in an amount of 3 wt % based on the total weight of the mixture. The resulting mixture was compacted using a roller compactor, and then granulated. Then, white bean powder (crude fat content: 16±4%) was added to and mixed with the granules in an amount of 3 wt % based on the total weight of the granules. Then, the mixture was compressed into tablets with a total weight of 800±50 mg and an average hardness of 10±3 kg using a rotary tablet compression machine.

Comparative Example 1

(14) Magnesium stearate was added to and mixed with the mixed powder of Example 1 for 5 minutes in an amount of 1 wt % based on the total weight of the mixture. Then, the mixture was compressed into tablets with a total weight of 800±?50 mg and an average hardness of 10±3 kg using a rotary tablet compression machine.

Test Example 1

Evaluation of Lubricant Properties

(15) In order to examine the degree of improvement in lubricant properties, which is caused by the use of the natural lubricant according to the present invention, sticking during the tablet compression process in Examples 1 to 6 and Comparative Example 1 was observed and measured. Example 1 was used as a control. The lubricant property during the tablet compression process in the Examples was evaluated on the following scale: (−) poor; (+) moderate; (++) good; and (+++) excellent. In addition, the flowability was evaluated on the same scale as above.

(16) Criteria for evaluating the lubricant property were based on the time point that the occurrence of sticking is shown during the tablet compression with the high-speed rotary tablet compression machine.

(17) Specifically, the lubricant property was evaluated on the following scale: 10 or less tablets: poor; 10-50 tablets: moderate; 50-500 tablets: good; and 500 or more tablets: excellent. Criteria for evaluating the flowability of the mixture are associated with the degree to which the mixture is filled in the hopper of the tablet compression machine. Specifically, the flowability was evaluated based on the variation in the weight of tablets on the following scale: excellent: the variation in the total weight of 20 tablets is 5 wt % or less; good: 5-8 wt %; moderate: 8-12 wt %; and poor: 12 wt % or more.

(18) The results of the evaluation are shown in Table 1 below.

(19) TABLE-US-00001 TABLE 1 Lubricant property Example (evaluation of sticking) Flowability Example 5 +++ +++ Example 4 + +++ Example 3 +++ − Example 2 ++ + Example 1 − + Comparative +++ ++ Example 1

(20) As can be seen in Table 1 above, the lubricant property in Example 3 in which the white bean powder (crude fat content: 16±4%) was used in an amount of 6 wt % based on the total weight of the mixture was excellent compared to that in Example 2 in which the white bean powder was used in an amount of 3 wt %, but the flowability in Example 3 was significantly reduced compared to that in Example 2. Thus, it could be seen that the white bean powder should be used in an amount of 1-10 wt %, and preferably 2-4 wt %, in order to ensure the flowability of the mixture.

(21) When Examples 2 and 4 were compared, it was shown that the flowability was ensured by the roller compaction process, but the lubricant property was slightly reduced. Based on these results, it can be seen that the white bean powder was additionally added to the mixture as described in Example 5 in order to increase the lubricant property of the mixture.

(22) Accordingly, it could be seen that the use of the crude fat-containing bean powder as a natural lubricant according to the present invention can provide an effect equal to or higher than that obtained by the use of a conventional synthetic lubricant.