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Fast wet-massing method for the preparation of calcium-containing compositions

一种组合物、钙化合物的技术，应用在药物组合、铝/钙/镁有效成分、块状输送等方向，能够解决不易患者吞咽、不能够装入、片剂大小太大等问题

Inactive Publication Date: 2008-02-20
TAKEDA AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Also, the fluidized bed method typically produces more porous granules, resulting in porous tablets, i.e., such tablets may be too large to fit into the capsule of a dosing machine
[0005] Also, the fluidized bed method generally cannot be used for applications such as the preparation of tablets for sucking or for swallowing.
The reason is that the administration of calcium requires a relatively high dose, and in order for a single dosage form (tablet) to contain this dose, the size of the tablet would be too large for the patient to swallow easily

Method used

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  • Fast wet-massing method for the preparation of calcium-containing compositions
  • Fast wet-massing method for the preparation of calcium-containing compositions
  • Fast wet-massing method for the preparation of calcium-containing compositions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0216] Wet pellets, design of experiments and production of pellets

[0217] The purpose of this example was to investigate whether a process involving rapid and efficient addition of a granulation fluid to a calcium-containing compound, combined with a rapid and efficient wet coalescence process, could produce granules with suitable compaction and compressibility characteristics, And whether the tablets obtained are suitable for the treatment of conditions requiring calcium supplementation. As mentioned earlier, the porosity of calcium-containing tablets has become recognized as an important parameter, eg in judging whether a tablet is suitable as a chewable tablet (especially in view of its pleasing taste and mouthfeel).

[0218] In a Nauta mixer, 111.8 kg of calcium carbonate (average particle size approximately 5-25 μm) was mixed with 35.0 kg of sorbitol before being transferred to a funnel. In some experiments, experiments 6 and 7 described below, only calcium carbonate ...

Embodiment 2

[0241] Effect of method parameters, sorbitol particle size, PVP30 concentration and particle size distribution (psd) of the obtained particles on tablet thickness and tablet compressive strength

[0242] When the granule composition is fixed, the weight of the tablet, the diameter of the tablet, and the compressive force and porosity of the tablet are directly proportional to the thickness of the tablet, i.e., by comparing tablets prepared using different process parameters, the smaller the tablet thickness , the lower the porosity.

[0243] During tablet formation, the porosity of the tablet is important, especially the mechanical strength of the tablet. Also, for example a chewable tablet must not be too "hard", ie it must be easy to chew, so especially the porosity of a chewable tablet is important. Finally, it should be noted that the inventors have found the importance of the wettability of the tablet in order to avoid bad taste and mouthfeel of calcium-containing compou...

Embodiment 3

[0265] Comparison of tablet thickness and compressive strength produced by fluid bed and high shear mixers and Schugiflex technology

[0266] Tablet thickness and compressive strength for experiments 1-5, 8-13 and 14-15 are listed in Figures 3-6.

[0267] Experimental analysis using fluid bed or high shear mixer granulated tablets as a reference showed that:

[0268] Fluidized bed reference:

[0269] According to experiments 4, 8 and 9, it is possible to obtain tablets with similar thickness and compressive strength as those produced by fluidized bed by proper control of process parameters.

[0270] Experiments 1, 3 and 5 deviated from the reference. This may be due to the lack of a small amount of binder (PVP30).

[0271] High shear mixer reference:

[0272] Experiments 10, 11 and 12 had higher compressive strength and relatively lower tablet thickness

[0273] Experiments 2 and 13 had lower compressive strength and approximate thickness. The lower compressive s...

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Abstract

The present invention relates to a novel process for the preparation of a granulate comprising a calcium-containing compound as an active substance. The method comprises a method for the preparation of a granulate comprising a calcium-containing compound as an active substance, the method comprising, i) feeding a granulation chamber with a composition comprising the calcium-containing compound, ii) wet-massing the composition with a granulation liquid optionally comprising a pharmaceutically acceptable binder for a time period of at the most 30 sec to obtain a wet granulate, iii) drying the thus obtained wet granulate. A granulate obtained by the present method is especially suitable in the preparation of solid dosage forms, in particular in the preparation of tablets.

Description

technical field [0001] The present invention relates to a new process for the preparation of granules comprising calcium-containing compounds as active ingredients. The granules obtained by applying the method are especially suitable for the preparation of solid dosage forms, especially the preparation of tablets. technical background [0002] Calcium, either as calcium ion or as a calcium complex, is an essential element for many critical functions in the body. Many diseases, especially bone-related diseases, are treated therapeutically or preventively by consuming adequate amounts of calcium-containing compounds. Calcium usually has to be taken orally in relatively high amounts, which makes special dosage forms such as chewable or suckable tablets suitable for use. However, the main problem in this regard is to obtain compositions that can achieve sufficient compliance from consumers for proper and effective treatment. This problem is associated with the undesirable tas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/20A61K33/06
CPCA61K9/1694A61K9/2018A61K9/1623A61P19/08A61P3/02
Inventor 保罗·埃贡·贝特尔森佩德·莫尔·奥尔森卡斯坦·马蒂尼·尼尔森马格努斯·威廉·托尔斯海于格
Owner TAKEDA AS