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Method for producing extended-release potassium citrate wax matrix tablet

A technology of potassium citrate tablets and potassium citrate, which can be used in pill delivery, pharmaceutical formulations, non-active ingredients of oil/fat/wax, etc., and can solve problems for a long time

Active Publication Date: 2015-05-27
温德尔·G·门多萨 +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It takes a long time to heat the carnauba wax until it melts and there is a problem with draining the molten potassium citrate-carnauba wax mixture from the mixer

Method used

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  • Method for producing extended-release potassium citrate wax matrix tablet
  • Method for producing extended-release potassium citrate wax matrix tablet
  • Method for producing extended-release potassium citrate wax matrix tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0018] The 10-mg equivalent tablets were prepared by drying the combined potassium citrate and carnauba wax. The recipe is shown in Table 3.

[0019] table 3

[0020]

[0021] Potassium citrate was sieved through a 18 screen and then mixed with carnauba wax in a Sigma mixer for 5 minutes. Magnesium stearate sieved through a 30 sieve was added to the potassium citrate-carnauba wax mixture and mixed for 1 minute. The granules were compressed into 18.9x8.6mm oval tablets in a Stokes-Pennwalt rotary tablet press model 900. The tablet hardness was 7kp and the tablet had an abrasion of 1.8%, which was unacceptable. The dissolution profile is as follows:

[0022] Table 4 (Solubility, 12 units)

[0023]

[0024] The above products do not meet the dissolution requirements of USP 35. This example illustrates that dry blending of 14% by weight carnauba wax used to produce granules for direct compression does not produce tablets meeting the USP requirements for potassium citra...

Embodiment 3

[0026] The 10-meq tablets were prepared by dry blending potassium citrate and carnauba wax. The formula is shown in Table 5.

[0027] table 5

[0028]

[0029] Sift through a 18 sieve of potassium citrate, then blend with carnauba wax in a Sigma mixer for 5 minutes. Magnesium stearate sieved through a 30 sieve was added to the potassium citrate-carnauba wax mixture and mixed for 1 minute. The granules were compressed into 18.9x8.6mm oval tablets in a Stokes-Pennwalt rotary tablet press model 900. The tablet hardness was 7kp and the abrasion of the tablet was 2%, which was not acceptable. The dissolution profile is as follows:

[0030] Table 6 (Solubility, 12 units)

[0031]

[0032] This example illustrates that dry blending of 20% by weight carnauba wax for the production of granules for direct compression, while meeting compendial solubility requirements, did not produce tablets with acceptable abrasion.

Embodiment 4

[0034] 10-mequivalent tablets were prepared using the same formulation as in Example 2 by sufficiently melting carnauba wax. The process is as follows:

[0035] 1. Crush the potassium citrate with a knife forward in the Fitzmill D6, using a perforated screen 8.

[0036] 2. Mix the crushed potassium citrate from #1 with carnauba wax in a sigma mixer for 20 minutes.

[0037] 3. In the Fitzmill D6, knives forward to crush the granules from #2, using a perforated screen 12.

[0038] 4. In a jacketed Sigma mixer, heat the pellets from #3 with constant mixing. Continue heating until the carnauba wax is completely melted (above 80°C), and thereafter for an additional 10 minutes.

[0039] 5. Pour the liquid mass from #4 into a 2"x 2"x 2" mold and allow to cool to room temperature.

[0040] 6. In Fitzmill D6, knives forward to break up lumps from #5, using perforated screen 16.

[0041] 7. Sift the magnesium stearate through a sieve 30 and blend with the crushed granules from #6 i...

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PUM

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Abstract

The present invention relates to a method for producing extended-release potassium citrate tablet containing camauba wax, wherein the method comprises heating the potassium citrate-carnauba wax mixture to a temperature below the temperature at which carnauba wax liquefies. This invention simplifies the production of extended release potassium citrate wax-matrix tablet.

Description

Background technique [0001] Clinically, potassium citrate is used to treat kidney stones by making the urine pH alkaline and increasing the urine citrate concentration. However, it causes gastrointestinal complications such as irritation and ulceration, thus limiting its therapeutic efficacy. Sustained-release tablets of potassium citrate minimize these side effects and have been shown to maintain elevated urine pH and citrate concentrations (Pak et al., 1984). [0002] Considerable difficulties have been encountered in the preparation of sustained release matrix tablets containing potassium citrate. Potassium citrate is very soluble in water and requires very high doses. The only way to achieve sustained release of potassium citrate tablets while maintaining a tablet size that can be swallowed is to use a hydrophobic wax matrix in which the total content of inactive ingredients is less than 25% by weight. [0003] Mission Pharmacal (San Antonio, TX, USA) sells an extended-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/20A61K31/19A61K33/06
CPCA61K9/2013A61K36/889A61K31/194A61P13/12A61K9/2068A61K9/2095A61K47/44
Inventor 温德尔·G·门多萨丽塔·约瑟菲娜·M·桑托斯尤洛吉欧·C·辛格肯尼·U·迪
Owner 温德尔·G·门多萨
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