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Pharmaceutical dosage form comprising metformin and calcium citrate

A pharmaceutical dosage form, metformin technology, applied in the treatment of type 2 diabetes, metformin field, can solve problems such as affecting patient compliance

Inactive Publication Date: 2022-01-28
DSM IP ASSETS BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This can also adversely affect patient compliance, as feeling little relief while taking the drug can influence a patient's decision to discontinue their treatment regimen

Method used

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  • Pharmaceutical dosage form comprising metformin and calcium citrate
  • Pharmaceutical dosage form comprising metformin and calcium citrate
  • Pharmaceutical dosage form comprising metformin and calcium citrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0187] first test

[0188] Three similar tablet blends were prepared, each containing metformin hydrochloride, a spray-dried formulation of vitamin B12 (available at Nutritional Products), binders and calcium salts. Thus, three different calcium salts were used respectively: calcium carbonate, calcium phosphate and tricalcium dicitrate tetrahydrate. In all three cases, capping was observed. Therefore, none of the three tablet blends of the first trial could be successfully compressed into tablets.

[0189] second test

[0190] Similar to the first trial, in the second trial three tablet mixtures were prepared. However, this time, granulated metformin (Metformin with a DC of 92.6%, granulated, with magnesium stearate as lubricant, available at Vistin Pharma) was used instead of non-granulated metformin hydrochloride. In the second experiment, no capping was observed regardless of which calcium salt was used.

[0191] Example 1 illustrates the preferred use of granulated ...

Embodiment 2

[0193] In Example 2, four similar tablet blends were prepared, each comprising a DC of 92.6% granulated metformin, a spray-dried formulation of vitamin B12 (available at Nutritional Products), Aerosol 200 as flow agent, magnesium stearate as lubricant, SMCC90 (available at JRS Pharma), and calcium salt. Therefore, four different types of calcium salts were tested: calcium carbonate (95MD, available at Particle Dynamics), dicalcium phosphate anhydrous (DiCafos A150, anhydrous, available at Budenheim), tricalcium dicitrate tetrahydrate (available at Merck) and calcium citrate anhydrous (available at Gadot).

[0194] For compressing the tablets, a single-punch tablet press (Korsch XP-1, available at Korsch, Berlin) was used.

[0195] All four tablet blends were successfully compressed into tablets regardless of the calcium salt used. Each of the tablets contains the same amount of metformin, vitamin B12 (spray-dried formulation), Ca 2+ (100mg / tablet), fluids and lubricants....

Embodiment 3

[0200] To further increase tablet hardness, four similar tablet blends were prepared as shown in Table 1 below:

[0201]

[0202] 1 Tricalcium dicitrate tetrahydrate (available at Merck)

[0203] 2 Calcium Carbonate (95MD, available at Particle Dynamics)

[0204] PH102 (available at FMC Biopolymer)

[0205] SMCC90 (available at JRS Pharma)

[0206] Table 1

[0207] Similar to Example 2, the four tablet blends were compressed into tablets. Tablet hardness is then measured. result in Figure 2a and Figure 2b shown in .

[0208] Figure 2a shows the compression curve of the tablet containing as Ca 2+ source of tricalcium dicitrate tetrahydrate and as a binder PH102(3a) or SMCC90 (3a').

[0209] Figure 2b shows the compression curve of the tablet containing as Ca 2+ source of calcium carbonate and as a binder PH102(3b) or SMCC90 (3b').

[0210] Example 3 shows that by using microcrystalline cellulose as a binder, the hardness of tablets comprising m...

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PUM

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Abstract

The present invention relates to a pharmaceutical dosage form comprising a) metformin or a pharmaceutical acceptable salt thereof, and b) calcium citrate. In a preferred embodiment of the invention, the dosage form further comprises vitamin B12. The invention also relates to its use in the prevention or alleviation of metformin induced vitamin B12 malabsorption.

Description

technical field [0001] The invention relates to the use of metformin for treating type 2 diabetes. Background technique [0002] During long-term use of metformin, the absorption of vitamin B12 may be decreased. For example, The product monograph contains the following warning: [0003] "long-term use Treatment has been associated with decreased serum vitamin B12 levels, which may lead to peripheral neuropathy. Reportedly used in cases of vitamin B12 deficiency Treatment-emergent cases of severe peripheral neuropathy (see ADVERSE REACTIONS, Postmarketing Adverse Drug Reactions). Monitoring of serum vitamin B12 levels is recommended. " [0004] Just one brand of metformin hydrochloride tablets sold. Similar warnings can be found in other drug manufacturers' package inserts. [0005] Bauman et al. have shown that metformin-induced vitamin B12 malabsorption can be reversed by increasing calcium carbonate intake (Diabetes Care, Vol. 23, No. 9, September 2000, pp. 1...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/155A61K31/714A61P3/02
CPCA61K9/2013A61K31/155A61K31/714A61P3/02A61K47/12A61P25/02A61K2300/00
Inventor 马丁·托马斯·昆茨兹德拉芙卡·米斯克拉尔夫·施耐特阿拉克夏·托普奇安
Owner DSM IP ASSETS BV
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