Composition comprising metformin hci, vitamin b12 and at least one flow additive
A technology of metformin hydrochloride and flow aids, which can be used in drug combinations, medical preparations containing active ingredients, and pill delivery, etc. It can solve problems such as extra space and staff, poor patient compliance, and high cost, and improve compliance Sexuality, the effect of increasing compliance
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Embodiment 1
[0153] Embodiment 1 (pre-test)
[0154] In Example 1, several pre-tests were performed.
[0155] The fluidity measurement of commercially available metformin hydrochloride is as follows:
[0156] Powder flowability was determined with a Pharmatest PTG-S4 automated powder characterization instrument (Pharma Test Apparatebau AG, Hainburg, Germany). The system measures the flow properties of granules and powders according to the current EP and USP pharmacopoeias as well as the international ISO 4324 standard.
[0157] Mass flow rate (g / min) was determined by the method of flow through anorifice. Flow rate is interpreted as the time required to flow a specific amount of powder (100 g) through orifices of different diameters. A free flowing powder should be able to flow through integral collections of diameters 5mm, 7mm, 9mm, 10mm and 15mm. A plot of flow rate versus orifice diameter is called a flow curve. Perform three parallel measurements to determine the flow rate.
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Embodiment 2
[0168] Embodiment 2 (fluidity of mixture)
[0169] Two mixtures were prepared comprising metformin hydrochloride, a spray-dried vitamin B12 formulation and one of the two flow aids of Example 1 (ie DiCafos A150 or CaCO3 95MD). The weight ratio between metformin hydrochloride and flow aid was about 4:1 in both cases.
[0170] The flow properties of the two mixtures were then tested as described in Example 1.
[0171] Regardless of the size of the orifice, the mixture containing DiCafos A150 as a flow aid had a higher flow rate than the mixture containing CaCO3 95MD (see figure 1 ). This is very surprising since pre-tests of Example 1 showed the opposite.
[0172] A summary of the measurement results of Example 2 is given in Table 1 below.
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[0174]
[0175] Table 1
[0176] Example 2 does not show that the result of Example 1 is wrong. However, Example 2 shows that in the specific case of a Metformin HCl / Vitamin B12 blend, DiCafos A150 increases flow more than...
Embodiment 3
[0179] Four similar tablet blends were prepared, each containing a DC of 92.6% granulated metformin, a spray-dried formulation of vitamin B12 (available at Nutritional Products), aerosol 200, magnesium stearate as a lubricant, SMCC90 (available at JRS Pharma), and calcium salt as flow aid. Therefore, four different types of calcium salts were tested: calcium carbonate (95MD, available at ParticleDynamics), dicalcium phosphate anhydrous (DiCafos A150, anhydrous, available at Budenheim), tricalcium dicitrate tetrahydrate ( available at Merck) and calcium citrate anhydrous (available at Gadot).
[0180] For compressing the tablets, a single-punch tablet press (Korsch XP-1, available at Korsch, Berlin) was used.
[0181] 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), Aerosol 200 and lubricant. Then sel...
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