Solid pharmaceutical tablet
A tablet and solid technology, applied in drug delivery, pill delivery, pharmaceutical formulations, etc., can solve problems such as oral discomfort
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Examples
Embodiment 1 to 7
[0180] Seven different water insoluble organic compound complex samples are provided in Examples 1 to 7, given sample numbers 101 to 107. Compositions are given in Table 1, and samples were prepared by the following procedure:
[0181] The elastomer and about 1 / 3 of the resin are mixed together with the filler in a preheated mixer with a horizontally positioned Z-arm for mixing at 120°C. The filler is talc or non-DC calcium carbonate. The mechanical action of the mixer causes shearing and grinding, which softens the elastomer.
[0182] When softening the elastomer, slowly add more resin to the elastomer, resin and filler until the mixture becomes homogeneous. The remaining resin was then added to the mixer and mixed for 10 to 20 minutes. Softeners (ie emulsifiers, waxes and vegetable fats) are then added and mixed for 20 to 40 minutes until the entire mixture becomes homogeneous.
[0183] After a total mixing time of about 45 to 60 minutes, the mixture was granulated in a ...
Embodiment 8 to 14
[0192] Tablet preparation
[0193] Tablets were prepared as follows using compounds as provided in Examples 1 to 7, respectively, given sample numbers 1001 to 1007:
[0194] The compounds of Examples 1 to 7 are present in the form of microparticles / granules.
[0195] Based on the composition of Table 2A as an example, the particulate compound of Examples 1 to 7, additional tablet compound, and DC-calcium carbonate (measured at about 100%) were weighed in appropriate amounts.
[0196] The weighed amount was then added to the Turbula mixer in the stainless steel container and mixed for 4 minutes at 50 rpm, and then the magnesium stearate was added and mixed for an additional minute.
[0197] The blend was then compressed through a Piccola RIVA DC-SC-041-2. Also available with Fette 3090i.
[0198] The resulting tablets according to Examples 8 to 14 are then obtained by tableting with a suitable pressure of about 28 to 30 kN as the main compression force. The tablet weight fo...
Embodiment 15
[0202] Example 15 - In Vitro Release of Calcium Carbonate from Tablets
[0203] In this example, calcium carbonate release was determined in vitro. According to the procedure shown in European Pharmacopoeia Sixth Edition. 2.9.25, the chewing rate was 60 chews per minute in phosphate buffered saline at pH = 7.4, and the temperature of the medium was set at 37°C. Measurement. The chewing process was interrupted every minute to replace the phosphate buffer, thereby preventing buffer saturation and simulating swallowing during chewing in vivo. For each sample, one tablet was chewed at the indicated time intervals of 3, 5 and 10 minutes to generate tablet residue at each time point. This was repeated 6 times to obtain 6 replicates for each time point in the test.
[0204] The calcium carbonate content of the residue after chewing was determined by standard atomic absorption spectroscopy (AAS). For analysis, tablet residues were dissolved in a mixture of hydrochloric acid (HCl) ...
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