Pharmaceutical formulation having improved stability
A technology for pharmaceutical preparations and stability, applied in the field of pharmaceutical preparations with improved stability, can solve problems such as failure to disclose stability test results and the like
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[0031] According to another aspect of the present invention, there is provided a method for preparing a pharmaceutical preparation containing ramipril with improved stability, which includes: granulating ramipril and a super disintegrant with an aqueous solution of a suitable binder, preferably Water-soluble polymers and convert the mixture into pellets or granules. The granulation operation can be carried out using methods known in the art of pharmaceutical technology (pl. Isaac Ghebre-Sellassie: Pharmaceutical Pelletization Technology, Marcel Dekker, Inc., New York, Basel, 1989).
[0032] As binder, any compatible binder known in the art may be used, preferably water-soluble polymers, such as modified cellulose derivatives, most advantageously hydroxypropylmethylcellulose.
[0033] There are several prior art methods suitable for the production of pellets or granules, derived from the following three basic methods:
[0034] 1. Layering method,
[0035] 2. Extrusion spheron...
Embodiment 4
[0058] The comparative stability results of Example 4 show that in the combined dosage form according to Example 3, the concentration of ramipril decomposition products and the sum of impurities (respectively ramipril diacid, impurity E; ramipril The sum of the concentrations of impurity D and impurity E) is more favorable than that obtained for the formulation of the comparative example, although the dosage form according to example 3 contains amlodipine besylate in addition to ramipril, and there is no comparative example Sodium bicarbonate as a stabilizer. Furthermore, it was concluded from the stability tests that the easily decomposed amlodipine besylate remained stable until the end of the 6-month stability test period.
[0059] Another aspect of the invention is exemplified by the following examples, without limiting the invention to the examples only.
Embodiment 1
[0064] Embodiment 1. Ramipril Granules
[0065] To prepare 10.5 kg of ramipril granules, 2000 g of ramipril and 8000 g of crospovidone (Poliplasmdone XL-10GAF) were charged into a Hüttlin Pilotmix vortex granulator, and the mixture was homogenized at 15 rpm. for 2 minutes.
[0066] One day before the actual preparation, 470 g of hypromellose (Pharmacoat 603) was dissolved in 7.7 kg of purified water, and the granulated solution thus obtained was filtered.
[0067] A 3670 g portion of the granulation solution was sprayed into the powder mixture with a mixer at 30 to 50 rpm, a chopper at 1000 to 1400 rpm, and a spray pressure set at 1.5 bar. After spraying, the mixture was kneaded for a further 5 minutes.
[0068] The wet product was screened and regranulated using a Glatt OR5030 oscillating regranulator with a 0.8 mm mesh screen.
[0069] The pre-granulated mixture was transferred to the container of the Hüttlin Pilotlab fluidized granulation unit and further granulated by spr...
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