Fenelinone orally disintegrating tablets and their preparation method

Abstract

This invention relates to the field of pharmaceutical technology, specifically to a fenelazol orally disintegrating tablet and its preparation method. The fenelazol orally disintegrating tablet has fenelazol as its active ingredient, and its components, by weight percentage, are as follows: fenelazol 3-45%; filler 48-70%; binder 0.5-2%; flow aid 1-4%; lubricant 1-4%; first disintegrant 0-15%; second disintegrant 2-6%; and third disintegrant 2-6%, wherein the first, second, and third disintegrants are the same or at least two are different. Preferably, the weight content of fenelazol is 10-15%, and / or the weight content of the filler is 59-70%. The fenelazol orally disintegrating tablet of this invention is suitable for diabetic patients, exhibits rapid disintegration and dissolution, stable product quality, requires no water for administration, and has high patient compliance. Furthermore, the preparation process of the fenelazol orally disintegrating tablet of this invention is simple, low-cost, and suitable for large-scale production.

Claims

1. A fenelinone orally disintegrating tablet, wherein, by weight percentage, the ingredients comprise: 3-45% fenelinone; 48-70% filler; 0.5-2% binder; 1-4% flow aid; 1-4% lubricant; 0-15% first disintegrant; 2-6% second disintegrant; and 2-6% third disintegrant, wherein the first, second, and third disintegrants are the same or at least two of them are different.

2. The fenelinone orally disintegrating tablet as claimed in claim 1, wherein the first disintegrant, the second disintegrant, and the third disintegrant are each independently selected from a crospovidone, a crospovidone sodium carboxymethyl cellulose, a sodium carboxymethyl starch, or a low-substituted hydroxypropyl cellulose.

3. The fenelinone orally disintegrating tablet as claimed in claim 2, wherein the first disintegrant and the second disintegrant are each independently selected from the low-substituted hydroxypropyl cellulose and the croscarmellose sodium, and the third disintegrant is the croscarmellose.

4. The fenelinone orally disintegrating tablet as described in claim 3, wherein the weight ratio of the first disintegrant, the second disintegrant, and the third disintegrant is 12.5~15:2~6:2~6.

5. The fenelitonee orally disintegrating tablet as claimed in claim 1, wherein the adhesive is ethyl cellulose or polyacrylic acid resin.

6. The fenelinone orally disintegrating tablet as claimed in claim 1, wherein the filler is mannitol, lactose, or a combination thereof.

7. The fenelinone orally disintegrating tablet as claimed in claim 1, wherein the gliding agent is at least one of a gelled silica, a micronized silica, and a talc, preferably the talc and / or the gelled silica; and the lubricant is at least one of a calcium stearate, a sodium fumarate stearate, or a magnesium stearate.

8. The fenelitonee orally disintegrating tablet as claimed in claim 1, wherein, by weight percentage, the ingredients comprise: 10-15% fenelitonee; 59-70% mannitol; 0.5-2% ethyl cellulose or the polyacrylic acid resin; 12.5-15% low-substituted hydroxypropyl cellulose; 2-6% crospovidone; 2-6% sodium crospovidone carboxymethyl cellulose; 1-4% talc; and 1-2% magnesium stearate, wherein... Each of these orally disintegrating fenelone tablets contains 10 mg or 20 mg of fenelone.

9. The fenelitonee orally disintegrating tablet as claimed in claim 1, wherein, by weight percentage, the ingredients comprise: 10-15% fenelitonee; 59-70% lactose; 0.5-2% ethyl cellulose or the polyacrylic acid resin; 12.5-15% low-substituted hydroxypropyl cellulose; 2-6% crospovidone; 2-6% sodium crospovidone carboxymethyl cellulose; 1-2% gelling silica; 1-2% talc; and 1-2% magnesium stearate, wherein, Each of these orally disintegrating fenelone tablets contains 10 mg or 20 mg of fenelone.

10. A method for preparing a felindone orally disintegrating tablet according to any one of claims 1 to 9, comprising the following steps: (a) mixing a prescribed amount of a first disintegrant, a second disintegrant, a filler, and a glidant to obtain a mixture; (b) dissolving a felindone and a binder in a suitable solvent to obtain a mixed solution, adding the mixed solution to the mixture obtained in step (a) to obtain a slurry, preparing a soft material, drying it, and obtaining dry granules; and (c) mixing the dry granules obtained in step (b) with a prescribed amount of a third disintegrant and a lubricant, and compressing the mixture to obtain a felindone orally disintegrating tablet.