CN110946840B - Canagliflozin pharmaceutical composition and preparation method thereof - Google Patents
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Abstract
The invention relates to a canagliflozin pharmaceutical composition and a preparation method thereof. The canagliflozin pharmaceutical composition comprises active ingredients of canagliflozin, an additive, an organic acid, a diluent, a disintegrating agent, an adhesive and a lubricant, and the additive is added to ensure that the canagliflozin is stably and uniformly released, so that the stable blood sugar reducing effect is realized.
Description
Technical Field
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a canagliflozin pharmaceutical composition and a preparation method thereof.
Background
Canagliflozin tablets (Canagliflozin, trade name:
) Is the first SGLT inhibitor approved by FDA and jointly developed by Yanseng pharmaceutical under Qiangsheng flag (Janssen) in the United states and Mitsubishi Tanabe pharmaceutical under Japan. It can inhibit SGLT-2 to make the glucose in renal tubule incapable of being reabsorbed into blood and excreted with urine, so as to reduce blood concentration, and is suitable for adjuvant diet and exercise therapy to improve blood sugar control of type II diabetic.
Several patents relating to canagliflozin compositions are disclosed in the prior art, such as:
patent document CN103655539A discloses an oral solid preparation of canagliflozin, which comprises amorphous canagliflozin, a filler, a disintegrant and a surfactant, wherein the average particle size of the canagliflozin is limited to 2.5-30um at the same time.
Patent document CN104688670A discloses a slow release formulation of canagliflozin, which is composed of the following raw materials: 49-51 parts of canagliflozin; 10-25 parts of polymethacrylate; 5-15 parts of sodium polymethacrylate; 5-30 parts of lactose; 1-5 parts of micro silica gel powder, and the patent emphasizes that the drug release amount of the sustained-release preparation is respectively 30-50%, 54-70% and more than 77% of the marked amount in 1 hour, 3 hours and 10 hours, but the patent can not ensure the more stable, uniform and long-acting release of the drug.
Patent document CN105769803A discloses a pharmaceutical composition for treating type 2 diabetes and a preparation method thereof, wherein the composition comprises active ingredient canagliflozin and pharmaceutic adjuvants such as water-soluble solid dispersion carriers, disintegrants, lubricants and the like.
Patent document CN107744512A discloses a canagliflozin composition, which also aims to solve the problem of low dissolution of canagliflozin.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a pharmaceutical composition capable of continuously, stably and uniformly releasing canagliflozin.
Specifically, the invention is realized by the following technical scheme:
a pharmaceutical composition of canagliflozin, the composition comprising an additive comprising at least one of glucomannan, carboxymethyl glucomannan; and/or at least one of polyethylene glycol, glyceryl behenate, and ethyl cellulose.
The weight ratio of canagliflozin to the additive is 1: (0.1-2.5); for example, 1:0.2, 1: 0.3, 1: 0.4, 1: 0.5, 1: 0.6, 1: 0.7, 1: 0.8, 1: 0.9, 1: 1. 1: 1.1, 1: 1.2, 1: 1.3, 1: 1.4, 1: 1.5, 1: 1.6, 1: 1.7, 1: 1.8, 1: 1.9, 1: 2.0, 1: 2.1, 1: 2.2, 1: 2.3, 1: 2.4.
the composition also comprises an organic acid, wherein the organic acid is at least one of citric acid, tartaric acid and malic acid.
The composition further comprises a diluent, a disintegrant, a binder, and a lubricant.
The composition comprises the following components:
the amount of canagliflozin in the composition can be, for example, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%.
The content of the additive in the composition may be, for example, 10%, 15%, 20%, 25%, 30%, 35%.
The organic acid content in the composition may be, for example, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%.
The diluent is selected from one or more of lactose, microcrystalline cellulose, silicified microcrystalline cellulose, mannitol, xylitol, pregelatinized starch and starch, and the content of the diluent can be 15%, 20%, 25%, 30% and 35%.
The disintegrant is selected from one or more of low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, croscarmellose sodium, sodium carboxymethyl starch, sodium starch glycolate and crospovidone, and the content of the disintegrant can be 2%, 3%, 4%, 5%, 6%, 7%, 8% and 9%.
The adhesive is selected from one or more of starch, dextrin, hydroxypropyl methylcellulose, sodium carboxymethylcellulose and polyvinylpyrrolidone, and the content of the adhesive can be 2%, 3% or 4%.
The lubricant is selected from one or more of magnesium stearate, stearic acid, sodium stearate, zinc stearate, sodium stearate fumarate, calcium stearate, talcum powder and superfine silica gel powder, and the content of the lubricant can be 1%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0% and 4.5%.
The composition is a tablet.
The preparation method of the pharmaceutical composition comprises the following steps:
(1) premixing canagliflozin, an additive and organic acid to obtain a mixture I;
(2) adding a diluent, a disintegrating agent and an adhesive, and premixing to obtain a mixture II;
(3) adding a lubricant after blending and uniformly mixing;
(4) finishing the grains;
(5) and (6) tabletting.
Alternatively, the preparation method of the pharmaceutical composition comprises the following steps:
(1) premixing canagliflozin and an additive to obtain a mixture i;
(2) dissolving an organic acid in purified water, and carrying out atomization mixing on the organic acid and the mixture i to obtain a mixture ii;
(3) uniformly mixing the mixture ii with a diluent, a disintegrating agent and an adhesive, and then adding a lubricant for uniform mixing;
(4) finishing the grains;
(5) and (6) tabletting.
The tablets may be further coated with a water soluble coating material selected from the group consisting of opadry or polyvinylpyrrolidone; the coating solvent is selected from ethanol, water or mixture of water and ethanol.
Wherein, the water-soluble coating material is preferably Opadry, and the coating solvent is preferably water.
The pharmaceutical composition of canagliflozin disclosed by the invention can ensure the sustained, stable and uniform release of canagliflozin by adding the specific additive, can still maintain the drug effect 10-24 hours after the administration, and can ensure the sustained blood glucose reduction effect of canagliflozin while reducing the administration frequency.
Drawings
FIG. 1 is a statistical graph of cumulative release for examples 1-4 and comparative examples 1-2.
Detailed Description
To further illustrate the present invention, the present invention will be specifically described with reference to specific examples, but the scope of the present invention is not limited to the specific examples.
Example 1
A canagliflozin pharmaceutical composition having a prescription:
| composition of | Weight percent (%) |
| Canagliflozin | 40 |
| Glucomannan | 5 |
| |
5 |
| |
20 |
| Pre-crosslinked |
20 |
| |
5 |
| Methyl cellulose | 3 |
| Magnesium stearate | 2 |
The preparation method of the tablet comprising the formula comprises the following steps:
(1) sieving lactose and pregelatinized starch with 60 mesh sieve
(2) Adding prescription amounts of canagliflozin, glucomannan and citric acid into a fixed hopper mixer, and mixing for 30min at 15 rpm;
(3) adding the sieved lactose and the pre-crosslinked starch according to the prescription amount after the mixing is finished, and mixing for 15min at 15 rpm;
(4) adding the sodium carboxymethyl starch and the methylcellulose in the formula amount, further mixing, and mixing for 15min at 15 rpm;
(5) adding magnesium stearate, mixing, and mixing at 15rpm for 10 min;
(6) adding the obtained mixture into a feed hopper of a dry granulator, adjusting parameters, pressing the powder into sheets, and finishing the particles by a sieve with the diameter of 0.8 mm;
(7) tabletting, with specification of 40 mg/tablet, 60 mg/tablet, 100 mg/tablet.
Example 2
A canagliflozin pharmaceutical composition having a prescription:
the preparation method of the tablet comprising the formula comprises the following steps:
(1) sieving mannitol with 60 mesh sieve
(2) Adding prescription dose of canagliflozin, carboxymethyl glucomannan, glyceryl behenate and malic acid into a fixed hopper mixer, and mixing for 30min at 15 rpm;
(3) adding the screened mannitol with the amount of the prescription after the mixing is finished, and mixing for 15min at 15 rpm;
(4) adding the crospovidone and the carboxymethyl cellulose with the prescription amount, further mixing, and mixing for 15min at 15 rpm;
(5) adding magnesium stearate, mixing, and mixing at 15rpm for 10 min;
(6) adding the obtained mixture into a feed hopper of a dry granulator, adjusting parameters, pressing the powder into sheets, and finishing the particles by a sieve with the diameter of 0.8 mm;
(7) tabletting, wherein the specification is 40 mg/tablet, 60 mg/tablet and 100 mg/tablet.
Example 3
A canagliflozin pharmaceutical composition having a prescription:
| composition of | Weight percent (%) |
| Canagliflozin | 50 |
| |
15 |
| |
5 |
| |
5 |
| Silicified |
15 |
| Low substituted |
6 |
| Polyvinylpyrrolidone | 2 |
| |
2 |
The preparation method of the tablet comprising the formula comprises the following steps:
(1) silicified microcrystalline cellulose is sieved by a 60-mesh sieve for standby
(2) Adding prescription dose of canagliflozin, glucomannan, ethyl cellulose and tartaric acid into a fixed hopper mixer, and mixing for 30min at 15 rpm;
(3) adding the sieved silicified microcrystalline cellulose with the formula amount after the mixing is finished, and mixing for 15min at 15 rpm;
(4) adding the low-substituted hydroxypropyl cellulose sodium and the polyvinylpyrrolidone with the formula amount, further mixing, and mixing for 15min at 15 rpm;
(5) adding magnesium stearate, mixing, and mixing at 15rpm for 10 min;
(6) adding the obtained mixture into a feed hopper of a dry granulator, adjusting parameters, pressing the powder into sheets, and finishing the particles by a sieve with the diameter of 0.8 mm;
(7) tabletting, with specification of 40 mg/tablet, 60 mg/tablet, 100 mg/tablet.
Example 4
A canagliflozin pharmaceutical composition having a prescription:
| composition of | Weight percent (%) |
| Canagliflozin | 30 |
| |
30 |
| |
8 |
| |
24 |
| |
4 |
| Polyvinylpyrrolidone | 2 |
| |
2 |
The preparation method of the tablet comprising the formula comprises the following steps:
(1) adding prescription amounts of canagliflozin, glucomannan and citric acid into a fixed hopper mixer, and mixing for 30min at 15 rpm;
(2) adding the starch with the amount of the prescription after the mixing is finished, and mixing for 15min at 15 rpm;
(3) adding the cross-linked sodium carboxymethylcellulose and the polyvinylpyrrolidone with the prescription amount, further mixing, and mixing for 15min at 15 rpm;
(4) adding magnesium stearate, mixing, and mixing at 15rpm for 10 min;
(5) adding the obtained mixture into a feed hopper of a dry granulator, adjusting parameters, pressing the powder into sheets, and finishing the particles by a sieve with the diameter of 0.8 mm;
(6) tabletting, with specification of 40 mg/tablet, 60 mg/tablet, 100 mg/tablet.
Comparative example 1
A canagliflozin pharmaceutical composition having a prescription:
| composition of | Weight percent (%) |
| Canagliflozin | 30 |
| Lactose | 38 |
| |
24 |
| |
4 |
| Polyvinylpyrrolidone | 2 |
| |
2 |
The preparation method of the tablet comprising the formula comprises the following steps:
(1) adding the prescription amount of canagliflozin and starch into a fixed hopper mixer, and mixing for 30min at 15 rpm;
(2) adding the cross-linked sodium carboxymethylcellulose and the polyvinylpyrrolidone with the prescription amount, further mixing, and mixing for 15min at 15 rpm;
(3) adding magnesium stearate, mixing, and mixing at 15rpm for 10 min;
(4) adding the obtained mixture into a feed hopper of a dry granulator, adjusting parameters, pressing the powder into sheets, and finishing the particles by a sieve with the diameter of 0.8 mm;
(5) tabletting, with specification of 40 mg/tablet, 60 mg/tablet, 100 mg/tablet.
Comparative example 2
A canagliflozin pharmaceutical composition having a prescription:
| composition of | Weight percent (%) |
| Canagliflozin | 50 |
| Silicified |
40 |
| Low substituted |
6 |
| Polyvinylpyrrolidone | 2 |
| |
2 |
The preparation method of the tablet comprising the formula comprises the following steps:
(1) silicified microcrystalline cellulose is sieved by a 60-mesh sieve for standby
(2) Adding the prescription amount of canagliflozin and the sieved silicified microcrystalline cellulose into a fixed hopper mixer, and mixing for 30min at 15 rpm;
(3) adding the low-substituted hydroxypropyl cellulose sodium and the polyvinylpyrrolidone with the formula amount, further mixing, and mixing for 15min at 15 rpm;
(4) adding magnesium stearate, mixing, and mixing at 15rpm for 10 min;
(5) adding the obtained mixture into a feed hopper of a dry granulator, adjusting parameters, pressing the powder into sheets, and finishing the particles by a sieve with the diameter of 0.8 mm;
(6) tabletting, with specification of 40 mg/tablet, 60 mg/tablet, 100 mg/tablet.
Data detection
Purpose of the experiment: in order to confirm that the canagliflozin pharmaceutical composition of the present application can be released continuously, stably and uniformly, experiments for in vitro release degree detection were performed for examples 1 to 4 and comparative examples 1 to 2, respectively.
The experimental process comprises the following steps: taking 6 tablets of each 100 mg/tablet of the samples in examples 1-4 and comparative examples 1-2, according to the dissolution determination method (second method of 0931 appendix of the four parts of the national pharmacopoeia 2015 edition), using 900ml of 0.1mol/L hydrochloric acid solution as dissolution medium and 75rpm per minute, operating according to the method, taking 10ml of solution after 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours, filtering, and taking the filtrate as the sample solution. Meanwhile, 10ml of 0.1mol/L hydrochloric acid solution was supplemented. A canagliflozin control solution was also prepared. The cumulative release was calculated by HPLC and reported as the average of 6 samples per example. The release results were as follows:
the statistics of the data in the table above are shown in fig. 1, and as can be seen from the data in the table above, the canagliflozin pharmaceutical composition disclosed by the application can be continuously and stably released under the action of the additive disclosed by the application, so that the long-acting hypoglycemic effect of canagliflozin is ensured, the canagliflozin pharmaceutical composition without the additive is completely released within a short time, and the hypoglycemic effect can be ensured only by multiple administrations within 24 h.
The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, substitutions, combinations, simplifications, and modifications which do not depart from the spirit and principle of the present invention should be regarded as equivalent substitutions and equivalents, which are included in the scope of the present invention.
Claims (4)
1. A pharmaceutical composition of canagliflozin, the composition comprising the following:
the additive is characterized by comprising at least one of glucomannan and carboxymethyl glucomannan; and at least one of glyceryl behenate and ethyl cellulose;
the weight ratio of canagliflozin to the additive is 1: (0.1-2.5);
the composition also comprises organic acid, the organic acid is at least one of citric acid, tartaric acid and malic acid,
the diluent is selected from one or more of lactose, microcrystalline cellulose, silicified microcrystalline cellulose, mannitol, xylitol, pregelatinized starch and starch;
the disintegrant is selected from one or more of low-substituted hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose sodium, croscarmellose sodium, sodium carboxymethyl starch, sodium starch glycolate and crospovidone;
the adhesive is selected from one or more of starch, dextrin, hydroxypropyl methylcellulose, sodium carboxymethylcellulose and polyvinylpyrrolidone;
the lubricant is selected from one or more of magnesium stearate, stearic acid, sodium stearate, zinc stearate, sodium stearyl fumarate, calcium stearate, talcum powder and superfine silica gel powder.
2. The pharmaceutical composition of claim 1, wherein the composition is a tablet.
3. A process for the preparation of a pharmaceutical composition according to any one of claims 1-2, comprising the steps of:
(1) premixing canagliflozin, an additive and organic acid to obtain a mixture I;
(2) adding a diluent, a disintegrating agent and an adhesive, and premixing to obtain a mixture II;
(3) adding a lubricant after blending and uniformly mixing;
(4) finishing the grains;
(5) and (6) tabletting.
4. A process for preparing a pharmaceutical composition according to claim 3, comprising the steps of:
(1) premixing canagliflozin and an additive to obtain a mixture i;
(2) dissolving an organic acid in purified water, and carrying out atomization mixing on the organic acid and the mixture i to obtain a mixture ii;
(3) uniformly mixing the mixture ii with a diluent, a disintegrating agent and an adhesive, and then adding a lubricant for uniform mixing;
(4) finishing the grains;
(5) and (6) tabletting.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502518A (en) * | 2008-09-04 | 2009-08-12 | 山东淄博新达制药有限公司 | Glipizide sustained-release granular formulation and preparation method thereof |
| CN102985075A (en) * | 2010-05-11 | 2013-03-20 | 田边三菱制药株式会社 | Canagliflozin containing tablets |
| WO2014030051A1 (en) * | 2012-08-23 | 2014-02-27 | Aurobindo Pharma Limited | Stable pharmaceutical compositions comprising saxagliptin |
| CN106474484A (en) * | 2015-09-02 | 2017-03-08 | 常州方楠医药技术有限公司 | Compositionss of unformed canagliflozin and pharmaceutic adjuvant and preparation method thereof |
-
2019
- 2019-12-31 CN CN201911422253.7A patent/CN110946840B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502518A (en) * | 2008-09-04 | 2009-08-12 | 山东淄博新达制药有限公司 | Glipizide sustained-release granular formulation and preparation method thereof |
| CN102985075A (en) * | 2010-05-11 | 2013-03-20 | 田边三菱制药株式会社 | Canagliflozin containing tablets |
| WO2014030051A1 (en) * | 2012-08-23 | 2014-02-27 | Aurobindo Pharma Limited | Stable pharmaceutical compositions comprising saxagliptin |
| CN106474484A (en) * | 2015-09-02 | 2017-03-08 | 常州方楠医药技术有限公司 | Compositionss of unformed canagliflozin and pharmaceutic adjuvant and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 魔芋葡甘聚糖在药物缓释应用中的发展;江贵林等;《膳食纤维与人体健康及应用技术研讨会》;20091217;第41-45页1-2.1、4部分 * |
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