CN111450068A - Sevelamer carbonate pharmaceutical composition and preparation method thereof - Google Patents
Sevelamer carbonate pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN111450068A CN111450068A CN201910051569.3A CN201910051569A CN111450068A CN 111450068 A CN111450068 A CN 111450068A CN 201910051569 A CN201910051569 A CN 201910051569A CN 111450068 A CN111450068 A CN 111450068A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
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Abstract
The invention discloses a pharmaceutical composition of sevelamer carbonate and a preparation method thereof, wherein the pharmaceutical composition contains sevelamer carbonate, a stabilizer, an excipient and a wetting agent, and the stabilizer is sucralose. The sevelamer carbonate tablet provided by the invention has more stable disintegration time and better compressibility, and can better play the role of active ingredients of medicines.
Description
Technical Field
The invention belongs to the technical field of hyperphosphatemia resistance, and particularly relates to a sevelamer carbonate pharmaceutical composition and a preparation method thereof.
Background
Hyperphosphatemia is common in end stage renal patients, and can cause hyperparathyroidism. Recent studies have found that hyperphosphatemia can induce soft tissue and vascular calcification, and is an important factor in increasing mortality and cardiovascular disease in end-stage renal patients. The existing treatment of hyperphosphatemia mainly comprises diet-limited phosphorus, dialysis treatment, application of phosphorus binding agent and excision of paraspinal gland as necessary. However, too strict restriction of phosphorus intake in the diet can cause malnutrition, which is particularly obvious for dialysis patients; adequate dialysis treatment can remove excess phosphorus from the body, however, currently widely practiced 3 times per week, 4h hemodialysis sessions are often inadequate to remove excess phosphorus from the body; about 90% of end-stage renal patients need to take phosphorus-binding agent to treat hyperphosphatemia.
Sevelamer carbonate, developed by Genzyme of America, is a non-absorbent ion exchange resin for binding phosphoric acid and is sold under the trade name RenvelaTMThe poly allyl amine carbonate is cross-linked poly allyl amine carbonate with the chemical name of 1-chloro-2, 3-propylene oxide allyl amine polymer carbonate, and the molecular structure is similar to a reticular resin structure. The structural formula is as follows:
a, b: number of primary amine groups (a + b ═ 9)
c: number of crosslinking groups (c ═ 1)
m is a larger number indicating an extended polymer network.
Researches show that compared with sevelamer hydrochloride, sevelamer carbonate contains less chloride ions, so that acidosis and toxemia of renal failure patients can be avoided to a certain extent. And because sevelamer carbonate has higher hydrophilicity, the sevelamer carbonate can be hydrated in the gastrointestinal tract to form gel, the volume is expanded to be several times, a plurality of amino groups carried by the sevelamer carbonate can be protonated and positively charged in the small intestine under physiological pH, and the sevelamer carbonate is combined with phosphate and bile acid in the small intestine through ion exchange and hydrogen bonds to reduce the level of phosphate in human blood. Meanwhile, sevelamer carbonate does not cause hypercalcemia or aluminum poisoning, compared to calcium-containing, aluminum-containing phosphorus binders. However, the compressibility of the sevelamer carbonate raw material medicine is poor, the hardness of the compressed plain tablet is often low, and the requirement of the subsequent coating process cannot be met, or the disintegration time limit of the coated tablet cannot meet the general requirement of the tablet.
CN102908325A finds that when medicinal auxiliary materials of crospovidone and silicon dioxide with a certain weight ratio are added, the obtained plain tablets can meet the technical requirements of the subsequent coating process, and the disintegration time of the prepared sevelamer carbonate tablets is short. However, experimental studies have found that the disintegration time of the composition increases with longer storage time.
CN101043878B found that the addition of a monovalent anion to sevelamer carbonate tablets significantly increased the shelf life and prevented an increase in disintegration time when stored under standard storage conditions. However, the composition obtained by this method is inferior in tablet moldability.
Disclosure of Invention
The invention aims to overcome the problems in the prior art and provide a sevelamer carbonate pharmaceutical composition which has good stability and good compressibility.
The invention also aims to provide a preparation method of the sevelamer carbonate pharmaceutical composition.
The last object of the invention is to provide a preparation prepared from the sevelamer carbonate pharmaceutical composition.
In order to achieve the purpose, the technical scheme provided by the invention is as follows:
a pharmaceutical composition of sevelamer carbonate comprises sevelamer carbonate, a stabilizer, an excipient and a wetting agent, wherein the stabilizer is sucralose.
The weight ratio of the sevelamer carbonate to the stabilizer is 1: (0.002-0.02), preferably 1: (0.002-0.012), and more preferably 1: (0.002 to 0.008), more preferably 1:0.002, 1: 0.004 or 1: 0.008.
The weight ratio of the sevelamer carbonate to the excipient is 1: (0.02 to 1), preferably 1: (0.1 to 0.4), and more preferably 1: (0.2 to 0.4), more preferably 1:0.2, 1: 0.3 or 1: 0.4.
the excipient is microcrystalline cellulose, lactose or mannitol, preferably microcrystalline cellulose, lactose or mannitol, and more preferably microcrystalline cellulose.
The wetting agent is water, and the weight ratio of the sevelamer carbonate to the wetting agent is 1: (0.05 to 0.2), preferably 1: (0.1 to 0.15), and more preferably 1: (0.1 to 0.125), and more preferably 1:0.1 or 1: 0.125.
Also contains a lubricant, wherein the lubricant is stearic acid, PEG4000, PEG6000 or magnesium stearate, preferably stearic acid.
The weight ratio of the sevelamer carbonate to the lubricant is 1: (0.001 to 0.01), preferably 1: (0.001 to 0.004), and more preferably 1: (0.002-0.003), more preferably 1:0.002, 1:0.0025 or 1: 0.003.
Preferably, the pharmaceutical composition of sevelamer carbonate contains sevelamer carbonate, sucralose, microcrystalline cellulose, stearic acid and water, wherein the weight ratio of sevelamer carbonate, sucralose, microcrystalline cellulose, stearic acid and water is 1: (0.002-0.02): (0.02-1): (0.001-0.01): (0.05 to 0.2), preferably 1: (0.002-0.012): (0.1-0.4): (0.001-0.004): (0.1 to 0.15), and more preferably 1: (0.002-0.008): (0.2-0.4): (0.002-0.003): (0.1 to 0.125), more preferably 1: 0.004: 0.2: 0.0025: 0.1.
the preparation method of the sevelamer carbonate pharmaceutical composition comprises the following steps: the preparation method comprises the following steps of uniformly mixing sevelamer carbonate, an excipient and a stabilizer, adding a wetting agent, stirring and granulating to obtain a soft material, and sieving the soft material by using a screen to obtain granules.
Preferably, the aperture of the screen mesh is 550-830 μm.
Further, the granules were mixed with a lubricant and tabletted to obtain tablets.
The preparation prepared from the sevelamer carbonate pharmaceutical composition is a tablet.
The pharmaceutical composition can be prepared into sevelamer carbonate tablets in the processes of wet granulation and tabletting.
The invention provides a sevelamer carbonate pharmaceutical composition and a preparation method thereof, which are used for treating hyperphosphatemia of patients with end-stage renal disease syndrome. The invention adopts the sucralose as the stabilizer, so that the disintegration time of the sevelamer carbonate tablet does not change obviously after a period of time. Meanwhile, the research finds that the sevelamer carbonate medicinal composition can obtain better compressibility by using the preferable prescription.
Has the advantages that: the sevelamer carbonate tablet provided by the invention has more stable disintegration time and better compressibility, and can better play the role of active ingredients of medicines. The pharmaceutical active ingredients have better effectiveness for patients.
Detailed Description
The present invention will now be described in detail with reference to examples, which should not be construed as limiting the scope of the invention.
Example 1
The prescription composition is as follows:
the preparation process comprises the following steps:
the tablet is prepared according to the prescription in the table and the following process, the prescription amount of sevelamer carbonate is uniformly mixed with microcrystalline cellulose and sucralose, water is added, the mixture is stirred and granulated to obtain a soft material, the soft material is sieved by a 24-mesh sieve to obtain granules, the granules are mixed with the prescription amount of stearic acid, and the mixture is tabletted to obtain the tablet.
The obtained product is a milky elliptic tablet, has smooth surface and no obvious defect.
The mean time for tablet disintegration in a medium having a pH of 1.2 after storage of the prescribed tablets at 60 ℃ for 0, 1, 4 weeks was determined. The results are shown in table 1 below.
TABLE 1
As can be seen from table 1, when sucralose is used as a stabilizer, the disintegration time of the formulation does not become longer with the standing time, i.e., sucralose can function as a stabilizer, keeping the disintegration time stable over the period of time. At the same time, both formulations produced flawless tablets, indicating that sucralose as a stabilizer did not significantly affect the compressibility of the formulation.
Example 2
The prescription composition is as follows:
the preparation process comprises the following steps:
the tablet is prepared according to the prescription in the table and the following process, the prescription amount of sevelamer carbonate is uniformly mixed with microcrystalline cellulose and sucralose, water is added, the mixture is stirred and granulated to obtain a soft material, the soft material is sieved by a 24-mesh sieve to obtain granules, the granules are mixed with the prescription amount of stearic acid, and the mixture is tabletted to obtain the tablet.
The hardness and properties of the above prescription tablets are shown in Table 2.
TABLE 2
As can be seen from table 2, different lubricants have an effect on tablet hardness and the manufacturing process. When stearic acid is used as a lubricant, the tablet hardness is the greatest and the tablets produced have no significant defects; when PEG4000 and PEG6000 are used as lubricants, the hardness is slightly low, but abnormal sound occurs in the preparation process, the friction between a punch and a die is large, and the lubricating effect is not ideal; when magnesium stearate is used as a lubricant, the tablet hardness is low and the tablet surface is not smooth, indicating that magnesium stearate affects the compressibility of the formulation. As described above, stearic acid is a more preferred disintegrant.
Example 3
The prescription composition is as follows:
the preparation process comprises the following steps:
the tablet is prepared according to the prescription in the table and the following process, the prescription amount of sevelamer carbonate is uniformly mixed with microcrystalline cellulose and sucralose, water is added, the mixture is stirred and granulated to obtain a soft material, the soft material is sieved by a 24-mesh sieve to obtain granules, the granules are mixed with the prescription amount of stearic acid, and the mixture is tabletted to obtain the tablet.
The hardness and properties of the above prescription tablets are shown in Table 3.
TABLE 3
As can be seen from Table 3, the amount of water used as a wetting agent affects the hardness of the tablet, the hardness of the tablet gradually increases with the increase of the amount of water, the tablet has no obvious defect and has larger hardness when the amount of water is increased by the amount of formula 1, the hardness is not obviously increased when the amount of water is continuously increased to the amount of formula 8, but the risk of indexes such as microorganisms with higher moisture is increased, and the amount of water in formula 1 is preferably the preferred formula.
Example 4
The prescription composition is as follows:
the preparation process comprises the following steps:
the tablet is prepared according to the prescription in the table and the following process, the prescription amount of sevelamer carbonate is uniformly mixed with microcrystalline cellulose or lactose or mannitol and sucralose, water is added, the mixture is stirred and granulated to obtain a soft material, the soft material is sieved by a 24-mesh sieve to obtain granules, and the granules are mixed with the prescription amount of stearic acid and tabletted to obtain the tablet.
The mean time and hardness of tablet disintegration of the prescribed tablet in a medium with a pH value of 1.2 were measured. The results are shown in Table 4 below.
TABLE 4
As is clear from Table 4, microcrystalline cellulose is preferred as an excipient because the use of microcrystalline cellulose in formulation 1 gives the best results in tableting.
Example 5
The prescription composition is as follows:
the preparation process comprises the following steps:
the tablet is prepared according to the prescription in the table and the following process, the sevelamer carbonate with the prescription amount is uniformly mixed with microcrystalline cellulose and sucralose, water is added, the mixture is stirred and granulated to obtain a soft material, the soft material is sieved by a 24-mesh sieve to obtain granules, and the granules are mixed with the stearic acid with the prescription amount and tabletted to obtain the tablet.
Example 6
The prescription composition is as follows:
the preparation process comprises the following steps:
the tablet is prepared according to the prescription in the table and the following process, the sevelamer carbonate with the prescription amount is uniformly mixed with microcrystalline cellulose and sucralose, water is added, the mixture is stirred and granulated to obtain a soft material, the soft material is sieved by a 24-mesh sieve to obtain granules, and the granules are mixed with the stearic acid with the prescription amount and tabletted to obtain the tablet.
Claims (12)
1. A pharmaceutical composition of sevelamer carbonate, comprising sevelamer carbonate, a stabilizer, an excipient and a wetting agent, wherein the stabilizer is sucralose.
2. The composition according to claim 1, characterized in that the weight ratio of sevelamer carbonate and stabilizer is 1: (0.002-0.02), preferably 1: (0.002-0.012), and more preferably 1: (0.002-0.008).
3. The composition according to claim 1, characterized in that the weight ratio of sevelamer carbonate and excipients is 1: (0.02 to 1), preferably 1: (0.1 to 0.4), and more preferably 1: (0.2-0.4).
4. Composition according to claim 1, characterized in that the excipient is microcrystalline cellulose, lactose or mannitol, preferably microcrystalline cellulose, lactose or mannitol, further preferably microcrystalline cellulose.
5. The composition according to claim 1, wherein the wetting agent is water, and the weight ratio of sevelamer carbonate to wetting agent is 1: (0.05 to 0.2), preferably 1: (0.1 to 0.15), and more preferably 1: (0.1-0.125).
6. Composition according to claim 1, characterized in that it contains a lubricant which is stearic acid, PEG4000, PEG6000 or magnesium stearate, preferably stearic acid.
7. The composition according to claim 6, characterized in that the weight ratio of sevelamer carbonate and lubricant is 1: (0.001 to 0.01), preferably 1: (0.001 to 0.004), and more preferably 1: (0.002-0.003).
8. The composition according to claim 1, comprising sevelamer carbonate, sucralose, microcrystalline cellulose, stearic acid, and water, wherein the weight ratio of sevelamer carbonate, sucralose, microcrystalline cellulose, stearic acid, and water is 1: (0.002-0.02): (0.02-1): (0.001-0.01): (0.05 to 0.2), preferably 1: (0.002-0.012): (0.1-0.4): (0.001-0.004): (0.1 to 0.15), and more preferably 1: (0.002-0.008): (0.2-0.4): (0.002-0.003): (0.1-0.125).
9. A process for the preparation of a pharmaceutical composition of sevelamer carbonate according to claim 1, comprising the steps of: the preparation method comprises the following steps of uniformly mixing sevelamer carbonate, an excipient and a stabilizer, adding a wetting agent, stirring and granulating to obtain a soft material, and sieving the soft material by using a screen to obtain granules.
10. The method of claim 9, wherein the mesh size is 550 μm to 830 μm.
11. The method of claim 9, wherein the granules are mixed with a lubricant and compressed to form a tablet.
12. The formulation of sevelamer carbonate pharmaceutical composition of claim 1, in the form of a tablet.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910051569.3A CN111450068A (en) | 2019-01-21 | 2019-01-21 | Sevelamer carbonate pharmaceutical composition and preparation method thereof |
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| CN201910051569.3A CN111450068A (en) | 2019-01-21 | 2019-01-21 | Sevelamer carbonate pharmaceutical composition and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100034894A1 (en) * | 2008-08-08 | 2010-02-11 | Szymczak Christopher E | Use of Sucralose as a Granulating Agent |
| CN102641251A (en) * | 2012-04-19 | 2012-08-22 | 天津太平洋制药有限公司 | Underwater-dispersible tablet of Sevelamer carbonate |
| CN104434866A (en) * | 2014-12-30 | 2015-03-25 | 济南康和医药科技有限公司 | Sevelamer carbonate effervescent tablets and preparation method thereof |
| CN107157947A (en) * | 2017-05-04 | 2017-09-15 | 方达医药技术（苏州）有限公司 | A kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate piece and preparation method thereof |
-
2019
- 2019-01-21 CN CN201910051569.3A patent/CN111450068A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100034894A1 (en) * | 2008-08-08 | 2010-02-11 | Szymczak Christopher E | Use of Sucralose as a Granulating Agent |
| CN102641251A (en) * | 2012-04-19 | 2012-08-22 | 天津太平洋制药有限公司 | Underwater-dispersible tablet of Sevelamer carbonate |
| CN104434866A (en) * | 2014-12-30 | 2015-03-25 | 济南康和医药科技有限公司 | Sevelamer carbonate effervescent tablets and preparation method thereof |
| CN107157947A (en) * | 2017-05-04 | 2017-09-15 | 方达医药技术（苏州）有限公司 | A kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate piece and preparation method thereof |
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