CN111110647A - Pharmaceutical composition containing colesevelam hydrochloride and preparation method thereof - Google Patents
Pharmaceutical composition containing colesevelam hydrochloride and preparation method thereof Download PDFInfo
- Publication number
- CN111110647A CN111110647A CN201811281793.3A CN201811281793A CN111110647A CN 111110647 A CN111110647 A CN 111110647A CN 201811281793 A CN201811281793 A CN 201811281793A CN 111110647 A CN111110647 A CN 111110647A
- Authority
- CN
- China
- Prior art keywords
- pharmaceutical composition
- colesevelam hydrochloride
- magnesium stearate
- premix
- mixing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- VTAKZNRDSPNOAU-UHFFFAOYSA-M 2-(chloromethyl)oxirane;hydron;prop-2-en-1-amine;n-prop-2-enyldecan-1-amine;trimethyl-[6-(prop-2-enylamino)hexyl]azanium;dichloride Chemical compound Cl.[Cl-].NCC=C.ClCC1CO1.CCCCCCCCCCNCC=C.C[N+](C)(C)CCCCCCNCC=C VTAKZNRDSPNOAU-UHFFFAOYSA-M 0.000 title claims abstract description 37
- 229920002905 Colesevelam Polymers 0.000 title claims abstract description 37
- 229960000674 colesevelam hydrochloride Drugs 0.000 title claims abstract description 37
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 22
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 19
- 238000000034 method Methods 0.000 claims abstract description 17
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 11
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 10
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 10
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 10
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 10
- 239000000843 powder Substances 0.000 claims abstract description 7
- 238000007908 dry granulation Methods 0.000 claims abstract description 6
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 6
- 238000005469 granulation Methods 0.000 claims abstract description 3
- 230000003179 granulation Effects 0.000 claims abstract description 3
- 238000000576 coating method Methods 0.000 claims description 19
- 239000011248 coating agent Substances 0.000 claims description 18
- 238000002156 mixing Methods 0.000 claims description 13
- 239000000463 material Substances 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 12
- 238000003756 stirring Methods 0.000 claims description 11
- 239000008187 granular material Substances 0.000 claims description 6
- 239000002245 particle Substances 0.000 claims description 6
- 238000007873 sieving Methods 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 3
- 229910002024 Aerosil® 200 Pharma Inorganic materials 0.000 claims description 2
- 229920003084 Avicel® PH-102 Polymers 0.000 claims description 2
- 239000012467 final product Substances 0.000 claims description 2
- 229910002012 Aerosil® Inorganic materials 0.000 claims 2
- 239000007891 compressed tablet Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 8
- 229940079593 drug Drugs 0.000 abstract description 4
- 238000009776 industrial production Methods 0.000 abstract description 3
- 238000007906 compression Methods 0.000 description 6
- 230000006835 compression Effects 0.000 description 6
- 239000000741 silica gel Substances 0.000 description 5
- 229910002027 silica gel Inorganic materials 0.000 description 4
- 238000007639 printing Methods 0.000 description 3
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000009702 powder compression Methods 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 2
- BRLQWZUYTZBJKN-UHFFFAOYSA-N Epichlorohydrin Chemical compound ClCC1CO1 BRLQWZUYTZBJKN-UHFFFAOYSA-N 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 201000005577 familial hyperlipidemia Diseases 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- USGYNNGHZHARJS-UHFFFAOYSA-N n-prop-2-enyldecan-1-amine Chemical compound CCCCCCCCCCNCC=C USGYNNGHZHARJS-UHFFFAOYSA-N 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 229910021487 silica fume Inorganic materials 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Diabetes (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention discloses a pharmaceutical composition containing colesevelam hydrochloride and a preparation method thereof, wherein the pharmaceutical composition comprises the following components in parts by mass: 1 part of colesevelam hydrochloride, 0.248-0.304 part of microcrystalline cellulose, 0.016-0.064 part of superfine silica powder and 0.0064-0.0192 part of magnesium stearate; the pharmaceutical composition is prepared by a process comprising the steps of granulating; the granulation process is dry granulation. The pharmaceutical composition has stable and reliable quality, good uniformity of drug content, low friability, moderate hardness and good reproducibility, and the preparation method of the pharmaceutical composition is simple and feasible and is suitable for large-scale industrial production.
Description
Technical Field
The invention relates to a pharmaceutical composition containing colesevelam hydrochloride and a preparation method thereof.
Background
The chemical name of colesevelam hydrochloride is as follows: the copolymer hydrochloride of 2-propylene-1-amine and epichlorohydrin, N-2-propenyl-1-decylamine and N, N, N-trimethyl-6- (2-propylamino) -1-hexylamine, the name Colesevelamhydrochloride in England, is a novel non-absorbable polymer oral medicine for treating hyperlipemia, developed by American Gel Tex Pharmaceuticals company, and is suitable for treating overhigh level of serum Total Cholesterol (TC) or Triglyceride (TG), and the structural formula is shown as the following formula:
CN103585128A discloses a pharmaceutical composition containing colesevelam hydrochloride, which is prepared by a direct powder compression method, but the flowability of the colesevelam hydrochloride raw material drug is poor, and the direct powder compression method can cause large tablet weight difference.
Disclosure of Invention
The invention aims to overcome the defects of lower content uniformity and poorer stability of the existing colesevelam hydrochloride tablet, and provides a pharmaceutical composition containing colesevelam hydrochloride and a preparation method thereof. The pharmaceutical composition has stable and reliable quality, good uniformity of drug content, low friability, moderate hardness and good reproducibility, and the preparation method of the pharmaceutical composition is simple and feasible and is suitable for large-scale industrial production.
The invention solves the technical problems through the following technical scheme.
The invention provides a pharmaceutical composition containing colesevelam hydrochloride, which comprises the following components in parts by mass: 1 part of colesevelam hydrochloride, 0.248-0.304 part of microcrystalline cellulose, 0.016-0.064 part of superfine silica powder and 0.0064-0.0192 part of magnesium stearate; the pharmaceutical composition is prepared by a process comprising the steps of granulating; the granulation process is dry granulation.
Wherein, the grain diameter of the colesevelam hydrochloride is preferably below 380 mu m.
Among them, the microcrystalline cellulose may be one conventionally used in the art, and is preferably a microcrystalline cellulose of type avicel ph 102.
Wherein the silica gel micropowder can be silica gel micropowder conventionally used in the field, and preferably silica gel micropowder of model AEROSIL200 Pharma. The particle size of the silica gel micropowder is preferably 380 μm or less.
Wherein the particle size of the magnesium stearate is preferably 380 μm or less.
In some embodiments of the invention, the parameters of the pharmaceutical composition are as follows:
the unit weight is as follows: 800-900 mg/unit;
hardness: 169-270N.
In some embodiments of the invention, colesevelam hydrochloride is the only pharmaceutically active ingredient in the pharmaceutical composition.
In some embodiments of the invention, the pharmaceutical composition further comprises a coating material. The coating material may be a coating material conventional in the art, such as a film coating premix of gastric soluble type and the like. The mass of the coating material is preferably 3.7 to 6.5% of the total mass of the substances other than the coating material.
The invention also provides a preparation method of the pharmaceutical composition containing colesevelam hydrochloride, which comprises the following steps:
(1) mixing and stirring part of colesevelam hydrochloride and the superfine silica powder, and sieving to obtain a sieved mixture;
(2) mixing and stirring the remaining colesevelam hydrochloride and the sieved mixture to obtain a premix 1;
(3) dry granulating the premix 1, and mixing the obtained granules with the microcrystalline cellulose to obtain a premix 2;
(4) mixing the premix 2 and the magnesium stearate to obtain a total mixture;
(5) tabletting the total mixture and optionally coating the coating material to obtain the final product;
wherein the part of the colesevelam hydrochloride accounts for 15-35% of the total mass of the colesevelam hydrochloride.
According to the common knowledge in the art, the total mass of part of the colesevelam hydrochloride and the remaining colesevelam hydrochloride is the mass of said colesevelam hydrochloride.
In the steps (1) to (4), the mixing method and conditions are conventional in the art, as long as the materials are uniformly mixed. In the step (1) and the step (2), the rotation number of the stirring is preferably 280-330 r.
In step (1), the screening is preferably under a 40 mesh screen. The particle size of the material passing through a 40-mesh sieve is below 380 mu m according to the common knowledge in the field.
In step (3), the dry granulation method and conditions may be those conventional in the art.
In step (4), the magnesium stearate is preferably sieved through a 40-mesh sieve.
In step (5), the tabletting method and conditions may be those conventional in the art. The compression force of the tablet is preferably 30 to 50kN, more preferably 38 to 43 kN. The rotation speed of the tablet is preferably 5-25 rpm.
In step (5), the coating method and conditions may be those conventional in the art. The temperature of the coating is preferably 30-38 ℃.
Operations including, but not limited to, printing, packaging, inspection, etc. may also be performed after the coating step described in step (5), as is common in the art.
On the basis of the common knowledge in the field, the above preferred conditions can be combined randomly to obtain the preferred embodiments of the invention.
The reagents and starting materials used in the present invention are commercially available.
The positive progress effects of the invention are as follows:
the pharmaceutical composition containing colesevelam hydrochloride has stable and reliable quality, good uniformity of drug content, low friability and moderate hardness. The preparation method of the invention overcomes the defects of poor flowability of the raw material medicine, easy water absorption and expansion and the like, has simple working procedures, and the prepared medicine composition has stable and reliable quality and good reproducibility and is suitable for large-scale industrial production.
Detailed Description
The invention is further illustrated by the following examples, which are not intended to limit the scope of the invention. The experimental methods without specifying specific conditions in the following examples were selected according to the conventional methods and conditions, or according to the commercial instructions.
Example 1
Pharmaceutical compositions were prepared according to the recipe of table 1.
TABLE 1
The preparation process comprises the following steps:
(1) firstly, mixing and stirring part of colesevelam hydrochloride (accounting for 15 percent of the total mass) and micro silica gel powder for 10min at the revolution of 280r, and then sieving by a 40-mesh sieve to obtain a sieved mixture;
(2) mixing and stirring the remaining colesevelam hydrochloride and the sieved mixture for 30min at the revolution of 280r to obtain a premix 1;
(3) dry granulating the premix 1, and mixing the obtained granules with microcrystalline cellulose for 30min to obtain a premix 2;
(4) adding magnesium stearate sieved by a 40-mesh sieve into the premix 2, and mixing for 10min to obtain a total mixture;
(5) tabletting with a rotary tablet press in combination with different technological parameters, and finally coating and printing at 30 ℃.
The friability and hardness of the plain tablets were measured after compression, and the disintegration time of the finished tablets after printing was examined, the specific test results are shown in table 2. As can be seen from Table 2, the average hardness of the tablets can be adjusted by adjusting the compression force and the compression rotation speed, and the friability of the obtained tablets is satisfactory within a wide range of the compression force and the compression rotation speed, indicating that the granules obtained by dry granulation have good compressibility. The content uniformity RSD of the tablets was well below the limit of 5% at each tabletting parameter, indicating good flowability of the granules during tabletting. In addition, the disintegration time of the tablets under each tabletting parameter meets the requirement, which indicates that the disintegration of the colesevelam hydrochloride tablet is not retarded due to hardening of granules in a dry granulation process.
Table 2 prescription 1 results of colesevelam hydrochloride quality measurements at different tableting parameters
Example 2
Pharmaceutical compositions were prepared according to the recipe of table 3.
TABLE 3
The preparation method is the same as example 1, wherein part of the colesevelam hydrochloride accounts for 25% of the total mass, the stirring revolution number in the steps (1) and (2) is 330r, the tabletting is carried out under the conditions that the tabletting pressure is 41 +/-1 KN and the tabletting revolution speed is 10rpm, and the coating temperature is 38 ℃. The detection shows that the average hardness is 213N, the friability is-0.18%, the content uniformity is 0.70%, and the disintegration time is 9m13 s.
Example 3
Pharmaceutical compositions were prepared according to the recipe of table 4.
TABLE 4
The preparation method is the same as example 1, wherein part of the colesevelam hydrochloride accounts for 35% of the total mass, the stirring revolution number in the steps (1) and (2) is 300r, the tabletting is carried out under the conditions that the tabletting pressure is 41 +/-1 KN and the tabletting rotation speed is 10rpm, and the coating temperature is 35 ℃. The detection shows that the average hardness is 169N, the friability is-0.14%, the content uniformity is 0.59%, and the disintegration time is 6m10 s.
Claims (10)
1. The pharmaceutical composition containing colesevelam hydrochloride is characterized by comprising the following components in parts by mass: 1 part of colesevelam hydrochloride, 0.248-0.304 part of microcrystalline cellulose, 0.016-0.064 part of superfine silica powder and 0.0064-0.0192 part of magnesium stearate; the pharmaceutical composition is prepared by a process comprising the steps of granulating; the granulation process is dry granulation.
2. The pharmaceutical composition according to claim 1, wherein the particle size of colesevelam hydrochloride is less than 380 μm.
3. The pharmaceutical composition of claim 1, wherein the microcrystalline cellulose is microcrystalline cellulose type Avicel PH 102.
4. The pharmaceutical composition of claim 1, wherein the AEROSIL is AEROSIL200Pharma model AEROSIL; and/or the particle size of the superfine silica powder is below 380 mu m.
5. The pharmaceutical composition according to claim 1, wherein the magnesium stearate has a particle size of 380 μm or less.
6. The pharmaceutical composition of claim 1, further comprising a coating material; the mass of the coating material is 3.7-6.5% of the total mass of the substances except the coating material.
7. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 6, characterized in that it comprises the following steps:
(1) mixing and stirring part of colesevelam hydrochloride and the superfine silica powder, and sieving to obtain a sieved mixture;
(2) mixing and stirring the remaining colesevelam hydrochloride and the sieved mixture to obtain a premix 1;
(3) dry granulating the premix 1, and mixing the obtained granules with the microcrystalline cellulose to obtain a premix 2;
(4) mixing the premix 2 and the magnesium stearate to obtain a total mixture;
(5) tabletting the total mixture and optionally coating with the coating material to obtain the final product.
Wherein the part of the colesevelam hydrochloride accounts for 15-35% of the total mass of the colesevelam hydrochloride.
8. The method according to claim 7, wherein in the step (1), the sieving is performed under a 40-mesh sieve;
in the step (1), the stirring rotation number is 280-330 r;
in the step (2), the stirring rotation number is 280-330 r;
in the step (4), the magnesium stearate is magnesium stearate sieved by a 40-mesh sieve;
and/or, in the step (5), the temperature of the coating is 30-38 ℃.
9. The process according to claim 7, wherein in the step (5), the pressure of the compressed tablet is 30 to 50 kN; and/or the rotating speed of the tabletting is 5-25 rpm.
10. The process according to claim 9, wherein in the step (5), the pressure of the tablet is 38 to 43 kN.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811281793.3A CN111110647A (en) | 2018-10-31 | 2018-10-31 | Pharmaceutical composition containing colesevelam hydrochloride and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811281793.3A CN111110647A (en) | 2018-10-31 | 2018-10-31 | Pharmaceutical composition containing colesevelam hydrochloride and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111110647A true CN111110647A (en) | 2020-05-08 |
Family
ID=70484958
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811281793.3A Pending CN111110647A (en) | 2018-10-31 | 2018-10-31 | Pharmaceutical composition containing colesevelam hydrochloride and preparation method thereof |
Country Status (1)
| Country | Link |
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| CN (1) | CN111110647A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN118267368A (en) * | 2024-04-09 | 2024-07-02 | 东莞西典医药科技有限公司 | Preparation method of colesevelam hydrochloride tablet preparation |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100008988A1 (en) * | 2008-07-14 | 2010-01-14 | Glenmark Generics, Ltd. | Tablet compositions of amine polymers |
| WO2010041268A2 (en) * | 2008-09-02 | 2010-04-15 | Usv Limited | Crosslinked polymers |
| CN101757627A (en) * | 2009-09-29 | 2010-06-30 | 北大方正集团有限公司 | Combined drug and drug combination for treating diabetes |
| WO2015075065A1 (en) * | 2013-11-20 | 2015-05-28 | Sanovel Ilac Sanayi Ve Ticaret A.S. | Tablet formulation of colesevelam |
| US20150374744A1 (en) * | 2013-02-08 | 2015-12-31 | Wockhardt Limited | Oral pharmaceutical composition of aliphatic amine polymer or salts thereof |
| CN105338958A (en) * | 2013-01-15 | 2016-02-17 | 铁木医药有限公司 | Gastro-retentive sustained-release oral dosage form of a bile acid sequestrant |
-
2018
- 2018-10-31 CN CN201811281793.3A patent/CN111110647A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100008988A1 (en) * | 2008-07-14 | 2010-01-14 | Glenmark Generics, Ltd. | Tablet compositions of amine polymers |
| WO2010041268A2 (en) * | 2008-09-02 | 2010-04-15 | Usv Limited | Crosslinked polymers |
| CN101757627A (en) * | 2009-09-29 | 2010-06-30 | 北大方正集团有限公司 | Combined drug and drug combination for treating diabetes |
| CN105338958A (en) * | 2013-01-15 | 2016-02-17 | 铁木医药有限公司 | Gastro-retentive sustained-release oral dosage form of a bile acid sequestrant |
| US20150374744A1 (en) * | 2013-02-08 | 2015-12-31 | Wockhardt Limited | Oral pharmaceutical composition of aliphatic amine polymer or salts thereof |
| WO2015075065A1 (en) * | 2013-11-20 | 2015-05-28 | Sanovel Ilac Sanayi Ve Ticaret A.S. | Tablet formulation of colesevelam |
Non-Patent Citations (1)
| Title |
|---|
| 梁素红等: "药品生产企业质量控制浅谈", 《大科技》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN118267368A (en) * | 2024-04-09 | 2024-07-02 | 东莞西典医药科技有限公司 | Preparation method of colesevelam hydrochloride tablet preparation |
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