CN102727459A - Preparation with first active medicament and second active medicament - Google Patents
Preparation with first active medicament and second active medicament Download PDFInfo
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- CN102727459A CN102727459A CN2012101072455A CN201210107245A CN102727459A CN 102727459 A CN102727459 A CN 102727459A CN 2012101072455 A CN2012101072455 A CN 2012101072455A CN 201210107245 A CN201210107245 A CN 201210107245A CN 102727459 A CN102727459 A CN 102727459A
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- pharmaceutical preparation
- medicine
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- pioglitazone
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
Abstract
The invention relates to a preparation with a first active medicament and a second active medicament, and an application thereof for preparing a medicament for treating type II diabetes.
Description
Technical field
The present invention relates to a kind of preparation and purposes in the medicine of preparation type ii diabetes thereof with first and second active medicines.
Background technology
At present people have used many technology to provide sustained release and pharmaceutical dosage form slow release to keep the Drug therapy serum-concentration and to reduce because the patient lacks the influence that the caused drug dose deficiency of compliance is brought.For example, prior art discloses slow releasing tablet, and it has by the drug core of the osmotically active of semipermeable membrane parcel.The function of these tablets be through make in the body fluid water soluble ingredient for example gastro-intestinal Fluid penetrate coating membrane and lytic activity composition, thereby the drug solution that is produced can discharge through the passage in the coating membrane.Perhaps, if active component does not dissolve in penetrating fluid, it can pass through passage through extender such as hydrogel.In United States Patent(USP) Nos. 3,845,770; 3,916,899; 4,034,758; Some representational instance of these permeability tablet systems is disclosed in 4,077,407 and 4,783,337.United States Patent(USP) No. 3,952,741 disclose a kind of permeability device, wherein only in film, have had enough pressure and can be after making the film cracking on the vulnerable area of film or breaking, and activating agent is just from being discharged by the core of semipermeable membrane parcel.
At present, people have made great efforts the basic permeability apparatus described in the above-mentioned patent of quoting has been carried out improving to provide the better sustained release of active component.For example, United States Patent(USP) Nos. 4,777,049 and 4,851,229 have described the osmotic dosage form that comprises the semipermeable membrane that wraps up core.This core comprises a kind of active component and a kind of regulator, and the passage that wherein said regulator passes through on the semipermeable membrane active component discharges with pulse mode.Improvement further comprises the semipermeable membrane that improves the coating active core, and for example United States Patent(USP) Nos. 5,178,867; 4,587,117 and 4,522; Such ratio that changes over film component described in 625, perhaps United States Patent(USP) Nos. 5,650 for example; 170 and 4,892, such number that increases the coating of coating active core described in 739.
Some uses hyperglycemia medicine, and for example sustained release or the slow releasing preparation of metformin hydrochloride have been restricted to use and have expanded or gellant is controlled medicine and from dosage form, discharged.This restricted research is by the disclosed content of W096/08243 with available from the metformin hydrochloride sustained release product G LUCOPHAGETM XR institute illustration of Bristol-Myers Squibb Co..
At United States Patent(USP) No. 4,687, thiazolidine diketone derivative has been described in 777.The therapeutical effect of these chemical compounds in therapeutic alliance is described in United States Patent(USP) Nos. 5,859,037 further; 5,952,356; 5,965,584; In 6,150,384 and 6,172,090.
Public use comprises the pharmaceutical dosage form of the combination of antihypertensive drug and thiazolidine diketone derivative in the art.For example, EPOO 749751 (being introduced into this paper as a reference) discloses the pharmaceutical composition that comprises euglycemic agent (it can be thiazolidinedione compound), and comprises other antidiabetic drug.More particularly; It is pioglitazone that EPOO 749751 discloses preferred euglycemic agent; It can with for example metformin, phenformin or the combination of butyl biguanide of other antidiabetic drug, and these medicines can make up (mixing and/or coating) with conventional excipients and provide and cover abnormal smells from the patient or slow release further.Another instance of hyperglycemia medicine and thiazolidine diketone derivative combination is a United States Patent(USP) No. 6,011,049 (being introduced into this paper as a reference).This patent discloses the single medicine compositions that comprises pioglitazone or troglitazone and metformin with the slow release form such as osmotic pumps or transdermal patches.Other combination with hyperglycemia medicine and thiazolidine diketone derivative can be found in United States Patent(USP) Nos. 6,524,621; 6,475,521; 6,451,342 and 6,153,632 with PCT patent application WO01/3594 and W001/3594 in.
Disclose in also known in the art W099/47125 and the United States Patent(USP) No. 6,099,862 with discharging the metformin osmotic tablet that coating comes coating immediately, said coating comprises hyperglycemia or hypoglycemic medicine.
CN100544717C discloses a kind of pharmaceutical dosage form with first and second active medicines, and what wherein adopt is low this routine techniques of viscosity water-soluble binder, does not creatively relate to high viscosity or water insoluble adhesive.
Summary of the invention
Content of the present invention is to provide a kind of preparation with first and second active medicines, and said preparation comprises:
A) sustained release label, it contains hyperglycemia medicine and at least a pharmaceutically acceptable excipient; With
B) rapid release coatings, this coatings comprise second active medicine and high viscosity water-soluble binder or the water insoluble adhesive that discharges immediately.
Preferably, first active medicine is metformin and pharmaceutically acceptable salt thereof, and perhaps second active medicine is pioglitazone and pharmaceutically acceptable salt thereof.
Further preferably, said preparation comprises:
A) sustained release label wherein comprises about 60%～90% first active medicine, 5%～40% binding agent, 0～20% absorption enhancer and 0～3% lubricant;
B) semipermeable membrane;
C) rapid release coatings, this coatings contains: second active medicine, high viscosity water-soluble binder or water insoluble adhesive and absorption enhancer or surfactant.
Further preferably, at 20 ℃ during as 2% determination of aqueous solution, said high viscosity water-soluble binder has the viscosity greater than 6mPa.s.
Further preferably, the binding agent of immediate release layer is hydroxypropyl methylcellulose or acrylic resin.
Pharmaceutical preparation provided by the present invention has overcome technological prejudice of the prior art, has courageously adopted unconventional binding agent, has obtained suitable even better patent medicine effect and drug effect performance than prior art.
The specific embodiment
The example that below provides only is used for explanation but not the expression restriction.
Embodiment 1 comprises the preparation of the metformin hydrochloride sustained release tablet of 33.07mg pioglitazone hydrochloride (in pioglitazone 30mg) and 1000mg
Method for preparing:
1. 1～5% PVP K90 is mixed with 15% aqueous solution, remaining PVP mixes with metformin hydrochloride, with wet granulation technology said mixture is prepared into granule and is pressed into label;
2. the preparation of semipermeable membrane coating solution: earlier cellulose acetate is mixed with clarifying acetone soln, PEG400 is mixed with clarifying aqueous solution, and two kinds of solution are mixed, and stirs to clarify solution, and is subsequent use;
3. the preparation of release layer coating solution: NaCl is dissolved in adds behind a spot of water in 95% the ethanol, add HPMC and pioglitazone hydrochloride more respectively, make coating solution after the dispersion;
4. each makes a call to a hole at the label upper and lower surface with laser-beam drilling machine;
5. after coating finishes,, take out, get final product in 40 ℃ of condition held 24 hours.
The mensuration of metformin hydrochloride release degree:
Sample thief according to the algoscopy of release degree, adopts two appendix XD first methods of Chinese Pharmacopoeia version in 2005; The device of dissolution method first method is a release medium with the hydrochloric acid solution 900mL of 0.1N, and rotating speed is 100rpm; Operation in accordance with the law; Got a little at the 2nd, 4,8,12 hour, adopt HPLC to carry out drug release determination, the release data of medicine is following:
The pioglitazone hydrochloride determination of dissolution rate:
Sample thief according to the algoscopy of release degree, adopts two appendix XD first methods of Chinese Pharmacopoeia version in 2005; The device of dissolution method first method is a release medium with the hydrochloric acid solution 900mL of 0.1N, and rotating speed is 50rpm; Operation in accordance with the law; Got a little at the 15th, 30,45 minute, adopt HPLC to carry out drug release determination, the stripping result of medicine is following:
15min 94.8％
30min 98.6％
45min 98.9％
Embodiment 2 comprises the preparation of the metformin hydrochloride sustained release tablet of 33.07mg pioglitazone hydrochloride (in pioglitazone 30mg) and 1000mg
Method for preparing:
1. label, semipermeable membrane prepare with embodiment 1.
2. the preparation of release layer coating solution: Macrogol 4000 is dissolved in adds behind a spot of water in 95% the ethanol, add HPMC and pioglitazone hydrochloride more respectively, make coating solution after the dispersion;
3. each makes a call to a hole at the label upper and lower surface with laser-beam drilling machine;
4. after coating finishes,, take out, get final product in 40 ℃ of condition held 24 hours.
The mensuration of metformin hydrochloride release degree:
Algoscopy is with embodiment 1, and its release data is following:
The pioglitazone hydrochloride determination of dissolution rate:
Algoscopy is with embodiment 1, and the result is following in its stripping:
15min 85.2％
30min 99.5％
45min 98.7％
Embodiment 3 comprises the preparation of the metformin hydrochloride sustained release tablet of 33.07mg pioglitazone hydrochloride (in pioglitazone 30mg) and 1000mg
Method for preparing:
1. 1～5% PVP K30 is mixed with 30% aqueous solution, remaining PVP mixes with metformin hydrochloride, with wet granulation technology said mixture is prepared into granule and is pressed into label;
2. the preparation of semipermeable membrane coating solution: earlier cellulose acetate is mixed with clarifying acetone soln, Macrogol 4000 is mixed with clarifying aqueous solution, and two kinds of solution are mixed, and stirs to clarify solution, and is subsequent use;
3. the preparation of release layer coating solution: polyethylene glycol 6000 is dissolved in adds behind a spot of water in 95% the ethanol, add HPMC and pioglitazone hydrochloride more respectively, make coating solution after the dispersion;
4. each makes a call to a hole at the label upper and lower surface with laser-beam drilling machine;
5. after coating finishes,, take out, get final product in 40 ℃ of condition held 24 hours.
The mensuration of metformin hydrochloride release degree:
Algoscopy is with embodiment 1, and its release data is following:
The pioglitazone hydrochloride determination of dissolution rate:
Algoscopy is with embodiment 1, and the result is following in its stripping:
15min 55.2％
30min 85.7％
45min 97.6％
Embodiment 4 comprises the preparation of the metformin hydrochloride sustained release tablet of 33.07mg pioglitazone hydrochloride (in pioglitazone 30mg) and 1000mg
Method for preparing:
1. label, semipermeable membrane prepare with embodiment 3.
2. the preparation of release layer coating solution: NaCl is dissolved in the suitable quantity of water, and Eudragit E 100 dissolves in 95% the ethanol, makes coating solution after disperseing pioglitazone hydrochloride wherein again after the two mixes;
3. each makes a call to a hole at the label upper and lower surface with laser-beam drilling machine;
4. after coating finishes,, take out, get final product in 40 ℃ of condition held 24 hours.
The mensuration of metformin hydrochloride release degree:
Detection method is with embodiment 1, and its release data is following:
The pioglitazone hydrochloride determination of dissolution rate:
Algoscopy is with embodiment 1, and the result is following in its stripping:
15min 95.4％
30min 98.6％
45min 99.4％
Embodiment 5 comprises the preparation of the metformin hydrochloride sustained release tablet of 33.07mg pioglitazone hydrochloride (in pioglitazone 30mg) and 1000mg
Method for preparing:
1. label, semipermeable membrane prepare with embodiment 3.
2. the preparation of release layer coating solution: lactose is dissolved in the suitable quantity of water, and Eudragit E 100 dissolves in 95% the ethanol, makes coating solution after disperseing pioglitazone hydrochloride wherein again after the two mixes;
3. each makes a call to a hole at the label upper and lower surface with laser-beam drilling machine;
4. after coating finishes,, take out, get final product in 40 ℃ of condition held 24 hours.
The mensuration of metformin hydrochloride release degree:
Detection method is with embodiment 1, and its release data is following:
The pioglitazone hydrochloride determination of dissolution rate:
Algoscopy is with embodiment 1, and the result is following in its stripping:
15min 89.5％
30min 95.7％
45min 96.8％
Embodiment 6 comprises the preparation of the metformin hydrochloride sustained release tablet of 33.07mg pioglitazone hydrochloride (in pioglitazone 30mg) and 1000mg
(a) the sustained release label is with embodiment 5
(b) semipermeable membrane is with embodiment 5
(c) rapid release coatings
Pioglitazone hydrochloride 30.0%
Eudragit E 100 70.0%
Method for preparing: with embodiment 5
The pioglitazone hydrochloride determination of dissolution rate:
Algoscopy is with embodiment 1, and the result is following in its stripping:
15min 56.5％
30min 89.8％
45min 99.6％
Embodiment 7 comprises the preparation of the metformin hydrochloride sustained release tablet of 16.54mg pioglitazone hydrochloride (in pioglitazone 15mg) and 1000mg
(a) the sustained release label is with embodiment 5
(b) semipermeable membrane is with embodiment 5
(c) rapid release coatings
Pioglitazone hydrochloride 70.0%
Eudragit E 100 30.0%
Method for preparing: with embodiment 5.
The pioglitazone hydrochloride determination of dissolution rate:
Algoscopy is with embodiment 1, and the result is following in its stripping:
15min 95.5％
30min 96.7％
45min 96.8％
Embodiment 8 comprises the preparation of the metformin hydrochloride sustained release tablet of 16.54mg pioglitazone hydrochloride (in pioglitazone 15mg) and 500mg
Method for preparing: with embodiment 5.
The mensuration of metformin hydrochloride release degree:
Detection method is with embodiment 1, and its release data is following:
The pioglitazone hydrochloride determination of dissolution rate:
Algoscopy is with embodiment 1, and the result is following in its stripping:
15min 92.3％
30min 96.7％
45min 98.8％?。
Claims (10)
1. pharmaceutical preparation with first and second active medicines, said preparation comprises:
A) sustained release label, it contains hyperglycemia medicine and at least a pharmaceutically acceptable excipient; With
B) rapid release coatings, this coatings comprise second active medicine and high viscosity water-soluble binder or the water insoluble adhesive that discharges immediately.
2. pharmaceutical preparation according to claim 1 is characterized in that, said first active medicine is metformin and pharmaceutically acceptable salt thereof.
3. pharmaceutical preparation according to claim 1 is characterized in that, said second active medicine is pioglitazone and pharmaceutically acceptable salt thereof.
4. pharmaceutical preparation according to claim 2 is characterized in that, said first active medicine is a metformin hydrochloride.
5. pharmaceutical preparation according to claim 3 is characterized in that, said second active medicine is a pioglitazone hydrochloride.
6. according to any described pharmaceutical preparation of claim 1～5, it is characterized in that said preparation comprises:
A) sustained release label wherein comprises about 60%～90% first active medicine, 5%～40% binding agent, 0～20% absorption enhancer and 0～3% lubricant;
B) semipermeable membrane;
C) rapid release coatings, this coatings contains: second active medicine, high viscosity water-soluble binder or water insoluble adhesive and absorption enhancer or surfactant.
7. pharmaceutical preparation according to claim 6 is characterized in that, said high viscosity water-soluble binder at 20 ℃ during as 2% determination of aqueous solution, has the viscosity greater than 6mPas.
8. pharmaceutical preparation according to claim 5, wherein said high viscosity water-soluble binder is a hydroxypropyl methylcellulose.
9. pharmaceutical preparation according to claim 5, wherein said water insoluble adhesive are acrylic resin.
10. according to the application of any described pharmaceutical preparation of claim 1～9 in the medicine of preparation treatment type ii diabetes.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012101072455A CN102727459A (en) | 2011-04-15 | 2012-04-12 | Preparation with first active medicament and second active medicament |
| CN201610012615.5A CN105663130B (en) | 2011-04-15 | 2012-04-12 | A kind of preparation with the first and second active medicines |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110098544.2 | 2011-04-15 | ||
| CN201110098544 | 2011-04-15 | ||
| CN2012101072455A CN102727459A (en) | 2011-04-15 | 2012-04-12 | Preparation with first active medicament and second active medicament |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201610012615.5A Division CN105663130B (en) | 2011-04-15 | 2012-04-12 | A kind of preparation with the first and second active medicines |
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| CN102727459A true CN102727459A (en) | 2012-10-17 |
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| CN2012101072455A Pending CN102727459A (en) | 2011-04-15 | 2012-04-12 | Preparation with first active medicament and second active medicament |
| CN201610012615.5A Active CN105663130B (en) | 2011-04-15 | 2012-04-12 | A kind of preparation with the first and second active medicines |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114929210A (en) * | 2020-09-22 | 2022-08-19 | 赛乐医药科技有限公司 | Antidiabetic pharmaceutical composition and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1681496A (en) * | 2002-09-20 | 2005-10-12 | 安壮奇实验室公司 | Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
| CN101222912A (en) * | 2005-03-30 | 2008-07-16 | 华生制药公司 | Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040081697A1 (en) * | 1998-11-12 | 2004-04-29 | Smithkline Beecham P.L.C. | Pharmaceutical composition for modified release of an insulin sensitiser and another antidiabetic agent |
| GB0318824D0 (en) * | 2003-08-11 | 2003-09-10 | Glaxo Group Ltd | Novel composition |
-
2012
- 2012-04-12 CN CN2012101072455A patent/CN102727459A/en active Pending
- 2012-04-12 CN CN201610012615.5A patent/CN105663130B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1681496A (en) * | 2002-09-20 | 2005-10-12 | 安壮奇实验室公司 | Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
| CN101222912A (en) * | 2005-03-30 | 2008-07-16 | 华生制药公司 | Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
Non-Patent Citations (2)
| Title |
|---|
| 张兆旺等: "《中药药剂学》", 31 January 2002, 中国中医药出版社 * |
| 彼得厄特: "《尤特奇（聚甲基丙烯酸酯）应用技术指南》", 31 August 2009, 化学工业出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114929210A (en) * | 2020-09-22 | 2022-08-19 | 赛乐医药科技有限公司 | Antidiabetic pharmaceutical composition and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN105663130A (en) | 2016-06-15 |
| CN105663130B (en) | 2019-08-09 |
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Application publication date: 20121017 |