CN1140996A - Ranitidine and calcium carbonate pharmaceutical combination product - Google Patents
Ranitidine and calcium carbonate pharmaceutical combination product Download PDFInfo
- Publication number
- CN1140996A CN1140996A CN94193540A CN94193540A CN1140996A CN 1140996 A CN1140996 A CN 1140996A CN 94193540 A CN94193540 A CN 94193540A CN 94193540 A CN94193540 A CN 94193540A CN 1140996 A CN1140996 A CN 1140996A
- Authority
- CN
- China
- Prior art keywords
- pharmaceutical composition
- ranitidine
- calcium carbonate
- milligrams
- heartburn
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Abstract
A pharmaceutical composition for gastrointestinal conditions comprising ranitidine and calcium carbonate.
Description
Background of invention
The ranitidine chemical name is N-[2-[[[5-(dimethylamino) methyl-2-furyl] methyl] sulfur] ethyl]-N '-methyl-2-nitro-1, and the 1-ethylenediamine (referring to USP4,128,658; 4,521,431; 4,585,790 and 4,672,133; Be incorporated herein by reference herein), it is a histamine H
2The antagonist of receptor.Except as otherwise noted, used here term " ranitidine " is meant its free alkali and its pharmaceutically-acceptable acid addition.This medicine is widely used in the human duodenal ulcer of treatment with its hydrochloride form.Though, be preferred with the oral way normally with oral or injection system administration.Ranitidine hydrochloride by the Glaxo company of North Carolina State Research Triangle Park with Zantac
For trade mark is sold.
Calcium carbonate is used for hyperchlorhydria dyspepsia as antacid, the extenuating fast of the stomach discomfort that heartburn, gastric acid (sourstomach) and combine with these symptoms take place.In the Smithkline Beecham Consumer Brands of the Pittsburgh in guest sunset Fan Niya state with Tums
Used calcium carbonate in the commercially available antacid of trade mark, the Ascriptin that in the Rorer Consumer Pharmaceuticals of the Fort Washington in guest sunset Fan Niya state, sells
In the analgesic, calcium carbonate still is a kind of buffer agent, is used in combination with aspirin, magnesium hydroxide and aluminium hydroxide.The USP4 of Alexander has narrated the pharmaceutical formulation that contains calcium carbonate in 650,669.
Contain ranitidine or another kind of H simultaneously
2Receptor antagonist and NaHCO
3Medicine comprise Schaeffer at USP5, the effervescence combination of narration in 102,665.At the USP4 of Tarral, narrated in 824,664 and contained a pair of antiacid effervescent, a kind of antacid and a kind of histamine H
2The effervescent medicine of-antagonist.At European patent specification No.286, some H are also disclosed in 781
2The compound medicine of-antagonist and antacid.
Narrated histamine H among the PCT application publication number WO/92/00102 of Davis (on January 9th, 1992 is open)
2-receptor antagonist and antacid co-administered are with treatment gastropathy, and for example embodiment 17 has been listed calcium carbonate.
On July 8th, 1993 disclosed Davis PCT application publication number WO93/12779 in narrated histamine H
2-receptor antagonist and antacid co-administered are with treatment gastropathy, and for example embodiment 14 has been listed calcium carbonate.
The USP5 of Wofle has narrated histamine H in 229,137
2Anti-agent of-receptor and antacid co-administered are with the heartburn of treatment outbreak, and for example embodiment IV relates to ranitidine and Tums
The tablet co-administered.
Summary of the invention
Pharmaceutical composition (as tablet) contains calcium carbonate and ranitidine simultaneously.Said composition is extenuated many gastrointestinal disease and symptom.
Detailed Description Of The Invention
Compositions of the present invention does not contain acid in fact, and for example, not containing can be in order to those acid of the part of the Acid-Base centering that produces effervescent effect.
Ranitidine
Used ranitidine its hydrochloride form and be Form 2 crystal forms preferably among the present invention.
Calcium carbonate
Calcium carbonate is also referred to as the calcium salt of carbonic acid, and being present in natural form has mineral aragonite, calcite and vaterite six side's ball calcites.Among the present invention, the calcium carbonate of available calcite form wherein is substantially free of aragonite crystal form.
Used calcium carbonate can be a particulate form among the present invention.Suitable microgranule calcium carbonate is Albaglos
, provide at the laboratory (facility) of the Adams of its Massachusetts by Pfizer company.Albaglos is a kind of sedimentary calcium carbonate, and preparation process is earlier by high-quality CaCO
3Beginning obtains CO through calcination
2And CaO (Calx).CaO is dissolved in H
2O obtains emulsus lime solution (CaCOH/2).With the CO that collects in advance
2Inject this solution, make pure CaCO
3Crystal settling.
Other compositions
Other known drug excipient all can randomly add in the tablet composition of the present invention as flavouring agent, deodorant, lubricant, surfactant, binding agent or colouration agent and analog.Typical flavouring agent comprises Fructus Citri grandis, Fructus Citri Limoniae, Herba Menthae and orange, and/or sweetener such as aspartame or saccharin sodium.For example can add 2-Sulfosuccinic acid dioctyl sodium (DOSS is also referred to as docusate sodium) solution in a small amount as surfactant, and/or can add a spot of fumaric acid as lubricant.The amount that these excipient add is generally 0.001% to 100% w/w of calcium carbonate, more preferably 0.01% to 60% w/w.
Go to distinguish the flavor of composition and preparation technique as known in the art can be applicable in the present composition.Example comprises british patent specification 2198352 (liquid preparation), 2219940 (effervescent tableies), 2218333 (ranitidine resinates), 2218336 (coated tablet), 2229094 (gelatine capsules), 2262445 (pulsation-releasing preparations), European patent specification 349103,459695,473431,523847 and 538034 (chewable tablets), 542364 (sustained release preparations), international patent specification WO92/21328 (chewing composition), WO94/08560 (chewable tablet) WO94/05260 (Aquo-composition), WO94/08576 (fat coating granule), Canadian patent specification 2068366 (removing the powder of distinguishing the flavor of), disclosed those go to distinguish the flavor of composition and preparation technique in the US Patent specification 5169864 and 5304571 (Aquo-composition), these patent specifications are incorporated herein by reference herein.
The used binding agent that is fit to of preparation tablet comprises methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, alginic acid, ethyl cellulose, arabic gum, gelatin, starch,pregelatinized, sucrose slurry, polyvinyl pyrrolidone and guar gum.Special binding agent is polyvinyl pyrrolidone (povidone).
The used lubricant that is fit to of preparation tablet comprises magnesium stearate, zinc stearate, calcium stearate; stearic acid; the stearyl fumaric acid sodium, hydrogenated vegetable oil, glyceryl palmitosterate behenic acid glyceride; sodium benzoate, sodium lauryl sulfate, lauryl magnesium sulfate; mineral oil, Talcum and their mixture.Magnesium stearate is a kind of special lubricant.
The desiccant that is suitable for when the preparation tablet comprises silica gel.
Dosage
The consumption of ranitidine in the present composition can be every dosage 25 to being less than 100 milligrams, for example about 30 to 90 milligrams, presses ranitidine alkali and calculates.Specifically, can be with about 50 to 80 milligrams, 75 milligrams dosage for example.
The consumption of calcium carbonate in the present composition of unit dose can be about 250 milligrams to 1000 milligrams, and the antiacid neutralising capacity of about 5 to 40 milliequivalents (mEq) is provided.A special dosage is about 500 milligrams of calcium carbonate.
Unit dose can be divided into for example 6 administrations at the most every day, and this depends on used unit dose, the character of the disease that treat and the order of severity, and patient's age and body weight.So, for example, some need reduce gastric acid and when producing the slight disease of beneficial effect in treatment, for example hyperchlorhydria dyspepsia, excessively let alone diet, acid stomach, hyperchlorhydria, water brash/regurgitation, heartburn as outbreak heartburn, night heartburn and meals induce heartburn, gastritis and dyspepsia, the ranitidine usual amounts can or high or low, for example, as required, adopt the 25-95 milligram, for example 40-75 milligram ranitidine free alkali, as 83.7 milligrams of ranitidine hydrochlorides, the every day of administration 6 times at the most.
So-called treatment should also comprise prevention and alleviate existing symptom.
Drug introduction
The form of pharmaceutical composition of the present invention can be a solid particle, and as powder, two distributed components make that system of unit amount will be as measuring device the teaspoon.Perhaps, compositions also can be used by liquid form, and at this moment unit dose is exactly that a liquid is measured, as 10 milliliters.Be more easily, the present composition uses with the preform unit dosage form, and as tablet, ranitidine and divided calcium carbonate other places are at the bilayer tablet of diverse location, capsule or other special modification, and as gelcap, caplet, tongue piece or chewable tablet.
Film-making
For the present composition is made tablet, active component and excipient can be carried out dried slugging, wet granulation or do mixed, then in blocks with the tablet machine that the is suitable for compacting that has suitable staking punch.
Capsule
In order to produce present composition capsule, active component and inactive excipient are mixed and incapsulate, this is this area conventional method.
On the other hand, the invention provides the application of combination of oral medication in the preparation medicine that contains ranitidine or its officinal salt and a kind of antacid, described medicine is to be used for the treatment of that needs reduce gastric acid and the disease that produces beneficial effect, and this purposes is characterised in that this antacid comprises calcium carbonate.
Embodiment 1
Following ingredients is mixed and make tablet with conventional method.Ranitidine hydrochloride 83.7 gram calcium carbonate 500 gram starch 80 gram powdery lactose 80 gram Talcums
20 grams
763.7 gram
Above-mentioned each composition is merged, mixes and is pressed into fritter.These fritters are ground, and formation can be by the granule of 14-16 mesh sieve.With suitable pressing mold the granule repress is made 1000, heavily about 763.7 milligrams of each sheet.
Embodiment 2
What introduce below is a kind of bilayer tablet, and it has overcome any incompatibility requirement between the composition.Ranitidine layer milligram/sheet ranitidine hydrochloride 84.0 microcrystalline Cellulose USP 64.5 magnesium stearate USNF 1.5
With ranitidine hydrochloride (carrying out taste in case of necessity covers up) and microcrystalline Cellulose and magnesium stearate blending.Calcium carbonate USP 500.0 sucrose 346.0 flavouring agents of the antacid layer milligram/pellet/an amount of magnesium stearate USNF 4.0 of sweetener
The calcium carbonate and the sucrose of antacid layer usefulness are made granule together with conventional method.This calcium carbonate/sucrose granules is with flavouring agent sweetener and magnesium stearate blending.
The granule and the antacid granule that will contain ranitidine with suitable tablet machine are pressed into bilayer tablet together.
Claims (15)
1. pharmaceutical composition, wherein each dosage contains 25-and is less than 100 milligrams of ranitidines and calcium carbonate.
2. the pharmaceutical composition of claim 1, wherein in fact said composition does not contain acid.
3. the pharmaceutical composition of claim 1, wherein said ranitidine is a ranitidine hydrochloride.
4. the pharmaceutical composition of claim 1, wherein to calculate content with free alkali form be about 30 to 90 milligrams to ranitidine described in the described pharmaceutical composition of per unit dosage.
5. the pharmaceutical composition of claim 1, wherein to calculate content with free alkali form be 25 or 75 milligrams to ranitidine described in the described pharmaceutical composition of per unit dosage.
6. the pharmaceutical composition of claim 1, wherein calcium carbonate content described in the described pharmaceutical composition of per unit dosage is about 250 to 1000 milligrams.
7. the pharmaceutical composition of claim 1 is solid particulate.
8. the pharmaceutical composition of claim 1 is liquid form.
9. the pharmaceutical composition of claim 1 is solid unit dose forms.
10. the pharmaceutical composition of claim 9, wherein said solid unit dose is tablet or capsule.
11. the pharmaceutical composition of claim 1 further comprises one or more flavouring agents, deodorant, adhesive, lubricant, surfactant or stain.
12. the pharmaceutical composition of claim 1 is the bilayer tablet form.
13. the pharmaceutical composition of claim 1, the contained active component of wherein said compositions has only described ranitidine and calcium carbonate.
14. treat ictal heartburn, night heartburn, meals induce heartburn, gastritis, dyspepsia or with the method for excessively letting alone the relevant gastroenteropathy of diet, comprise the pharmaceutical composition that uses claim 1 to patient.
15. treat and prevent the method for duodenal ulcer, pathologic supersecretion disease, gastric ulcer, stomach-esophageal reflux or aggressivity esophagitis, comprise the pharmaceutical composition that uses claim 1 to patient.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12951793A | 1993-09-30 | 1993-09-30 | |
| US08/129,517 | 1993-09-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1140996A true CN1140996A (en) | 1997-01-22 |
Family
ID=22440376
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN94193540A Pending CN1140996A (en) | 1993-09-30 | 1994-09-29 | Ranitidine and calcium carbonate pharmaceutical combination product |
Country Status (17)
| Country | Link |
|---|---|
| EP (1) | EP0721338A1 (en) |
| JP (1) | JPH09503212A (en) |
| CN (1) | CN1140996A (en) |
| AU (1) | AU677108B2 (en) |
| BG (1) | BG100456A (en) |
| CA (1) | CA2168846A1 (en) |
| CZ (1) | CZ76996A3 (en) |
| HU (1) | HUT75061A (en) |
| IL (1) | IL111094A0 (en) |
| NO (1) | NO961297L (en) |
| NZ (1) | NZ274713A (en) |
| OA (1) | OA10717A (en) |
| PL (1) | PL316855A1 (en) |
| SG (1) | SG44715A1 (en) |
| SK (1) | SK40596A3 (en) |
| WO (1) | WO1995008997A1 (en) |
| ZA (1) | ZA947553B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5560701B2 (en) * | 2008-12-26 | 2014-07-30 | ライオン株式会社 | Ranitidine-containing pharmaceutical solid preparation and method for producing ranitidine-carrying particles |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2222772B (en) * | 1988-09-20 | 1992-05-13 | Glaxo Group Ltd | Pharmaceutical compositions |
| CA2085873A1 (en) * | 1990-06-22 | 1991-12-23 | Adrian Francis Davis | Treatment |
| GB9127150D0 (en) * | 1991-12-20 | 1992-02-19 | Smithkline Beecham Plc | Novel treatment |
| US5229137A (en) * | 1992-05-06 | 1993-07-20 | Brigham And Women's Hospital, Inc. | Methods and pharmaceutical compositions for treating episodic heartburn |
-
1994
- 1994-09-28 ZA ZA947553A patent/ZA947553B/en unknown
- 1994-09-29 CA CA002168846A patent/CA2168846A1/en not_active Abandoned
- 1994-09-29 SK SK405-96A patent/SK40596A3/en unknown
- 1994-09-29 JP JP7510481A patent/JPH09503212A/en active Pending
- 1994-09-29 NZ NZ274713A patent/NZ274713A/en unknown
- 1994-09-29 CZ CZ96769A patent/CZ76996A3/en unknown
- 1994-09-29 IL IL11109494A patent/IL111094A0/en unknown
- 1994-09-29 CN CN94193540A patent/CN1140996A/en active Pending
- 1994-09-29 SG SG1996006196A patent/SG44715A1/en unknown
- 1994-09-29 HU HU9600810A patent/HUT75061A/en unknown
- 1994-09-29 PL PL94316855A patent/PL316855A1/en unknown
- 1994-09-29 WO PCT/US1994/011132 patent/WO1995008997A1/en not_active Application Discontinuation
- 1994-09-29 AU AU79253/94A patent/AU677108B2/en not_active Ceased
- 1994-09-29 EP EP94929984A patent/EP0721338A1/en not_active Withdrawn
-
1996
- 1996-03-08 OA OA60792A patent/OA10717A/en unknown
- 1996-03-27 BG BG100456A patent/BG100456A/en unknown
- 1996-03-29 NO NO961297A patent/NO961297L/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| JPH09503212A (en) | 1997-03-31 |
| NO961297D0 (en) | 1996-03-29 |
| BG100456A (en) | 1996-11-29 |
| HUT75061A (en) | 1997-03-28 |
| CA2168846A1 (en) | 1995-04-06 |
| EP0721338A1 (en) | 1996-07-17 |
| OA10717A (en) | 2002-12-09 |
| NZ274713A (en) | 1997-10-24 |
| IL111094A0 (en) | 1994-11-28 |
| AU7925394A (en) | 1995-04-18 |
| WO1995008997A1 (en) | 1995-04-06 |
| SK40596A3 (en) | 1997-02-05 |
| SG44715A1 (en) | 1997-12-19 |
| NO961297L (en) | 1996-03-29 |
| AU677108B2 (en) | 1997-04-10 |
| PL316855A1 (en) | 1997-02-17 |
| ZA947553B (en) | 1995-05-26 |
| HU9600810D0 (en) | 1996-05-28 |
| CZ76996A3 (en) | 1996-10-16 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C01 | Deemed withdrawal of patent application (patent law 1993) | ||
| WD01 | Invention patent application deemed withdrawn after publication |