AU2021107513A4 - Novel Dissolution methods estimation of for Rabeprazole sodium (EC) Pellets by liquid chromatography - Google Patents
Novel Dissolution methods estimation of for Rabeprazole sodium (EC) Pellets by liquid chromatography Download PDFInfo
- Publication number
- AU2021107513A4 AU2021107513A4 AU2021107513A AU2021107513A AU2021107513A4 AU 2021107513 A4 AU2021107513 A4 AU 2021107513A4 AU 2021107513 A AU2021107513 A AU 2021107513A AU 2021107513 A AU2021107513 A AU 2021107513A AU 2021107513 A4 AU2021107513 A4 AU 2021107513A4
- Authority
- AU
- Australia
- Prior art keywords
- pellets
- sodium
- dilute
- rabeprazole
- rabeprazole sodium
- 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.)
- Ceased
Links
- ZGDLVKWIZHHWIR-UHFFFAOYSA-N 4-[5-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)pyridin-2-yl]morpholine Chemical compound O1C(C)(C)C(C)(C)OB1C1=CC=C(N2CCOCC2)N=C1 ZGDLVKWIZHHWIR-UHFFFAOYSA-N 0.000 title claims abstract description 31
- 229960001778 rabeprazole sodium Drugs 0.000 title claims abstract description 29
- 239000008188 pellet Substances 0.000 title claims abstract description 19
- 238000004811 liquid chromatography Methods 0.000 title claims abstract description 7
- 238000011978 dissolution method Methods 0.000 title claims abstract description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract description 24
- 239000000243 solution Substances 0.000 claims abstract description 11
- 238000004090 dissolution Methods 0.000 claims abstract description 9
- 238000002360 preparation method Methods 0.000 claims abstract description 9
- 239000000203 mixture Substances 0.000 claims abstract description 8
- 239000012085 test solution Substances 0.000 claims abstract description 4
- 238000012546 transfer Methods 0.000 claims abstract description 4
- 238000000034 method Methods 0.000 claims description 4
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 abstract description 5
- 239000011734 sodium Substances 0.000 abstract description 5
- 229910052708 sodium Inorganic materials 0.000 abstract description 5
- 229960004157 rabeprazole Drugs 0.000 abstract description 4
- YREYEVIYCVEVJK-UHFFFAOYSA-N rabeprazole Chemical compound COCCCOC1=CC=NC(CS(=O)C=2NC3=CC=CC=C3N=2)=C1C YREYEVIYCVEVJK-UHFFFAOYSA-N 0.000 abstract description 4
- 239000003826 tablet Substances 0.000 description 8
- 238000012360 testing method Methods 0.000 description 4
- 150000001556 benzimidazoles Chemical class 0.000 description 3
- 238000003556 assay Methods 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000002662 enteric coated tablet Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-M hydroxide Chemical compound [OH-] XLYOFNOQVPJJNP-UHFFFAOYSA-M 0.000 description 2
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical class COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- -1 benzimidazole compound Chemical class 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 229960003174 lansoprazole Drugs 0.000 description 1
- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical class CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 description 1
- HCWCAKKEBCNQJP-UHFFFAOYSA-N magnesium orthosilicate Chemical compound [Mg+2].[Mg+2].[O-][Si]([O-])([O-])[O-] HCWCAKKEBCNQJP-UHFFFAOYSA-N 0.000 description 1
- 239000000395 magnesium oxide Substances 0.000 description 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
- 239000000391 magnesium silicate Substances 0.000 description 1
- 229910052919 magnesium silicate Inorganic materials 0.000 description 1
- 235000019792 magnesium silicate Nutrition 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229960000381 omeprazole Drugs 0.000 description 1
- 229960005019 pantoprazole Drugs 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 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
- A61K31/33—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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
NOVEL DISSOLUTION METHODS ESTIMATION OF FOR RABEPRAZOLE
SODIUM (EC) PELLETS BY LIQUID CHROMATOGRAPHY
This invention relates to Novel Dissolution methods estimation of for Rabeprazole
5 sodium (EC) Pellets by liquid chromatography. Standard preparation: Weight
accurately 20.0 mg of Rabeprazole Sodium equiv. working standard into a 100 ml
volumetric flask, dissolve and dilute to volume with 0.1M sodium hydroxide solution
and mix. Further dilute to 5 ml to 50 ml with mobile phase. Test Solution: Put 100 mg
Rabeprazole Sodium pellets in six dissolution vessels containing 900 ml of medium
0 that has been equilibrated to 370 0.50 C, start the apparatus immediately. After 2
hours drain 0.1M HCI slowly without losing pellets and transfer the pellets
quantitatively to a 100 ml volumetric flask, dissolve in 50 ml 0.1 sodium hydroxide
solution, and complete to volume with same. Dilute 5 ml to 50 ml with mobile phase.
The result should not be less than 90 % Weight accurately 20.0 mg of Rabeprazole
5 Sodium equiv. working standard into a 100 ml volumetric flask, dissolve and dilute to
volume with 0.1M sodium hydroxide solution and mix. Further dilute to 5 ml to 50 ml
with mobile phase.
20
9
Description
Title of the Invention
Novel Dissolution methods estimation of for Rabeprazole sodium (EC) Pellets
by liquid chromatography
Field of the Invention
This invention relates to Novel Dissolution methods estimation of for Rabeprazole
sodium (EC) Pellets by liquid chromatography.
Background of the Invention
CN104873471A Rabeprazole sodium tablet and rabeprazole sodium enteric-coated
tablet discloses provides a rabeprazole sodium tablet which comprises the following
components in part by weight: 20-40 parts of rabeprazole sodium, 260-300 parts of
lactose, 50-80 parts of magnesium silicate, 35-45 parts of magnesium oxide and 1-5
parts of microcrystalline cellulose. According to the invention, the components of the
rabeprazole sodium tablet and the dosage of each component are controlled, and
the rabeprazole sodium tablet has high dissolution rate and bioavailability through
the integrated action of all components and is reasonable in component design.
Experimental results show that the dissolution rate of the rabeprazole sodium tablet
is 97.5%. The invention further provides a rabeprazole sodium enteric-coated tablet
which is prepared from the rabeprazole sodium tablet above; the rabeprazole sodium
tablet is reasonable in component design, so that the prepared rabeprazole sodium
enteric-coated tablet has good stability.
W02004098573A1 AN IMPROVED AND STABLE PHARMACEUTICAL
PROCESS FOR ITS PREPARATION discloses to improved pharmaceutical
preparations containing substituted benzimidazoles,(i.e.omeprazole, lansoprazole, pantoprazole, and rabeprazole). The preparations comprise an inert core, constituted by starch and sugar, surrounded by active coating containing at least one substituted benzimidazole in the micronized form, which is mixed with pharmaceutically acceptable non-alkaline and inert excipients, followed by intermediate coating and an enteric coating, in order to guarantee the integrity of the product until it reaches the proximal part of the small intestine, where the formulation will be disaggregated to facilitate the absorption of the substituted benzimidazole compound.None of the cited references above disclose or teach what the present invention discloses or teaches. The present invention distinguishable over these cited prior art references.
The detailed description of various exemplary embodiments of the disclosure is
described herein with reference to the accompanying drawings. It should be noted
that the embodiments are described herein in such details as to clearly communicate
the disclosure. However, the amount of details provided herein is not intended to
limit the anticipated variations of embodiments; on the contrary, the intention is to
cover all modifications, equivalents, and alternatives falling within the scope of the
present disclosure as defined by the appended claims.
Put 100 mg Rabeprazole Sodium pellets in six dissolution vessels containing
900 ml of medium that has been equilibrated to 370 ±0.50 C, start the apparatus
immediately. After 2 hours drain 0.1M HCI slowly without losing pellets and transfer
the pellets quantitatively to a 100 ml volumetric flask, dissolve in 50 ml 0.1 sodium
hydroxide solution, and complete to volume with same. Dilute 5 ml to 50 ml with
mobile phase.
The result should not be less than 90 %
Chromographic Conditions:
Column: C 1 8 [4.6 x 250 mm; 5p]
Flow rate: 1.0 ml/min
Detector: 280 nm.
R.T.: Rabeprazole Sodium : 5.5: MIN (Approx)
It is also to be understood that various arrangements may be devised that, although
not explicitly described or shown herein, embody the principles of the present
disclosure. Moreover, all statements herein reciting principles, aspects, and
embodiments of the present disclosure, as well as specific examples, are intended to
encompass equivalents thereof.
The terminology used herein is for the purpose of describing particular embodiments
only and is not intended to be limiting of example embodiments. As used herein, the
singular forms "a"," "an" and "the" are intended to include the plural forms as well,
unless the context clearly indicates otherwise. It will be further understood that the
terms "comprises," "comprising," "includes" and/or "including," when used herein,
specify the presence of stated features, integers, steps, operations, elements and/or
components, but do not preclude the presence or addition of one or more other
features, integers, steps, operations, elements, components and/or groups thereof.
It should also be noted that in some alternative implementations, the functions/acts
noted may occur out of the order noted in the figures. For example, two figures
shown in succession may, in fact, be executed concurrently or may sometimes be
executed in the reverse order, depending upon the functionality/acts involved.
In addition, the descriptions of "first", "second", "third", and the like in the present
invention are used for the purpose of description only, and are not to be construed
as indicating or implying their relative importance or implicitly indicating the number
of technical features indicated. Thus, features defining "first" and "second" may
include at least one of the features, either explicitly or implicitly.
Unless otherwise defined, all terms (including technical and scientific terms) used
herein have the same meaning as commonly understood by one of ordinary skill in
the art to which example embodiments belong. It will be further understood that
terms, e.g., those defined in commonly used dictionaries, should be interpreted as
having a meaning that is consistent with their meaning in the context of the relevant
art and will not be interpreted in an idealized or overly formal sense unless expressly
so defined herein.
Dissolution Rabeprazole Sodium (EC): Determine by liquid chromatography.
Acid Resistance in 0.1 M HCI:
Apparatus USP Apparatus II
Medium 0.1M HCI Solution
Volume :900 ml
R.P.M :50
Duration 120 Minutes
Temperature 370 0.50 C
Standard preparation:
Weight accurately 20.0 mg of Rabeprazole Sodium equiv. working standard into a
100 ml volumetric flask, dissolve and dilute to volume with 0.1M sodium hydroxide
solution and mix. Further dilute to 5 ml to 50 ml with mobile phase.
Test Solution:
Put 100 mg Rabeprazole Sodium pellets in six dissolution vessels containing
900 ml of medium that has been equilibrated to 370 0.50 C, start the apparatus
immediately. After 2 hours drain 0.1M HCI slowly without losing pellets and transfer
the pellets quantitatively to a 100 ml volumetric flask, dissolve in 50 ml 0.1 sodium
hydroxide solution, and complete to volume with same. Dilute 5 ml to 50 ml with
mobile phase.
The result should not be less than 90 %
Chromographic Conditions:
Column: C 1 8 [4.6 x 250 mm; 5p]
Flow rate: 1.0 ml/min
Detector: 280 nm.
R.T.: Rabeprazole Sodium : 5.5: MIN (Approx)
Calculation:
AT x WS x 5 x 100 x 50 x 100 x Purity.= % of Drug retained
AS x 100 x 50 x WT x 5 x % of Assay
AT = Area of test
AS = Area of standard
WS = Weight of standard
WT = Weight of test
Dissolution in buffer:
Apparatus USP Apparatus II
Medium Phosphate buffer pH 8.0
Volume :900 ml
R.P.M. :100
Duration :60 minutes
Temperature :370 0.50 C
Standard preparation:
Weight accurately (20.0 mg of Rabeprazole Sodium) working standard into a 100 ml
volumetric flask, dissolve and dilute to volume with 0.1M sodium hydroxide solution
and mix. Further dilute to 5 ml to 50 ml with Buffer solution.
Test Solution:
Put 100 mg Rabeprazole Sodium Pellets in six dissolution vessels containing
900 ml of medium that has been equilibrated to 370 0.50 C, start the apparatus
immediately. Collect the sample after the specified time withdraw sample from a
zone midway between the
Surface of the medium and top of the rotating blade and not less than 1 cm from the
vessel wall and filter. The result should not be less than 70
% Chromatographic Conditions
Column: C 1 8 [4.6 x 250 mm; 5p]
Flow rate: 1.0 ml/min
Detector: 280 nm.
R.T.: Rabeprazole Sodium : 5.5: MIN (Approx)
Calculation:
AT x WS x 5 x 900 x 100 x Purity = % of Drug released
AS x 100 x 50 x WT x % of Assay
Where
AT = Area of test
AS = Area of standard
WS = Weight of standard
WT = Weight of test
Claims (4)
1. Novel Dissolution methods estimation of for Rabeprazole sodium (EC) Pellets by
liquid chromatography.
2. The method as claimed in claim 1, Standard preparation: Weight accurately 20.0
mg of Rabeprazole Sodium equiv. working standard into a 100 ml volumetric flask,
dissolve and dilute to volume with 0.1M sodium hydroxide solution and mix. Further
dilute to 5 ml to 50 ml with mobile phase.
3. The method as claimed in claim 1, Standard preparation Test Solution: Put 100
mg Rabeprazole Sodium pellets in six dissolution vessels containing 900 ml of
medium that has been equilibrated to 370 0.50 C, start the apparatus immediately.
After 2 hours drain 0.1M HC slowly without losing pellets and transfer the pellets
quantitatively to a 100 ml volumetric flask, dissolve in 50 ml 0.1 sodium hydroxide
solution, and complete to volume with same. Dilute 5 ml to 50 ml with mobile phase.
4. The method as claimed in claim 1, Standard preparation The result should not be
less than 90 % Weight accurately 20.0 mg of Rabeprazole Sodium equiv. working
standard into a 100 ml volumetric flask, dissolve and dilute to volume with 0.1M
sodium hydroxide solution and mix. Further dilute to 5 ml to 50 ml with mobile phase.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021107513A AU2021107513A4 (en) | 2021-08-25 | 2021-08-25 | Novel Dissolution methods estimation of for Rabeprazole sodium (EC) Pellets by liquid chromatography |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021107513A AU2021107513A4 (en) | 2021-08-25 | 2021-08-25 | Novel Dissolution methods estimation of for Rabeprazole sodium (EC) Pellets by liquid chromatography |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2021107513A4 true AU2021107513A4 (en) | 2022-03-10 |
Family
ID=80533962
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2021107513A Ceased AU2021107513A4 (en) | 2021-08-25 | 2021-08-25 | Novel Dissolution methods estimation of for Rabeprazole sodium (EC) Pellets by liquid chromatography |
Country Status (1)
| Country | Link |
|---|---|
| AU (1) | AU2021107513A4 (en) |
-
2021
- 2021-08-25 AU AU2021107513A patent/AU2021107513A4/en not_active Ceased
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AU722879B2 (en) | Pharmaceutical formulation of omeprazole | |
| EP0069097B1 (en) | Pharmaceutical mixture | |
| KR100794078B1 (en) | Controlled-leaching preparation and process for producing the same | |
| US20090220621A1 (en) | Pharmaceutical compositions of a non-enteric coated proton pump inhibitor with a carbonate salt and bicarbonate salt combination | |
| EP1978935B1 (en) | Coated formulations | |
| AU2008304033A1 (en) | Pharmaceutical composition containing esomeprazole | |
| RU2713889C2 (en) | Vortioxyetine pyroglutamate | |
| CN111670030A (en) | Pharmaceutical preparation containing esomeprazole and sodium bicarbonate | |
| US20220031622A1 (en) | Stable benzimidazole formulation | |
| JP2009519943A (en) | Pharmaceutical composition of ilaprazole | |
| EP2641594B1 (en) | Enteric coated solid pharmaceutical compositions for proton pump inhibitors | |
| CN105126111A (en) | Preparation for improving bioavailability of sorafenib | |
| AU2021107513A4 (en) | Novel Dissolution methods estimation of for Rabeprazole sodium (EC) Pellets by liquid chromatography | |
| CN107106568B (en) | Pharmaceutical compositions of fused aminodihydrothiazine derivatives | |
| EP1353624B1 (en) | Pharmaceutical compositions of a non-enteric coated proton pump inhibitor with a carbonate salt and bicarbonate salt combination | |
| CN103505421B (en) | A kind of enteric coated pellets formulation of duloxetine hydrochloride | |
| AU2021107512A4 (en) | Novel dissolution methods for RABEPRAZOLE SODIUM (EC) + EVOSULPIRIDE (SR) pellets | |
| AU2021107504A4 (en) | Novel dissolution methods for RABEPRAZOLE SODIUM (EC) + EVOSULPIRIDE (SR) pellets | |
| AU2021107494A4 (en) | Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets | |
| US20040146558A1 (en) | Oral enteric-coated preparation | |
| AU2021107503A4 (en) | Novel Dissolution methods for RABEPRAZOLE SODIUM(EC)+DOMPERIDONE (SR) pellets | |
| CN103565747B (en) | Esomeprazole composition and preparation method thereof | |
| US20130115253A1 (en) | Sustained Release Suspension Preparation For Dextromethorphan | |
| CA2607272A1 (en) | Formulations of mast cell stabilizing agents for delivery to the colon | |
| US20030236285A1 (en) | Stabilized pharmaceutical compositions containing benzimidazole compounds |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FGI | Letters patent sealed or granted (innovation patent) | ||
| MK22 | Patent ceased section 143a(d), or expired - non payment of renewal fee or expiry |