AU2021107494A4 - Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets - Google Patents
Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets Download PDFInfo
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- AU2021107494A4 AU2021107494A4 AU2021107494A AU2021107494A AU2021107494A4 AU 2021107494 A4 AU2021107494 A4 AU 2021107494A4 AU 2021107494 A AU2021107494 A AU 2021107494A AU 2021107494 A AU2021107494 A AU 2021107494A AU 2021107494 A4 AU2021107494 A4 AU 2021107494A4
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- AU
- Australia
- Prior art keywords
- pantoprazole
- pellets
- testing procedure
- dissolution testing
- medium
- 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.)
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- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 title claims abstract description 24
- 229960005019 pantoprazole Drugs 0.000 title claims abstract description 20
- 239000008188 pellet Substances 0.000 title claims abstract description 16
- 238000000034 method Methods 0.000 title claims abstract description 11
- 238000009506 drug dissolution testing Methods 0.000 title claims abstract description 7
- 238000004090 dissolution Methods 0.000 claims abstract description 7
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 12
- 238000012546 transfer Methods 0.000 claims description 2
- 239000011248 coating agent Substances 0.000 description 8
- 238000000576 coating method Methods 0.000 description 8
- YNWDKZIIWCEDEE-UHFFFAOYSA-N pantoprazole sodium Chemical compound [Na+].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC YNWDKZIIWCEDEE-UHFFFAOYSA-N 0.000 description 7
- 239000008194 pharmaceutical composition Substances 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 3
- 229960004048 pantoprazole sodium Drugs 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 239000012085 test solution Substances 0.000 description 3
- 239000002253 acid Substances 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 210000001072 colon Anatomy 0.000 description 2
- 239000007884 disintegrant Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 206010009657 Clostridium difficile colitis Diseases 0.000 description 1
- 206010009900 Colitis ulcerative Diseases 0.000 description 1
- 208000019399 Colonic disease Diseases 0.000 description 1
- 208000011231 Crohn disease Diseases 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 201000006704 Ulcerative Colitis Diseases 0.000 description 1
- 239000008351 acetate buffer Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 230000000112 colonic effect Effects 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 230000006862 enzymatic digestion Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 244000005706 microflora Species 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- PIEPQKCYPFFYMG-UHFFFAOYSA-N tris acetate Chemical compound CC(O)=O.OCC(N)(CO)CO PIEPQKCYPFFYMG-UHFFFAOYSA-N 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Physics & Mathematics (AREA)
- Biochemistry (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Analytical Chemistry (AREA)
- Food Science & Technology (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets
This invention relates to a Novel dissolution testing procedure for Pantoprazole (EC)
pellets. Put 100 mg Pantoprazole Pellets in six dissolution vessels containing 1000
5 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
80%
0
5
20
25 9
Description
Title of the Invention
Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets
Field of the Invention
This invention relates to a Novel dissolution testing procedure for PANTOPRAZOLE
(EC) pellets
Background of the Invention
W02007014928A1 PHARMACEUTICAL COMPOSITION COMPRISING
GRANULAR PANTOPRAZOLE discloses Pharmaceutical composition comprising
pantoprazole as the active ingredient. The pantoprazole is present in the form of
particles having an average particle size within the range of 60 pm to 250 pm.
Pantoprazole having an average particle size within the range of 60 pm to 250 pm is
prepared by a process comprising the steps of wetting pantoprazole with water
having a pH of 10 to 12 in a high shear mixer, passing the wet pantoprazole through
a sieve having a mesh size of 0.8 to 2 mm, and drying the mass in a fluid bed dryer
. W02017156214A1 PHARMACEUTICAL COMPOSITIONS FOR COLON-SPECIFIC
Disclosed are pharmaceutical particulates which release a pharmaceutical
compound into the colon following oral administration. A particulate comprises a core
comprising a pharmaceutical compound, an inner coating surrounding the core,
wherein the inner coating comprises a pharmaceutically acceptable polysaccharide
that is susceptible to enzymatic digestion by one or more enzymes present colonic
microflora, and an outer coating surrounding the inner coating, wherein the outer
coating comprises a polymer which is stable at upper gastrointestinal pH but can
dissolve at colon luminal pH in less than about 60 minutes. The core of a particulate can further comprise an excipient such as a diluent, a binder, a disintegrant, a lubricant, a glidant or a combination thereof. Particulates can comprise pharmaceutical compounds for treating colonic diseases such as C. difficile colitis, ulcerative colitis, and Crohn's disease.
US2005042277A1 Pharmaceutical compositions having a swellable coating
A pharmaceutical dosage form containing a pharmaceutical active that is not stable
in the presence of acid comprises a core containing the active and a disintegrant, a
swellable coating surrounding the core, and an enteric coating surrounding the
swellable coating.
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.
This invention relates to a Novel dissolution testing procedure for PANTOPRAZOLE
(EC) pellets
Test Solution:
Put 100 mg Pantoprazole Pellets in six dissolution vessels containing 1000 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 80 %
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.
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.
These and other advantages of the present subject matter would be described in
greater detail with reference to the following figures. It should be noted that the
description merely illustrates the principles of the present subject matter. It will thus
be appreciated that those skilled in the art will be able to devise various
arrangements that, although not explicitly described herein, embody the principles of
the present subject matter and are included within its scope.
Dissolution Pantoprazole Sodium (EC):
Determine by liquid chromatography.
Acid Resistance in 0.1M HCI:
Apparatus USP Apparatus II
Medium 0.1M HCI Solution
Volume :900 ml
R.P.M :100
Duration 120 Minutes
Temperature 370 0.50 C
Standard preparation:
Weight accurately in mg (40.0 mg of Pantoprazole 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 Pantoprazole 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 %
Chromatographic Conditions:
Column: C 1 8 [4.6 x 250 mm; 5p]
Flow rate: 1.0 ml/min
Detector: 280 nm.
R.T.: Pantoprazole Sodium : 4.5: 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 Tris Acetate buffer pH-8.0
Volume :1000 ml
R.P.M. :75
Duration :60 Minutes
Temperature :370 0.50 C
Standard preparation:
Weight accurately (40.0 mg of Panto prazole )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 Pantoprazole Pellets in six dissolution vessels containing 1000 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 80
Chromatographic Conditions: %
Column: C 1 8 [4.6 x 250 mm; 5p]
Flow rate: 1.0 ml/min
Detector: 280 nm.
R.T.: Pantoprazole Sodium : 4.5: 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 testing procedure for PANTOPRAZOLE (EC) pellets.
2. The procedure as claimed in claim 1, wherein Put 100 mg Pantoprazole pellets in
six dissolution vessels containing 900 ml of medium that has been equilibrated to
370 0.50 C, start the apparatus immediately.
3. The procedure as claimed in claim 1, wherein 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 procedure as claimed in claim 1, wherein the result should not be less than 90
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021107494A AU2021107494A4 (en) | 2021-08-25 | 2021-08-25 | Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021107494A AU2021107494A4 (en) | 2021-08-25 | 2021-08-25 | Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2021107494A4 true AU2021107494A4 (en) | 2021-12-23 |
Family
ID=78958221
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2021107494A Ceased AU2021107494A4 (en) | 2021-08-25 | 2021-08-25 | Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets |
Country Status (1)
| Country | Link |
|---|---|
| AU (1) | AU2021107494A4 (en) |
-
2021
- 2021-08-25 AU AU2021107494A patent/AU2021107494A4/en not_active Ceased
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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 |