WO2014102755A4 - Bortezomib formulations - Google Patents
Bortezomib formulations Download PDFInfo
- Publication number
- WO2014102755A4 WO2014102755A4 PCT/IB2013/061430 IB2013061430W WO2014102755A4 WO 2014102755 A4 WO2014102755 A4 WO 2014102755A4 IB 2013061430 W IB2013061430 W IB 2013061430W WO 2014102755 A4 WO2014102755 A4 WO 2014102755A4
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- bortezomib
- lyophilized composition
- composition according
- solution
- lactic acid
- 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
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
- A61K31/69—Boron compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to Bortezomib pharmaceutical compositions and processes for preparing the same.
Claims
1. A lyophilized composition comprising Bortezomib (I) as monohydrate Form-SB
(I),
devoid of any pharmaceutically acceptable excipient, wherein the said composition is having moisture content in the range of 3.5%-6.5 %w/w.
2. A process for preparing a lyophilized composition according to claim 1, which process comprises the steps of:
i) Water for injection is subjected to nitrogen purging till the dissolved oxygen content is less than 2 ppm.
ii) Dissolving Bortezomib (I) monohydrate Form-SB in tertiary butanol to form a uniform white suspension;
iii) Mix the suspension of step (ii) with (i) under stirring.
iv) Filtering the solution obtained in step (iii) to obtain a filtered solution;
v) Lyophilizing the filtered solution of step (iv), Wherein the lyophilized composition is having moisture content of 3.5%-6.5 %w/w.
3. A lyophilized composition comprising Bortezomib, polyvinyl pyrrolidone, lactic acid, and an antioxidant.
4. A lyophilized composition according to claim 3, wherein the antioxidant is selected from sodium metabisulphite, butylated hydroxytoluene, butylated hydroxyanisole, propyl gallate, DL-tocopherol, tocopherol acetate, tocopherol polyethylene glycol Succinate, L-cysteine, or mixtures thereof.
5. A lyophilized composition according to claim 3, comprising Bortezomib, polyvinyl pyrrolidone, lactic acid and sodium metabisulphite.
6. A process of preparing lyophilized composition of claim 5, comprising :
a) Dissolving polyvinylpyrrolidone in water for injection, and adding sodium metabisulphite and lactic acid, and mixed to get clear solution .
b) Dispersing Bortezomib in Tertiary Butanol and added to the step (a), and mixed to get clear solution.
c) Step (b) solution is made up to final volume with water for injection.
d) Lyophilizing the solution of step (c) .
7. A lyophilized composition according to claims 3-6, wherein the polyvinylpyrrolidone is in the range of 20 to 200 mg, for 3.5mg of bortezomib.
8. A lyophilized composition according to claims 3-7, wherein the lactic acid is in the range of 0.1 to 0.8 mg, for 3.5mg of bortezomib.
9. A lyophilized composition according to claims 3-8, wherein the sodium metabisulfite is in the range of 3 to 6 mg, for 3.5mg of bortezomib.
10. A lyophilized composition according to claims 3-9, wherein impurity 2 is not more than 0.5%.
11. The reconstitution time of bortezomib lyophilized composition according to claims 3-10, is below 1 minute.
ARTICLE 19 STATEMENT
Date: July 03, 2014
This is with reference to International Publication No. WO2014/102755 (International application No - PCT/IB2013/061430), which got published under Title: "BORTEZOMIB FORMULATIONS".
The Patent Applicant herewith submits a statement that the claim amendments made under provisions of Article 19 does not impact on the scope of invention described within the meaning of specification, description part and the drawings of the aforementioned Originally Filed International Application.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN5517CH2012 | 2012-12-31 | ||
| IN5517/CHE/2012 | 2012-12-31 | ||
| IN5769/CHE/2013 | 2013-12-13 | ||
| IN5769CH2013 IN2013CH05769A (en) | 2013-12-13 | 2013-12-31 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2014102755A1 WO2014102755A1 (en) | 2014-07-03 |
| WO2014102755A4 true WO2014102755A4 (en) | 2014-08-21 |
Family
ID=51019977
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2013/061430 Ceased WO2014102755A1 (en) | 2012-12-31 | 2013-12-31 | Bortezomib formulations |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2014102755A1 (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016059515A1 (en) * | 2014-10-18 | 2016-04-21 | Shilpa Medicare Limited | Bortezomib formulations |
| US20190290718A1 (en) * | 2015-08-06 | 2019-09-26 | Ftf Pharma Private Limited | Composition comprising bortezomib |
| EA038105B1 (en) * | 2018-06-13 | 2021-07-07 | Тютор С.А.С.И.Ф.И.А. | Method of producing a pharmaceutical composition comprising bortezomib, product of the method |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8158152B2 (en) * | 2005-11-18 | 2012-04-17 | Scidose Llc | Lyophilization process and products obtained thereby |
| JP2010539183A (en) * | 2007-09-12 | 2010-12-16 | ドクター・レディーズ・ラボラトリーズ・リミテッド | Bortezomib and process for its production |
| EA201170527A1 (en) * | 2008-10-01 | 2011-10-31 | Др. Редди'С Лабораторис Лтд. | PHARMACEUTICAL COMPOSITIONS, INCLUDING BORONIC ACID COMPOUNDS |
| EP2238973A1 (en) * | 2009-04-07 | 2010-10-13 | Cephalon France | Lyophilized preparations of proteasome inhibitors |
| US8263578B2 (en) * | 2010-03-18 | 2012-09-11 | Innopharma, Inc. | Stable bortezomib formulations |
| WO2012131707A2 (en) * | 2011-03-28 | 2012-10-04 | Laurus Labs Private Limited | Novel crystalline form of bortezomib, process for the preparation and pharmaceutical composition thereof |
-
2013
- 2013-12-31 WO PCT/IB2013/061430 patent/WO2014102755A1/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| WO2014102755A1 (en) | 2014-07-03 |
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