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WO2013057724A1 - Emballage pour alitrétinoïne - Google Patents

Emballage pour alitrétinoïne Download PDF

Info

Publication number
WO2013057724A1
WO2013057724A1 PCT/IB2012/055762 IB2012055762W WO2013057724A1 WO 2013057724 A1 WO2013057724 A1 WO 2013057724A1 IB 2012055762 W IB2012055762 W IB 2012055762W WO 2013057724 A1 WO2013057724 A1 WO 2013057724A1
Authority
WO
WIPO (PCT)
Prior art keywords
alitretinoin
vacuum
oxygen absorber
bag
oxygen
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
Application number
PCT/IB2012/055762
Other languages
English (en)
Inventor
Suresh Babu Jayachandra
Tarun Kumar SINGH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ranbaxy Laboratories Ltd
Original Assignee
Ranbaxy Laboratories Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
Priority to US14/351,928 priority Critical patent/US20140262858A1/en
Publication of WO2013057724A1 publication Critical patent/WO2013057724A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2007—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under vacuum
    • B65D81/2023—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under vacuum in a flexible container
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2069—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere
    • B65D81/2084—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere in a flexible container

Definitions

  • the present invention relates to the use of an oxygen absorber and silica gel desiccant in a vacuum-sealed pack for the reduction or prevention of oxidative degradation of alitretinoin.
  • Alitretinoin is a first generation retinoid.
  • the chemical name of alitretinoin is 9-cis retinoic acid or (2£ , ,4£ , ,6Z,8£)-3,7-dimethyl-9-(2,6,6-trimethyl-l-cyclohexenyl)-2,4,6,8- nonatraenoic acid and the structural formula is as follows:
  • U.S. Patent No. 6,007,529 discloses a flexible transparent container for the improved storage of oxygen sensitive parenterally administrable agents that is comprised of an inner primary container that is enclosed in an oxygen impermeable outer envelope with an oxygen absorber capable of consuming all residual oxygen after the outer envelope is sealed.
  • PCT Publication No. WO 2006/008651 discloses a package to protect pharmaceuticals, e.g., atorvastatin, which comprises a bottle, a desiccant disposed within the first sub-container, and a self-activated metal based oxygen absorber disposed within the second sub-container.
  • U.S. Publication No. 2005/0268573 relates to a method for packaging a sterile article that comprises providing a container; placing the article into the interior of the container; exposing the permeable portion of the container to the exterior environment; and removing the sterilizing gas.
  • U.S. Publication No. 2009/0071855 discloses a vacuum-sealed pack comprising an amorphous statin or a pharmaceutical composition thereof and at least one stabilizer, for example, an oxygen absorber, a moisture absorber, or a combination thereof.
  • a method for the reduction or prevention of oxidative degradation of alitretinoin using an oxygen absorber and a silica gel desiccant in a vacuum-sealed pack comprising alitretinoin, an oxygen absorber and a silica gel desiccant.
  • a vacuum-sealed pack comprising a pharmaceutical composition comprising alitretinoin, an oxygen absorber, and a silica gel desiccant.
  • a method for the reduction or prevention of oxidative degradation of alitretinoin comprising an oxygen absorber and a silica gel desiccant in a vacuum-sealed pack.
  • a vacuum-sealed pack comprising alitretinoin, an oxygen absorber and a silica gel desiccant.
  • a vacuum-sealed pack which includes a pharmaceutical composition comprising alitretinoin, an oxygen absorber, and a silica gel desiccant.
  • vacuum-sealed pack refers to a low density polyethylene (LDPE) bag that is twisted and tied with a plastic fastener under nitrogen. This bag is packed into a middle bag of polyester/LDPE, a vacuum is applied to the middle bag, and it is heat sealed. The sealed middle bag is packed into a polyester/alumi- num/polyester/LDPE bag. Vacuum is applied to the polyester/aluminum/polyester/LDPE bag and it is then heat sealed.
  • LDPE low density polyethylene
  • oxygen absorber is a material capable of absorbing oxygen from the surrounding atmosphere.
  • Oxygen absorbers can be inorganic metal based oxygen absorbers; ascorbic acid based absorbers; enzymatic absorbers; or polymer based oxygen absorbers. Examples of specific oxygen absorbers include, but are not limited to, O-Buster®, FreshPax®, Ageless®, StabilOx® or ZPTJTM.
  • Stability studies of alitretinoin were conducted by loading alitretinoin samples at various stability conditions, for example, at 25 ⁇ 2°C/60 ⁇ 5% relative humidity (RH) and 40 ⁇ 2°C/75 ⁇ 5% RH in the absence or presence of an oxygen absorber and a silica desiccant for 1 month, 2 months, 3 months, or 6 months.
  • the stability studies were performed on a stability incubator (for accelerated stability studies, Hotpack was used and for real time stability studies, NuAire® was used).
  • the degradation products were identified using an Agilent® 1 100 series HPLC system.
  • the “pharmaceutical composition”, as used herein, includes both capsule and gel forms.
  • Example 1 Stability Studies of Alitretinoin at 25 ⁇ 2°C/60 ⁇ 5%RH and 40 ⁇ 2°C/75 ⁇ 5% RH in the Absence of Oxygen Absorber and Silica Gel Desiccant
  • Alitretinoin was packed in a LDPE bag.
  • the bag was twisted and tied with a plastic fastener under nitrogen.
  • the LDPE bag was placed into a middle bag of polyester/LDPE and vacuum was applied to the middle bag and then it was heat sealed.
  • the sealed middle bag was packed into a polyester/aluminum/polyester/LDPE bag.
  • Example 2 Stability Studies of Alitretinoin at 25 ⁇ 2°C/60 ⁇ 5 % RH in the Presence of Oxygen Absorber (Stabilox® and Silica Gel Desiccant
  • Alitretinoin was packed in a LDPE bag.
  • the bag was twisted and tied with a plastic fastener under nitrogen.
  • the LDPE bag was placed into a middle bag of polyester/LDPE along with an oxygen absorber. A vacuum was applied to the middle bag and then it was heat sealed.
  • the sealed middle bag was packed into a
  • polyester/aluminum/polyester/LDPE bag along with silica gel as a desiccant. Vacuum was applied to this bag and it was then heat sealed. The vacuum-sealed pack was loaded on stability at 25 ⁇ 2°C and 60 ⁇ 5% RH. The results are presented in Table 2.
  • Alitretinoin was packed in a LDPE bag; the bag was twisted and tied with a plastic fastener under nitrogen. It was placed into a middle bag of polyester/LDPE along with an oxygen absorber. Vacuum was applied to the middle bag and then it was heat sealed. This sealed middle bag was packed into a polyester/aluminum/polyester/LDPE bag along with silica gel as a desiccant. Vacuum was applied to this bag and then it was heat sealed. The vacuum-sealed pack was loaded on stability at 40 ⁇ 2°C and 75 ⁇ 5% RH. The results are presented in Table 3.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Food Science & Technology (AREA)
  • Packages (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)
  • Drying Of Gases (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne l'utilisation d'un absorbeur d'oxygène et d'un dessicatif à base de gel de silice dans un emballage soudé sous vide pour réduire ou prévenir la dégradation par oxydation de l'alitrétinoïne.
PCT/IB2012/055762 2011-10-21 2012-10-19 Emballage pour alitrétinoïne Ceased WO2013057724A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/351,928 US20140262858A1 (en) 2011-10-21 2012-10-19 Packaging for alitretinoin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN3019DE2011 2011-10-21
IN3019/DEL/2011 2011-10-21

Publications (1)

Publication Number Publication Date
WO2013057724A1 true WO2013057724A1 (fr) 2013-04-25

Family

ID=47278918

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2012/055762 Ceased WO2013057724A1 (fr) 2011-10-21 2012-10-19 Emballage pour alitrétinoïne

Country Status (2)

Country Link
US (1) US20140262858A1 (fr)
WO (1) WO2013057724A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59176247A (ja) 1983-03-28 1984-10-05 Taiyo Yakuhin Kogyo Kk 水溶性アズノ−ルの分解防止方法
US6007529A (en) 1996-04-10 1999-12-28 Pharmacia & Upjohn Ab Containers for parenteral fluids
US20050268573A1 (en) 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
WO2006008651A1 (fr) 2004-07-16 2006-01-26 Pfizer Products Inc. Emballage pharmaceutique permettant de maintenir simultanement un faible taux d'humidite et un faible taux d'oxygene
WO2009024946A1 (fr) * 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Kit d'emballage comprenant un médicament sensible à la lumière, à l'humidité et/ou à l'oxygène
US20090071855A1 (en) 2007-09-14 2009-03-19 Bahuguna Sumit Packaging for amorphous statins and compositions thereof
US20090249747A1 (en) * 2008-04-02 2009-10-08 Sumitomo Electric Industries, Ltd. Method of Packaging Compound Semiconductor Substrates

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5414049A (en) * 1993-06-01 1995-05-09 Howmedica Inc. Non-oxidizing polymeric medical implant
WO2011075798A1 (fr) * 2009-12-24 2011-06-30 Bm Gol Pty Ltd Récipients à usage unique et utilisations de ceux-ci

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59176247A (ja) 1983-03-28 1984-10-05 Taiyo Yakuhin Kogyo Kk 水溶性アズノ−ルの分解防止方法
US6007529A (en) 1996-04-10 1999-12-28 Pharmacia & Upjohn Ab Containers for parenteral fluids
US20050268573A1 (en) 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
WO2006008651A1 (fr) 2004-07-16 2006-01-26 Pfizer Products Inc. Emballage pharmaceutique permettant de maintenir simultanement un faible taux d'humidite et un faible taux d'oxygene
WO2009024946A1 (fr) * 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Kit d'emballage comprenant un médicament sensible à la lumière, à l'humidité et/ou à l'oxygène
US20090071855A1 (en) 2007-09-14 2009-03-19 Bahuguna Sumit Packaging for amorphous statins and compositions thereof
US20090249747A1 (en) * 2008-04-02 2009-10-08 Sumitomo Electric Industries, Ltd. Method of Packaging Compound Semiconductor Substrates

Also Published As

Publication number Publication date
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