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 (2E,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)-2,4,6,8-nonatraenoic acid and the structural formula is as follows:
• Japanese Patent No. JP 59-176247 discloses a method for preventing the decomposition of water-soluble azunole of Formula II
• U.S. Pat. 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 is provided.
• 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/aluminum/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® 1100 series HPLC system.
• the “pharmaceutical composition”, as used herein, includes both capsule and gel forms.
• 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. Vacuum was applied to this bag and then it was heat sealed.
• the vacuum-sealed pack was loaded on stability at stations 40 ⁇ 2° C. and 75 ⁇ 5% RH (accelerated) and 25 ⁇ 2° C. and 60 ⁇ 5% RH. The results are presented in Table 1.
• 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)
• Drying Of Gases (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Solid-Sorbent Or Filter-Aiding Compositions (AREA)

Applications Claiming Priority (3)

Publications (1)

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Family Applications (1)

Country Status (2)

Citations (3)

Family Cites Families (6)

• 2012
  • 2012-10-19 WO PCT/IB2012/055762 patent/WO2013057724A1/fr active Application Filing
  • 2012-10-19 US US14/351,928 patent/US20140262858A1/en not_active Abandoned

Patent Citations (3)

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