EP2178486A2 - Nécessaire de conditionnement pour statines et compositions à base de celles-ci - Google Patents

Nécessaire de conditionnement pour statines et compositions à base de celles-ci

Info

Publication number
EP2178486A2
EP2178486A2 EP08807276A EP08807276A EP2178486A2 EP 2178486 A2 EP2178486 A2 EP 2178486A2 EP 08807276 A EP08807276 A EP 08807276A EP 08807276 A EP08807276 A EP 08807276A EP 2178486 A2 EP2178486 A2 EP 2178486A2
Authority
EP
European Patent Office
Prior art keywords
oxygen
absorber
packaging kit
container
kit according
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.)
Withdrawn
Application number
EP08807276A
Other languages
German (de)
English (en)
Inventor
Rahul Bhargava
Romi Singh
Rajeev Shanker Mathur
Benoit Portier
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.)
Airsec SAS
Ranbaxy Laboratories Ltd
Original Assignee
Airsec SAS
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 Airsec SAS, Ranbaxy Laboratories Ltd filed Critical Airsec SAS
Publication of EP2178486A2 publication Critical patent/EP2178486A2/fr
Withdrawn legal-status Critical Current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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers

Definitions

  • This invention relates to a packaging kit comprising a sealed oxygen impermeable container comprising a statin and at least one stabilizer selected from the group consisting of an oxygen absorber, a moisture absorber or a combination thereof. It further relates to a packaging kit for a solid pharmaceutical composition of a statin comprising the statin composition and at least one stabilizer selected from the group consisting of an oxygen absorber, a moisture absorber or a combination thereof in an oxygen impermeable container.
  • Statins are currently among the most therapeutically effective drugs available for reducing the level of LDL in the blood stream of a patient at risk for cardiovascular disease. Statins are also known to raise HDL cholesterol levels and decrease total triglyceride levels. The mechanism of action of statins has been elucidated in some detail. It is believed that statins disrupt the biosynthesis of cholesterol and other sterols in the liver by competitively inhibiting the 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase enzyme ("HMG-CoA reductase"). HMG-CoA reductase catalyzes the conversion of HMG-CoA to mevalonate, which is the rate determining step in the biosynthesis of cholesterol. Consequently, its inhibition leads to a reduction in the rate of formation of cholesterol in the liver.
  • HMG-CoA reductase catalyzes the conversion of HMG-CoA to mevalonate, which is the rate determining step in the biosynthesis of cholesterol. Consequently, its inhibition leads to
  • the main statins currently used in therapeutics are: pravastatin, simvastatin, lovastatin, fluvastatin, atorvastatin and rosuvastatin.
  • lovastatin, simvastatin and pravastatin are fully or partially fermentation based products, whereas fluvastatin, rosuvastatin and atorvastatin are entirely synthetic.
  • Simvastatin is a chemically modified 2,2-dimethyl- butyrate analogue of lovastatin.
  • Pravastatin is a purified active metabolite of mevastatin with an open hydroxyacid instead of a lactone ring.
  • statins are relatively unstable, and their degradation may be catalyzed by several parameters like oxygen, humidity, low pH and temperature. These statins are known to occur in various crystalline as well as amorphous forms. However, amorphous forms may be susceptible to oxidation, heat, light, moisture and low pH, as compared to crystalline forms. Impurities generated upon degradation of active substances may reduce the therapeutic effects of an active substance and unnecessarily burden the body with degradation products. For example, oxidative degradation of atorvastatin may lead to impurities such as Atorvastatin diepoxide, dihydroxy epoxide or diketoepoxide.
  • a packaging kit comprising a sealed oxygen impermeable container comprising a statin and at least one stabilizer selected from the group consisting of an oxygen absorber, a moisture absorber or a combination thereof.
  • a packaging kit for a solid pharmaceutical composition of a statin comprising a sealed oxygen impermeable container comprising said composition and at least one stabilizer selected from the group consisting of an oxygen absorber, a moisture absorber or a combination thereof.
  • a method of stabilizing a statin by packaging said statin in a sealed oxygen impermeable container along with at least one stabilizer selected from the group consisting of an oxygen absorber, a moisture absorber or a combination thereof.
  • a method of stabilizing pharmaceutical composition comprising a statin by packaging said composition in a sealed oxygen impermeable container along with at least one stabilizer selected from the group consisting of an oxygen absorber, a moisture absorber or a combination thereof.
  • statin refers to any crystalline or amorphous form of pravastatin, simvastatin, rosuvastatin, lovastatin, fluvastatin, atorvastatin and cerivastatin.
  • Pharmaceutically acceptable base addition salts of statins are formed with metals or amines, such as alkali and alkaline earth metals or organic amines. Examples of metals used as cations are sodium, potassium, magnesium, calcium, and the like. Examples of suitable amines are N, N-1-dibenzylethylenediamine, chloroprocaine, choline, diethanolamine, dicyclohexylamine, ethylenediamine, N-methylglucamine, and procaine.
  • oxygen impermeable means a material having an oxygen permeability of less than 5 cm 3 /sqm.day.atm, more particularly 2 cm 3 /sqm.day.atm.
  • the container as used herein include air-tight drums or bottles made up of oxygen impermeable material such as glass or plastic such as polyvinyl chloride, polyethylene terpthalate, ethylene vinylalcohol.
  • Multilayer containers containing polyvinyl chloride, polyethylene terpthalate, ethylene vinylalcohol may additionally comprise layers of oxygen permeable materials for example, polyethylene such as HDPE (high density polyethylene), LDPE (low density polyethylene), polypropylene or polystyrene, however the oxygen barrier properties should not be altered.
  • Glass container is tamper-proof, transparent, impermeable to gas and resistant to any interaction between containers and the content, and hence provides a total product safety. Also, for products which are light sensitive amber glass may be used which further protects the product from harmful UV light.
  • Ethylene vinyl alcohol provides excellent oxygen impermeability, however, it is moisture sensitive, hence a multilayer container may be used wherein ethylene vinyl alcohol may be coextruded with polyethylene or polypropylene, wherein polyethylene or polypropylene help to overcome moisture sensitivity by acting as a barrier to moisture. Coextrusion with polyethylene provides additional advantage of providing transparent container.
  • This coextruded layer comprising ethylene vinylalcohol sandwiched between two layers of HDPE having a total thickness of 1.3 mm was found to have oxygen permeability of 0.45 cm 3 /sqm.day.atm as measured according to ASTM Fl 307 (American Society for Testing and Materials).
  • Coextruded layer with polyethylene terpthalate as disclosed US 6,521,159 may also be used.
  • the container may be sealed using heat induction seal wherein the sealing liner is additionally made up of oxygen impermeable film such as aluminum.
  • oxygen absorbers means agents used to trap oxygen that is present in the overhead space of closed container. Concerning the chemical and physical mechanisms of active oxygen absorbers, they can be classified into the following categories:
  • Inorganic, metal-based oxygen absorbers are inexpensive, available with different 0 2 -scavenging capacities in sachets and are commonly used in foods and beverages.
  • the broadest range of iron-based products are offered by Mitsubishi Gas Chemicals AgelessTM. Similar products are also offered by Multisorb under the trade name Fresh PaxTM.
  • the reaction is based on the well-known corrosion of iron.
  • Another variant for oxygen absorbers is self- activated oxygen absorbers which involve combining moisture-retaining additives to metals such as iron.
  • Another modification of metal absorbers is "stealth absorbers", which is also based on corrosion of iron but the metal is embedded in an extendable plastic.
  • Ascorbic acid is a well-known preserving agent and may also be used as one of the options.
  • There are also available enzymatic oxygen absorber which are based on glucose/glucose oxidase.
  • Polymer based scavengers are suitable for moisture protected applications.
  • Polymer-based compounds consist of high molecular weight, ethylenically-unsaturated hydrocarbons.
  • An activation step often enables the user to start the oxygen scavenging when desired.
  • sachets include D Series FreshPaxTM (available from Multisorb Technologies Inc), AgelessTM Z (Ageless-Z is designated as Z-IOO, Z-1000, etc., to indicate the milliliters of oxygen with which a single packet will react), StabilOx D (available from Multisorb Technologies Inc) and ZPTJTM sachets (both available from Mitsubishi Gas Corporation), O-BusterTM (available from Hsiao Sung Non-Oxygen Chemical Co., Ltd), BiokaTM Oxygen Absorber (available from Bioka Ltd) and the like.
  • the moisture absorbers include activated carbon, silicas, zeolites, molecular sieves, hydrogels, calcium oxide and diatomaceous earth.
  • the particular moisture -retaining materials used will depend upon the humidity level of the environment. For example, in a very low-humidity environment, a moisture-carrying material such as a hydrogel that partially binds water may be preferred.
  • the moisture absorber can be supplied in the form of a sachet, cartridge or canister.
  • a preferred form is a canister of silica gel, such as SorBitTM (commercially supplied by Sud-Chemie Corporation).
  • Multisorb provides variety of moisture absorbers under trade name of Natrasorb M, Natrasorb S, Natrasorb C, and Hi-dry, which comprise diatomaceous earth, silica gel, calcium oxide and molecular sieve, respectively.
  • packets or sachets which comprise a combination of oxygen absorber and moisture absorber such as Pharmakeep oxygen- and moisture-absorbing packets (PharmaKeep KD or KC) (distributed jointly by
  • combination of oxygen absorber and moisture absorber can be used together in a packaging kit.
  • Oxygen absorbers usually lead to an increase in moisture levels, hence a combination of moisture absorber and oxygen absorber will regulate moisture levels as well as oxygen levels.
  • the moisture/oxygen absorber may be in the form of packet, sachet, strips or canisters.
  • the packet, sachet, strips or canisters may additionally comprise a moisture- indicating card.
  • a packaging kit for a statin can be obtained by
  • statin and oxygen absorber and/or a moisture absorber into a oxygen impermeable drum
  • a packaging kit for a solid pharmaceutical composition comprising statin is obtained by:
  • composition i) putting the composition into impermeable bottle along with an oxygen absorber and/or a moisture absorber;
  • composition as used herein includes both immediate and extended release compositions.
  • the statin may be present in the composition between 1% to about 50% by weight of the composition.
  • the solid pharmaceutical composition includes tablet, capsule, pills, dry powder, dragees or granulate.
  • composition may further contain other pharmaceutically acceptable excipients, such as antioxidants, chelating agents, alkali metal salt additives, alkaline earth metal salt additives, binders, diluents, disintegrants, surfactants or lubricants.
  • suitable pharmaceutically acceptable antioxidants may include butylated hydroxyanisole (BHA), sodium ascorbate, butylated hydroxytoluene (BHT), sodium sulfite, propyl gallate, tocopherol, citric acid, malic acid, and ascorbic acid.
  • the chelating agents may be selected from amongst one or more of those suitable chelating agents known in the art.
  • suitable chelating agents include disodium edetate (EDTA).
  • EDTA disodium edetate
  • the chelating agents can be present at a concentration of up to approximately 5% by weight of the composition.
  • Alkali metal salt additives may be, for example, one or more of sodium carbonate, sodium hydroxide, sodium silicate, disodium hydrogen orthophosphate, sodium aluminate or other suitable alkali metal salts.
  • the stabilizing alkali metal salt additive may be, for example, sodium carbonate or disodium hydrogen orthophosphate, although the other alkali metal salt additives may also be selected.
  • Alkaline earth metal salt additives can include one or more of calcium carbonate, calcium hydroxide, magnesium carbonate, magnesium hydroxide, magnesium silicate, magnesium aluminate, and aluminum magnesium hydroxide.
  • the binders may be, for example, one or more binders known in the art.
  • suitable binders include starch, polyvinyl pyrrolidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and carboxymethylcellulose.
  • the diluents may be, for example, one or more diluents known in the art.
  • Suitable diluents include lactose, mannitol, pregelatinized starch, microcrystalline cellulose, corn starch, sucrose, and silicic anhydride.
  • the disintegrant may be, for example, one or more disintegrants known in the art.
  • disintegrants include croscarmellose sodium, crospovidone, sodium starch glycolate and starch.
  • the surfactants may be, for example, one or more surfactants known in the art.
  • surfactants include polysorbate 80, polyoxyethylene sorbitan, polyoxyethylene-polyoxypropylene copolymer, and sodium lauryl sulphate.
  • the lubricants may be, for example, one or more lubricants known in the art.
  • lubricants examples include magnesium stearate, stearic acid, palmitic acid and talc.
  • the glidants may be, for example, one or more glidants known in the art.
  • An example of a pharmaceutically acceptable glidant includes colloidal silicon dioxide.
  • the pharmaceutical composition may be prepared by a wet or dry granulation technique or by a direct compression technique.
  • the composition may be optionally coated with film forming polymers and/or coating additives.
  • the coating may be, for example, one or more coating materials known in the art.
  • the coating material can be Opadry or Opadry AMB (aqueous moisture barrier).
  • a composition of amorphous statin may be prepared by formula and method given in the PCT application WO 03/068191 Example 2 as follows.
  • the amorphous atorvastatin was milled to reduce its mean particle size dso to approximately 20-50 ⁇ m and dgo to approximately 80-100 ⁇ m.
  • Butylated hydroxy anisole (0.12 mg/tablet) and butylated hydroxy toluene (0.12 mg/tablet) were dissolved in isopropyl alcohol and applied on to lactose under high shear mixing.
  • the lactose was dried at 40-45 0 C in a fluidized bed dryer.
  • Amorphous atorvastatin (80 mg/tablet), microcrystalline cellulose (300 mg/tablet) and lactose (628 mg/tablet) were mixed.
  • composition 2 Following the mixing, the dry binder, hydroxypropyl cellulose-L, (24 mg/tablet) and disintegrant, croscarmellose sodium, (72 mg/tablet) were added to the mixture. Following this addition, an alkali metal salt, sodium carbonate (52 mg/tablet), surfactant, sodium lauryl sulphate (2 mg/tablet), and colloidal silicon dioxide (24 mg/tablet) were added. Next, the mixture was lubricated with magnesium stearate (12 mg/tablet) and compressed into tablets. The tablets then were coated with Opadry AMB. The values given above are per tablet and can be adjusted appropriately to provide the desired batch size. Composition 2
  • composition may be prepared by the formula and method given below:
  • microcrystalline cellulose, pregelatinized starch and colloidal silicon dioxide were passed through a screen and transferred to a rapid mixer granulator.
  • step 1 was added to the bulk of step 2 and mixed.
  • the wet mass was dried at 40 C - 45 C in a fluidized bed drier and passed through a sieve.
  • Atorvastatin calcium, sodium lauryl sulphate and hydroxypropylcellulose were passed through the screen of a quadro comil.
  • step 5-7 were added to the blend of step 8 and mixed together.
  • step 4 was added to the blend of step 9 and mixed together.
  • step 10 The blend of step 10 was lubricated with magnesium stearate and compressed into tablets.
  • step 11 The compressed tablets of step 11 were coated with a dispersion of Opadry AMB in water.
  • Bottle - Multilayered bottle made up of ethylene vinyl alcohol in between two layer of polyethylene having a total thickness of 1.3 mm.
  • Atorvastatin tablets of Composition 1 were packaged in following packaging options:
  • Tablets and moisture absorber were packaged into multilayered bottle.
  • Tablets and oxygen absorber were packaged into multilayered bottle.
  • Atorvastatin tablet composition 2 along with moisture absorber were packaged into impermeable multilayered bottle.
  • Bottled compositions of Example 1 (option 3) and Example 2 were subjected to stability studies at 40° C and 75% RH.
  • the stability studies indicate the atorvastatin tablets are stable under the given stability conditions when packaged as per the present invention.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (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)
  • Food Science & Technology (AREA)
  • Mechanical Engineering (AREA)
  • Emergency Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un nécessaire de conditionnement comportant un récipient imperméable à l'oxygène scellé comprenant une statine et au moins un stabilisant choisi dans le groupe constitué d'un absorbeur d'oxygène, d'un absorbeur d'humidité ou d'une combinaison de ceux-ci. Elle concerne, en outre, un nécessaire de conditionnement pour une composition pharmaceutique solide à base de statine comprenant la composition et au moins un stabilisant choisi dans le groupe constitué d'un absorbeur d'oxygène, d'un absorbeur d'humidité ou d'une combinaison de ceux-ci dans un récipient imperméable à l'oxygène.
EP08807276A 2007-08-09 2008-08-09 Nécessaire de conditionnement pour statines et compositions à base de celles-ci Withdrawn EP2178486A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1698DE2007 2007-08-09
PCT/IB2008/053200 WO2009019668A2 (fr) 2007-08-09 2008-08-09 Nécessaire de conditionnement pour statines et compositions à base de celles-ci

Publications (1)

Publication Number Publication Date
EP2178486A2 true EP2178486A2 (fr) 2010-04-28

Family

ID=40185008

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08807276A Withdrawn EP2178486A2 (fr) 2007-08-09 2008-08-09 Nécessaire de conditionnement pour statines et compositions à base de celles-ci

Country Status (2)

Country Link
EP (1) EP2178486A2 (fr)
WO (1) WO2009019668A2 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7867511B2 (en) 2004-01-23 2011-01-11 Travanti Pharma Inc. Abuse potential reduction in abusable substance dosage form
EP2748000B1 (fr) * 2011-09-05 2020-11-18 Siegfried Ltd. Matériau de conditionnement pour produit pharmaceutique ou nutraceutique solide
JP2014528276A (ja) * 2011-09-30 2014-10-27 テイコク ファーマ ユーエスエー インコーポレーテッド 一般用医薬品廃棄システム
WO2013049380A1 (fr) 2011-09-30 2013-04-04 Teikoku Pharma Usa, Inc. Système d'élimination de timbres cutanés
US11389844B2 (en) 2018-03-20 2022-07-19 Verde Environmental Technologies, Inc. Blister pack disposal system

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU639379B2 (en) * 1990-11-07 1993-07-22 Otsuka Pharmaceutical Factory, Inc. Multi-chamber vessel
AU669773B2 (en) * 1993-01-22 1996-06-20 Otsuka Pharmaceutical Factory, Inc. Bicarbonate-containing powdered medicine storage container and method of stabilizing the same medicine
JP3419139B2 (ja) * 1995-04-11 2003-06-23 ニプロ株式会社 可撓性複室容器
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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2009019668A3 *

Also Published As

Publication number Publication date
WO2009019668A3 (fr) 2009-04-02
WO2009019668A2 (fr) 2009-02-12

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