EP1836101A2 - Non-tearable child resistant blister package - Google Patents
Non-tearable child resistant blister packageInfo
- Publication number
- EP1836101A2 EP1836101A2 EP06718280A EP06718280A EP1836101A2 EP 1836101 A2 EP1836101 A2 EP 1836101A2 EP 06718280 A EP06718280 A EP 06718280A EP 06718280 A EP06718280 A EP 06718280A EP 1836101 A2 EP1836101 A2 EP 1836101A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- blister
- package
- sheet
- recess
- dosage form
- 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- Withdrawn
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
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
- B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
- B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
- B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
- B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
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- 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
- B65D2215/00—Child-proof means
- B65D2215/04—Child-proof means requiring the combination of different actions in succession
-
- 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
- B65D2575/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
- B65D2575/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by association or interconnecting two or more sheets or blanks
- B65D2575/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
- B65D2575/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
- B65D2575/3209—Details
- B65D2575/3218—Details with special means for gaining access to the contents
- B65D2575/3227—Cuts or weakening lines
- B65D2575/3236—Cuts or weakening lines for initiating or facilitating subsequent peeling off of the non-rigid sheet
Definitions
- Standard dosage forms are typically packaged in blister packages, which are comprised of multi-layered sheets of material having pockets, blisters or wells for containing the dosage forms .
- blister packages are comprised of multi-layered sheets of material having pockets, blisters or wells for containing the dosage forms .
- One type of conventional blister packages include packages having a foil layer through which a user of the package must push the tablet , thereby breaking the foil .
- An example of such a conventional blister package is shown in U. S . Pat . No . 4, 158 , 411 to Hall et al . , the disclosure of which is hereby incorporated by reference herein. While this type of package is sufficient for packaging standard dosage forms , packaging of frangible dosage forms in such a package would cause damage to the frangible dosage form when attempting to push it through the foil layer .
- These types of packages are also generally not child proof .
- Another concern with the packaging of pharmaceutical dosage forms relates to safety.
- Child proof or child resistant packaging is often very desirable for the packaging of dosage forms .
- a big concern with having medication in the home is the possibility of a child gaining access to it .
- certain medications would be deadly to a child if consumed, even in small quantities .
- packaging is often rated based upon the number of children who can gain access to the drug in five minutes .
- One example of testing procedure standards for achieving ratings such as this are set forth in 16 C . F . R . ⁇ 1700.20.
- the present invention relates to packages including but not limited to packages for frangible pharmaceutical dosage forms or tablets , more particularly, the packages invented are non-tearable child resistant packages that require the cutting of the package with a scissor to expose a flap allowing for the package to be opened and its contents removed.
- a first aspect of the present invention is a non- tearable blister package for frangible or non-frangible pharmaceutical dosage forms .
- the package preferably includes a unitary blister sheet defining a plurality of unit package regions , each unit package region including a recess having an open top and a flange surrounding the recess . Each recess may accommodate one or more dosage forms .
- the package also includes a unitary sheet of lidding material peelably sealed to the flanges .
- the blister sheet and the sheet of lidding material define unsealed areas for facilitating peeling of the lidding material from the blister sheet . The unsealed areas are only accessible by cutting at least a portion of the blister package .
- the blister package is constituted of materials and configured to retard access through tearing or chewing, especially by children.
- the blister sheet and/or lidding material includes indicia indicating that the blister must be cut with a scissors or other similar devices .
- the blister package is designed to reduce breakage of a frangible or friable tablet housed therein.
- the frangible dosage forms disposed in each recess of the preferred blisters preferably engages the walls of each recess so that the walls hold the dosage form away from the bottom of the recess and adjacent the lidding material .
- This aspect protects the dosage form from damage by preventing shifting of the dosage form during transport .
- An empty space between each dosage form and the bottom of the recess in which the dosage form is disposed cushions the dosage form from impact when the package is dropped.
- the recesses of the package and the dosage forms disposed in the recesses may have essentially any shape .
- the dosage forms may be disk-shaped tablets, oblong capsules or square-shaped pills .
- shapes for recesses include circular, oblong, polygonal or star shapes in the plane of the blister sheet .
- the walls and bottom of the recesses may define a shape in the form of a surface of revolution, about a vertical axis normal to the flange surrounding each of the recesses .
- the recesses may have a curved, cup- like shape .
- the dosage forms may be disc-shaped, they may- each have an edge which contacts the walls of the recess in which each dosage form is disposed.
- the edge and walls preferably define an annular region of contact coaxial with the vertical axis of the recess .
- the edge of such a disc-shaped dosage form may comprise a bevel which contacts the walls of the recess . This annular region of contact may prevent shifting of the dosage form within the blister and the damage to the dosage form associated with such shifting .
- the packaging can be rated as a highly child resistant package such as packages generally referred to in the industry as "F4 " , "F3 " , “F2 “ or “Fl” .
- F4 packages generally referred to in the industry as "F4 " , "F3 " , “F2 " or "Fl” .
- These monikers are given to packages that pass certain tests relating to how many children can gain access to the dosage forms housed in the packages in a certain amount of time .
- the number following the "F” refers to the number of tablets that would cause serious personal injury or serious illness to a twenty five pound child if ingested .
- one such test begins with a base of fifty children, their goal being to access the dosage form housed in the package .
- the children are first given the packages without instructions to access the dosage forms , and are given five minutes to attempt to gain access . After the five minutes expires , the children are asked to stop, at which point they are shown the proper steps to take in order to gain access to the dosage forms . Thereafter, the children are given an additional five minutes to work with the package . According to this one test , an Fl package would be one in which no more than five children can gain access to one pill during the ten minute period. A package would be given the F2 label if no more than five children can gain access to two pills . And, an F3 package would be one in which no more than five children can gain access to three pills in the ten minute period.
- Another aspect of the present invention is a method of removing a dosage form from a blister package .
- the method according to this aspect includes providing a blister package having a blister sheet defining a plurality of unit package regions, each unit package region including a recess having an open top and a flange surrounding the recess and a unitary sheet of lidding material peelably sealed to the flanges , the blister sheet and the sheet of lidding material defining unsealed areas for facilitating peeling of the lidding material from the blister sheet , where the unsealed areas are only accessible by cutting at least a portion of the blister package .
- the method also includes the steps of cutting at least a portion of the blister package to reveal at least one of the unsealed areas , peeling away at least a portion of the lidding material to reveal at least one dosage form disposed in the recess , and removing the at least one dosage form from the recess .
- the blister package is constructed of materials and configured to retard access through tearing, chewing, puncture , etc . especially by children .
- the blister sheet and/or lidding material includes indicia indicating that the blister must be cut with a scissors or other similar device .
- the blister package is designed to reduce breakage of a frangible or friable tablet housed therein .
- Another embodiment of the present invention is another method of removing a dosage form from a blister package .
- the method according to this embodiment includes providing a blister sheet including unit package regions and a lidding sheet for sealing the unit package regions, the lidding sheet including peelable and non-peelable areas, the non- peelable areas surrounding the package periphery.
- the method also may include the step of accessing the peelable areas with a cutting instrument , such as scissors .
- FIG. 1 is a bottom plan view of the blister package according to the present invention.
- FIG. 2 is top a plan view of the blister package of FIG. 1.
- FIG. 3 is a cross-sectional side view of a unit package region of the blister package taken along line A-A of FIG . 1.
- FIG. 4 is a top plan view of the blister package according to another embodiment of the present invention.
- FIG. 5 is a bottom plan view of the blister package according to yet another embodiment of the present invention. DETAILED DESCRIPTION
- FIGS . 1-3 A non-tearable child resistant blister package 10 in accordance with an embodiment of the present invention is shown in FIGS . 1-3.
- the blister package 10 shown is non-tearable, to create a child resistant container for tablets that requires the cutting of specific portions in order to access the dosage forms contained therein.
- Blister package 10 includes a blister sheet 12 and a lidding material sheet 14. It is contemplated that blister package 10 can be designed so that the cutting may be performed with the use of ordinary scissors , or other common cutting devices .
- the overall design of blister package 10 prevents easy access of often highly dangerous and poisonous dosage forms , by children or the like .
- at least one of the blister sheet 12 or the lidding sheet 14 will not include a structure at its edge (the periphery of the package) , which facilitate tearing such as indentations , cuts , scores or the like .
- the edge may be thickened or reinforced to retard tearing .
- at least one of the lidding material or the blister sheet may be composed of materials that will be difficult to tear.
- the thickness of the lidding material or the blister sheet may also play a role .
- blister sheet 12 may be constructed of material supplied by Alcan Pharma Center of Shelbyville, KY ( “Alcan” ) and offered as PCS technical and material specification no . 92011 ( “the 92011 material " ) having a thickness of approximately 205 ⁇ m.
- the 92011 material includes several different individual layers , for example, approximately 60 ⁇ m of PVC film, approximately 25 ⁇ m of polyamide film, approximately 60 ⁇ m of aluminum foil and approximately 60 ⁇ m of additional PVC film, which are preferably at least joined together by suitable adhesives .
- Lidding material sheet 14 may be constructed of PCS technical and material specification nos . 15144 having a thickness of approximately 37 ⁇ m or 15127 having a thickness of approximately 37 ⁇ m.
- Both of these materials are also supplied by Alcan, and preferably include a paper layer, an approximately 12 ⁇ m thick polyester film, an approximately 25 ⁇ m thick aluminum foil layer and a heat seal coating .
- Alcan adhesive supplied under the No . 4516 one can obtain a so-called "Fl" package using the construction illustrated in Figure 5 and the materials described above .
- the package depicted in Figure 5 may have a length of approximately of one hundred (100) mm, and most preferably 104 mm, and a width of approximately sixty (60 ) mm, and most preferably 68 mm.
- certain materials may be tearable if they are thin enough.
- Non-tearable blister package 10 is formed by blister sheet 12 and lidding material sheet 14 shown in FIGS . 1 and 2 , respectively.
- Blister sheet 12 includes a plurality of unit package regions 16 , each unit package region including a recess 18 and a flange 20 surrounding the recess (shown in FIGS . 1 and 3 ) .
- Blister sheet 12 includes six package regions 16 , although any number of package regions 16 can be included .
- each recess 18 is dimensioned and configured to house a tablet 1, and includes an open top 22 and a closed bottom 24.
- recesses in accordance with the present invention will be circular and one (1) inch in diameter or less , preferably three quarters (3/4) of an inch or less, more preferably eleven sixteenths (11/16) of an inch or less , and most preferably one half (1/2 ) of an inch are less .
- larger recesses are indeed possible, such larger recesses may make rupture by biting or puncture easier .
- Blister sheet 12 also includes raised areas 26 and 28.
- Raised and/or unsealed area 26 further includes raised finger sections 30 , 32 , and 34
- raised and/or unsealed area 28 further includes raised finger sections 36 , 38 , and 40.
- the terms raised and unsealed are used interchangeably throughout .
- Raised connection section 42 connects raised areas 26 and 28 together, thereby creating a continuous raised section between each of the raised areas and their respective finger sections .
- none of the raised areas and/or finger sections extends to any of the edges of blister sheet 12. This creates a blister package 10 that is non- tearable . It is contemplated that the particular size and/or shape of the same may vary in different embodiments .
- These raised areas will be discussed further below in the discussion relating to removing lidding material .
- Lidding material sheet 14 is a unitary sheet that overlies recesses 18 and is peelably attached to flanges 20 , thereby covering tablets 1 housed in the recesses . It is contemplated that lidding material sheet 14 may be attached to flanges 20 through the use of an adhesive, for example , certain embodiments utilize adhesive supplied by Alcan under the number 4563 or the aforementioned 4516. However, it is also contemplated that other modes of attaching lidding material sheet 14 to flanges 20 can be utilized, and that the strength of the attachment mode can be varied to determine the difficulty required to remove the lidding material .
- Cut lines 44 may also be welded indicia and are designed to instruct a user on where to cut in order to create individual lidding sections 46. These individual lidding sections 46 are configured so that they correspond to unit package regions 16. Cutting along cut lines 44 , creates a separated unit package region 16 with a corresponding lidding section 46 attached thereto, as is best shown in FIG . 3.
- Lidding material sheet 14 may further include cutting indicia 48 , which along with cut lines 44 , instructs a user on how and where make the various cuts .
- the indicia may be written instructions or symbols .
- Lidding sheet may also include peeling indicia 50 that instructs a user where and how to peel away lidding section 46 from its corresponding unit package region 16.
- blister package 10 may include reinforced areas 60 cut on adjacent edges thereof to provide further tear resistance . These may be regions of increased thickness , embossed or glued on structures and the like .
- FIG. 3 depicts raised area 26 , however, it is noted that the separation of other unit package regions 16 from the other unit package regions 16 may allow for any raised area or section to become accessible .
- raised area 26 creates a non-attached region between blister sheet 12 and lidding material sheet 14. Essentially, the raised areas prevent peelable attachment of lidding sheet 14 to blister sheet 12 along the entire area of the given raised areas , and thus create areas where a user can grasp the lidding material and peel it away.
- the aforementioned raised finger sections provide additional unsealed areas that may allow for the easier pealing away of the lidding material along different lengths of the unit package region.
- the embodiment shown in FIGS . 1 and 2 is configured so that the cutting of individual unit package regions 16 and corresponding lidding sections 46 away from blister package 10 may allow for the easy accessibility to dosage forms stored in more than a single recess 18. In other words , the embodiment depicted in FIGS .
- blister package 110 is provided having a different configuration from that of blister package 10.
- Blister package 110 may include a blister sheet similarly configured to that of blister package 10.
- lidding sheet 114 includes differently arranged cut lines 144 , thus creating differently arranged lidding sections 146.
- Lidding sheet 114 may also include cutting indicia 148 and peeling indicia 150 , similar to that of blister sheet 14.
- Cut lines 144 are arranged so that the cutting away of a single unit package region only allows for the peeling away of the lidding section 146 corresponding to that particular unit package region. As shown in FIG. 4 , cutting away of the individual unit package regions leaves a remainder section 152. In certain embodiments , remainder sections 152 extend around the raised fingers of blister sheet 12. This , in turn, prevents the peeling away of other lidding sections 146 , as after cutting away the unit package region, only a portion of the raised area, and none of the raised finger, is accessible to a user .
- blister sheets that are configured in such a manner so as to allow for both a raised area and a finger area to be accessed upon the removal of the lidding section 146. Essentially, these blister sheets would provide a configuration that compliments lidding sheet 114.
- the design of blister package 10 may also provide protection for frangible dosage forms by including recesses 18 that cooperate with such dosage forms to prevent shifting of the frangible dosage forms during transport and/or cushioning in the event of impact from the dropping of the package .
- the ' 423 patent discloses a blister package having a peelable layer which when pealed away allows for access to the dosage form. Therefore, the ' 423 patent provides a user accessibility to his or her frangible dosage form without the possibility of damaging the dosage form.
- the blister package of the ' 423 is also designed to help protect the tablet during storage , shipment and use .
- the present invention may utilize a similar design.
- frangible dosage forms may be disposed in each recess 18 of blister sheet 12 such that the dosage forms engage the walls of each recess 18 , and the walls hold the dosage form away from closed bottom 24 of recess 18 and adjacent lidding material 14.
- This aspect protects the dosage form from damage by preventing shifting of the dosage form during transport .
- An empty space between each dosage form and closed bottom 24 of the recess 18 in which the dosage form is disposed cushions the dosage form from impact if and when package 10 is dropped or otherwise jarred.
- Recesses 18 and the corresponding dosage forms disposed in recesses 18 may, have essentially any shape .
- the dosage forms may be disk-shaped tablets , oblong capsules or square-shaped pills .
- shapes for recesses 18 include circular, oblong, polygonal or star shapes in the plane of the blister sheet .
- the walls and closed bottom 24 of recess 18 may define a shape in the form of a surface of revolution, about a vertical axis normal to flange 20 surrounding each of the recesses 18.
- recesses 18 may have a curved, cup-like shape .
- the dosage forms are disc-shaped, they may each have an edge which contacts the walls of recess 18 in which each dosage form is disposed.
- the edge and walls define an annular region of contact coaxial with the vertical axis of recess 18.
- the edge of such a disc-shaped dosage form may comprise a bevel which contacts the walls of recess 18. The annular region of contact prevents shifting of the dosage form within the blister and the damage to the dosage form associated with such shifting .
- the tablet packaging according to the present invention is designed to be child resistant .
- the packaging can be rated as a highly child resistant package or better .
- tablet package 10 is designed to prevent a relatively high amount of children from accessing the drug in a given time .
- Certain embodiments according to the present invention may be rated as high as the well known industry standard known as Pl packaging, as discussed above .
- Other embodiments may achieve an F2 or F3 rating .
- Different embodiments are therefore envisioned for housing different types of dosage forms . While the present invention has been discussed with respect to frangible or friable dosage forms , it is also contemplated that other types of dosage forms may also be housed. Of course, it is noted that a user should select proper packaging for the particular active .
- blister sheet 12 is then preferably moved to a sealing station where upper and lower sealing plates may be utilized to seal lidding material 14 to blister sheet 12.
- the aforementioned sealing plates preferably utilize heat and pressure over the course of a certain dwell time (cycles/speed) to heat a suitable adhesive (like those described above) to seal lidding material 14 to blister sheet 12.
- desired perforations may be formed in the package, and individual blister cards 10 (with multiple recesses 18) may be punched out . It is noted that the formed perforations may be useful in this punch out procedure , but may also remain in the final blister package 10 as discussed above .
- the individual packages 10 are preferably delivered to final packaging stations via conveyors or the like .
- the dosage forms usually tablets , which can be packaged using the present invention are not at all limited by the type of tablet or the type of active pharmaceutical ingredient ( "API " ) used therein .
- API ' s include, without limitation, analgesics , anti-inflammatories, antipyretics , antibiotics, antimicrobials, anxiolytics, laxatives, anorexics, antihistamines , antidepressants , antiasthmatics , antidiuretics , antiflatuents , antimigraine agents , antispasmodics , sedatives , antihyperactives , antihypertensives , tranquilizers , decongestants, beta blockers , peptides , proteins , oligonucleotides and other substances of biological origin, and combinations thereof .
- Mantelle U. S . Pat . No . 5 , 234 , 957 , in columns 18 through 21. That text of Mantelle is hereby incorporated by reference .
- Any of the forgoing API ' s can be used in the form of any salt , hydrate, solvate, polymorph, or individual optical isomer, and any mixture thereof .
- opiates drugs used to treat pain, drugs used in psychiatry or in the treatment of schizophrenia, such as clozapine and cytotoxic substances are particularly preferred.
- any API which is intended to treat the elderly or any API which requires the use of a childproof package, and more particularly an "Fl" package .
- Legal opiates which may be packaged according to the invention include prescription drugs such as , without limitation, alfentanil , alphaprodine , anileridine , benzylmorphine, bezitratnide, buprenorphine, butorphanol, clonitazene, codeine , codeine phosphate, desomorphine, dextromoramide, dezocine , diampromide, dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol , dimepheptanol , dimethylthiat ⁇ butene , dioxaphetyl butyrate , dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine , etonitazene, fentanyl , hydrocodone, hydromorphone , hydroxypethidine,
- the class of compounds generally known as opiates also includes illicit drugs such as heroin and ***e .
- Opiates in accordance with the present invention include those identified above as well as any listed as controlled substances pursuant to 21 C . F . R. ⁇ 1308.12. Opiates are given to patients for a variety of reasons, most frequently for pain mitigation of one type or another .
- a cytotoxic substance includes any agent that kills cells . These substances are generally used in the treatment of malignant and other diseases . They are designed to destroy rapidly growing cancer cells . They have been shown to be mutagenic , carcinogenic and/or teratogenic, either in treatment doses or animal and bacterial assays . Cytotoxic drugs that interfere with critical cellular processes including DNA, RNA, and protein synthesis, have been conjugated to antibodies and subsequently used for in vivo therapy.
- Such drugs include, but are not limited to : [0037] i) intercalating agents , in particular doxorubicin (Adriamycin) , daunorubicin, epirubicin, idarubicin, zorubicin, aclarubicin, pirarubicin, acridine, mitoxanthrone, actinotnycin D, eptilinium acetate;
- intercalating agents in particular doxorubicin (Adriamycin) , daunorubicin, epirubicin, idarubicin, zorubicin, aclarubicin, pirarubicin, acridine, mitoxanthrone, actinotnycin D, eptilinium acetate;
- alkylating agents chosen from platinum derivatives (cisplatin, carboplatin, oxaliplatin) ; [0039] iii) a compound chosen from the other groups of alkylating agents : cyclophosphamide, ifosfamide, chlormetrine, melphalan, chlorambucil , estramustine, busulfan, mitomycin C, nitrosoureas : BCNU (carmustine) , CCNU (lomustine) , fotemustine, streptozotocin, triazines or derivatives : procarbazine, dacarbazine, pipobroman, ethyleneimines : altretamine, triethylene-thio-phosphoramide,
- anti- metabolic agents antifolic agents : methotrexate , raltitrexed, antipyrimidine agents : 5-fluorouracil (5-FU) , cytarabine (Ara- C) , hydroxyurea antipurine agents : purinethol , thioguanine , pentostatin, cladribine, cytotoxic nucleoside synthesis inducers : gemcitabine,
- a compound chosen from the other groups of tubulin-affinity agents vinca alkaloids which disrupt the mitotic spindle : vincristine, vinblastine, vindesine, navelbine, agents which block the depolymerization of the mitotic spindle : paclitaxel , docetaxel , agents which induce DNA cleavage by inhibition of topoisomerase II : etoposide , teniposide , topoisomerase I inhibitors which induce DNA cleavage : topotecan, irinotecan,
- a DNA splitting or fragmenting agent such as bleomycin
- an antiestrogen agent tamoxifen, droloxifen, raloxifen, aminoglutethimide ,
- a steroidal antiandrogenic agent eg cyproterone
- a non-steroidal antiandrogenic agent flutamide, nilutamide
- the dosage forms of the invention can, in addition or instead, include vitamins , minerals and dietary supplements .
- vitamin refers to trace organic substances that are required in the diet .
- vitamin (s) includes , without limitation, thiamine, riboflavin, nicotinic acid, pantothenic acid, pyridoxine, biotin, folic acid, vitamin B . sub .12 , lipoic acid, ascorbic acid, vitamin A, vitamin D, vitamin E and vitamin K.
- coenzymes are specific chemical forms of vitamins .
- Coenzymes include thiamine pyrophosphates (TPP) , flavin mononucleotide (FMM) , flavin adenine dinucleotide (FAD) , Nicotinamide adenine dinucleotide (NAD) , Nicotinamide adenine dinucleotide phosphate (NADP) , Coenzyme A (CoA) , pyridoxal phosphate, biocytin, tetrahydrofolic acid, coenzyme B . sub .12 , lipoyllysine, ll-cis-retinal , and 1 , 25- dihydroxycholecalciferol .
- TPP thiamine pyrophosphates
- FMM flavin mononucleotide
- FAD flavin adenine dinucleotide
- NAD flavin adenine dinucleotide
- NADP Nicotinamide adenine dinucleot
- vitamin (s) also includes choline, carnitine, and alpha, beta, and gamma carotenes .
- the term “mineral” refers to inorganic substances , metals, and the like required in the human diet .
- the term “mineral” as used herein includes , without limitation, calcium, (calcium carbonate) , iron, zinc, selenium, copper, iodine, magnesium, phosphorus, chromium and the like, and mixtures thereof .
- dietary supplement as used herein means a substance which has an appreciable nutritional effect when administered in small amounts .
- Dietary supplements include, without limitation, such ingredients as bee pollen, bran, wheat germ, kelp, cod liver oil, ginseng, and fish oils , amino-acids , proteins and mixtures thereof .
- dietary supplements may incorporate vitamins and minerals .
- the amount of active ingredient incorporated in each tablet or dosage form may be selected according to known principles of pharmacy.
- An effective amount of API is specifically contemplated.
- effective amount it is understood that , with respect , to for example, a “pharmaceutically effective amount” is contemplated.
- a “pharmaceutically effective amount” is the amount or quantity of a drug or API which is sufficient to elicit the required or desired therapeutic response, or in other words, the amount which is sufficient to elicit an appreciable biological response when administered to a patient .
- the term “effective amount” means an amount at least about 10% of the United States Recommended Daily Allowance ( "RDA” ) of that particular ingredient for a patient .
- RDA United States Recommended Daily Allowance
- an effective amount of vitamin C would include an amount of vitamin C sufficient to provide 10% or more of the RDA.
- the tablet includes a mineral or vitamin, it will incorporate higher amounts, preferably about 100% or more of the applicable RDA.
- the amount of active ingredient used can vary greatly. Of course, the size of the dosage form, the requirements of other ingredients , and the number of , for example, tablets which constitute a single dose will all impact the upper limit on the amount of pharmacologically active ingredient which can be used. However, generally, the active ingredient is provided in an amount of between greater than zero and about 80% by weight of the finished tablet and, more preferably, in a range of between greater than zero and about 60% by weight thereof . Put in other terms, the active ingredient can be included in an amount of between about 1 microgram to about 2 grams , and more preferably between about 0.01 and about 1000 milligrams per dosage form, i . e . , per tablet .
- the present invention enjoys wide industrial applicability including, but not limited to, providing packaging for medications , especially those in tablet form and frangible tablet form.
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- Packages (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Auxiliary Devices For And Details Of Packaging Control (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US64426305P | 2005-01-14 | 2005-01-14 | |
PCT/US2006/001188 WO2006076552A2 (en) | 2005-01-14 | 2006-01-12 | Non-tearable child resistant blister package |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1836101A2 true EP1836101A2 (en) | 2007-09-26 |
EP1836101A4 EP1836101A4 (en) | 2008-03-19 |
Family
ID=36678222
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP06718280A Withdrawn EP1836101A4 (en) | 2005-01-14 | 2006-01-12 | Non-tearable child resistant blister package |
Country Status (6)
Country | Link |
---|---|
US (1) | US20060278558A1 (en) |
EP (1) | EP1836101A4 (en) |
JP (1) | JP2008526639A (en) |
CA (1) | CA2593785A1 (en) |
MX (1) | MX2007008575A (en) |
WO (1) | WO2006076552A2 (en) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1836103B1 (en) * | 2005-01-14 | 2010-03-03 | Cima Labs Inc. | Child resistant tablet package |
JP5039434B2 (en) * | 2007-06-06 | 2012-10-03 | 住化農業資材株式会社 | Package to store coated seeds |
JP5150338B2 (en) * | 2008-03-31 | 2013-02-20 | 小林製薬株式会社 | Blister container |
EP2159164A1 (en) * | 2008-08-29 | 2010-03-03 | Alcan Technology & Management Ltd. | Container with peelable lid with protection against unauthorized opening |
JP5244553B2 (en) * | 2008-11-17 | 2013-07-24 | 日東電工株式会社 | Blister packaging |
JP2012144288A (en) * | 2011-01-14 | 2012-08-02 | Biofuerumin Seiyaku Kk | Impact resistive ptp package |
JP2013100128A (en) * | 2011-11-08 | 2013-05-23 | Omori Mach Co Ltd | Package body |
JP5997924B2 (en) * | 2012-04-18 | 2016-09-28 | 富士製薬工業株式会社 | Easy-open blister pack |
US9938075B2 (en) * | 2014-11-26 | 2018-04-10 | The Procter & Gamble Company | Beverage cartridge containing pharmaceutical actives |
CN106241044A (en) * | 2016-10-14 | 2016-12-21 | 上海海顺新型药用包装材料股份有限公司 | Easily take off cold stamping shaped aluminothermy sealing method |
HUE051758T2 (en) * | 2018-07-26 | 2021-03-29 | Uhlmann Pac Systeme Gmbh & Co Kg | Blister package for medical products and tool for producing the blister package |
DE202019101861U1 (en) * | 2019-04-01 | 2019-04-09 | Varta Microbattery Gmbh | Sales and supply pack of blister card type for button cells |
WO2023063326A1 (en) * | 2021-10-15 | 2023-04-20 | 株式会社村田製作所 | Package |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2000024647A1 (en) * | 1998-10-22 | 2000-05-04 | Novartis Ag | Child resistant package and method of dispensing medication |
US6155423A (en) * | 1997-04-01 | 2000-12-05 | Cima Labs Inc. | Blister package and packaged tablet |
WO2001002265A1 (en) * | 1999-07-06 | 2001-01-11 | Pago Limited | Blister packs |
US20030209461A1 (en) * | 2002-05-08 | 2003-11-13 | French Gary Stuart | Child-resistant blister pack |
Family Cites Families (23)
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US3811564A (en) * | 1972-07-12 | 1974-05-21 | Lehigh Press | Container construction |
US3924746A (en) * | 1972-07-12 | 1975-12-09 | Paco Packaging | Childproof package |
US3921805A (en) * | 1972-10-10 | 1975-11-25 | Newton L Compere | Rupturable blister pill package with safety backing |
DE2322055A1 (en) * | 1973-05-02 | 1975-01-30 | Bosch Gmbh Robert | CHILD RESISTANT TABLET PACK |
US4011949A (en) * | 1975-06-18 | 1977-03-15 | The Lehigh Press, Inc. | Package construction for opening only by a predetermined procedure |
US4158411A (en) * | 1976-05-10 | 1979-06-19 | Hall Douglas C | Dispensing package |
US4988004A (en) * | 1987-08-21 | 1991-01-29 | Intini Thomas D | Bend 'n peel child resistant/tamper evident blister package |
US5234957A (en) * | 1991-02-27 | 1993-08-10 | Noven Pharmaceuticals, Inc. | Compositions and methods for topical administration of pharmaceutically active agents |
US5178878A (en) * | 1989-10-02 | 1993-01-12 | Cima Labs, Inc. | Effervescent dosage form with microparticles |
US5223264A (en) * | 1989-10-02 | 1993-06-29 | Cima Labs, Inc. | Pediatric effervescent dosage form |
US5046618A (en) * | 1990-11-19 | 1991-09-10 | R. P. Scherer Corporation | Child-resistant blister pack |
US5310060A (en) * | 1992-10-13 | 1994-05-10 | G. D. Searle & Co. | Tamper-evident, child-resistant blister packages for medicaments and non-medicaments |
US5851553A (en) * | 1993-09-10 | 1998-12-22 | Fuisz Technologies, Ltd. | Process and apparatus for making rapidly dissolving dosage units and product therefrom |
JP3594313B2 (en) * | 1994-07-26 | 2004-11-24 | ファルマシア・アンド・アップジョン・カンパニー | Reusable child-safe blister container |
US5944191A (en) * | 1998-01-14 | 1999-08-31 | Fuisz Technologies Ltd. | Peelable entry-resistant package |
US6047829A (en) * | 1998-09-18 | 2000-04-11 | Westvaco Corporation | Unit dose packaging system (UDPS) having a child resistant locking feature |
SE9803240D0 (en) * | 1998-09-24 | 1998-09-24 | Diabact Ab | A pharmaceutical composition having a rapid action |
US6230893B1 (en) * | 2000-02-11 | 2001-05-15 | Westvaco Corporation | Unit dose packaging system (udps) having a child resistant locking feature |
US6352158B1 (en) * | 2000-07-06 | 2002-03-05 | Warner Lambert Company | Unit dose blister package with keyhole assisted opening feature |
US6752272B2 (en) * | 2001-09-13 | 2004-06-22 | Mead Westvaco Corporation | Unit dose packaging system with exterior pocket feature |
US7093716B2 (en) * | 2001-12-14 | 2006-08-22 | Intini Thomas D | Bend & peel medication dispenser |
AU2003225973A1 (en) * | 2002-03-26 | 2003-11-11 | Glaxo Group Limited | A method for forming a laminate assembly and products formed thereby |
US7395928B2 (en) * | 2005-07-14 | 2008-07-08 | Abbott Laboratories | Child-resistant blister package |
-
2006
- 2006-01-12 CA CA002593785A patent/CA2593785A1/en not_active Abandoned
- 2006-01-12 MX MX2007008575A patent/MX2007008575A/en not_active Application Discontinuation
- 2006-01-12 JP JP2007551389A patent/JP2008526639A/en active Pending
- 2006-01-12 EP EP06718280A patent/EP1836101A4/en not_active Withdrawn
- 2006-01-12 WO PCT/US2006/001188 patent/WO2006076552A2/en active Application Filing
- 2006-01-12 US US11/330,729 patent/US20060278558A1/en not_active Abandoned
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6155423A (en) * | 1997-04-01 | 2000-12-05 | Cima Labs Inc. | Blister package and packaged tablet |
WO2000024647A1 (en) * | 1998-10-22 | 2000-05-04 | Novartis Ag | Child resistant package and method of dispensing medication |
WO2001002265A1 (en) * | 1999-07-06 | 2001-01-11 | Pago Limited | Blister packs |
US20030209461A1 (en) * | 2002-05-08 | 2003-11-13 | French Gary Stuart | Child-resistant blister pack |
Non-Patent Citations (1)
Title |
---|
See also references of WO2006076552A2 * |
Also Published As
Publication number | Publication date |
---|---|
CA2593785A1 (en) | 2006-07-20 |
WO2006076552A2 (en) | 2006-07-20 |
EP1836101A4 (en) | 2008-03-19 |
JP2008526639A (en) | 2008-07-24 |
MX2007008575A (en) | 2007-09-07 |
WO2006076552A3 (en) | 2007-11-15 |
US20060278558A1 (en) | 2006-12-14 |
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