US20040104142A1 - Blister package for topiramate tablets - Google Patents

Blister package for topiramate tablets Download PDF

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Publication number
US20040104142A1
US20040104142A1 US10/258,006 US25800603A US2004104142A1 US 20040104142 A1 US20040104142 A1 US 20040104142A1 US 25800603 A US25800603 A US 25800603A US 2004104142 A1 US2004104142 A1 US 2004104142A1
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Prior art keywords
sheet
blister package
drying
layer
pan
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US10/258,006
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English (en)
Inventor
Monika Dobler
Stefan Merkle
Pedro Lorca
Dieter Bachmann
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    • 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
    • A61J1/035—Blister-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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

Definitions

  • the present invention provides a blister package for topiramate tablets. More particularly, the blister package contains dried topiramate tablets and comprises a metal layer cover sheet sealed to a composite metal and plastic layer pan sheet.
  • Typical formulations for oral administration include liquid solutions, emulsions, or suspensions, as well as solid forms such as capsules or tablets (as used herein, the term “tablet” means any shaped and compressed solid dosage form, including caplets).
  • tablette means any shaped and compressed solid dosage form, including caplets.
  • topiramate the compound 2,3:4,5-bis-O-(1-methylethylidene)- ⁇ -D-fructopyranose sulfamate, hereinafter referred to as “topiramate”, is presently commercially available as a tablet product in strengths of 25, 50, 100 and 200 mg as adjunctive therapy for the treatment of adults with partial onset seizures (TOPAMAX® (topiramate) Tablets).
  • Topiramate can be prepared following the processes disclosed in U.S. Pat. Nos. 4,513,006 and 5,387,700 and, preferably, by the process described in Examples 1 to 3 of U.S. Pat. No. 5,387,700.
  • topiramate tablets have been packaged into both high-density polyethylene (HDPE) bottles containing a desiccant and blister packages containing a desiccant. Stability testing over time has demonstrated that the tablets in such packages have been preserved under various temperature, humidity and light conditions.
  • Blister packages offer advantages over the HDPE bottles used in the current marketed package and are, therefore, a preferred packaging format for topiramate tablets. Blister packages match the stability and marketing characteristics of HDPE bottles while being less expensive to package, lighter in weight and more conveniently stored; in addition, they offer rapid access, unit dose accountability and better physical protection for the product. Blister packages are especially advantageous for packaging moisture sensitive tablets such as topiramate because each tablet cavity then becomes a primary container in direct contact with the tablet, inherently enclosing a minimum of air and associated moisture.
  • Tablet stability in a blister package therefore, becomes a function of the physical characteristics of the materials used in the composite blister package which affect permeability to moisture vapor and the ability to protect the enclosed product from light and humidity.
  • manufacturers and packagers have focused on enhancing the stability performance of blister packages by providing cavities for additional materials such as desiccants in addition to the tablet cavities.
  • EP 0466068 A describes a blister package wherein each tablet cavity is connected with one desiccant cavity.
  • FR 2593152 A describes a blister package wherein several tablet cavities are connected with one desiccant cavity.
  • the present invention provides a blister package for topiramate tablets comprising a pan sheet having preformed cavities containing topiramate tablets, and a cover sheet sealed to the pan sheet; wherein the topiramate tablets have a free water content of between about 0.4% to about 1.4% (preferably, between about 0.7% to about 1.2%, more preferably, between about 0.8% to about 1.0%) at the time the cover sheet is sealed to the pan sheet, and wherein the blister package thus formed contains no desiccant.
  • step (b) placing the dried topiramate tablets from step (a) into a pan sheet having a plurality of cavities;
  • the topiramate tablets are dried by a method selected from the group consisting of microwave drying, vacuum drying, hot air drying, infrared drying, drying using very dry air either statically or dynamically and drying by placing a desiccant in a storage drum of bulk product for a period of time.
  • the pan sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a single plastic layer, multiple plastic layers, and a composite metal and plastic layer
  • the cover sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a composite metal and plastic layer, a composite metal and paper layer and a composite metal, plastic and paper layer.
  • a composite layer refers to metal, plastic and/or paper layers adhered together using techniques known to those skilled in the art.
  • the metal, plastic and/or paper layers may be independently selected from one or more of the materials listed above. Examples of a multiple plastic layer include, but are not limited to, PVC/PVDC, PVC/PE/PVDC, PVC/PVDC/PE and PVC/PE.
  • Illustrative of the invention is the blister package wherein the pan sheet is a composite metal and plastic layer of OPA/aluminum foil/PVC and the cover sheet is a single aluminum foil layer.
  • FIG. 1 shows the stability results over time for 100 mg and 200 mg topiramate tablets having various amounts of free water stored at 40° C./75% Relative Humidity (RH).
  • FIG. 2 shows the stability results over time for 100 mg and 200 mg topiramate tablets having various amounts of free water stored at 30° C./60% RH.
  • FIG. 3 shows the rate of moisture re-uptake by dried 25 mg topiramate tablets under various humidity conditions.
  • the process for preparing topiramate tablet blister packages includes the steps of:
  • the drying methods include, without limitation, microwave drying, vacuum drying, hot air drying, infrared drying, using very dry, heated air either statically or dynamically or placing a desiccant in a storage drum of bulk tablets for a period of time.
  • microwave drying vacuum drying
  • hot air drying infrared drying
  • very dry, heated air either statically or dynamically or placing a desiccant in a storage drum of bulk tablets for a period of time.
  • the temperature of the surrounding air may vary over a broad range, but should not be so high as to render the active agent inactive.
  • this invention contemplates using dynamic hot air drying, increasing the inlet air volume in a tablet coating drum by 10 m 3 per Kg of tablets from 850 m 3 for a tablet batch size of 42 Kg to 2800 m 3 for a tablet batch size of 240 Kg and varying the drum speed from interval rotation to full rotation based on the tablet batch size.
  • the term “interval rotation” refers to the practice of rotating a coating drum at a standard coating drum rotation speed in revolutions per minute (rpm) for less than one minute.
  • an interval rotation of “10 s/min at 10 rpm” would describe rotating a coating drum at a speed of 10 rpm for 10 seconds and then allowing the drum to coast to idle for 50 seconds.
  • full rotation refers to the practice of rotating a coating drum at a standard coating drum rotation speed.
  • a full rotation of “3 rpm” would describe rotating a coating drum at a continuous speed of 3 rpm.
  • the improved tablet stability and blister package shelf-life contemplated by the present invention depends on the unbound water, hereinafter referred to as “free water,” content of the tablets after further drying. Since the total water content of the tablets, hereinafter referred to as “total water,” as determined by Karl-Fischer (KF) titration, includes both crystalline bound water, hereinafter referred to as “bound water,” and free water, the free water content can be calculated by subtracting the bound water content from the total water content.
  • the bound water is a constant that can be calculated from the known amount of lactose in the granulate formulation.
  • topiramate tablet formulations with different amounts of lactose will have different amounts of bound water existing within the tablets.
  • the target free water content contemplated by the present invention for such formulations is between about 0.4% to about 1.4% free water; preferably, from about 0.7% to about 1.2% free water; more preferably, from about 0.8% to about 1.0% free water; and, most preferably, less than about 1.0% free water.
  • TABLE 1 Calculation of Free Water Content 25 mg, 50 mg, 200 mg 100 mg tablets (%) tablets (%) Target free water ⁇ 1.00% ⁇ 1.00% Target total water ⁇ 2.86% ⁇ 1.60% Lactose monohydrate 37.00% 11.99% Calculated bound water 1.86% 0.60% Calculated free water ⁇ 1.00% ⁇ 1.00%
  • the pan sheet and the cover sheet may each be independently formed from continuous sheets of roll stock registered for being simultaneously fed as websheets on a blister packaging machine.
  • the cover sheet may further comprise a composite metal and paper layer; wherein the paper layer has a surface capable of accepting print.
  • the metal layer is aluminum foil having a paper layer adhered thereto; wherein the paper layer is commercially available in a variety of thicknesses and is adhered to the metal layer using methods known in the art.
  • the free water content for each formulation was determined throughout the drying process by the use of in-process control (IPC) testing.
  • IPC samples were taken every 30 min and tested for loss on drying (LOD) using a Mettler HR73 halogen dryer, manufactured by Mettler-Toledo, Gsammlungsee, Switzerland, wherein 5 gm samples of topiramate tablets were powderized and measured using the dryer's fast dry mode at 105° C. with a medium weight loss smaller than about 1 mg in about 50 seconds.
  • the drying time required for each batch of tablets to reach the target free water content varied from about 1.25 h to about 4 h; preferably, from about 2 to about 3 h.
  • drying time was the same for both pilot and production scale drying using the method of the present invention.
  • the blister package pan sheet was prepared from a continuous sheet of OPA/alu/PVC 25 ⁇ m/45 ⁇ m/60 ⁇ m foil on roll stock manufactured by Lawson Mardon Neher AG, Buchlingen, Switzerland was web-fed at 18 cycles per minute to the pan sheet forming die wherein the tablet cavities were cold-formed by the forming punches.
  • the blister package cover sheet was prepared from a continuous 20.0 ⁇ m (54.0 g/m 2 ) sheet of hard aluminum foil with a heatseal lacquer (7.0 g/m 2 ) LA723 on roll stock manufactured by Lawson Mardon Neher AG, Buchlingen, Switzerland simultaneously web-fed at 18 cycles per minute with the pan sheet web to a sealing die maintained at a temperature of about 180° C. to about 190° C., wherein the web-fed cover sheet was sealed to the web-fed pan sheet at a sealing pressure of 80 bar, to thus simultaneously form a set of four side by side sealed blister packages.
  • DUMA HDPE bottles (30, 50, 75 ml), manufactured by DUMA International AB, Sweden, having a desiccant according to approved marketed specifications independently containing 60 tablets of the 25, 50, 100 or 200 mg strengths used as a reference;
  • Blister packages having a PVC/PE/PVDC (200 ⁇ m/25 ⁇ m/90 g/m 2 ) (sold under the Tristar® brand of plastic film) pan sheet and a hard aluminum foil (20 ⁇ m) cover sheet and 10 cavities each containing a tablet of the 25, 50, 100, or 200 mg strength were placed in a PE/Alu/PE (12 ⁇ m/12 ⁇ m/75 ⁇ m) pouch with a MinipaxTM (2 g Silicagel) desiccant unit therein, hereinafter referred to as the “blister in pouch” package;
  • Blister packages having a PVC/PE/PVDC (200 ⁇ m/25 ⁇ m/90 g/m 2 ) (sold under the Tristar® brand of plastic film) pan sheet and a hard aluminum foil (20 ⁇ m) cover sheet and 10 cavities each containing a tablet of the 25, 50, 100, or 200 mg strength.
  • the plastic film used for the foregoing blister packages was manufactured by PERLEN CONVERTING AG, Perlen, Switzerland and marketed under the trademark Tristar® (brand of plastic film). According to the schedule shown below in Table 4, the packages described above were placed into stability chambers under various conditions and periodically tested. At the times and under the conditions shown in Table 4, (X) indicates that testing was performed on request only. At the times and under the conditions shown in Table 4, X indicates that appearance, active ingredient and sulfate assay, purity and dissolution testing were performed. Appearance testing was performed every month during the first 7 months and as indicated by X in Table 4. TABLE 4 Blister Evaluation Study: Storage time 25° C./ 30° C./ 40° C./ (months) 5° C.
  • Package format 1 provided protection that met product specifications. but a pharmaceutically elegant, less expensive alternative package is desired.
  • the “blister in pouch” package provided better protection from humidity than the other package formats tested, but such a package is bulky and expensive to produce on a commercial scale.
  • the “alu-alu” blister package as studied in Example 3 i.e., tablets having about 1.7% free water content
  • the results of Example 4 for the “alu-alu” blister package demonstrate that by drying the tablet prior to packaging, a surprisingly improved shelf life and stability for topiramate tablets in an “alu-alu” blister package is acheived.
  • the approved specifications for the stability of topiramate are the appearance specifications as shown in Table 6.
  • the appearance of the tablet has been established as a very sensitive indicator for topiramate stability.
  • Alu-alu blister packages having an OPA/Alu/PVC (25 ⁇ m/45 ⁇ m/60 ⁇ m) pan sheet (composite sheet manufactured by Louis Patz&Comp., Natschbach, Austria) and a hard aluminum foil (20 ⁇ m) cover sheet (manufactured by Tscheulin-Rothal GmbH, Teningen, Germany) and 10 cavities each containing a tablet of the 100 or 200 mg strength, each tablet having a free water content of about 0.8%.
  • OPA/Alu/PVC 25 ⁇ m/45 ⁇ m/60 ⁇ m
  • pan sheet compact sheet manufactured by Louis Patz&Comp., Natschbach, Austria
  • a hard aluminum foil (20 ⁇ m) cover sheet manufactured by Tscheulin-Rothal GmbH, Teningen, Germany
  • Alu-alu blister packages having an OPA/Alu/PVC (25 ⁇ m/45 ⁇ m/60 ⁇ m) pan sheet (composite sheet manufactured by Louis Patz&Comp., Natschbach, Austria) and a hard aluminum foil (20 ⁇ m) cover sheet (manufactured by Tscheulin-Rothal GmbH, Teningen, Germany) and 10 cavities each containing a tablet of the 100 or 200 mg strength, each tablet having a free water content of about 1.4%.
  • OPA/Alu/PVC 25 ⁇ m/45 ⁇ m/60 ⁇ m
  • pan sheet compact sheet manufactured by Louis Patz&Comp., Natschbach, Austria
  • a hard aluminum foil (20 ⁇ m) cover sheet manufactured by Tscheulin-Rothal GmbH, Teningen, Germany
  • Alu-alu blister packages having an OPA/Alu/PVC (25 ⁇ m/45 ⁇ m/60 ⁇ m) pan sheet (composite sheet manufactured by Louis Patz&Comp., Natschbach, Austria) and a hard aluminum foil (20 ⁇ m) cover sheet (manufactured by Tscheulin-Rothal GmbH, Teningen, Germany) and 10 cavities each containing a tablet of the 100 or 200 mg strength, each tablet having a free water content of about 1.8%.
  • OPA/Alu/PVC 25 ⁇ m/45 ⁇ m/60 ⁇ m
  • pan sheet compact sheet manufactured by Louis Patz&Comp., Natschbach, Austria
  • a hard aluminum foil (20 ⁇ m) cover sheet manufactured by Tscheulin-Rothal GmbH, Teningen, Germany
  • the appearance data resulting from the study demonstrated that the topiramate tablets with a free water content of about 0.8% in an alu/alu blister package met the appearance specification for 18 months at 40° C./75% RH.
  • the study also demonstrated that the topiramate tablets with a free water content of from about 0.8% to about 1.4% in an alu/alu blister package met the appearance specification for 36 months at 30° C./60% RH.
  • the results of the study after 36 months described in Example 4 are summarized in Table 7.
  • Example 3 Comparing the “alu-alu” blister package studied in Example 3 with the results of Example 4 demonstrate that the tablet drying method of the present invention provides a surprisingly improved shelf life and stability for topiramate tablets in the “alu-alu” blister package.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
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US10/258,006 2000-05-25 2001-05-22 Blister package for topiramate tablets Abandoned US20040104142A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP00111229A EP1157682A1 (fr) 2000-05-25 2000-05-25 Emballage blister pour comprimés de topiramate
EP00111229.1 2000-05-25
PCT/EP2001/005878 WO2001089445A1 (fr) 2000-05-25 2001-05-22 Emballage coque destine a des comprimes de topiramate

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US20040104142A1 true US20040104142A1 (en) 2004-06-03

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US (1) US20040104142A1 (fr)
EP (2) EP1157682A1 (fr)
JP (1) JP4986360B2 (fr)
AT (1) ATE286704T1 (fr)
AU (1) AU777753B2 (fr)
CA (1) CA2409975C (fr)
DE (1) DE60108376T3 (fr)
DK (1) DK1284711T4 (fr)
ES (1) ES2236258T5 (fr)
MX (1) MXPA02010522A (fr)
NZ (1) NZ522077A (fr)
PT (1) PT1284711E (fr)
WO (1) WO2001089445A1 (fr)

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US20070199856A1 (en) * 2001-10-18 2007-08-30 Michael Pesachovich Methods of stabilizing azithromycin
US20080197045A1 (en) * 2005-07-27 2008-08-21 Burkhard Metzger Medicament Blister
US20090152155A1 (en) * 2005-11-17 2009-06-18 Erwin Pasbrig Cold-Formable Laminate for Blister Base Parts
EP2127628A1 (fr) * 2008-05-27 2009-12-02 Ranbaxy Laboratories Limited Emballage de dose d'unité
US20100170820A1 (en) * 2008-02-28 2010-07-08 Ludovic Leplatois Paper-based lidding for blister packaging
US20110111026A1 (en) * 2008-03-10 2011-05-12 Adel Penhasi Humidity-resistant drug formulations and methods of preparation thereof
US9150119B2 (en) 2013-03-15 2015-10-06 Aesynt Incorporated Apparatuses, systems, and methods for anticipating and delivering medications from a central pharmacy to a patient using a track based transport system
US9511945B2 (en) 2012-10-12 2016-12-06 Aesynt Incorporated Apparatuses, systems, and methods for transporting medications from a central pharmacy to a patient in a healthcare facility
US20190233159A1 (en) * 2018-02-01 2019-08-01 Westrock Mwv, Llc Unit dose packaging system (udps) inner card configurations
WO2023122520A1 (fr) * 2021-12-23 2023-06-29 Bio-Lab, Inc. Composition flottante à désintégration rapide

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CA2478156C (fr) 2002-03-26 2011-02-15 Boehringer Ingelheim Pharmaceuticals, Inc. Mimetiques de glucocorticoiques, procedes de fabrication, compositions pharmaceutiques, et utilisations correspondants
GB0225621D0 (en) 2002-11-02 2002-12-11 Glaxo Group Ltd Medicament carrier
WO2004043823A1 (fr) * 2002-11-11 2004-05-27 Wright, Fenn & Co. Ltd. Plaquette alveolaire
BRPI0606180A2 (pt) * 2005-02-23 2009-06-02 Topas Advanced Polymers Inc pelìculas de multicamadas incluindo copolìmero de cicloolefina e copolìmero de estireno-butadieno
CN1985799B (zh) * 2005-12-19 2011-11-09 量子高科（北京）研究院有限公司 口腔崩解制剂的制备方法
JP5424571B2 (ja) * 2007-04-12 2014-02-26 協和発酵キリン株式会社 トピラマート含有固形製剤
US8652527B1 (en) 2013-03-13 2014-02-18 Upsher-Smith Laboratories, Inc Extended-release topiramate capsules
US9101545B2 (en) 2013-03-15 2015-08-11 Upsher-Smith Laboratories, Inc. Extended-release topiramate capsules
CN104417913A (zh) * 2013-08-30 2015-03-18 李和伟 一种含有粘结剂的冻干赋型制剂的包装装置及其制备方法
EP4276800A3 (fr) 2016-07-29 2024-01-24 Rimasys GmbH Procédé de production reproductible de fractures osseuses définies
EP3883546A1 (fr) 2018-11-21 2021-09-29 Rosemont Pharmaceuticals Ltd Formulations de suspension de topiramate orale présentant une stabilité de conservation prolongée et une biodisponibilité améliorée

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Cited By (22)

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Publication number Priority date Publication date Assignee Title
US20070199856A1 (en) * 2001-10-18 2007-08-30 Michael Pesachovich Methods of stabilizing azithromycin
US20080149521A9 (en) * 2001-10-18 2008-06-26 Michael Pesachovich Methods of stabilizing azithromycin
US20040226852A1 (en) * 2003-02-19 2004-11-18 Michael Pesachovich Method of stabilizing azithromycin
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Publication number Publication date
EP1157682A1 (fr) 2001-11-28
JP2003534051A (ja) 2003-11-18
ES2236258T3 (es) 2005-07-16
DK1284711T3 (da) 2005-04-04
EP1284711A1 (fr) 2003-02-26
PT1284711E (pt) 2005-03-31
DE60108376T3 (de) 2012-09-20
ES2236258T5 (es) 2012-06-14
CA2409975C (fr) 2010-02-09
DK1284711T4 (da) 2012-04-16
DE60108376T2 (de) 2006-01-05
CA2409975A1 (fr) 2001-11-29
WO2001089445A1 (fr) 2001-11-29
ATE286704T1 (de) 2005-01-15
MXPA02010522A (es) 2004-05-17
AU6903001A (en) 2001-12-03
EP1284711B1 (fr) 2005-01-12
NZ522077A (en) 2004-07-30
AU777753B2 (en) 2004-10-28
JP4986360B2 (ja) 2012-07-25
EP1284711B2 (fr) 2012-03-28
DE60108376D1 (de) 2005-02-17

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