US3823816A - Water-soluble package - Google Patents

Water-soluble package Download PDF

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Publication number
US3823816A
US3823816A US00223123A US22312372A US3823816A US 3823816 A US3823816 A US 3823816A US 00223123 A US00223123 A US 00223123A US 22312372 A US22312372 A US 22312372A US 3823816 A US3823816 A US 3823816A
Authority
US
United States
Prior art keywords
water
shell
capsule
film
apertures
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.)
Expired - Lifetime
Application number
US00223123A
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English (en)
Inventor
J Controulis
K Larsen
L Wheeler
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.)
Parke Davis and Co LLC
Original Assignee
Parke Davis and Co LLC
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
Priority to BE794951D priority Critical patent/BE794951A/xx
Priority to US00223123A priority patent/US3823816A/en
Application filed by Parke Davis and Co LLC filed Critical Parke Davis and Co LLC
Priority to DE2305280A priority patent/DE2305280C2/de
Priority to ZA730766A priority patent/ZA73766B/xx
Priority to ES411206A priority patent/ES411206A1/es
Priority to JP1299073A priority patent/JPS5532381B2/ja
Priority to CA162,753A priority patent/CA990238A/en
Priority to AR246401A priority patent/AR196325A1/es
Priority to BR73827A priority patent/BR7300827D0/pt
Priority to GB543573A priority patent/GB1377452A/en
Priority to FR7303665A priority patent/FR2170751A5/fr
Priority to IT48043/73A priority patent/IT977185B/it
Priority to AU51719/73A priority patent/AU463254B2/en
Application granted granted Critical
Publication of US3823816A publication Critical patent/US3823816A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules

Definitions

  • ABSTRACT A water-soluble package is provided in the formof a hard shell capsule filled with powder, granules, or the like.
  • the capsule shell is apertured, and the apertures or holes are covered over by a water-soluble barrier film which seals the holes and blocks any escape of the contents from the shell.
  • the film is more watersoluble than the cap and body parts of the shell so that when thepackage is contacted with water, as in the digestive tract, the film rather than the shell dissolves first exposing the contents for dissolution and/or release by way of the apertures while the shell is still intact.
  • This invention relates to a novel water-soluble or water-reactive package in the form of an apertured cap and body capsule containing a particulate solid fill.
  • capsules have been a preferred means for packaging dry powder, granules or other particulate matter.
  • the objective was in some instances not obtained because the capsule shell remained intact and failed to dissolve as quickly as desired.
  • the apertures allowed the dry contents to leak out. While the slightest leakage is intolerable for many applications, fast-release loss-proof capsules have hitherto not been available.
  • FIG. 1 is a side view of a packaged article according to a preferred embodiment of the invention.
  • FIG. 2 is a fragmented expanded view in vertical section taken on line 2--2 of F IG. 1 showing the construction of the sealed wall of the article;
  • FIG. 3 is a plan view of the article when incorporated with a body of water according to the invention.
  • the article in the form illustrated has a cap part 11 and a matching telescopicallyengaged body part 12 which together provide a closed envelope shell.
  • the cap 11 and the body 12 each have open ends (not shown) and closed ends 11b and 12b as well as cylindrical walls 110 and 120.
  • the walls overlap in a double-walled portion 13.
  • the capsule shell contains a particulate fill l4, and the walls include aperture means 15 extending through the thickness (FIG. 2, single or double wall) toprovide open communication'with the ,shell interior containing the fill 14.
  • a continuous film or barrier 17 overlies each aperture means 15 and seals the same.
  • the film is in a single strip form covering a row of apertures, as illustrated in FIG. 1.
  • the film 17 is generallyof uniform thickness, being slightly thicker within the, margin of the apertures where it occupies the spacewithin each aperture in the form of plugs 16 (FIG.'2).
  • the film can, according to the invention, have various shapes and is not limited to the strip shape illustrated.
  • the capsule may conveniently cover the entire outer surface of the capsule or it may cover discontinuqi sal a s qh EQYQFELEE. siss seaata e 9255992 9 apertures.
  • the shape should be such that it alone, or in combination with other barrier films (having the same or different shapes), completely covers and seals all of the apertures. It is an advantageous feature that in the embodiment where the barrier film covers both the cap and body surface, for example, in a single strip (as in FIGS. 1 and 2) or the entire capsule surface, the film serves to lock the capsule parts to- 'gether.
  • the packaged articles of the invention are conveniently prepared in several steps. First, empty capsules (preferably pharmaceutical-grade gelatin or an equivalent) are filled with the selected particulate substance (e.g., medicament, chemical, or other substance) and are joined, using conventional means. The apertures 15 are then made in the filled joined capsules in a perforating step, using any suitable hole-forming means such as heated needles, knives, drills or the like. The apertured filled capsules are next treated with a liquid solution of the film-forming substance as by spraying, dipping, brushing, printing or the like to produce the desired film bridging and sealing the holes in the capsule wall. Any of various water-soluble film-forming substances will be suitable for the purpose such as polyvinylpyrrolidone, gelatin, hydroxypropylmethyl.
  • the selected particulate substance e.g., medicament, chemical, or other substance
  • Polyvinylpyrrolidone is a preferred film-forming substance. Conveniently, it is used for film-forming purposes as a dilute (e.g., 5-10 percent) aqueous or alcoholic solution and the capsules to be film-coated are dipped in a bath of the solution to completely coat the outer surface of each capsule with the film solution. Area coating, such as the preferred strip configuration 17 illustrated in FIG. 1, can be printed as a moist film over the apertures using conventional machinery. The coating film following application is dried until tack-free and sufficiently firm and-dimensionally stable to seal the apertures and prevent escape of the granular fill.
  • the size, shape, number and distribution of the apertures 15 in the capsule shell can be varied widely, as desired. Aperture sizes made with hypodermic needles, for example, ranging from No. 27 (OD, 0.41 mm.) to No. 21 (0.81 mm.) have been particularly satisfactory.
  • the holes can be round, crescent-shaped, square, etc although round holes are preferred. Numerous holes can be used, and the distribution can be spaced over the end and/or wall surfaces of the capsule. However, in general it is found that from one to six aperturesin the capsule issufficient for purposes of the invention.
  • the in-line configuration illustrated is one preferred embodiment, usually with two to six apertures.
  • Another preferred embodiment is a single-hole configuration centered at one or both ends of the capsule shell. In test procedures measuring solubility.
  • the invention contemplates as contents for the package or capsule any particulate substance which, al-
  • the shell or envelope is reactive-or soluble in water or any of various aqueous media such as gastro-intestinal fluid.
  • the invention is particularly well-suited in this respect to particulate fill material, which effervesces in the presence of water either as an active ingredient, for example, of a, pharmaceutical dosage form or as an aid per se to promote a mixing or dissolving effect for other components in the fill.
  • the typical capsule filled, for example, with low density powder usually floats (capsule A, FIG. 3) on the surface 20'of the water.
  • the capsule Unless stirred or otherwise moved, the capsule remains afloat for a brief period until the film 17 is wetted and dissolved in the area of the apertures 15.
  • the capsule sinks of its own accord into the body 21 of the liquid (capsule B, FIG. 3) while the dissolving and release actions continue and, because of the increased wetting contact, even at a greater rate.
  • an ingestible water-reactive unit package including a cylindrical hard shell capsule having matching water-soluble cap and body parts telescopically joined to define a closed envelope shell, the cap and body each having an open end, a closed end, and side walls overlapping in a double-walled portion, a particulate solid fill in the shell, and aperture means in the shell providing open communication between the interior and the exterior of the shell, the improvement characterized by a water-soluble barrier in the form of a dimensionally stable film bridging the aperture means comprising a plurality of apertures located in line, the film occupying space within each aperture in the form of plugs in sealing engagement therewith sufficient to block escape of solid fill from the shell, the barrier being substantially more water-soluble than the cap and body parts such that continued contact of the package with water in an aqueous environment causes the barrier to dissolve prior to dissolution of the shell thereby affording direct access of water to the fill while the shell is intact.
  • aperture means comprises at least one aperture located at the end of the capsule.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
US00223123A 1972-02-03 1972-02-03 Water-soluble package Expired - Lifetime US3823816A (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
BE794951D BE794951A (fr) 1972-02-03 Conditionnement soluble dans l'eau
US00223123A US3823816A (en) 1972-02-03 1972-02-03 Water-soluble package
GB543573A GB1377452A (en) 1972-02-03 1973-02-02 Water-soluble capsules
ES411206A ES411206A1 (es) 1972-02-03 1973-02-02 Una disposicion mejorada de embase unitario reactivo con elagua.
JP1299073A JPS5532381B2 (US07534539-20090519-C00280.png) 1972-02-03 1973-02-02
CA162,753A CA990238A (en) 1972-02-03 1973-02-02 Water-soluble package
DE2305280A DE2305280C2 (de) 1972-02-03 1973-02-02 Wasserlösliche hartschalige Gelatinekapsel
BR73827A BR7300827D0 (pt) 1972-02-03 1973-02-02 Embalagem soluvel em agua
ZA730766A ZA73766B (en) 1972-02-03 1973-02-02 Water-soluble package
FR7303665A FR2170751A5 (US07534539-20090519-C00280.png) 1972-02-03 1973-02-02
IT48043/73A IT977185B (it) 1972-02-03 1973-02-02 Perfezionamento nelle capsule o contenitori solubili in acqua
AU51719/73A AU463254B2 (en) 1972-02-03 1973-02-02 Water-soluble package
AR246401A AR196325A1 (es) 1972-02-03 1973-02-02 Envase soluble en agua

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US00223123A US3823816A (en) 1972-02-03 1972-02-03 Water-soluble package

Publications (1)

Publication Number Publication Date
US3823816A true US3823816A (en) 1974-07-16

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Family Applications (1)

Application Number Title Priority Date Filing Date
US00223123A Expired - Lifetime US3823816A (en) 1972-02-03 1972-02-03 Water-soluble package

Country Status (13)

Country Link
US (1) US3823816A (US07534539-20090519-C00280.png)
JP (1) JPS5532381B2 (US07534539-20090519-C00280.png)
AR (1) AR196325A1 (US07534539-20090519-C00280.png)
AU (1) AU463254B2 (US07534539-20090519-C00280.png)
BE (1) BE794951A (US07534539-20090519-C00280.png)
BR (1) BR7300827D0 (US07534539-20090519-C00280.png)
CA (1) CA990238A (US07534539-20090519-C00280.png)
DE (1) DE2305280C2 (US07534539-20090519-C00280.png)
ES (1) ES411206A1 (US07534539-20090519-C00280.png)
FR (1) FR2170751A5 (US07534539-20090519-C00280.png)
GB (1) GB1377452A (US07534539-20090519-C00280.png)
IT (1) IT977185B (US07534539-20090519-C00280.png)
ZA (1) ZA73766B (US07534539-20090519-C00280.png)

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US4088864A (en) * 1974-11-18 1978-05-09 Alza Corporation Process for forming outlet passageways in pills using a laser
US4478658A (en) * 1982-12-20 1984-10-23 Warner-Lambert Company Method for sealing non-enteric capsules
US4503030A (en) * 1983-06-06 1985-03-05 Alza Corporation Device for delivering drug to certain pH environments
US4567613A (en) * 1984-05-08 1986-02-04 Frank Meehan Method and article for neutralizing offensive odors
US4609403A (en) * 1984-03-12 1986-09-02 Warner-Lambert Company Foam soft gelatin capsules and their method of manufacture
US4719112A (en) * 1982-10-29 1988-01-12 Warner-Lambert Company Foam capsules
US4800056A (en) * 1984-03-21 1989-01-24 Alza Corporation Process for making dispenser with cooperating elements
US4876003A (en) * 1988-05-09 1989-10-24 Olin Corporation Encased pool chemical tablet with domed ends
US4923618A (en) * 1988-05-09 1990-05-08 Olin Corporation Method of chlorinating a swimming pool
US4928813A (en) * 1989-06-02 1990-05-29 Olin Corporation Encased pool chemical capsule with extended ends and method of making the same
WO1994001239A1 (en) * 1992-07-07 1994-01-20 Merck & Co., Inc. High speed process for preparing orifices in pharmaceutical dosage forms
US5958451A (en) * 1996-09-03 1999-09-28 Yung Shin Pharm Ind. Co., Ltd. Process for producing porous, controlled-release capsules and encapsulated composition
WO2001007107A2 (en) * 1999-07-23 2001-02-01 Pharmaceutical Discovery Corporation Unit dose capsules and dry powder inhaler
WO2001055293A2 (en) * 2000-01-25 2001-08-02 The Victoria University Of Manchester Delayed release of fluids
WO2002085737A1 (en) * 2001-04-20 2002-10-31 Reckitt Benckiser (Uk) Limited Water-soluble container having at least two openings
WO2002092456A1 (en) * 2001-05-17 2002-11-21 Reckitt Benckiser (Uk) Limited A water-soluble injection moulded container
WO2002092455A1 (en) * 2001-05-17 2002-11-21 Reckitt Benckiser (Uk) Limited A water-soluble injection moulded container
EP1299006A1 (en) 2000-05-03 2003-04-09 Societe Des Produits Nestle S.A. Confectionery product having an enhanced cooling effect
GB2386069A (en) * 2002-02-20 2003-09-10 Mach Ind Etablissements Consumable container
WO2003084836A1 (de) * 2002-04-10 2003-10-16 Henkel Kommaditgesellschaft Auf Aktien 'wasserlöslicher behälter'
US20030219484A1 (en) * 2001-09-28 2003-11-27 Sowden Harry S. Immediate release dosage form comprising shell having openings therein
WO2004028513A1 (en) * 2002-09-28 2004-04-08 Mcneil-Ppc, Inc. Immediate release dosage form comprising shell having openings therein
US20040182387A1 (en) * 1999-07-23 2004-09-23 Mannkind Corporation Unit dose cartridge and dry powder inhaler
US20050152970A1 (en) * 2004-01-13 2005-07-14 Rinker Roger A. Rapidly disintegrating gelatinous coated tablets
EP1602363A1 (en) 2004-06-04 2005-12-07 McNeil-PPC, Inc. Immediate release dosage form comprising shell having openings therein
US20060121145A1 (en) * 2004-12-07 2006-06-08 Sowden Harry S System and process for providing at least one opening in dosage forms
US20060118991A1 (en) * 2004-12-07 2006-06-08 Sowden Harry S System and process for providing at least one opening in dosage forms
US7305986B1 (en) 1999-07-23 2007-12-11 Mannkind Corporation Unit dose capsules for use in a dry powder inhaler
US20080011779A1 (en) * 1994-07-25 2008-01-17 Klima William L Dispensing devices, and systems
US20080102116A1 (en) * 2004-09-13 2008-05-01 Perrigo Company Quick Dissolve Medicament and Method of Manufacturing
AU2003225945B2 (en) * 2002-09-28 2009-04-23 Mcneil-Ppc, Inc. Immediate release dosage form comprising shell having openings therein
US20090110721A1 (en) * 2007-10-15 2009-04-30 Mcallister Stephen Mark Paneled capsule shells for release of pharmaceutical compositions
US20090110723A1 (en) * 2007-10-15 2009-04-30 Mcallister Stephen Mark Linkers for multipart dosage forms for release of one or more pharmaceutical compositions, and the resulting dosage forms
US20090108492A1 (en) * 2007-10-15 2009-04-30 Mcallister Stephen Mark Method and apparatus for manufacturing filled linkers
US20090241949A1 (en) * 2008-03-27 2009-10-01 Smutney Chad C Dry powder inhalation system
US8067029B2 (en) 2004-01-13 2011-11-29 Mcneil-Ppc, Inc. Rapidly disintegrating gelatinous coated tablets
CN102939925A (zh) * 2012-11-15 2013-02-27 浙江海洋学院 乌贼放流种群强化装置
US20150072915A1 (en) * 2013-09-06 2015-03-12 The Procter & Gamble Company Pouches comprising apertured film wall materials and methods for making same
CN104555111A (zh) * 2014-12-05 2015-04-29 中国农业科学院兰州畜牧与兽药研究所 一种当归药材的储藏方法
US9192675B2 (en) 2008-06-13 2015-11-24 Mankind Corporation Dry powder inhaler and system for drug delivery
US9220687B2 (en) 2008-12-29 2015-12-29 Mannkind Corporation Substituted diketopiperazine analogs for use as drug delivery agents
US9233159B2 (en) 2011-10-24 2016-01-12 Mannkind Corporation Methods and compositions for treating pain
US9241903B2 (en) 2006-02-22 2016-01-26 Mannkind Corporation Method for improving the pharmaceutic properties of microparticles comprising diketopiperazine and an active agent
US9283193B2 (en) 2005-09-14 2016-03-15 Mannkind Corporation Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
US9346766B2 (en) 2004-08-20 2016-05-24 Mannkind Corporation Catalysis of diketopiperazine synthesis
US9364619B2 (en) 2008-06-20 2016-06-14 Mannkind Corporation Interactive apparatus and method for real-time profiling of inhalation efforts
US9364436B2 (en) 2011-06-17 2016-06-14 Mannkind Corporation High capacity diketopiperazine microparticles and methods
US9630930B2 (en) 2009-06-12 2017-04-25 Mannkind Corporation Diketopiperazine microparticles with defined specific surface areas
US9662461B2 (en) 2008-06-13 2017-05-30 Mannkind Corporation Dry powder drug delivery system and methods
US9675674B2 (en) 2004-08-23 2017-06-13 Mannkind Corporation Diketopiperazine salts for drug delivery and related methods
US9700690B2 (en) 2002-03-20 2017-07-11 Mannkind Corporation Inhalation apparatus
US9706944B2 (en) 2009-11-03 2017-07-18 Mannkind Corporation Apparatus and method for simulating inhalation efforts
US9801925B2 (en) 1999-06-29 2017-10-31 Mannkind Corporation Potentiation of glucose elimination
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US9943571B2 (en) 2008-08-11 2018-04-17 Mannkind Corporation Use of ultrarapid acting insulin
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US10307464B2 (en) 2014-03-28 2019-06-04 Mannkind Corporation Use of ultrarapid acting insulin
EP3452003A4 (en) * 2016-05-05 2019-06-26 Triastek, Inc. PHARMACEUTICAL FORM WITH CONTROLLED RELEASE
US10342938B2 (en) 2008-06-13 2019-07-09 Mannkind Corporation Dry powder drug delivery system
US10421729B2 (en) 2013-03-15 2019-09-24 Mannkind Corporation Microcrystalline diketopiperazine compositions and methods
US10561806B2 (en) 2014-10-02 2020-02-18 Mannkind Corporation Mouthpiece cover for an inhaler
US10625034B2 (en) 2011-04-01 2020-04-21 Mannkind Corporation Blister package for pharmaceutical cartridges
EP3651721A4 (en) * 2017-07-10 2021-04-21 Gel Cap Technologies, LLC DUAL RELEASE CAPSULE AND METHODS, DEVICES AND SYSTEMS FOR THEIR MANUFACTURE
US11173125B2 (en) * 2010-06-03 2021-11-16 Catalent Ontario Limited Multiphase soft gel capsules, apparatus and method thereof
US11278499B2 (en) 2015-06-03 2022-03-22 Triastek, Inc. Oral drug dosage form comprising various release profiles
US11446127B2 (en) 2013-08-05 2022-09-20 Mannkind Corporation Insufflation apparatus and methods
US11571391B2 (en) 2018-01-09 2023-02-07 Triastek, Inc. Oral drug dosage forms compromising a fixed-dose of an ADHD non-stimulant and an ADHD stimulant

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DE3907973A1 (de) * 1989-03-11 1990-09-13 Merck Patent Gmbh Trockenmittel-tablette
GB9004702D0 (en) * 1990-03-02 1990-04-25 Polysystems Limited Dispensing device
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Cited By (119)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4088864A (en) * 1974-11-18 1978-05-09 Alza Corporation Process for forming outlet passageways in pills using a laser
US4719112A (en) * 1982-10-29 1988-01-12 Warner-Lambert Company Foam capsules
US4478658A (en) * 1982-12-20 1984-10-23 Warner-Lambert Company Method for sealing non-enteric capsules
US4503030A (en) * 1983-06-06 1985-03-05 Alza Corporation Device for delivering drug to certain pH environments
US4609403A (en) * 1984-03-12 1986-09-02 Warner-Lambert Company Foam soft gelatin capsules and their method of manufacture
US4800056A (en) * 1984-03-21 1989-01-24 Alza Corporation Process for making dispenser with cooperating elements
US4567613A (en) * 1984-05-08 1986-02-04 Frank Meehan Method and article for neutralizing offensive odors
US4876003A (en) * 1988-05-09 1989-10-24 Olin Corporation Encased pool chemical tablet with domed ends
US4923618A (en) * 1988-05-09 1990-05-08 Olin Corporation Method of chlorinating a swimming pool
US4928813A (en) * 1989-06-02 1990-05-29 Olin Corporation Encased pool chemical capsule with extended ends and method of making the same
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DE2305280A1 (de) 1973-08-09
DE2305280C2 (de) 1983-12-29
BE794951A (fr) 1973-05-29
ES411206A1 (es) 1976-04-01
CA990238A (en) 1976-06-01
JPS4882025A (US07534539-20090519-C00280.png) 1973-11-02
JPS5532381B2 (US07534539-20090519-C00280.png) 1980-08-25
BR7300827D0 (pt) 1973-10-25
AR196325A1 (es) 1973-12-18
FR2170751A5 (US07534539-20090519-C00280.png) 1973-09-14
ZA73766B (en) 1974-09-25
AU463254B2 (en) 1975-07-17
IT977185B (it) 1974-09-10
AU5171973A (en) 1974-08-08
GB1377452A (en) 1974-12-18

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