WO2002089823A1 - Methode de conservation pour un suppositoire - Google Patents

Methode de conservation pour un suppositoire Download PDF

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Publication number
WO2002089823A1
WO2002089823A1 PCT/JP2002/003424 JP0203424W WO02089823A1 WO 2002089823 A1 WO2002089823 A1 WO 2002089823A1 JP 0203424 W JP0203424 W JP 0203424W WO 02089823 A1 WO02089823 A1 WO 02089823A1
Authority
WO
WIPO (PCT)
Prior art keywords
suppository
desiccant
effervescent
package
effervescent suppository
Prior art date
Application number
PCT/JP2002/003424
Other languages
English (en)
Japanese (ja)
Inventor
Hideyuki Morihisa
Tetsuya Nakamoto
Chika Takeuchi
Fumio Fukata
Original Assignee
Kyoto Pharmaceutical Industries, 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 Kyoto Pharmaceutical Industries, Ltd. filed Critical Kyoto Pharmaceutical Industries, Ltd.
Priority to JP2002586956A priority Critical patent/JP4346311B2/ja
Publication of WO2002089823A1 publication Critical patent/WO2002089823A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives

Definitions

  • the present invention relates to a method for storing effervescent suppositories, and more particularly to a package for storing effervescent suppositories, and more particularly, to a method for preserving effervescent suppositories in which effervescent suppositories can be stably present even at room temperature.
  • the present invention relates to a package for storing foamable suppositories.
  • Effervescent suppositories include, for example, effervescent suppositories containing sodium bicarbonate and anhydrous sodium dihydrogen phosphate as basic and acidic drugs, respectively, which are commonly used as laxatives for rectal administration Have been.
  • Effervescent suppositories generally melt in rectal secretion after rectal administration and release carbon dioxide through the normal neutralization reaction (Equation 1) between a basic drug and an acidic drug as described above. .
  • Effervescent suppositories are susceptible to ambient humidity during storage because they use a normal neutralization reaction. This is because the neutralization reaction as shown in (Equation 1) proceeds in the presence of moisture.
  • effervescent suppositories are commercially available in a package form in which a suppository is filled in a container made of vinyl chloride as a primary container and then placed directly in a paper box.
  • the container made of vinyl chloride used for packaging effervescent suppositories can be used at room temperature (especially above 15 ° C to 30 ° C) because the container itself has moisture permeability.
  • the moisture absorbed causes the neutralization reaction between the basic drug and the acidic drug to proceed.
  • the content of both drugs is reduced, and the amount of carbon dioxide released upon administration is reduced, thereby reducing the therapeutic effect.
  • the present invention overcomes the drawbacks of the conventionally used methods for storing effervescent suppositories, and can stably store effervescent suppositories even at a temperature exceeding the surrounding urn of 15 ° C.
  • the purpose of this study is to develop a storage method and a package for it.
  • the inventors of the present invention have made intensive studies in view of the above problems, and have found that effervescent suppositories are placed in a dry atmosphere, and that effervescent suppositories and desiccants (particularly, silica gel) are stored in a sealed system. Further, they have found that the foamable suppository can be stably stored even at an ambient temperature of more than 15 ° C, and have further studied to complete the present invention. That is, the present invention is as follows.
  • a method for preserving an effervescent suppository comprising placing the effervescent suppository in a dry atmosphere.
  • a method for storing an effervescent suppository comprising storing an effervescent suppository and a desiccant in a sealed system.
  • examples of the effervescent suppository include preparations that generate gas upon administration by a neutralization reaction between a basic drug and an acidic drug.
  • Specific examples include rectal preparations which are laxatives that generate carbon dioxide by the reaction between a carbonate and an acidic drug.
  • the formulation may also contain additives for various purposes.
  • examples of the “putting the effervescent suppository under a dry atmosphere” include, for example, a method of storing the effervescent suppository and the desiccant in a sealed system.
  • the desiccant is not particularly limited as long as it can be used with pharmaceuticals. Examples thereof include silica gel, calcium oxide, calcium chloride, and silica alumina gel (montmorillonite, alofen, zeolite, molecular sieve, etc.). Silica gel, calcium oxide, and calcium chloride are more preferable, and among them, silica gel is particularly preferable. These desiccants may be used alone or in combination.
  • the amount of the desiccant used is usually 0.004 to 0.077 parts by weight, preferably 0.019 to 0 parts by weight, per part by weight of the foaming suppository. 0.38 parts by weight.
  • the term “sealed” means a state in which gaseous moisture does not enter during daily handling or in a normal storage state (the 13th revised Japanese Pharmacopoeia).
  • a container for storing the effervescent suppository desiccant in a sealed system use a sealed external
  • the container is not particularly limited as long as it can prevent the intrusion of moisture from the container.
  • a container such as a multilayer film bag can be used.
  • the container for filling the suppository is not particularly limited as long as it is a container made of a material permeable to moisture, but preferred examples thereof include a container made of Shiridani Bull, a container made of polyethylene terephthalate, a container made of polypropylene, and the like.
  • a container made of chloride chloride is particularly preferred.
  • effervescent suppositories can be stored at a temperature above 15 ° C, for example at room temperature, more particularly above 15 ° C to 30 ° C.
  • the upper limit of the temperature range in which an effervescent suppository can be stored according to the present invention varies depending on the stability at high temperatures of the base and additives contained in the suppository.
  • a base having a melting point of 36 ° C or less is usually selected so that it melts at body temperature, so it is preferable to store the base at a temperature at least not exceeding its melting point. .
  • effervescent suppositories include sodium hydrogencarbonate and anhydrous sodium dihydrogen phosphate, and an oily base (for example, witebzol, pharmazol, cocoa butter, laurin butter, Nikkay butter, hardened oil, etc.).
  • an oily base for example, witebzol, pharmazol, cocoa butter, laurin butter, Nikkay butter, hardened oil, etc.
  • a suppository may contain a thickener, a dispersant, and the like in addition to the base.
  • the preparation is carried out by means known per se.
  • Example 1 Storage package using silica gel as a desiccant
  • Silica gel desiccant for packaging type A (Fuji Silysia Chemical) 0.2 lg, 0.2 g, 0.5 lb. 1.
  • O g was placed in a cellonium (ZPFP-30150930, Fujimori Plastic Chemical) bag, the inside air was expelled by pressing the bag, and then sealed by heat sealing using an electric sealer.
  • Example 2 Storage package using calcium chloride as a desiccant
  • 2.6 g of a suppository was weighed into a weighing bottle having a constant weight, and 0.175 g of dried anhydrous sodium dihydrogen phosphate was added thereto. To this, 1 mL of water was added, and the mixture was heated at 50 ° C for 20 minutes to completely generate carbon dioxide gas, and then dried at 130 ° C for 3 hours. After cooling in a desiccator, the weight was weighed, and the content of sodium hydrogen carbonate was determined from the amount of generated carbon dioxide gas.
  • Table 1 shows the measurement results of the sodium hydrogencarbonate content
  • Table 2 shows the observation results of the appearance of the cellonium bag.
  • each symbol of appearance in Table 2 indicates that the state shown in the following criteria was exhibited.
  • Effervescent suppositories can be stored stably at room temperature, especially at temperatures above 15 ° C.
  • This application is based on a patent application No. 2001-132783 filed in Japan, the contents of which are incorporated in full herein.

Abstract

L'invention concerne une méthode de conservation pour un suppositoire, consistant à placer le suppositoire dans une atmosphère sèche. L'invention concerne également un emballage destiné à la conservation d'un suppositoire, caractérisé en ce qu'il présente une forme permettant de conserver le suppositoire dans une atmosphère sèche. L'invention concerne plus particulièrement un emballage hermétique destiné à la conservation d'un suppositoire, renfermant un suppositoire et un déshydratant. Cette méthode permet ainsi de conserver des suppositoires dans un environnement stable à température ambiante, en particulier à une température supérieure à 15 °C.
PCT/JP2002/003424 2001-04-27 2002-04-05 Methode de conservation pour un suppositoire WO2002089823A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2002586956A JP4346311B2 (ja) 2001-04-27 2002-04-05 発泡性坐剤の保存方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2001132783 2001-04-27
JP2001-132783 2001-04-27

Publications (1)

Publication Number Publication Date
WO2002089823A1 true WO2002089823A1 (fr) 2002-11-14

Family

ID=18980744

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2002/003424 WO2002089823A1 (fr) 2001-04-27 2002-04-05 Methode de conservation pour un suppositoire

Country Status (2)

Country Link
JP (1) JP4346311B2 (fr)
WO (1) WO2002089823A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009532344A (ja) * 2006-03-31 2009-09-10 グノーシス ソシエタ ペル アチオニ Ｓ−アデノシルメチオニンおよび／またはｎａｄｈをベースにした固形経口組成物およびそれを得る方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1374105A (en) * 1970-12-03 1974-11-13 Scherico Ltd Effervescent compositions
JPS60224614A (ja) * 1984-04-23 1985-11-09 Kao Corp 発泡性グリセリン坐剤
JPS6165823A (ja) * 1984-09-07 1986-04-04 Kao Corp 直腸投与製剤
US4853211A (en) * 1982-03-05 1989-08-01 Eisai Co., Ltd. Stable, effervescent vaginal suppositories
US5102665A (en) * 1988-06-24 1992-04-07 Glaxo Group Limited Pharmaceutical compositions
EP0837069A1 (fr) * 1996-10-21 1998-04-22 Bayer Ag Méthode pour la stabilité de stockage d'acarbose

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1374105A (en) * 1970-12-03 1974-11-13 Scherico Ltd Effervescent compositions
US4853211A (en) * 1982-03-05 1989-08-01 Eisai Co., Ltd. Stable, effervescent vaginal suppositories
JPS60224614A (ja) * 1984-04-23 1985-11-09 Kao Corp 発泡性グリセリン坐剤
JPS6165823A (ja) * 1984-09-07 1986-04-04 Kao Corp 直腸投与製剤
US5102665A (en) * 1988-06-24 1992-04-07 Glaxo Group Limited Pharmaceutical compositions
EP0837069A1 (fr) * 1996-10-21 1998-04-22 Bayer Ag Méthode pour la stabilité de stockage d'acarbose

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009532344A (ja) * 2006-03-31 2009-09-10 グノーシス ソシエタ ペル アチオニ Ｓ−アデノシルメチオニンおよび／またはｎａｄｈをベースにした固形経口組成物およびそれを得る方法
US10471088B2 (en) 2006-03-31 2019-11-12 Gnosis Spa Solid oral compositions based on S-adenosyl methionine and/or NADH and process for obtaining them

Also Published As

Publication number Publication date
JP4346311B2 (ja) 2009-10-21
JPWO2002089823A1 (ja) 2004-08-19

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