Use of plastics with polar molecule groups for isolation coating of plugs for injection and infusion bottles and coated plugs for injection and infusion bottles.
Abstract
Plastics containing polar molecule groups are used for insulation coating of stoppers for injection and infusion bottles.
Term
Term ended
Projected expiry passed 12 August 2008, 18.1 years ago.
- Priority
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- Published
- Projected expiry
- Today
9 claims: 8 independent, 1 dependent
- c-de-00011. The use of plastics having polar molecular groups for insulation coating stoppers for injection and infusion bottles.
- c-de-00022. The use of plastics having polar molecular groups for insulation coating of injection and infusion bottle stoppers for β-lactam antibiotics.
- c-de-00033. The use of plastics having polar molecular groups for insulation coating of injection and infusion bottle stoppers for cephalosporin derivatives.
- c-de-00044. The use of plastics having polar molecular groups for insulation coating of injection and infusion bottle stoppers for cefotaxime, cefodizime, cefpirome, and HOE 111 and pharmaceutically acceptable salts thereof, optionally mixed with pH-regulating compounds.
- c-de-00055. use of regenerated cellulose, cellulose acetate, polyamide, polyester or polyurethane as a material for insulation coating of injection and infusion bottle stoppers.
- c-de-00066. use of regenerated cellulose, cellulose acetate, polyamide, polyester or polyurethane as a material for insulation coating of injection and infusion bottle stoppers of cephalosporin derivatives.
- c-de-00077. stoppers for injection and infusion bottles, characterized in that they are coated with plastics having polar molecular groups.
- c-de-00099. The method for insulation coating stoppers for injection and infusion bottles, characterized in that coating the plug or the pins with plastics having polar molecular groups.
Independent claims8
16 paragraphs, as filed
For closure of injection bottles and infusion bottles with β-lactam antibiotics dry substances, such as cefotaxime, cefodizime, cefpirome or hydroxide, inner salt, 7²- (Z) - (0-methyloxime) (also referred to as HOE 111), their physiologically acceptable salts, optionally in admixture with pHregulierenden substances are plugs required, which are the product inert to and from damaging environmental influences protect, in particular a sufficient barrier effect against microbial and particulate contamination, water and water vapor must be given.
Stoppers for injection and infusion bottles usually consist essentially of rubber. Although they have good pierceable and recloseablility but cause poor clear solubility of the active substances, an intolerable disadvantage of injection solutions and infusion solutions.
To avoid this drawback, at present are injection and infusion bottle stoppers, whose pins are fluoropolymer-coated (cf.. German Offenlegungsschrift 3,346,351 corr. Derwent ref. 85-172 215/29). However, fluoropolymer-coated stoppers have their rigid coated pins have the disadvantage that they close compared to uncoated stopper the bottles less dense and so in particular the risk of ingress of moisture. The pierceable and recloseablility be adversely affected by the Fluorpolymebeschichtung.
Fluoropolymer film is expensive and fluoropolymer-coated stoppers are significantly more expensive than uncoated stoppers and also have serious drawbacks.
So far, no suitable material for injection bottle stopper and infusion bottle stopper for sterile cephalosporin such as cefotaxime, cefodizime, cefpirome and HOE 111 and the physiologically acceptable salts, optionally described in admixture with pH-regulating compounds, which, without as such, ie can be used uncoated that there is turbid solutions, fragmentation and damaging environmental influences due to lack of barrier action.
It has surprisingly been found that plugs that coatings made from plastics have having polar molecule groups such as cellophane, polyamide, polyester, polyurethane or acetylcellulose not cause Trüblöslichkeit at Cephalosporinderivatsubstanzen and have a sufficient barrier effect. Such plastics should due to the polar groups be as a coating material less suitable than the currently used as the inert force fluoropolymer.
The invention therefore relates to the use of plastics having polar molecular groups for coating stoppers for injection and infusion bottles, in particular β-lactam antibiotics, as well as with plastics having polar molecular groups coated injection and infusion bottle stoppers, especially for β-lactam antibiotics.
The plastics used are particularly cellophane (eg ®Cellophan), cellulose acetate, polyamide (eg ®Pla-sterile), polyester and polyurethane into consideration. Particularly preferred are cellophane, polyamide and polyester.
As β-lactam derivatives are primarily cephalosporins into consideration, in particular cefotaxime, cefodizime, cefpirome and HOE 111, and pharmaceutically acceptable salts thereof, optionally mixed with pH-regulating compounds.
Suitable pH-regulating substances such as sodium carbonate, trisodium phosphate, and basic amino acids are suitable.
The plugs are either completely coated with plastic or it is just the pin coated. The coating or insulation for example, by applying a film of plastic having polar molecule groups, preferably only on the pin. The application of the coating material can also be effected by Sprühcoating.
The thickness of the coating may vary. It need only be ensured a sufficient barrier effect and an adequate mechanical stability.
By Beschi chtungen of plug or plug pins with soft sheets of plastics having polar molecular groups can again closing plugs are made that do not cause Trüblöslichkeit in β-lactam antibiotics dry substances good sealing, easy to piercing and after removal of the needle or the transfer element. Since films of these materials are cheaper, plug with insulating coatings of plastics having polar molecular groups are cheaper to produce than those with fluoropolymer coating.
The blocking action by the invention completely or partially coated stopper is very good. Is it with such stoppered bottles for example in water, so no weight gain is observed. The risk that the Zubördelung is not sufficiently dense is extremely low, because the coating material has as compared to fluoropolymer has a certain elasticity.
Plugs that are fully or partially coated with plastics having polar molecular groups, keep a sterilization for example by exposure to formaldehyde but also to autoclave sterilization, which is preferable to stand.
The following examples demonstrate that a coating or insulation of the plug with films of the said plastics enable the prescribed drugs for clear solubility under various kinds of stress, while the use of uninsulated plug a Trüblöslichkeit is already visible to the eye. <tables id="tabl0001" num="0001"><table frame="all"><title>example I</title><tgroup cols="5" colsep="1" rowsep="1"><colspec colnum="1" colname="col1" colwidth="31.50mm" /><colspec colnum="2" colname="col2" colwidth="31.50mm" /><colspec colnum="3" colname="col3" colwidth="31.50mm" /><colspec colnum="4" colname="col4" colwidth="31.50mm" /><colspec colnum="5" colname="col5" colwidth="31.50mm" /><thead valign="top"><row><entry namest="col1" nameend="col5" align="left">Cefodizime di-Na salt with various stoppers for injection bottles:</entry></row><row><entry namest="col1" nameend="col1" align="left">burden</entry><entry namest="col2" nameend="col2" align="center">Uncoated injection bottle stoppers</entry><entry namest="col3" nameend="col3" align="center">Injection bottle stoppers with polyamide film isolated</entry><entry namest="col4" nameend="col4" align="center">Injection bottle stoppers with regenerated cellulose film isolated</entry><entry namest="col5" nameend="col5" align="center">Injection bottle stoppers with polyester film isolated</entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col1" align="left">roll 7 days</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row><row><entry namest="col1" nameend="col1" align="left">7 days storage roll upside down at room temperature after 1 hour</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row><row><entry namest="col1" nameend="col1" align="left">7 days storage roll upside at + 40 ° C after 1 h</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row></tbody></tgroup></table></tables><tables id="tabl0002" num="0002"><table frame="all"><title>example II</title><tgroup cols="5" colsep="1" rowsep="1"><colspec colnum="1" colname="col1" colwidth="31.50mm" /><colspec colnum="2" colname="col2" colwidth="31.50mm" /><colspec colnum="3" colname="col3" colwidth="31.50mm" /><colspec colnum="4" colname="col4" colwidth="31.50mm" /><colspec colnum="5" colname="col5" colwidth="31.50mm" /><thead valign="top"><row><entry namest="col1" nameend="col5" align="left">Cefotaxime sodium salt with various stoppers for injection bottles:</entry></row><row><entry namest="col1" nameend="col1" align="left">burden</entry><entry namest="col2" nameend="col2" align="center">Uncoated injection bottle stoppers</entry><entry namest="col3" nameend="col3" align="center">Injection bottle stoppers with polyamide film isolated</entry><entry namest="col4" nameend="col4" align="center">Injection bottle stoppers with regenerated cellulose film isolated</entry><entry namest="col5" nameend="col5" align="center">Injection bottle stoppers with polyester film isolated</entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col1" align="left">roll 7 days</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row><row><entry namest="col1" nameend="col1" align="left">7 days storage roll upside down at room temperature after 1 hour</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row><row><entry namest="col1" nameend="col1" align="left">7 days storage roll upside at + 40 ° C after 1 h</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row></tbody></tgroup></table></tables><tables id="tabl0003" num="0003"><table frame="all"><title>example III</title><tgroup cols="5" colsep="1" rowsep="1"><colspec colnum="1" colname="col1" colwidth="31.50mm" /><colspec colnum="2" colname="col2" colwidth="31.50mm" /><colspec colnum="3" colname="col3" colwidth="31.50mm" /><colspec colnum="4" colname="col4" colwidth="31.50mm" /><colspec colnum="5" colname="col5" colwidth="31.50mm" /><thead valign="top"><row><entry namest="col1" nameend="col5" align="left">Cefpiromsulfat - Natriumkarbonatgemisch with various stoppers for injection bottles:</entry></row><row><entry namest="col1" nameend="col1" align="left">burden</entry><entry namest="col2" nameend="col2" align="center">Uncoated injection bottle stoppers</entry><entry namest="col3" nameend="col3" align="center">Injection bottle stoppers with polyamide film isolated</entry><entry namest="col4" nameend="col4" align="center">Injection bottle stoppers with regenerated cellulose film isolated</entry><entry namest="col5" nameend="col5" align="center">Injection bottle stoppers with polyester film isolated</entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col1" align="left">roll 7 days</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row><row><entry namest="col1" nameend="col1" align="left">7 days storage roll upside down at room temperature after 1 hour</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row><row><entry namest="col1" nameend="col1" align="left">7 days storage roll upside at + 40 ° C after 1 h</entry><entry namest="col2" nameend="col2" align="left">trüblöslich</entry><entry namest="col3" nameend="col3" align="left">completely soluble</entry><entry namest="col4" nameend="col4" align="left">completely soluble</entry><entry namest="col5" nameend="col5" align="left">completely soluble</entry></row></tbody></tgroup></table></tables>
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| EP0148426A2 | Cites | European Patent Office (EPO) | Search report |
| EP0199356A2 | Cites | European Patent Office (EPO) | Search report |
| US4254884A | Cites | United States of America | Search report |
17 members in 10 offices
Priority claims5
| Document | Office | Kind | Date |
|---|---|---|---|
| 3727626 | Germany | A | |
| 3727626 | Germany | A | |
| 3727626 | Germany | – | |
| 3727626 | – | – | – |
| DE19873727626 | – | – | – |
Members17
| Document | Office | Kind | |
|---|---|---|---|
| DK464888D0 | Denmark | D0 | |
| IL87481A0 | Israel | A0 | |
| IL87481D0 | Israel | D0 | |
| DK464888A | Denmark | A | |
| EP0303984A2This record | European Patent Office (EPO) | A2 | |
| AU2105688A | Australia | A | |
| DE3727626A1 | Germany | A1 | |
| JPS6470056A | Japan | A | |
| KR890003844A | Republic of Korea | A | |
| ZA886088B | South Africa | B | |
| PT88292A | Portugal | A | |
| DE3727626C2 | Germany | C2 | |
| EP0303984A3 | European Patent Office (EPO) | A3 | |
| US4977027A | United States of America | A | |
| AU608885B2 | Australia | B2 | |
| JPH0523786B2 | Japan | B2 | |
| IL87481A | Israel | A |
8 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Application withdrawnWithdrawn18W | 18W | |
| Information on the status of an ep patent application or granted ep patentGrantedSTATUS: THE APPLICATION HAS BEEN WITHDRAWNSTAA | STAA | |
| First examination report despatched17Q | 17Q | |
| Request for examination filed17P | 17P | |
| Designated contracting statesAK | AK | |
| Search report despatchedORIGINAL CODE: 0009013PUAL | PUAL | |
| Designated contracting statesAK | AK | |
| Public reference made under article 153(3) epc to a published international application that has entered the european phaseORIGINAL CODE: 0009012PUAI | PUAI |
Numbers
- Publication
- 0303984
- Publication, DOCDB
- 0303984
- Publication, EPODOC
- EP0303984
- Application
- 88113125
- Application, DOCDB
- 88113125
- Application, EPODOC
- EP19880113125
Titles6
- German
- Verwendung von Kunststoffen mit polaren Molekülgruppen zur Isolationsbeschichtung von Stopfen für Injektions- und Infusionsflaschen sowie beschichtete Injektions- und Infusionsflaschenstopfen
- English
- Use of plastics with polar molecule groups for isolation coating of plugs for injection and infusion bottles and coated plugs for injection and infusion bottles
- French
- Utilisation de plastiques à groupes de molécules polaires pour l'enduction isolante des bouchons de bouteilles d'injection ou d'infusion et bouchons de bouteilles d'injection et d'infusion enduites
- German
- Verwendung von Kunststoffen mit polaren Molekülgruppen zur Isolationsbeschichtung von Stopfen für Injektions- und Infusionsflaschen sowie beschichtete Injektions- und Infusionsflaschenstopfen.
- English
- Use of plastics with polar molecule groups for isolation coating of plugs for injection and infusion bottles and coated plugs for injection and infusion bottles.
- French
- Utilisation de plastiques à groupes de molécules polaires pour l'enduction isolante des bouchons de bouteilles d'injection ou d'infusion et bouchons de bouteilles d'injection et d'infusion enduites.
Classification
- CPC, 10
- A61J1/1406
- A61J1/00
- Y10S220/19
- Y10T428/31569
- Y10T428/31855
- Y10T428/31786
- Y10T428/31891
- Y10T428/31841
- Y10T428/31935
- Y10T428/31884
- IPC, 6
- A61J1 00
- A61J1 06
- A61J1 05
- A61J1 14
- A61L31 00
- C09D201 00
Designated states13
- Contracting states, 13
- Austria
- Belgium
- Switzerland
- Germany
- Spain
- France
- United Kingdom
- Greece
- Italy
- Liechtenstein
- Luxembourg
- Netherlands (Kingdom of the)
- Sweden