Use of plastic sheets with polar molecule groups as primary packing means for beta-lactams antibiotics and plastic bags.
Abstract
Films (sheets) made from plastics containing polar molecule groups are used as primary packing means for solid beta -lactam antibiotics. Primary packing means are plastic bags made from said plastics.
Term
Term ended
Projected expiry passed 12 August 2008, 18.1 years ago.
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7 claims: 7 independent, 0 dependent
- c-de-00011. The use of films of plastics having polar molecular groups as primary packaging for solid β-lactam antibiotics.
- c-de-00022. Plastic bags made from films of plastics having polar molecular groups as primary packaging for solid β-lactam antibiotics.
- c-de-00033. Plastic bags made from films of plastics having polar molecular groups as primary packaging for solid cephalosporin.
- c-de-00044. Plastic bags made from films of plastics having polar molecular groups as primary packaging for cefotaxime, cefodizime, cefpirome, and HOE 111, as well as physiologically acceptable salts thereof, optionally mixed with pH-regulating compounds, in solid form.
- c-de-00055. Use of sheets of cellophane, cellulose acetate, polyamide, polyester or polyurethane as a primary packaging for solid β-lactam antibiotics.
- c-de-00066. Plastic bags from sheets of cellophane, cellulose acetate, polyamide, polyester or polyurethane as a primary packaging for solid β-lactam antibiotics.
- c-de-00077. A method for packaging of solid β-lactam antibiotics, characterized in that plastic bags made from films of plastics are used as primary packaging materials having polar molecular groups.
Independent claims7
11 paragraphs, as filed
Aseptic-to-use sterile cephalosporin. to be used for the production of injection preparations, such as cefotaxime, cefodizime, cefpirome, or inner salt 7²- (Z) - (O-methyl) (also referred to as HOE 111) and the physiologically acceptable salts, optionally mixed with pH-regulating substances are packaged in sterile polyethylene plastic bags as primary packaging. The flexible bags are easy to handle and show no particle abrasion, as described in particular at the closure elements when not flexible primary packaging materials, eg stainless steel or glass, occurs.
A disadvantage is that polyethylene and polypropylene in the same way plastic bags cause during storage Trüblöslichkeit the packaged substances, even if both bags and abzupackende substance were sterile and performed the packaging under aseptic conditions. Substances used for the preparation of injection solutions, but they must be completely soluble.
Attempts known primary package to be replaced by those from composite film made of polyamide / high density polyethylene composite foil of polyester / low-density polyethylene or composite film of polyester / aluminum / polyethylene as they are used primarily for the packaging of food, did not show the desired results; it has been found occurring to the same extent Trüblöslichkeit. They represent no improvement to the polyethylene and polypropylene bags used. Based on these observations the expert had expected that even bags of plastics are unsuitable having polar molecular groups as primary packaging for β-lactam antibiotics, as they are chemically reactive than polyethylene and polypropylene.
It has now surprisingly been found that is caused in the use of plastic bags made of plastics having polar molecule groups such as cellophane film, polyamide, polyester, polyurethane oderZelluloseacetat, no Trüblöslichkeit in cephalosporin derivatives.
The invention therefore relates to the use of films of plastics having polar molecular groups as primary packaging for solid β-lactam antibiotics and plastic bags made from films of plastics having polar molecular groups as primary packaging for solid β-lactam antibiotics.
As plastics having polar molecular groups are particularly cellophane (eg ®Cellophan), cellulose acetate, polyamide (eg ®Pla-sterile), polyesters and polyurethanes into consideration. Preferably, regenerated cellulose, polyamide and polyester are used.
Plastic pouch made of said films may be opposed to plastic bags made of polyethylene autoclaved. A sterilized fumigation, eg with formaldehyde or ethylene oxide is possible, but can be avoided because of the heat resistance, which has the advantage that residues of sterile isere gas into the primary packaging can no longer occur.
The films can be prepared under aseptic conditions or clean-room conditions and may with no dust - be tainted, that contamination of the drug must be excluded from the outset - even sterile.
The bag is obtained eg by folding or welding the film. The bag for the primary package are sealed with cable ties. The thickness of the film depends of course on the strength of the film and by the quantity of bagged in bags agent. The bags have sufficient mechanical stability, abrasion was not observed.
As β-lactam antibiotics 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 compounds such as sodium carbonate, trisodium phosphate, and basic amino acids are suitable.
The following examples show that the use of sheets of the plastics mentioned the prescribed drugs clear solubility was also observed among different kinds of burden, while with the use of a polyethylene film Trüblöslichkeit was 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="center">Cefodizime di-sodium salt 0.5g dose packaged in pouches (5 cm length, 4 cm width)</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="center">polyethylene film</entry><entry namest="col3" nameend="col3" align="center">polyamide film</entry><entry namest="col4" nameend="col4" align="center">Cellophane</entry><entry namest="col5" nameend="col5" align="center">polyester film</entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col1" align="left">1 h vibration</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">1 h vibration danach7 days of storage at + 40 ° C</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">1 h vibration, after seven days of storage at room temperature</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">1 h vibration, after 7 days of storage at + 5 ° C</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 of storage at + 40 ° C</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 at room temperature</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 of storage at + 5 ° C</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="center">Cefotaxime sodium salt 0.5 g dose in bags (5 cm length, 4 cm width)</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="center">polyethylene film</entry><entry namest="col3" nameend="col3" align="center">polyamide film</entry><entry namest="col4" nameend="col4" align="center">Cellophane</entry><entry namest="col5" nameend="col5" align="center">polyester film</entry></row></thead><tbody valign="top"><row><entry namest="col1" nameend="col1" align="left">1 h vibration</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">1 h vibration, after 7 days of storage at + 40 ° C</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">1 h vibration, after seven days of storage at room temperature</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">1 h vibration, after 7 days of storage at + 5 ° C</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 of storage at + 40 ° C</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 at room temperature</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 of storage at + 5 ° C</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="6" colsep="1" rowsep="1"><colspec colnum="1" colname="col1" colwidth="26.25mm" /><colspec colnum="2" colname="col2" colwidth="26.25mm" /><colspec colnum="3" colname="col3" colwidth="26.25mm" /><colspec colnum="4" colname="col4" colwidth="26.25mm" /><colspec colnum="5" colname="col5" colwidth="26.25mm" /><colspec colnum="6" colname="col6" colwidth="26.25mm" /><thead valign="top"><row><entry namest="col1" nameend="col6" align="center">Cefpiromsulfat - Natriumkarbonatgemisch with 5 cm² per bag film g</entry></row><row><entry namest="col1" nameend="col1" /><entry namest="col2" nameend="col2" align="center">polyethylene film</entry><entry namest="col3" nameend="col3" align="center">polyamide film</entry><entry namest="col4" nameend="col4" align="center">cellophane</entry><entry namest="col5" nameend="col5" align="center">polyester film</entry><entry namest="col6" nameend="col6" align="center">without foil as compared</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><entry namest="col6" nameend="col6" align="left">completely soluble</entry></row><row><entry namest="col1" nameend="col1" align="left">7 days storage at room temperature after mixing</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><entry namest="col6" nameend="col6" align="left">completely soluble</entry></row><row><entry namest="col1" nameend="col1" align="left">7 days of storage at + 40 ° C after mixing</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><entry namest="col6" nameend="col6" align="left">completely soluble</entry></row></tbody></tgroup></table></tables>
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| EP0216639A2 | Cites | European Patent Office (EPO) | Search report |
| DE3247294A1 | Cites | Germany | Search report |
| DE3318875A1 | Cites | Germany | Search report |
| WO8602042A1 | Cites | World Intellectual Property Organization (WIPO) | Search report |
18 members in 10 offices
Priority claims5
| Document | Office | Kind | Date |
|---|---|---|---|
| 3727627 | Germany | A | |
| 3727627 | Germany | A | |
| 3727627 | Germany | – | |
| 3727627 | – | – | – |
| DE19873727627 | – | – | – |
Members18
| Document | Office | Kind | |
|---|---|---|---|
| DK464988D0 | Denmark | D0 | |
| IL87480A0 | Israel | A0 | |
| IL87480D0 | Israel | D0 | |
| DK464988A | Denmark | A | |
| EP0303985A2This record | European Patent Office (EPO) | A2 | |
| AU2105588A | Australia | A | |
| DE3727627A1 | Germany | A1 | |
| JPS6470057A | Japan | A | |
| KR890003849A | Republic of Korea | A | |
| ZA886089B | South Africa | B | |
| PT88291A | Portugal | A | |
| EP0303985A3 | European Patent Office (EPO) | A3 | |
| AU611471B2 | Australia | B2 | |
| DE3727627C2 | Germany | C2 | |
| US5093165A | United States of America | A | |
| IL87480A | Israel | A | |
| JPH0523785B2 | Japan | B2 | |
| DK167268B1 | Denmark | B1 |
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
- 0303985
- Publication, DOCDB
- 0303985
- Publication, EPODOC
- EP0303985
- Application
- 88113126
- Application, DOCDB
- 88113126
- Application, EPODOC
- EP19880113126
Titles6
- German
- Verwendung von Folien aus Kunststoffen mit polaren Molekülgruppen als Primärpackmittel für Beta-Laktam-Antibiotika sowie Kunststoffbeutel
- English
- Use of plastic sheets with polar molecule groups as primary packing means for beta-lactams antibiotics and plastic bags
- French
- Utilisation de feuilles en plastique à groupes de molécules polaires comme moyen d'emballage primaire pour antibiotiques "bêta-lactames" et comme récipients en plastique
- German
- Verwendung von Folien aus Kunststoffen mit polaren Molekülgruppen als Primärpackmittel für Beta-Laktam-Antibiotika sowie Kunststoffbeutel.
- English
- Use of plastic sheets with polar molecule groups as primary packing means for beta-lactams antibiotics and plastic bags.
- French
- Utilisation de feuilles en plastique à groupes de molécules polaires comme moyen d'emballage primaire pour antibiotiques "bêta-lactames" et comme récipients en plastique.
Classification
- CPC, 4
- A61J1/00
- A61K31/545
- B65D65/38
- Y10T428/1345
- IPC, 7
- A61J1 00
- A61J1 05
- A61J1 10
- A61K31 545
- A61L31 00
- B65D30 02
- B65D65 38
Designated states13
- Contracting states, 13
- Austria
- Belgium
- Switzerland
- Germany
- Spain
- France
- United Kingdom
- Greece
- Italy
- Liechtenstein
- Luxembourg
- Netherlands (Kingdom of the)
- Sweden