Innovative flexible primary packaging solutions for reconstitution and drug delivery systems

Transcription

1 February 12 th 2014 Pharmapack Paris Innovative flexible primary packaging solutions for reconstitution and drug delivery systems Ludwig Weibel CH-9104 Waldstatt, Switzerland

2 Our vision every parenteral drug is made available to the world in a «ready to use» form

3 PUBLIC-HEALTH PROBLEM: SAFETY Switzerland 1) hospital infections cost CHF 250 million each year. Error-related deaths amongst hospital patients 2) double the deaths caused by influenza, AIDS and traffic accidents together 3). USA 4) to reported needle stick injuries cost hospitals 1 to 3 billion US$ each year without the cost caused by subsequent infections 4). (a small stick with a hollow needle may carry over more than 20 pathogens 4) ) References: 1) Patientensicherheit als Public Health-Problem in Zahlen, Patient safety foundation, Fakten 2) Source: several actual studies, extrapolation for Switzerland 3) Source: Bundesamt für Statistik, Todesursachenstatistik ) IV Catheter Needlestick Prevention, B. Braun Melsungen AG, several sources cited in document 3

4 INJECTABLE DRUGS MARKET MiniBag Ampoules Mio pcs what is the future? Carpules Mio pcs mostly insulin and dental Vials Mio pcs Prefilled Syringes Mio pcs market share stagnating Vials liquid Mio pcs Vials Lyophilisate Mio pcs Drug Delivery System (prefilled patch pen) Reconstitution System 4

5 disposable syringe with staked needle and passive safety device EXAMPLES OF DEVICES FOR VIALS liquid products lyophilised products and solvent solvent vial, 13mm 13mm 20mm 13mm 20mm lyophilisate vial, 20mm 3ml LuerLock syringe 10ml LuerLock syringe 5ml LuerLock syringe 20ml LuerLock syringe transfer elements with drip stop / swabbable valve 13mm 20mm 13mm 20mm 5

6 PATIENT CENTRIC VIEW Full integration of all functions and parts The advantage for the end user is a reduction of contaminations handling errors needle stick injuries and a gain of time You can differentiate yourself from competition 6

7 RECONSTITUTION: TODAY/TOMORROW today 22 steps tomorrow 8 steps remove flip cap disinfect pierce rubber stopper open lid => a) closure opened, b) solvent squeezed into vial extract drug into syringe remove syringe inject withdraw syringe => automatic protection of needle 7

8 PREFILLED PATCH PEN disposable part: container (MiniBag) port micropump injection needle reusable part: pump drive needle insertion trigger battery controller The prefilled syringe of the future may be a prefilled patch pen with automatic needle insertion and controlled drug delivery. attach disposable part to reusable part active microinfusion with micropump Drug Delivery System ready to use => patch to skin needle injection steel cannula withdrawn => soft cannula stays in skin 8

9 MONO OR MULTILAYER FILM «classical» «exotic» «simple» «special» unlimited material selection film port film film: any film structure that allows thermosealing port: molded in different polymers compatible with the inner layer of the film «symmetric» «assymmetric» 9

10 NEW MANUFACTURING TREND mother roll injection molding of parts into cleanroom blown or cast multilayer film at the cleanroom: mother roll slitting MiniBag forming device assembly (MiniBag inserted into device) 10

11 ASEPTIC FILLING (PILOT EXAMPLE) 1. place MiniBag system 2. closure lifted 3. if necessary: remove remaining air with vacuum 4. fill 5. close with same closure 6. take off filled, ready to use MiniBag system 11

12 KEY BULLET POINTS sustainable and ecologic thanks to a streamlined, hygienic production and supply chain a Patient-centric view leads to pre-filled MiniBags directly incorporated in a device, allowing innovative solutions for Patient safety and Compliance combine different products in a closed system: MiniBags can be configurated as multichamber bags with multichannel ports or may be combined via external channels or transfer devices with vials via transfer devices all functions and parts may be included: the Patient opens only one disposable package scalability and versatility allow to brake human medicine boundaries: dosages from mice to elephants (e.g. from 0.2 to XXX ml) 12

13 MINIBAG BASED PRODUCT EXAMPLES Reconstyringe intuitive, automatic reconstitution Flyringe between ampoules and PFS drug in MiniBag Drug Delivery System Microinfusion-System disposable part: container (MiniBag) port micropump injection needle reusable part: pump drive needle insertion trigger battery controller Squeezer a totally new way to store and administer products 13

14 Booth 234 Thank you Weibel CDS - safer, easier and faster drug delivery 14