1. PREFILLED SYRINGESUnder the Guidance ofAbdul Mohd. BariAssociate professorBYSRIKANTH BANDI,H.T.NO:11H61S0303,DEPARTMENT :PHARMACEUTICS,SCHOOL OF PHARMACY,6/14/2012 ANURAGSCHOOL OF PHARMACY GROUP OF INSTITUTIONS 1

2. CONTENTS:What are prefilled syringes?Pupose of prefillsTypes of PFS systemsMaterials used for the preparation of PFSFilling process in PFSSterilization of prefilled syringesSteps to use prefilled syringesAdvantages & DisadvantagesFactors Responsible for Growth of Prefilled SyringesMarketed Products6/14/2012SCHOOL OF PHARMACY 2conclusion 3. What are prefilledsyringes? A prefilled syringe is a single-dose packet of parental drug to which a needle has been fixed by the manufacturer. Prefillable syringes have become an increasingly important option in the packaging and delivery of injectable drug products. 6/14/2012SCHOOL OF PHARMACY 3 4. PuRpose of prefills The prefilled syringe provides two major purposes to the administration of a drug. The first is primary packaging. The purpose of theprimary package is to assure that there is no adverseeffect on the identity, strength, quality, purity orpotency of the drug over its shelf life. Second, a prefillable syringe is a delivery systemdesigned to administer the appropriate amount of themedicament to the patient. 6/14/2012SCHOOL OF PHARMACY4 5. Types of PSF systems There are two major types of prefillable syringe systems available: Glass-based systems Plastic-based systems 6/14/2012SCHOOL OF PHARMACY5 6. Glass-based systems Traditionally, a prefillable syringe barrel has been made from glass tubing. These glass tubes are transformed by heat into the barrel that is used to hold the drug product. Syringe manufacturers typically form and process the glass and purchase the complementing elastomeric components (e.g., plungers, tip caps, needle shields) that complete the primary package from an elastomeric closure manufacturer. 6/14/2012 SCHOOL OF PHARMACY 6 7. The benefits of glass systems include: Health care practitioners long history offamiliarity with the product The majority of prefilled syringes in the marketplace,are glass with elastomeric components There are multiple proven suppliers6/14/2012SCHOOL OF PHARMACY7 8. Drawbacks: Breakage Dimensional variation Potential surface reactivity Particulate contamination Adhesive or other potential leachables Inconsistent application of silicone oil (added forfunctionality)6/14/2012SCHOOL OF PHARMACY 8 9. Glass prefilled syringesare of two types Oil siliconised syringes:In this type of prefilled syringe system there is direct contact of rubber to glass surface leads overtime to higher break out forces and leads to chances of contamination. Baked on silicone syringes: In this baked on silicone syringes provide consistent coating of the glass barrel Wales. Break out forces stay low during storage 6/14/2012 SCHOOL OF PHARMACY 9 10. 6/14/2012 SCHOOL OF PHARMACY 10 11. pH shift in glass syringes The shift in pH occurs because of use of type I glassused in prefilled syringes manufacturing is aborosilicate glass. Around the beginning of cooling phase at 580 c, sodium oxide is forms and remains in glass. During storage, sodium ions are released into the water for injection and increase the concentration of hydroxide ions, thus increasing alkalinity.6/14/2012 This causes change in pH in syringes. SCHOOL OF PHARMACY 11 12. pH shift in glass syringes:6/14/2012 SCHOOL OF PHARMACY 12 13. PLASTIC-BASED SYSTEMS Plastic-based syringe systems are gaining acceptance because of their benefits compared to glass systems. The Japanese market, which is well known for its high quality, has transitioned over 50% of its syringes to plastic because of its superior performance. The most widely used prefillable plastic syringe systems are manufactured from cyclopoly olefin (COP) resin. 6/14/2012 SCHOOL OF PHARMACY 13 14. Benefits of plastic-based systems include:Break resistanceDesign flexibilityDecreased surface reactivityLess absorption/adsorption of the drugCompatible with high or low pH6/14/2012SCHOOL OF PHARMACY14 15. Plastics materials used for prefilledsyringes are mainly of two types. Cyclo olefin polymer (cop) Cyclo olefin co polymer (coc)6/14/2012 SCHOOL OF PHARMACY15 16. Cyclo olefin polymer (cop) major properties:Low water absorbencyHigh transparencyLow specific gravityHigh heat resistanceLow impurities6/14/2012SCHOOL OF PHARMACY 16 17. Cyclo olefin co polymer (coc) major properties:clear amorphous copolymers based on cyclic andlinear olefins.These materials form a family of engineering resinsthat exhibit a unique combination of properties,including high transparency, low density, excellentmoisture barrier capabilities, and resistance toaqueous and polar organic media.Topas COC is being used for pre-filled syringes,needleless injectors and other drug delivery systems.6/14/2012 SCHOOL OF PHARMACY 17 18. Materials used for the preparationof PFS: componentscomposition BarrelGlass/plastic PistonElastomer Tip cap Elastomer Plunger Plastic Lubricant Silicone oil NeedleStainless steel NeedleElastomer Needle shield cover Plastic 6/14/2012 Finger grip extenderSCHOOL OF PHARMACY Plastic 18 19. 6/14/2012 SCHOOL OF PHARMACY 19 20. Filling process inPREFILLED SYRINGES: Newer technique developed by HCMs (Hyaluron Contractmanufacturing) patented method of syringe filling involvesvacuum filling coupled with online vacuum stoppering, Knownas bubble-free filling. It eliminates the air bubble inside the syringe, (known as "headspace"), that results from traditionally filling methods. Furthermore, totally removing the gas bubble improves thestability of oxygen sensitive compounds. In bubble-free filling, a vacuum (or, more accurately,differential pressure) is used to place the stopper.6/14/2012SCHOOL OF PHARMACY20 21. Sterilization of prefilledsyringes Sterilization of prefilled syringe is mainly done by autoclavingor by ionizing radiation. Autoclave is not suitable of glass prefilled syringes and normalplastics, as there occurs a pH shift in glass syringes duringautoclave sterilization process. Mainly used method of sterilization is ionizing radiations. Gamma sterilization has proved to be an efficient means ofsterilizing prefilled syringes. Ionizing radiation has the advantage of sterilization the syringeplungers while they remain in their packaging.6/14/2012SCHOOL OF PHARMACY 21 22. Steps to use prefilledsyringes Step 1: Verify the label on prefilled syringe as it may be serious if wrongly injected. Step 2: Take out the syringe cap and needle cap without touching the needle tip to prevent the contamination of the syringe. Step 3: Insert the needle. Manually inserting a needle into skin can be the most challenging element of self injection. Step 4: Once injection is completed, the patient must dispose the used syringe. 6/14/2012SCHOOL OF PHARMACY22 23. Advantages &Disadvantages The first prefilled syringes were made of polypropylene. The advantages of prefilled syringes are : Patient related: Ease of convenience & use for health care professionals and patients compared to a traditional vial packaging system Reduced risk of dosage error and contamination Greater efficiency Improved sterility assurance 6/14/2012 Enhanced product differentiation SCHOOL OF PHARMACY 23 24. Market related:Reduced therapy and injectioncostsIncreased market preference20% API savings vs. vial filling6/14/2012 SCHOOL OF PHARMACY 24 25. A D V A N T A G E S6/14/2012 SCHOOL OF PHARMACY 25 26. Disadvantages:These are complex medical devicesNeedle stick injuriesAdditional protection required6/14/2012 SCHOOL OF PHARMACY26 27. Factors Responsible forGrowth of PrefilledSyringes Ease of administration, more convenient for healthcare professionals and patients, easier for home use, easier in emerging situations, reduction of medication errors, better dose accuracy, increase assurance of sterility, Better use of controlled drugs such as narcotics, lower injection cost by less preparation, easy storage and disposal, 6/14/2012 product differentiation. SCHOOL OF PHARMACY 27 28. Marketed products:1)KINFERON (recombinant interferon product) Strengths:3,5,6MIU/ml Indications: Acute & chronic hepatitis(type-B&C)leukemia, Malignant melanoma, Renal cell carcinoma, Ovary carinoma etc., Route: IM,SC,intralesional. 6/14/2012 SCHOOL OF PHARMACY28 29. 2) AVONEX :(Interferon beta-1a)Strenght:30mcgCategory:anti viralRoute: IM6/14/2012SCHOOL OF PHARMACY 29 30. List of drug that are used via prefilled syringes Ardeparin Hospiral lidocaine 1%w/v Choriogonadotropin Lidocaine Hcl 2% DalteparinNadroparin Enoxaparin sodium Reviparin Diclofenac sodium Sodium hyaluronate 1%w/v vasopressin Tinozaparin erythromycinamiodarone 6/14/2012SCHOOL OF PHARMACY30 31. Market growth:6/14/2012 SCHOOL OF PHARMACY 31 32. EQUI FullyP AutomaticM Pre-FilledE SyringeN FillingT mechines:Model: 6/14/2012 SCHOOL OF PHARMACY PFT-A-05 32 33. EQUIPMENTs: 6/14/2012 SCHOOL OF PHARMACY 33 34. Conclusion: As there are many advantages of prefilled syringes like convenience, affordability, accuracy, sterility, safety, marketing advantages, manufacturing advantages, and marketing advantages,prefilled syringes will eventually replace the conventional type. 6/14/2012 SCHOOL OF PHARMACY 34 35. Bibliography: www.pharmatechnologyindex.com www.visongain.com www.jpionline.org www.biopharminternational.com www.avonex.com www.ondrugdelivery.com www.bd.com www.ec21.com www.harikrushnatechnopride.tradeindia.com www.pharmtech.com 6/14/2012 www.baxterbiopharmasolutions.comSCHOOL OF PHARMACY 35 36. 6/14/2012 SCHOOL OF PHARMACY 36