A ppt on prefilled syringes


Published on

  • supub
    Are you sure you want to  Yes  No
    Your message goes here
  • Very nice overview Shriknath. I would like a copy of the presentation. My mail id is timlee15@hotmail.com
    Are you sure you want to  Yes  No
    Your message goes here
  • dear shiknath it is very good ppt pls share with me...
    my mail id is juhisaxena1992@gmail.com
    Are you sure you want to  Yes  No
    Your message goes here
  • Dear shrikanth it is very good ppt pls share with me.........
    my mail id is juhisaxena1992@gmail.com
    Are you sure you want to  Yes  No
    Your message goes here
  • Dear Shriknath nice & very valuable iformation. Good compilation
    Are you sure you want to  Yes  No
    Your message goes here
No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

A ppt on prefilled syringes

  2. 2. CONTENTS: What are prefilled syringes? Pupose of prefills Types of PFS systems Materials used for the preparation of PFS Filling process in PFS Sterilization of prefilled syringes Steps to use prefilled syringes Advantages & Disadvantages Factors Responsible for Growth of Prefilled Syringes Marketed Products6/14/2012 SCHOOL OF PHARMACY 2 conclusion
  3. 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. 6/14/2012 SCHOOL OF PHARMACY 3
  4. 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 the primary package is to assure that there is no adverse effect on the identity, strength, quality, purity or potency of the drug over its shelf life.  Second, a prefillable syringe is a delivery system designed to administer the appropriate amount of the medicament to the patient. 6/14/2012 SCHOOL OF PHARMACY 4
  5. 5. Types of PSF systems There are two major types of prefillable syringe systems available:  Glass-based systems  Plastic-based systems 6/14/2012 SCHOOL OF PHARMACY 5
  6. 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. 7. The benefits of glass systems include:  Health care practitioners’ long history of familiarity with the product  The majority of prefilled syringes in the marketplace, are glass with elastomeric components  There are multiple proven suppliers6/14/2012 SCHOOL OF PHARMACY 7
  8. 8. Drawbacks:  Breakage  Dimensional variation  Potential surface reactivity  Particulate contamination  Adhesive or other potential leachables  Inconsistent application of silicone oil (added for functionality)6/14/2012 SCHOOL OF PHARMACY 8
  9. 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. 10. 6/14/2012 SCHOOL OF PHARMACY 10
  11. 11. pH shift in glass syringes  The shift in pH occurs because of use of type I glass used in prefilled syringes manufacturing is a borosilicate 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. 12. pH shift in glass syringes:6/14/2012 SCHOOL OF PHARMACY 12
  13. 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. 14. Benefits of plastic-based systems include: Break resistance Design flexibility Decreased surface reactivity Less absorption/adsorption of the drug Compatible with high or low pH6/14/2012 SCHOOL OF PHARMACY 14
  15. 15. Plastics materials used for prefilled syringes are mainly of two types. Cyclo olefin polymer (cop) Cyclo olefin co polymer (coc)6/14/2012 SCHOOL OF PHARMACY 15
  16. 16. Cyclo olefin polymer (cop) major properties: Low water absorbency High transparency Low specific gravity High heat resistance Low impurities6/14/2012 SCHOOL OF PHARMACY 16
  17. 17. Cyclo olefin co polymer (coc) major properties: clear amorphous copolymers based on cyclic and linear olefins. These materials form a family of engineering resins that exhibit a unique combination of properties, including high transparency, low density, excellent moisture barrier capabilities, and resistance to aqueous 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. 18. Materials used for the preparationof PFS: components composition Barrel Glass/plastic Piston Elastomer Tip cap Elastomer Plunger Plastic Lubricant Silicone oil Needle Stainless steel Needle Elastomer Needle shield cover Plastic 6/14/2012 Finger grip extender SCHOOL OF PHARMACY Plastic 18
  19. 19. 6/14/2012 SCHOOL OF PHARMACY 19
  20. 20. Filling process inPREFILLED SYRINGES:  Newer technique developed by HCMs (Hyaluron Contract manufacturing) patented method of syringe filling involves vacuum filling coupled with online vacuum stoppering, Known as bubble-free filling.  It eliminates the air bubble inside the syringe, (known as "head space"), that results from traditionally filling methods.  Furthermore, totally removing the gas bubble improves the stability of oxygen sensitive compounds.  In bubble-free filling, a vacuum (or, more accurately, differential pressure) is used to place the stopper.6/14/2012 SCHOOL OF PHARMACY 20
  21. 21. Sterilization of prefilledsyringes  Sterilization of prefilled syringe is mainly done by autoclaving or by ionizing radiation.  Autoclave is not suitable of glass prefilled syringes and normal plastics, as there occurs a pH shift in glass syringes during autoclave sterilization process.  Mainly used method of sterilization is ionizing radiations.  Gamma sterilization has proved to be an efficient means of sterilizing prefilled syringes.  Ionizing radiation has the advantage of sterilization the syringe plungers while they remain in their packaging. 6/14/2012 SCHOOL OF PHARMACY 21
  22. 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. 6/14/2012 SCHOOL OF PHARMACY 22
  23. 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. 24. Market related: Reduced therapy and injection costs Increased market preference 20% API savings vs. vial filling6/14/2012 SCHOOL OF PHARMACY 24
  25. 25. A D V A N T A G E S6/14/2012 SCHOOL OF PHARMACY 25
  26. 26. Disadvantages: These are complex medical devices Needle stick injuries Additional protection required6/14/2012 SCHOOL OF PHARMACY 26
  27. 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. 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 PHARMACY 28
  29. 29. 2) AVONEX® : (Interferon beta-1a) Strenght:30mcg Category:anti viral Route: IM6/14/2012 SCHOOL OF PHARMACY 29
  30. 30. List of drug that are used via prefilled syringes Ardeparin Hospiral lidocaine 1%w/v Choriogonadotropin ɑ Lidocaine Hcl 2% Dalteparin Nadroparin Enoxaparin sodium Reviparin Diclofenac sodium Sodium hyaluronate 1%w/v vasopressin Tinozaparin erythromycin amiodarone 6/14/2012 SCHOOL OF PHARMACY 30
  31. 31. Market growth:6/14/2012 SCHOOL OF PHARMACY 31
  32. 32. EQUI FullyP AutomaticM Pre-FilledE SyringeN FillingT mechines: Model: 6/14/2012 SCHOOL OF PHARMACY PFT-A-05 32
  33. 33. EQUIPMENTs: 6/14/2012 SCHOOL OF PHARMACY 33
  34. 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. 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.com SCHOOL OF PHARMACY 35
  36. 36. 6/14/2012 SCHOOL OF PHARMACY 36