PREFILLED SYRINGESUnder the Guidance of

Abdul Mohd. BariAssociate professor

BY

SRIKANTH BANDI,H.T.NO :11H61S0303,DEPARTMENT :PHARMACEUTICS,7/12/2012

SCHOOL OF PHARMACY, ANURAG GROUP OF PHARMACY SCHOOL OF INSTITUTIONS

1

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 SCHOOL OF PHARMACY 2 Prefilled Syringes

7/12/2012

What are prefilled syringes?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.

7/12/2012

SCHOOL OF PHARMACY

3

PuRpose of prefillsThe 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 OFsystem designed 4 to SCHOOL PHARMACY administer the appropriate amount of

7/12/2012

Types of PSF systemsThere are two major types of prefillable syringe systems available: Glass-based systems Plastic-based systems

7/12/2012

SCHOOL OF PHARMACY

5

Glass-based systems

Traditionally,

7/12/2012

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 6 the SCHOOL OF PHARMACY primary package from an elastomeric

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 suppliers7/12/2012 SCHOOL OF PHARMACY 7

Drawbacks: Breakage Dimensional variation Potential surface reactivity Particulate contamination Adhesive or other potential leachables Inconsistent application of silicone oil (added for functionality)7/12/2012 SCHOOL OF PHARMACY 8

Glass prefilled syringes are of two typesOil 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 SCHOOL 9 barrel Wales.OF PHARMACY

7/12/2012

7/12/2012

SCHOOL OF PHARMACY

10

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 580c, sodium oxide is forms and remains in glass. During storage, sodium ions are released into the water for injection SCHOOL OF PHARMACY and increase the concentration of 11

7/12/2012

pH shift in glass syringes:

7/12/2012

SCHOOL OF PHARMACY

12

PLASTIC-BASED SYSTEMSPlastic-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 SCHOOL OF PHARMACY 13 manufactured from cyclopoly olefin

7/12/2012

Benefits of plastic-based systems include: Break resistance Design flexibility Decreased surface reactivity Less absorption/adsorption of the drug Compatible with high or low pH7/12/2012 SCHOOL OF PHARMACY 14

Plastics materials used for prefilled syringes are mainly of two types.Cyclo olefin polymer (cop) Cyclo olefin co polymer (coc)

7/12/2012

SCHOOL OF PHARMACY

15

Cyclo olefin polymer (cop) major properties:Low water absorbency High transparency Low specific gravity High heat resistance Low impurities7/12/2012 SCHOOL OF PHARMACY 16

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 SCHOOL OF PHARMACY aqueous and polar organic media. 17

7/12/2012

Materials used for the preparation of PFS:components composition

7/12/2012

Barrel Piston Tip cap Plunger Lubricant Needle Needle Needle shield cover SCHOOL OF Finger grip PHARMACY

Glass/plastic Elastomer Elastomer Plastic Silicone oil Stainless steel Elastomer Plastic Plastic

18

7/12/2012

SCHOOL OF PHARMACY

19

Filling process in PREFILLED SYRINGES: Newer technique developed by HCM's (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 SCHOOL OF PHARMACY 20 accurately, differential pressure) is used to

7/12/2012

Sterilization of prefilled syringes 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 SCHOOL OF PHARMACY 21 sterilization the syringe plungers while they

7/12/2012

Steps to use prefilled syringesStep 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 thePHARMACY used syringe. SCHOOL OF 22

7/12/2012

Advantages & DisadvantagesThe first prefilled syringes were made of polypropylene.

The advantages of prefilled syringes are :

Patient related:

7/12/2012

Ease of convenience & use for health care professionals and patients compared to a traditional vial packaging system Reduced risk of dosage error and SCHOOL OF PHARMACY 23 contamination

Market related:

Reduced therapy and injection costs Increased market preference 20% API savings vs. vial filling7/12/2012 SCHOOL OF PHARMACY 24

A D V A N T A G E S7/12/2012 SCHOOL OF PHARMACY 25

Disadvantages:These are complex medical devices Needle stick injuries Additional protection required

7/12/2012

SCHOOL OF PHARMACY

26

Factors Responsible for Growth of Prefilled Syringes 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 injectionPHARMACY less preparation, SCHOOL OF cost by easy storage and disposal,

7/12/2012

27

Marketed products:

1)KINFERON(recombinant interferon product) Strengths:3,5,6MIU/ml Indications: Acute & chronic hepatitis(typeB&C)leukemia, Malignant melanoma, SCHOOL OF PHARMACY Renal cell carcinoma, 28

7/12/2012

2) AVONEX :(Interferon beta-1a) Strenght:30mcg Category:anti viral Route: IM

7/12/2012

SCHOOL OF PHARMACY

29

List of drug that are used via prefilled syringesArdeparin Hospiral lidocaine 1%w/v Choriogonadotropin Lidocaine Hcl 2% Dalteparin Enoxaparin sodium Diclofenac sodium vasopressin7/12/2012

Nadroparin Reviparin Sodium hyaluronate 1%w/v Tinozaparin30

erythromycin OF PHARMACY amiodarone SCHOOL

Market growth:

7/12/2012

SCHOOL OF PHARMACY

31

E Q U I P M E N T s:7/12/2012 SCHOOL OF PHARMACY

Fully Automat c Pre-Filled Syringe Filling mechine Model:PFT-A-0532

E Q U I P M E N T s:

7/12/2012

SCHOOL OF PHARMACY

33

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.7/12/2012 SCHOOL OF PHARMACY 34

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 www.baxterbiopharmasolutions.com SCHOOL OF PHARMACY 35

7/12/2012

7/12/2012

SCHOOL OF PHARMACY

36