The document discusses prefilled syringes. It describes prefilled syringes as single-dose packets of injectable drugs that have a pre-attached needle. It discusses the purpose of prefills for primary packaging and drug delivery. It also outlines the types of prefill systems using glass or plastic, describes common materials used, and the filling and sterilization processes. The document provides advantages like convenience and accuracy as well as some disadvantages. It also discusses factors driving the growth of prefilled syringes.
Packaging is an integral part of pharmaceutical product.The most common polyethylene types used in packaging are high density polyethylene (HDPE), low density polyethylene (LDPE), and linear low density polyethylene (LLDPE). They are different in density, chain branching, crystallinity and consequently, in mechanical, optical and barrier properties.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
Review of pharmaceutical product, packaging and ichDeepak Shukla
Review of stability of packaged material like containers and closures.
The whole ppt is regarding the test perform to know the stability of a container which is used for product storage.
It also contain the guidelines of ICH.
Prefilled Syringes - A Container of Choice for PharmaAjinomoto Althea
Special feature in the May 2012 issue of Drug Development and Delivery on Althea's Crystalomics technology, and how crystallized proteins create patient-friendly dosage and delivery.
Packaging is an integral part of pharmaceutical product.The most common polyethylene types used in packaging are high density polyethylene (HDPE), low density polyethylene (LDPE), and linear low density polyethylene (LLDPE). They are different in density, chain branching, crystallinity and consequently, in mechanical, optical and barrier properties.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
Review of pharmaceutical product, packaging and ichDeepak Shukla
Review of stability of packaged material like containers and closures.
The whole ppt is regarding the test perform to know the stability of a container which is used for product storage.
It also contain the guidelines of ICH.
Prefilled Syringes - A Container of Choice for PharmaAjinomoto Althea
Special feature in the May 2012 issue of Drug Development and Delivery on Althea's Crystalomics technology, and how crystallized proteins create patient-friendly dosage and delivery.
FDA on Prefilled Syringes and Combination Products (Lana Shiu,MD)Sun Kim
Audio at http://QbDWorks.com
(Courtesy of Dr. Lana Shiu of FDA)
I met Dr. Lana Shiu after her presentation at the PDA conference. She gladly agreed to share her talk with our QbDWorks community.
What Dr. Shiu covers:
Why FDA is focusing on Combination Products Now
Why this applies to all of us
Case study of failed combination product (prefilled syringe)
Background of Combination Products governed by FDA
Product Development Considerations
Human Factors Considerations
FDA Application Submission Guidelines
Lessons Learned
Key Steps to Successful Application
At the end of this article are links to the FDA guidelines:
Guidance Documents (finalized 2013)
Drug or Biologic using Injectors/Prefilled Syringes Assembled into Injectors
File a Patent Application for your Medical Device Invention. First, Protect your idea and never let someone else file first before patent office. Get your patent application reviewed by a Patent Attorney.
A syringe is essentially a device used in medicine to inject fluid into or withdraw fluid from the body. Medical syringes consist of a needle attached to a hollow cylinder that is fitted with a sliding plunger. The downward movement of the plunger injects fluid; upward movement withdraws fluid. A prefilled syringe is a single-dose packet of vaccine to which a needle has been fixed by the manufacturer. A prefilled syringe is not positioned as a high technology product such as needle free injectors which involves pioneering drug delivery technologies. Neither is it a simple technology (for example tabulating). Instead it is positioned in the middle, being on the border line of simple to advance.
The growth rate is to be expected to remain at a high level of more than 10% annually. This is due to a number of factors such as greater medication safety and increased convenience from using a prefillable device.
Prefilled syringes accommodate volumes that typically range from 0.25 to 5.0 ml. They are therefore best suited to products administered by subcutaneous or intramuscular injection. The categories account for the bulk of prefilled syringes: vaccines, blood stimulants, therapeutic proteins, erythroproteins, interferons and rheumatoid arthritis
Market Research Report : Syringes And Needles Market in India 2011Netscribes, Inc.
For the complete report, get in touch with us at : info@netscribes.com
In the highly import dependent Indian medical devices market, a large number of indigenous manufacturers of syringes & needles have managed to come up. However it does not mean that imports are low for this market. Imports, as in the case with other medical devices, are quite high but the domestic manufacturers have been able to tap foreign markets through increasing exports. The target base of consumers is growing steadily which is expected to significantly boost sales in the market.
The report provides a snapshot of the syringes & needles market. It begins with the introduction section which mentions the features and uses of syringes & needles along with a brief description of the various phases in their development. The market overview section provides an insight into the market and highlights the market size. Import and export figures for syringes & needles, both in terms of volume and value have been provided in the next section. It also includes the regional break-up of the imports and exports.
An analysis of the drivers explains the factors leading to the growth of the market which include increasing need of insulin doses, increasing demand for vaccines, improving health infrastructure, growing incidence of diseases, changing demographics and health check-up packages. Some of the major challenges to the market are illegal recycling of syringes & needles and problems associated with usage. Government legislation in the market has been discussed in the next section.
The competition section highlights the features of the major players operating in the market. A brief profile of the major domestic and foreign players in the market along with their financials has been included in this section.
A section providing strategic recommendations has been given at the end of the report which gives effective solutions to existing and potential players for improving market share and increasing profitability.
Lyostat4 freeze drying microscope provides brighter, clearer images for easy analysis of formulations for freeze drying. Freeze drying microscopy is used to identify the collapse temperature of a product, which is necessary for product and process development.
Market Research Reports, Inc. has announced the addition of “Syringes and Needles Market in India 2015 - 2020" research report to their offering. See more at: http://mrr.cm/oJy
Get the information about various types of syringes and needles. Giving medications by injection requires the use of the right syringe, the right needle and the right part of the body.
For the complete report, get in touch with us at : info@netscribes.com
Abstract:
Netscribes’ latest market research report titled Medical Devices Market in India 2014 captures the technologically driven aspect currently prevailing within the Indian healthcare sector. The booming Indian economy is also witnessing a tremendous surge in the domestic healthcare scenario which, in turn, is leading to perpetual demand for high quality medical products. The demand for high-end, quality devices is especially driven by the private healthcare sector in its efforts to provide sophisticated treatment to patients. However, India lags behind in manufacture of technologically advanced high-end medical equipment, and instead has to rely upon imports from multinationals with extensive service networks. On the other hand, the market for less cost intensive medical supplies and disposable equipment is dominated by domestic manufacturers.
Due to the industry’s dependence on imports, multinationals are showing interest in relocation of manufacturing facilities to India as well as in forging alliances with healthcare sector stakeholders in order to capture greater market share. This brings into focus a key role played by the government that involves taxation and import regulations. The government also takes up several initiatives for the benefit of the market.
Coverage
• Overview of the medical devices market in India and forecasted market size data over 2012 to 2018
• Market Segmentation of medical devices by types
• Overview of the medical devices market in India by types and forecasted market size data over 2012 to 2018
• Snapshot of market segmentation of medical equipment
New and Refurbished Medical Equipment
Regional Demand for Medical Equipment
• Export-import overview of medical devices, value of export-import over 2009-10 to 2012-13 and country-wise value of export-import for 2011-12 and 2012-13
• Qualitative analysis of market drivers, challenges, trends and regulatory measures taken by the government
• Overview of the government bodies and their responsibilities
• Analysis of the competitive landscape and detailed profiles of major players
Why Buy
• Get a clear understanding of the medical devices market in India, how it operates and the various stages of the value chain
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• Understand your competitors’ business structures, strategies and prospects, and respond accordingly
• Make more informed business decisions with the help of insightful recommendations provided to succeed in the Indian medical devices market
Containers are in intimate contact with the product. No container presently available is totally non reactive, particularly with aqueous solutions . Both the chemical and physical characteristics are given primary consideration in the selection of a protective container . Glass containers traditionally have been used for sterile products , many of which are closed with rubber stoppers. Interest in plastic containers for parenterals is increasing and such containers are being used for commercial ophthalmic preparations and IV solutions.
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The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
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Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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1. PREFILLED SYRINGES
Under the Guidance of
Abdul Mohd. Bari
Associate professor
BY
SRIKANTH 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 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 Products
6/14/2012 SCHOOL OF PHARMACY 2
conclusion
3. 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.
6/14/2012 SCHOOL 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 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. 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. 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 of
familiarity with the product
The majority of prefilled syringes in the marketplace,
are glass with elastomeric components
There are multiple proven suppliers
6/14/2012 SCHOOL OF PHARMACY 7
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. Glass prefilled syringes
are 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
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. 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 resistance
Design flexibility
Decreased surface reactivity
Less absorption/adsorption of the drug
Compatible with high or low pH
6/14/2012 SCHOOL OF PHARMACY 14
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. Cyclo olefin polymer (cop) major properties:
Low water absorbency
High transparency
Low specific gravity
High heat resistance
Low impurities
6/14/2012 SCHOOL OF PHARMACY 16
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. Materials used for the preparation
of 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
20. 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 accurately,
differential pressure) is used to place the stopper.
6/14/2012 SCHOOL OF PHARMACY 20
21. 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 sterilization the syringe
plungers while they remain in their packaging.
6/14/2012 SCHOOL OF PHARMACY 21
22. Steps to use prefilled
syringes
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. 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 injection
costs
Increased market preference
20% API savings vs. vial filling
6/14/2012 SCHOOL OF PHARMACY 24
25. A
D
V
A
N
T
A
G
E
S
6/14/2012 SCHOOL OF PHARMACY 25
26. Disadvantages:
These are complex medical devices
Needle stick injuries
Additional protection required
6/14/2012 SCHOOL OF PHARMACY 26
27. 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 injection cost by less preparation,
• easy storage and disposal,
6/14/2012 • product differentiation.
SCHOOL OF PHARMACY 27
29. 2) AVONEX® :
(Interferon beta-1a)
Strenght:30mcg
Category:anti viral
Route: IM
6/14/2012 SCHOOL OF PHARMACY 29
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
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.com
SCHOOL OF PHARMACY 35