Prefilled Syringes Can Prevent Inconvenient Symptons - Like Death!
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Bruce Rehlaender, Ph.D.
May 16, 2013, 5:36:02 PM5/16/13
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Article Title: Prefilled Syringes Can Prevent Inconvenient Symptons - Like Death!
Author: Bruce Rehlaender, Ph.D.
Word Count: 892
Article URL: http://www.isnare.com/?aid=1840128&ca=Medicines+and+Remedies
Format: 64cpl
Contact The Author: http://www.isnare.com/eta.php?aid=1840128
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One of the things I occasionally do to add some adventure to my life is to inadvertently consume foods containing peanuts or walnuts, and when I do, I reach for one of the best-known prefilled autoinjector products, the Epi-Pen. One jab into the thigh and 0.3 mg of epinephrine is rapidly making its way into my bloodstream to rescue me from a whole host of anaphylactic symptoms, potentially including the most inconvenient symptom of all, death.
Back in the old days, when I was a kid, my mother would break off the end of an ampule and then syringe out the appropriate amount of epinephrine before manually jabbing me and squirting it in. Being well versed in the use of needles and syringes, I have unsuccessfully attempted to buy vials of epinephrine so I would no longer need to carry the big bulky EpiPens with me, but I am in the minority. For most people pre-filled syringes and autoinjectors are a huge boon, and for good reasons
1. They are convenient for patients (at least for those without Ph.D.s in pharmaceutical sciences) and for practitioners.
2. They substantially reduce the risk of dosing error.
3. They eliminate the risk of contamination while filling syringes.
4. For very expensive drugs, they can actually reduce cost of goods, since less of an overfill is required than for a vial.
5. They can save precious seconds in emergency situations.
6. They can be made to look a lot more stylish than a vial and syringe.
7. In the case of autoinjectors, they can eliminate some of the unpleasantness and anxiety patients might have in poking themselves with a needle. With the Epipen, for example, you don�t even don�t even see the needle until you pull it out of your thigh, and by that time, it doesn�t matter if you freak out.
8. Autoinjectors and, to a lesser extent, pre-filled syringes can be used by patients who have disabilities that make normal syringing difficult or impossible.
All of these things have led to a rapid expansion in the products supplied in prefilled syringes and autoinjectors. In turn, the expanded market has given impetus to new research efforts to improve the design of syringes and autoinjectors and the materials they are made of. A particularly notable example of this innovation is the Unifill� EZMix syringe, a dual chamber syringe containing a liquid chamber and a lyophilized powder chamber. The two chambers are intermixed and the lyophilized powder is reconstituted when the plunger is pushed.
Of course, the story is not all rosy. As with any technology, especially those pushed by the marketing guys with their fast cars and perfect hair, there are drawbacks on the development side:
1. Since prefilled syringes and autoinjectors need to fill the dual role of containing a drug solution and delivering it, there are more contact materials, and these materials are not as easy to optimize for compatibility and low extraction. Hence there is considerably greater potential for compatibility and leachable issues than with drug solutions in vials.
2. Conversely, the contact materials that are important to the function of the device, such as plungers and seals, may be degraded over time by contact with the drug solution. For example, the lubrication between the plunger and the wall of the syringe may leach away, causing the syringe to freeze-up when it is needed.
3. Regardless of how the filled syringes and autoinjectors are sterilized, there are many more potential problems that could occur as the result of sterilization than would be encountered in a glass vial with a grey butyl rubber stopper.
4. Drugs for which the dose is quite variable may not lend themselves to pre-filled systems.
Aside from all this, there is another problem that has come up a few times in the past year with some of our early stage clients, and that is that pre-filled syringe manufacture is still fairly specialized, and it really has not reached the small scale yet. This is typically not a problem but can be if the drug product under development is dependent on some of the attributes of pre-filled syringe. For example one of my recent clients was developing an injectable as a two-vial system, and the accuracy of adding the vial B contents to vial A was quite critical. Since patients would be taking their medicine home, prefilled syringes would have been an ideal solution, but we were unable to identify a sterile products manufacturer with a syringe-filling line willing and able to manufacture as small a batch as we needed.
Unless you are working on a subcutaneous sustained release dosage form of some sort, there is not a lot of glamour in parenterals, and these new multichambered prefilled syringes and autoinjectors add a nice splash of innovation and excitement for us. Even the plain old boring pre-filled syringes play an important role in making healthcare easier and safer for both patients and practitioners. If those device engineers can just come up with an EpiPen that is the size of a Swiss Army knife, we will have made some real progress.
You can find more articles by searching for "PharmaDirections Formulation Development Blog."
About The Author: Bruce Rehlaender, Ph.D., Principal, Formulation Development at http://www.PharmaDirections.com, a pharmaceutical consulting and project management company specializing in preclinical development, formulation development and regulatory affairs. We design and direct preclinical programs for biotech.
Please use the HTML version of this article at:
http://www.isnare.com/html.php?aid=1840128
*********************** ARTICLE END ***********************
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Message delivered directly to members of the group:
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*****************************************************************
Please consider this free-reprint article written by:
Bruce Rehlaender, Ph.D.
*****************************
IMPORTANT - Publication/Reprint Terms
- You have permission to publish this article electronically in free-only publications such as a website or an ezine as long as the bylines are included.
- You are not allowed to use this article for commercial purposes. The article should only be reprinted in a publicly accessible website and not in a members-only commercial site.
- You are not allowed to post/reprint this article in any sites/publications that contains or supports hate, violence, porn and warez or any indecent and illegal sites/publications.
- You are not allowed to use this article in UCE (Unsolicited Commercial Email) or SPAM. This article MUST be distributed in an opt-in email list only.
- If you distribute this article in an ezine or newsletter, we ask that you send a copy of the newsletter or ezine that contains the article to http://www.isnare.com/eta.php?aid=1840128
- If you post this article in a website/forum/blog, ALL links MUST be set to hyperlinks and we ask that you send a copy of the URL where the article is posted to http://www.isnare.com/eta.php?aid=1840128
- We request that you ask permission from the author if you want to publish this article in print.
The role of iSnare.com is only to distribute this article as part of its Article Distribution feature ( http://www.isnare.com/distribution.php ). iSnare.com does NOT own this article, please respect the author's copyright and this publication/reprint terms. If you do not agree to any of these terms, please do not reprint or publish this article.
*****************************
Article Title: Prefilled Syringes Can Prevent Inconvenient Symptons - Like Death!
Author: Bruce Rehlaender, Ph.D.
Word Count: 892
Article URL: http://www.isnare.com/?aid=1840128&ca=Medicines+and+Remedies
Format: 64cpl
Contact The Author: http://www.isnare.com/eta.php?aid=1840128
Easy Publish Tool: http://www.isnare.com/html.php?aid=1840128
*********************** ARTICLE START ***********************
One of the things I occasionally do to add some adventure to my life is to inadvertently consume foods containing peanuts or walnuts, and when I do, I reach for one of the best-known prefilled autoinjector products, the Epi-Pen. One jab into the thigh and 0.3 mg of epinephrine is rapidly making its way into my bloodstream to rescue me from a whole host of anaphylactic symptoms, potentially including the most inconvenient symptom of all, death.
Back in the old days, when I was a kid, my mother would break off the end of an ampule and then syringe out the appropriate amount of epinephrine before manually jabbing me and squirting it in. Being well versed in the use of needles and syringes, I have unsuccessfully attempted to buy vials of epinephrine so I would no longer need to carry the big bulky EpiPens with me, but I am in the minority. For most people pre-filled syringes and autoinjectors are a huge boon, and for good reasons
1. They are convenient for patients (at least for those without Ph.D.s in pharmaceutical sciences) and for practitioners.
2. They substantially reduce the risk of dosing error.
3. They eliminate the risk of contamination while filling syringes.
4. For very expensive drugs, they can actually reduce cost of goods, since less of an overfill is required than for a vial.
5. They can save precious seconds in emergency situations.
6. They can be made to look a lot more stylish than a vial and syringe.
7. In the case of autoinjectors, they can eliminate some of the unpleasantness and anxiety patients might have in poking themselves with a needle. With the Epipen, for example, you don�t even don�t even see the needle until you pull it out of your thigh, and by that time, it doesn�t matter if you freak out.
8. Autoinjectors and, to a lesser extent, pre-filled syringes can be used by patients who have disabilities that make normal syringing difficult or impossible.
All of these things have led to a rapid expansion in the products supplied in prefilled syringes and autoinjectors. In turn, the expanded market has given impetus to new research efforts to improve the design of syringes and autoinjectors and the materials they are made of. A particularly notable example of this innovation is the Unifill� EZMix syringe, a dual chamber syringe containing a liquid chamber and a lyophilized powder chamber. The two chambers are intermixed and the lyophilized powder is reconstituted when the plunger is pushed.
Of course, the story is not all rosy. As with any technology, especially those pushed by the marketing guys with their fast cars and perfect hair, there are drawbacks on the development side:
1. Since prefilled syringes and autoinjectors need to fill the dual role of containing a drug solution and delivering it, there are more contact materials, and these materials are not as easy to optimize for compatibility and low extraction. Hence there is considerably greater potential for compatibility and leachable issues than with drug solutions in vials.
2. Conversely, the contact materials that are important to the function of the device, such as plungers and seals, may be degraded over time by contact with the drug solution. For example, the lubrication between the plunger and the wall of the syringe may leach away, causing the syringe to freeze-up when it is needed.
3. Regardless of how the filled syringes and autoinjectors are sterilized, there are many more potential problems that could occur as the result of sterilization than would be encountered in a glass vial with a grey butyl rubber stopper.
4. Drugs for which the dose is quite variable may not lend themselves to pre-filled systems.
Aside from all this, there is another problem that has come up a few times in the past year with some of our early stage clients, and that is that pre-filled syringe manufacture is still fairly specialized, and it really has not reached the small scale yet. This is typically not a problem but can be if the drug product under development is dependent on some of the attributes of pre-filled syringe. For example one of my recent clients was developing an injectable as a two-vial system, and the accuracy of adding the vial B contents to vial A was quite critical. Since patients would be taking their medicine home, prefilled syringes would have been an ideal solution, but we were unable to identify a sterile products manufacturer with a syringe-filling line willing and able to manufacture as small a batch as we needed.
Unless you are working on a subcutaneous sustained release dosage form of some sort, there is not a lot of glamour in parenterals, and these new multichambered prefilled syringes and autoinjectors add a nice splash of innovation and excitement for us. Even the plain old boring pre-filled syringes play an important role in making healthcare easier and safer for both patients and practitioners. If those device engineers can just come up with an EpiPen that is the size of a Swiss Army knife, we will have made some real progress.
You can find more articles by searching for "PharmaDirections Formulation Development Blog."
About The Author: Bruce Rehlaender, Ph.D., Principal, Formulation Development at http://www.PharmaDirections.com, a pharmaceutical consulting and project management company specializing in preclinical development, formulation development and regulatory affairs. We design and direct preclinical programs for biotech.
Please use the HTML version of this article at:
http://www.isnare.com/html.php?aid=1840128
*********************** ARTICLE END ***********************
- To distribute your articles go to http://www.isnare.com/distribution.php
- For more free-reprint articles go to http://www.isnare.com
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