Journal of Diabetes Science and Technology
` Volume 5, Issue 1, January 2011
` © Diabetes Technology Society
`
`ORIGINAL ARTICLES
`
`Analysis of the Injection Force of Solostar® Compared with Other
`Disposable Insulin Pen Devices at Constant Volume Flow Rates
`Alan W. Carter, Pharm.D.
`
`Abstract
`Insulin pen devices have greatly enhanced the portability and accessibility to insulin therapy for millions of
`people with diabetes. Comparison research data should be reviewed thoroughly.
`In this issue of Journal of Diabetes Science and Technology, the study presented by Thomas van der Burg is
`balanced in number of samples tested, same tensile meter, and identical units per second delivery rate into
`an open beaker. Mean plateau force of SoloSTAR® and KwikPen™ were significantly lower. KwikPen and
`SoloSTAR utilized 5-mm length 31-gauge (G) needles vs 6-mm 31G needles for FlexPen® and Next Generation
`FlexPen®, perhaps skewing results in favor of shorter needles instead of device design.
`Individual understanding of correct insulin use, appropriate self-monitoring of blood glucose, vision and
`dexterity capability, and affordability of therapy must be considered first. SoloSTAR holds one unique market
`advantage, delivery of up to 80 units of insulin per injection.
`J Diabetes Sci Technol 2011;5(1):156-157
`
`Insulin pen devices have greatly enhanced
`
`the
`portability and accessibility to insulin therapy for millions
`of people with diabetes. Availability of both short-acting
`and basal
`insulin
`in pen devices makes diabetes
`management more convenient for the
`individual and
`improves their chances of achieving tight glycemic
`control. Given that there are no obvious clinical differences
`in outcome between similar action insulin compounds,
`the only marketing differences become out-of-pocket cost,
`ease of use, and proper identification of insulin product
`before
`injecting. An
`informal survey of wholesale
`prices and
`insurance formulary preferences
`implied
`that out-of-pocket cost should be similar for all devices
`
`tested, leaving ease of use and identification as the two
`critical marketing points to consider. Injection force
`could be a factor in selecting one product over another,
`but comparison research data sponsored by a specific
`manufacturer touting one product’s benefit over another
`should be reviewed thoroughly before conclusions are made.
`
`In an article entitled Injection Force of SoloSTAR® Compared
`With Other Disposable Insulin Pen Devices at Constant
`Volume Flow Rates in this issue of Journal of Diabetes
`Science and Technology, Thomas van der Burg’s study
`methods appear to be balanced in number of samples
`tested (20 each), same tensile meter, and
`identical
`
`Author Affiliations: University of Missouri-Kansas City School of Pharmacy, Kansas City, Missouri; and Pharmacy, Cosentino’s Food Stores,
`Prairie Village, Kansas
`Abbreviations: (G) gauge, (NGFP) Next Generation FlexPen®, (SMBG) self-monitoring of blood glucose
`Keywords: affordability, compliance, ease of use, glycemic control, injection force
`Corresponding Author: Alan Carter, Pharm. D., Adjunct Faculty, University of Missouri-Kansas City School of Pharmacy, 3901 West 83rd Street,
`Prairie Village, KS 66208; email address acarter29@cs.com
`
`156
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`Mylan Ex.1072
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`Analysis of the Injection Force of Solostar® Compared with Other Disposable
`Insulin Pen Devices at Constant Volume Flow Rates
`
`Carter
`
`units per second delivery rate into an open beaker.1
`Unstated but assumed to be equivalent are temperature
`of insulin compound, room temperature, and atmospheric
`pressure for each test sequence. It is also assumed that
`the fluid viscosity of insulin glargine, insulin detemir,
`and insulin lispro remains identical between products
`at
`temperature and pressures
`tested. Manufacturer
`recommended needles were used to replicate home use,
`but needle length would affect injection force given the
`same 31-gauge (G) bore size. It is interesting to note
`that the mean plateau force of SoloSTAR® (sanofi-aventis,
`Bridgewater, NJ) and KwikPen™ (Eli Lilly and Company,
`Indianapolis, IN) was significantly lower than that of the
`FlexPen® (Novo Nordisk Inc., Princeton, NJ) products.
`In this test both KwikPen and SoloSTAR utilized
`5-mm length 31G needles vs 6-mm 31G needles for
`FlexPen and Next Generation FlexPen® (NGFP), perhaps
`skewing results reported in favor of shorter 31G needles
`instead of injection device design.
`
`While injection force is a valid point in evaluating ease
`of use for self-injection, another factor not discussed is
`indwelling time of needle in tissue. KwikPen directions
`for use state that the needle must remain in-situ for a
`slow 5 count, FlexPen and NGFP require a slow 6 count,
`while SoloSTAR instructions are for a slow 10 count
`before needle removal. When used according to manu-
`facturer supplied instructions, persons with impaired
`dexterity may have difficulty
`in maintaining
`less
`pressure for a longer duration, negating the advantage
`of lower injection force needed for actuation. Variance in
`tissue composition will also affect pressures needed,
`but is best evaluated by the individual and their health
`care provider.
`
`SoloSTAR holds one unique market advantage, the ability
`to deliver up to 80 units of insulin in a single injection.
`For some, this may be a key point for selecting SoloSTAR
`devices over competitors. Decision of what insulin
`compound to use should be the primary concern for the
`prescribing practitioner; lower injection force and shorter
`push-button travel may be less of a concern than
`out-of-pocket cost for the product prescribed.
`
`While appropriate therapy selection is most important to
`the prescriber, affordability is the primary concern of
`the individual for compliance to the prescribed therapy.
`Many life-saving medications are being abandoned at the
`pharmacy counter as the health care consumer struggles
`to cope with lower income, high-deductable insurance,
`and rising copayment. Recently a Consumer Reports
`survey found that 27% of individuals questioned did not
`
`take prescriptions as directed in order to save money.
`Cost-saving tactics include skipping doses, not getting
`prescriptions filled, sharing prescriptions, and taking
`expired medication. Reusing pen needles and lancets
`along with skipping self-monitoring of blood glucose
`(SMBG) tests to cut expenses are occasional admissions
`during detailed therapy review. Increasingly, diabetes
`specialists must choose lower cost therapy options to
`assist their patients with compliance.
`
`New insulin products, both basal and short acting, are
`expensive. Human recombinant insulin may not be the
`latest “drug of choice” given current therapeutic options,
`but it costs less. Failure to maintain reasonable glycemic
`control due to out-of-pocket expense is unacceptable.
`Practitioner assessment of
`individual understanding
`about correct insulin use and appropriate SMBG, vision
`and dexterity capability, and affordability of therapy are
`important factors to consider before a treatment plan
`is finalized. Other considerations, such as less injection
`force needed, become of secondary importance.
`
`References:
`1. Van der Burg T. Injection force of SoloSTAR® compared with
`other disposable insulin pen devices at constant volume flow rates.
`J Diabetes Sci Technol 2011;5(1):150-7.
`
`J Diabetes Sci Technol Vol 5, Issue 1, January 2011
`
`157
`
`www.journalofdst.org
`
`Mylan Ex.1072
`Mylan v. Sanofi - IPR2018-01676
`
`