Prefilled dual chamber devices (DCDs) – Promising high-quality and convenient drug delivery system

Ingle, Rahul G.; Fang, Wei-Jie

doi:10.1016/j.ijpharm.2021.120314

Cited by 6 publications

(5 citation statements)

References 96 publications

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“…[1–5] The syringe has 3 major components: the plunger, the barrel, and the needle. [6–10] The commonly used materials for the plunger and barrel are polypropylene [11–13] and materials for the needle are stainless, titanium, or other coated materials. [14]…”

Section: Introductionmentioning

confidence: 99%

“…[1][2][3][4][5] The syringe has 3 major components: the plunger, the barrel, and the needle. [6][7][8][9][10] The commonly used materials for the plunger and barrel are polypropylene [11][12][13] and materials for the needle are stainless, titanium, or other coated materials. [14] The average annual consumption of syringes in the medical field is approximately 16 billion.…”

Section: Introductionmentioning

confidence: 99%

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An analysis of the effect of syringe barrel volume on performance and user perception

et al. 2023

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In the market, there are many types and shapes of syringes. One of the groupings of syringe types is based on barrel volume. The shape of the product design affects performance and user perception. The aim of this study is to investigate the effect of barrel volume on its performance and user perception. We performed analysis following international organization for standardization 7886 procedures on syringe with 1 mL, 3 mL, 5 mL, and 10 mL volume. In addition, a user perception test was conducted on 29 respondents using a questionnaire with the Likert chart method. This study indicates that the bigger the syringe volume, the larger the dead space and the force to operate the piston are. A larger syringe volume also raises the volume that changes due to the plunger position increase. Meanwhile, the barrel volume does not affect water and water leakage, as we did not observe any leak during the syringe tests in our experiment. In addition, the user perception test shows that the barrel’s length influences the ease of device control during the injection. The volume of the barrel negatively correlated with its effect to the environment. The safety features of all syringes are similar except for the 3 mL syringe, which has a value of 0.1 points difference to other syringes.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An analysis of the effect of syringe barrel volume on performance and user perception

et al. 2023

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“…[13] The syringe consists of three main components of the syringe that is the barrel, plunger, and needle. [14][15][16][17][18][19][20][21][22][23] Of the 3 main components, the syringe is composed of several components as shown in Figure 1. There are many variations in the syringe material; most needles use stainless steel, titanium, and other coated materials, [25] and the majority of plunger and barrel materials are polypropylene.…”

Section: Introductionmentioning

confidence: 99%

The hypodermic syringe performance based on the ISO 7886-1:2017: A narrative review

et al. 2022

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A syringe is used to inject fluid or medicine into the patient's soft tissue. The main components of the syringe were the needle, barrel, and plunger. The use of syringes in the medical world is relatively high, and especially since the COVID-19 pandemic, the use of hypodermic syringes increased sharply due to vaccination. The syringe used must be effective and of good quality, so the International Organization for Standardization (ISO) has published test procedures and minimum specifications for hypodermic syringes. The performance of the syringe can be observed from the dead space, force piston operation, water and air leakage, and fitting position of the plunger in the barrel. This review shows that most researchers use the weighing method to measure the dead space, although some use other methods. The researchers found that most of the products met the minimum specifications of the ISO, and that the dimensions and shape of the syringe affected the dead space. Researchers have not examined other performance measures recommended by the ISO. Researchers have focused more on force injection than force piston operation, leakage after injection or back spray than air and water leakage, and reduction the friction of the plunger without considering the fitting position of the plunger in the barrel.

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“…Further, reconstitution of the lyophilised product prior to administration required additional steps and device components, making the process more complex and time-consuming. These drawbacks are reported to be a major barrier to treatment adherence [3,8,14,15] .…”

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confidence: 99%

“…Pre-filled syringes and dual-chamber devices are two examples of modern reconstitution devices developed to reduce the number of steps or components required, making it easier and more convenient for both PwH and caregivers to administer treatment [15][16][17][18] . Mix2Vial ® (West Pharmaceutical Services, Exton, PA, USA) and MixPro ® (Novo Nordisk A/S, Bagsvaerd, Denmark; design based on a vial adapter from West Pharmaceutical Services) are both drug reconstitution devices currently approved to administer a number of different replacement therapies to PwH (Supplementary Figure 1a).…”

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confidence: 99%

Comparative evaluation and preference of MixPro^® versus Mix2Vial^® reconstitution devices among people with haemophilia and caregivers

Hansen,

Percier,

Damgaard-Rasmussen

et al. 2022

The Journal of Haemophilia Practice

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Introduction People with haemophilia (PwH) require frequent infusions with plasma-derived or recombinant coagulation factors to help prevent and treat acute bleeding episodes. This ‘replacement therapy’ can be administered at home by PwH or their caregivers using a drug reconstitution device. MixPro® and Mix2Vial® are two such devices. Aims/Objectives To compare the experiences and evaluate the preferences of PwH and caregivers using two reconstitution devices: MixPro® and Mix2Vial®. Methods Qualitative interviews were conducted between the 22 June and 4 August 2021 with male PwH or caregivers of PwH. Participants were asked questions about the reconstitution devices they have used in general, followed by questions relating specifically to the MixPro® or Mix2Vial® devices. Demonstration devices were provided to all participants during the interview. Results In total, 105 participants (71 PwH and 34 caregivers) were interviewed in the USA, Italy, UK, and Japan. PwH had a mean age of 29 years (3–69 years). Overall, participants reported the number of parts, speed of reconstitution, and ease of use to be the largest unmet needs with reconstitution devices. Regarding the device features, low contamination risk was ranked as most important (importance score: 15.1) for all countries except Italy, where portability of the device was most important (11.7 for portability vs. 10.6 for low contamination risk). When MixPro® and Mix2Vial® features were independently evaluated, MixPro® outperformed Mix2Vial® across 17 of the 18 features; both devices were rated equally for low contamination risk. When asked which device performed best on each feature, MixPro® was chosen by the majority of participants (74%). MixPro® was associated with words such as quick (54%), user-friendly (47%), and easy (46%), while Mix2Vial® was associated with the words easy (33%), safe (32%), and awkward (30%). Participants felt MixPro® would make a positive difference to their lives citing reasons such as saving time, ease of portability, and general confidence in using the system. Relatively few participants thought Mix2Vial® would make a positive difference to their lives, with some noting it was not much different than the previous generation of devices. Conclusion In this study, MixPro® was preferred over Mix2Vial® as a reconstitution device for PwH and caregivers of PwH.

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Prefilled dual chamber devices (DCDs) – Promising high-quality and convenient drug delivery system

Cited by 6 publications

References 96 publications

An analysis of the effect of syringe barrel volume on performance and user perception

An analysis of the effect of syringe barrel volume on performance and user perception

The hypodermic syringe performance based on the ISO 7886-1:2017: A narrative review

Comparative evaluation and preference of MixPro^® versus Mix2Vial^® reconstitution devices among people with haemophilia and caregivers

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Prefilled dual chamber devices (DCDs) – Promising high-quality and convenient drug delivery system

Cited by 6 publications

References 96 publications

An analysis of the effect of syringe barrel volume on performance and user perception

An analysis of the effect of syringe barrel volume on performance and user perception

The hypodermic syringe performance based on the ISO 7886-1:2017: A narrative review

Comparative evaluation and preference of MixPro® versus Mix2Vial® reconstitution devices among people with haemophilia and caregivers

Contact Info

Product

Resources

About

Comparative evaluation and preference of MixPro^® versus Mix2Vial^® reconstitution devices among people with haemophilia and caregivers