Prefilled syringes: An innovation in parenteral packaging

Makwana, Sagar; Basu, Biswajit; Makasana, Yogita; Dharamsi, Abhay

doi:10.4103/2230-973x.93004

Cited by 74 publications

(19 citation statements)

References 4 publications

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“…Participants viewed the device's COP composition as generally neutral, with some considering it to be less likely to break than traditional glass syringes. While perhaps not perceptible to participants during the study, syringes made of plastic are known to have higher break resistance compared to typical glass syringes (35). This could potentially reduce the risk of breakage and associated complications during use or transport.…”

Section: Discussionmentioning

confidence: 99%

“…To date, marketed IVI medications are provided in glass primary containers (either vials or PFSs). Because of the potential for glass defects and the need for SO lubricant (35), novel polymer PFS devices are currently under development. The FDA recommends that manufacturers conduct human factors testing during the development of new medical devices to ensure they are safe and effective for the intended users, uses, and use environments.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of a Novel Prefilled Syringe Concept for Ophthalmic Applications: A Formative Human Factors Study

Franzese

Takeuchi

Carabello

et al. 2021

PDA Journal of Pharmaceutical Science and Technology

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Evaluation of a Novel Prefilled Syringe Concept for Ophthalmic Applications: A Formative Human Factors Study

Franzese

Takeuchi

Carabello

et al. 2021

PDA Journal of Pharmaceutical Science and Technology

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“…These pharmaceutical preparations are graded as high risk . Like the magistral formulas, these preparations are based on the SmPC of a product and reconstitution by the pharmacy reduces risks of miscalculations and contamination . Reconstitution can be executed conform good nursing practice in clinical areas, where upscaling above a certain volume leads to increasing risks because a deficient product may affect the health of a considerable number of patients.…”

Section: Unlicensed Pharmaceutical Preparationsmentioning

confidence: 99%

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety

Wilde

Jong

Brun

et al. 2017

Pharmacoepidemiology and Drug

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Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation.In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care.

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“…6 Consequently, the development of self-injection devices has improved patient acceptance of injections, ease of use compared with the conventional needle and syringe, 7 and patient experience and preference. 8 Newer autoinjector technologies are designed to further ease patient burden, facilitate self-injection, and improve treatment adherence and convenience; 6,8 these are considered by healthcare professionals to be advantageous to manual syringe injections. 9 In a recent study, participants reported a high likelihood (86% very likely or somewhat likely) of adherence to treatment using an autoinjector device.…”

Section: Introductionmentioning

confidence: 99%

<p>Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine</p>

Mead¹,

Dammerman²,

Rasmussen³

2020

PPA

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Purpose: Erenumab-aooe (erenumab, Aimovig ®)-a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) receptor-is approved for the prevention of migraine in adults in a number of countries. The approved monthly dosage of erenumab (70 and/or 140 mg, depending on the country) is available as a single, prefilled autoinjector for subcutaneous administration in most countries where it is approved. This study evaluated the patient-reported ease-of-use, ability to learn self-injection, confidence in performing a simulated self-injection, and ergonomics of a prefilled autoinjector device for erenumab (SureClick ® autoinjector) in individuals in the US with migraine. Patients and Methods: Participants with migraine headaches, all of whom were naïve to the use of an autoinjector for migraine or another condition and CGRP therapy, were recruited from three US-based headache centers. Each participant received a supervised demonstration of the autoinjector during a 30-minute one-on-one session using a standard protocol-driven script. Participants then practiced a simulated injection into an artificial tissue pad using the autoinjector and were asked to rate their agreement with 19 statements about the device on a 5-point Likert scale (1 = completely disagree, 2 = somewhat disagree, 3 = neutral, 4 = somewhat agree, 5 = completely agree). Results: Participants who completed the study and provided responses (n = 204) were between 21 and 85 years of age, inclusive, and 73% were female. More than 90% of the participants completely or somewhat agreed with 16/19 statements relating to the device, including ease-of-use, ability to self-inject, and confidence in using the device, with an average rating of >4.5 on the 5-point Likert scale. Participants rated the size of the device and the compactness of the device as 4.23/5 and 4.26/5, respectively. Conclusion: The erenumab-prefilled disposable autoinjector was consistently highly rated across categories by individuals with migraine, with an average rating of >4.5 on the 5-point Likert scale; results were consistent across the three study centers.

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Prefilled syringes: An innovation in parenteral packaging

Cited by 74 publications

References 4 publications

Evaluation of a Novel Prefilled Syringe Concept for Ophthalmic Applications: A Formative Human Factors Study

Evaluation of a Novel Prefilled Syringe Concept for Ophthalmic Applications: A Formative Human Factors Study

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety

<p>Patient Reported Ease-of-Use with a Disposable Autoinjector in Individuals with Migraine</p>

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