Expert opinion on drug delivery
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Expert Opin Drug Deliv · Nov 2020
ReviewEstradiol softgel inserts for the treatment of VVA symptoms: an expert opinion.
Vulvar and vaginal atrophy (VVA) affects up to two thirds of postmenopausal women, with symptoms of vaginal dryness, dyspareunia, and vulvar/vaginal irritation. Despite the availability of various treatments, women express dissatisfaction with their options. An estradiol (E2; 4-µg and 10-µg) softgel vaginal insert was approved by the Food and Drug Administration (FDA) to treat moderate to severe dyspareunia, a symptom of VVA, due to menopause. These inserts were designed to treat VVA effectively and safely while avoiding some of the drawbacks of other administration methods. ⋯ AE: adverse event; AUC: area under the concentration-time curve; BMI: body mass index; Cavg: average concentration; CI: confidence interval; Cmax: maximum concentration; Cmin: minimum concentration; E2: estradiol; FDA: Food and Drug Administration; FSFI: Female Sexual Function Index; GSM: genitourinary symptoms of menopause: MBS: most bothersome symptom; NAMS: North American Menopause Society; OR: odds ratio; PI: pulsatility index; PK: pharmacokinetic; REVIVE: Real Women's Views of treatment options for menopausal Vaginal changEs; RI: resistance index; ROC: receiver operating characteristic; TEAE: treatment-emergent adverse event; tmax: time to maximum concentration; VVA: vulvar and vaginal atrophy.
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Expert Opin Drug Deliv · Jul 2020
EditorialCan 3D printing of oral drugs help fight the current COVID-19 pandemic (and similar crisis in the future)?
The ongoing COVID-19 crisis has highlighted the importance of a robust drug supply chain which can be quickly and flexibly ramped up to produce life-saving drug treatments. 3D printing (3DP) of oral solid dosage forms (OSDF) could be a viable part of the emergency drug production response to support vulnerable patients in rural regions and other isolated locations. In the context of the current pandemic, the suitability of different 3DP technologies will depend on the physicochemical properties, unit dose strength and BCS classification of the repurposed drug compounds currently being trialed for COVID-19. Furthermore, the deployment strategy should focus on simplifying dosage forms and formulations, scaling down the size and complexity of the printing systems and real-time quality assurance via process analytical technologies (PAT).
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Expert Opin Drug Deliv · May 2020
Multicenter Study Observational StudyAn observational study demonstrating the adherence and ease of use of the injector device, RebiSmart®.
Background: Adherence to Multiple Sclerosis (MS) treatment is considered one of the crucial factors for ensuring optimal clinical outcomes. Research has shown that the use of self-injector devices improves patient compliance with treatment. Therefore, the main purpose of this study is to evaluate the ease of use of RebiSmart® 2.0 in clinically isolated syndrome/relapsing-remitting MS patients during 12 months treatment period. ⋯ Results: This study demonstrated a very high proportion (>95%) of patients with a positive rating of the overall ease of use and the overall convenience of RebiSmart®. The proportion of patients with a positive rating of the ease of use by individual domains and the functions of RebiSmart® were also high (>80%). Conclusion: The findings demonstrate a very good perception of the usability of the device by patients overall and in its individual functions.
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Expert Opin Drug Deliv · Feb 2020
Hold the device against the skin: the impact of injection duration on user's force for handheld autoinjectors.
Background: The recent development of high-volume subcutaneous drug delivery using handheld autoinjectors has resulted in longer injection durations. However, the usability of long injections has been neglected. This study aimed to investigate the effects of injection duration on users' ability to apply injections while holding the device against the skin at the injection site. ⋯ Initial empirical evidence was also determined on the negative association being more pronounced for users exerting lower force to hold the device against the skin. Conclusions: The results that are subject to future clinical validation suggest the feasibility of injections lasting up to approximately 30 s using handheld autoinjectors. The participants of the simulated use study successfully applied long-duration injections regardless of disease states, age, or visual and dexterity impairments.
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Expert Opin Drug Deliv · Aug 2019
ReviewIntrathecal drug delivery for pain management: recent advances and future developments.
Introduction: Chronic pain conditions of malignant and non-malignant etiology afflict a large group of the population and pose a vast economic burden on society. Intrathecal drug therapy is a viable treatment option in such patients who have failed conservative medical measures and less invasive pain management procedures. However, the clinical growth of intrathecal therapy in managing intractable chronic pain conditions continues to face many challenges and is likely underutilized secondary to its high-complexity and lack of understanding. ⋯ Expert opinion: IDDS offer an effective therapy for pain control in patients suffering from chronic intractable pain conditions. These devices provide a safer alternative to oral opioid medications with reduced systemic side effects. Adherence to best practices and continued clinical and basic science research is important to ensure continuing success of this therapy.