The safety and tolerability profile of bilastine for chronic urticaria in children

Papadopoulos, Nikolaos G.; Zuberbier, Torsten

doi:10.1186/s13601-019-0294-3

Cited by 11 publications

(7 citation statements)

References 41 publications

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“…In line with the recent guideline recommendation for the use of second generation H1 antihistamines in children with chronic urticaria, bilastine was found to have a good safety and tolerability profile [ 57 ].…”

Section: Urticaria and Angioedemamentioning

confidence: 82%

Highlights and recent developments in allergic diseases in EAACI journals (2019)

Bousquet

Grattan

Akdiş³

et al. 2020

Clin Transl Allergy

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The European Academy of Allergy and Clinical Immunology (EAACI) owns three journals: Allergy, Pediatric Allergy and Immunology and Clinical and Translational Allergy. One of the major goals of EAACI is to support health promotion in which prevention of allergy and asthma plays a critical role and to disseminate the knowledge of allergy to all stakeholders including the EAACI junior members. There was substantial progress in 2019 in the identification of basic mechanisms of allergic and respiratory disease and the translation of these mechanisms into clinics. Better understanding of molecular and cellular mechanisms, efforts for the development of biomarkers for disease prediction, novel prevention and intervention studies, elucidation of mechanisms of multimorbidities, entrance of new drugs in the clinics as well as recently completed phase three clinical studies and publication of a large number of allergen immunotherapy studies and meta-analyses have been the highlights of the last year.

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Section: Urticaria and Angioedemamentioning

confidence: 82%

Highlights and recent developments in allergic diseases in EAACI journals (2019)

Bousquet

Grattan

Akdiş³

et al. 2020

Clin Transl Allergy

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“…Twenty Phase 1 studies performed in healthy volunteers [18,19], and ten Phase 2 and 3 studies conducted in patients, one including with a one year long-term extension phase, show that bilastine 20 mg has an excellent safety and tolerability profile, with most adverse events described as either mild or moderate and none found to be more frequent than in the placebo group [14,20,21,17,22,16]. The safety profile of bilastine in children, adolescents, and elderly patients has been shown to be similar to that in adults [23][24][25][26][27]. Likewise, post-J Investig Allergol Clin Immunol 2023; Vol.…”

Section: Introductionmentioning

confidence: 93%

Efficacy of Once-Daily Ophthalmic Bilastine for the Treatment of Allergic Conjunctivitis: A Dose-Finding Study

Gomes¹,

Ciolino²,

Arranz³

et al. 2023

J Investig Allergol Clin

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Background and objectives: Bilastine is a non-sedating second-generation antihistamine for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. This trial aimed to evaluate the optimal dose, efficacy, and safety of a newly developed once-daily preservative-free ophthalmic formulation of bilastine for allergic conjunctivitis. Methods: This phase 2, single-center, double-masked, randomized study evaluated the efficacy of 3 doses of a bilastine ophthalmic formulation (0.2%, 0.4%, and 0.6%) compared to vehicle for the treatment of allergic conjunctivitis. The primary efficacy endpoint was ocular itching reduction. The Ora-CAC® Conjunctival Allergen Challenge model was used to assess ocular and nasal symptoms at the onset of action (15 minutes), 8- and 16-hours post-treatment. Tolerance and safety were also evaluated. Results: A total of 121 adults with seasonal and/or perennial ocular allergy were randomized. Bilastine ophthalmic formulation 0.2%, 0.4% and 0.6% were significantly superior (p>0.001) to vehicle for the treatment of ocular itching at 3, 5 and 7 minutes post-challenge at onset of action (15 minutes) and 8 hours post-treatment. Bilastine 0.6% was also effective at 16 hours post-treatment. Treatment differences for bilastine 0.6% were statistically significant (p<0.001) compared to vehicle at all timepoints for tearing, eyelid swelling, and nasal symptoms. No relevant adverse events were observed. Conclusions: All the tested ophthalmic bilastine doses were efficacious in rapidly reducing ocular itching. The 0.6% formulation was effective up to 16 hours post-treatment, making it suitable for once-daily administration. The new formulation was safe and well tolerated.

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“…An advantage of this pharmaceutical formulation is related to the fact that no water intake is needed during administration [ 4 , 5 , 6 ]. In the past, the targeted populations for the OD formulations were pediatric and geriatric patients with Parkinson’s disease, schizophrenia, or gastroesophageal reflux, but recently, ODTs are used for a large category of patients due to their numerous advantages: do not necessitate chewing; disintegration takes place directly in the mouth; pleasant taste; increased stability compared to solutions, emulsions, and suspensions; can be manufactured as controlled released pharmaceutical formulations; high amounts of Active Pharmaceutical Ingredient (API) can be used; ability to confer the advantages of a liquid formulation in a solid form; the therapeutic effect occurs fast [ 7 , 8 , 9 , 10 , 11 ]. …”

Section: Introductionmentioning

confidence: 99%

“…10) of 3 min [1][2][3]. An advantage of this pharmaceutical formulation the therapeutic effect occurs fast [7][8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Development and Evaluation of Cannabidiol Orodispersible Tablets Using a 23-Factorial Design

et al. 2022

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Orodispersible tablets (ODTs) are pharmaceutical formulations used to obtain fast therapeutic effects, usually recommended for geriatric and pediatric patients due to their improved compliance, bioavailability, ease of administration, and good palatability. This study aimed to develop ODTs with cannabidiol (CBD) phytocannabinoid extracted from Cannabis sativa used in the treatment of Lennox–Gastaut and Dravet syndromes. The tablets were obtained using an eccentric tableting machine and 9 mm punches. To develop CBD ODTs, the following parameters were varied: the Poloxamer 407 concentration (0 and 10%), the type of co-processed excipient (Prosolv® ODT G2—PODTG2 and Prosolv® EasyTab sp—PETsp), and the type of superdisintegrant (Croscarmellose—CCS, and Soy Polysaccharides—Emcosoy®—EMCS), resulting in eleven formulations (O1–O11). The following dependent parameters were evaluated: friability, disintegration time, crushing strength, and the CBD dissolution at 1, 3, 5, 10, 15, and 30 min. The dependent parameters were verified according to European Pharmacopoeia (Ph. Eur.) requirements. All the tablets obtained were in accordance with quality requirements in terms of friability (less than 1%), and disintegration time (less than 180 s). The crushing strength was between 19 N and 80 N. Regarding the dissolution test, only four formulations exhibited an amount of CBD released higher than 80% at 30 min. Taking into consideration the results obtained and using the Modde 13.1 software, an optimal formulation was developed (O12), which respected the quality criteria chosen (friability 0.23%, crushing strength of 37 N, a disintegration time of 27 s, and the target amount of CBD released in 30 min of 99.3 ± 6%).

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The safety and tolerability profile of bilastine for chronic urticaria in children

Cited by 11 publications

References 41 publications

Highlights and recent developments in allergic diseases in EAACI journals (2019)

Highlights and recent developments in allergic diseases in EAACI journals (2019)

Efficacy of Once-Daily Ophthalmic Bilastine for the Treatment of Allergic Conjunctivitis: A Dose-Finding Study

Development and Evaluation of Cannabidiol Orodispersible Tablets Using a 23-Factorial Design

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