Azelastine HCl: A Review of the Old and New Formulations

Horbal, Jonathan M.; Bernstein, Jonathan A.

doi:10.4137/cmt.s3865

Cited by 6 publications

(12 citation statements)

References 36 publications

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“…It is common that line-extension drugs are introduced prior to the introduction of generics ( 9 ). For example, Azelastine (Astelin ® ) was reformulated 1.5 years prior to patent expiry ( 10 ). Company developing the new product versus the original company A product can be repositioned or reformulated by the company that owns the original product or by a different company.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“… Excipients change without impact on pharmacokinetic parameters In some cases, the reformulation concerns the modification of particular ingredients without modification of the product's pharmacokinetic profile, administration route, or the pharmaceutical form. This was the case of azelastine (Astelin ® ) when reformulated to Astepro ® ( 10 ). Change in the structure of the active substance In contrast to all the reformulation cases cited above, the structure of the active pharmaceutical ingredient (API) can be modified to form a new formulation.…”

Section: Resultsmentioning

confidence: 99%

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Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature

Murteira

Ghezaiel

Karray

et al. 2013

Journal of Market Access & Health Policy

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BackgroundMedicinal products that have been developed and approved for one disease may be the object of additional clinical development in other disease areas or of additional pharmaceutical development for new and different formulations. The newly developed products can be named as repositioned or reformulated products, respectively. Market access of repositioned or reformulated products in Europe and the United States is an interesting object of study as it may provide clarity about which parameters are assessed and considered to bring added value, other than the molecule itself. As such, we aim to evaluate if the added value of repositioned or reformulated medicinal products can be systematically described, quantified, and predicted. As a first step toward investigating the impact of market access on drug research and development trends for repositioned and reformulated products, it is necessary to have consistency in the designations for the case studies evaluated in this project. In an attempt to achieve that consistency, the current study aims to propose harmonized definitions for the repositioning and reformulation strategies and to propose a taxonomy for the medicinal products derived thereof.MethodsA systematic literature review was conducted to collect information on existing cases of repositioning or reformulation. A search strategy was developed by defining the search objectives, targeted data sources, search keywords, and inclusion/exclusion criteria for the retrieved documents.ResultsA total of 505 publications were retrieved through a search of the main data sources. The screenings and the ad hoc search led to a total of 56 publications to be used for the case study data extraction. In total, 87 repositioning and/or reformulation cases were found described in the literature, 23 of which presented different definitions and/or classifications by different authors.ConclusionGiven the disparity and inconsistency of terminologies and classifications in the literature, a harmonized nomenclature for drug repositioning, reformulation, and combination cases will allow for a robust analysis of the added value and market access conditions attributed for each strategy and case type as assessed by regulators and payors in Europe and the United States. After evaluation of the existing terminologies and given the absence of clear and consistent definitions for drug reformulation and repositioning in the literature, we propose a global terminology and taxonomy in order to cover all of the previously unclear definitions and classifications for repositioned and reformulated products.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature

Murteira

Ghezaiel

Karray

et al. 2013

Journal of Market Access & Health Policy

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“…It is an intranasal antihistamine indicated for use in patients with seasonal allergic rhinitis (SAR) and non-allergic vasomotor rhinitis (VMR). It is also used topically in the symptomatic relief of allergic conditions including rhinitis and conjunctivitis [2,3]. Emedastine difumarate, is 1H-benzimidazole, 1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1H-1, 4-diazepin-1-yl), (E)-2-butenedioate (1:2) [4].…”

Section: Azelastine-hcl Is 4-(4-chlorobenzyl)-2-[(4rs)-1-methylhexahmentioning

confidence: 99%

“…Purity determination is officially listed in Merk index [25]. The effect of impurities on T o azelastine hydrochloride and emedastine difumarate was determined by DSC method based on Van't Hoff equation (3).…”

Section: Application Of Differential Scanning Calorimetry For Purity mentioning

confidence: 99%

Thermoanalytical Study and Purity Determination of Azelastine Hydrochloride and Emedastine Difumarate

Razeq¹

2012

Pharm Anal Acta

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The thermal behavior of antihistaminic drugs, azelastine hydrochloride, and emedastine difumarate in their drug substances were investigated using different thermal techniques. The thermogravimetry was used to study the thermal degradation and kinetic parameters; activation energy (E a ), frequency factor (A), and reaction order (n) of both drugs. The data revealed that the cited drugs followed first order kinetic behavior. The fragmentation pathway of azelastine hydrochloride with mass spectrometry was taken as example; to correlate the thermal decomposition with the resulted MS-EI. The melting point and purity were determined using DSC and Van't Hoff equation for the studied drugs. The results were in agreement with the recommended pharmacopoeias.

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The Nose as a Route for Therapy: Part 1. Pharmacotherapy

et al. 2021

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This article reviews nasal structure and function in the light of intranasal pharmacotherapy. The nose provides an accessible, fast route for local treatment of nose and sinus diseases, with lower doses than are necessary systemically and few adverse effects. It can also be used for other medications as it has sufficient surface area protected from local damage by mucociliary clearance, absence of digestive enzymes, responsive blood flow, and provides a rapid route to the central nervous system.

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Azelastine HCl: A Review of the Old and New Formulations

Cited by 6 publications

References 36 publications

Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature

Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature

Thermoanalytical Study and Purity Determination of Azelastine Hydrochloride and Emedastine Difumarate

The Nose as a Route for Therapy: Part 1. Pharmacotherapy

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